Icon Group Annual Research Report 2021

ICON ANNUAL RESEARCH REPORT 2021

ICON ANNUAL RESEARCH REPORT 2021

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ICON ANNUAL RESEARCH REPORT 2021

ICON GROUP CHIEF EXECUTIVE OFFICER

FOREWORD

“We are fortunate to have an international network of oncologists and haematologists passionate about clinical research and who advocate for trials as part of the patient journey.”

Despite an ongoing pandemic and unexpected disruptions, there has been much to celebrate across Icon Group in 2021. We expanded our cancer care offering with the opening of four new centres in Australia and one in China. We welcomed new hospital pharmacy locations across Australia’s eastern seaboard and announced the extension of our leading compounding service into New Zealand.

Icon Group proudly delivers an innovative full cancer care continuum on an international scale and research has and will always remain a cornerstone of delivering this exceptional cancer care. Our extensive clinical trials and research portfolio remains unparalleled within the private sector and continues to grow from strength to strength. Under the leadership of our Director of Research, John Bashford and our Group Executive Manager of Research, Sophie Mepham PhD, the past year has been one of great transformation.

Personally, I am most proud to see the expansion of clinical trials in Singapore and Hong Kong, which in its infancy has already been making a difference to patients in the region. The success of entering new markets is yet another example of how Icon is utilising our well-established centralised operations and remote clinical functions to remove healthcare barriers, increase partnerships and ultimately deliver more care to where it is needed.

We are fortunate to have an international network of oncologists and haematologists passionate about clinical research and who advocate for trials as part of the patient journey. They, and our research team, are leading the charge in introducing new trials across all disciplines and are also developing unique technical research that can help change the future of cancer care.

With a focus on innovation, quality and, most importantly, increased access to clinical trials, the future is looking bright for research at Icon. Clinical trials form the building blocks to groundbreaking discoveries and bring new possibilities and hope for patients now and in the future. The constant uncertainties of the past 20 months have been undoubtedly difficult, but the resilience of the Icon team and the bravery of our patients has provided endless inspiration. We have come out of this even stronger and will continue to play an essential role in reducing the global cancer burden.

MARK MIDDLETON Icon Group Chief Executive Officer Connect on LinkedIn

ICON ANNUAL RESEARCH REPORT 2021

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ICON ANNUAL RESEARCH REPORT 2021

“In 2021 we have doubled our Principal Investigators and strengthened our ability to care for more people. I see a bright future for clinical trials of innovative therapies in medical oncology, haematology and radiation medicine.”

2021 has been a great year of both progress and consolidation for Icon Group’s research division.

The Group’s Executive Manager of Research, Sophie Mepham PhD has defined a transformed strategic plan and implemented operational efficiencies and sector-leading quality systems to allow Icon to deliver an innovative international trials portfolio.

The acquisition of Adelaide’s Ashford Cancer Centre Research (ACCR) in 2020 has brought newfound opportunities for the Group. ACCR’s longstanding industry reputation has added to our extensive clinical experience, expanded our Phase I capabilities, and increased our research capacity by over 50%. It has also brought fresh intellectual vigour and capacity to the benefit of the whole portfolio.

Similarly, Icon’s Singapore doctors have come together to invigorate and grow an impressive clinical trials portfolio, including a paediatric oncology trial. With these expansions we have doubled our Principal Investigators and strengthened our ability to care for more people in more centres. As we look to the year ahead, I see a bright future for clinical trials of innovative therapies in medical oncology, haematology and radiation medicine in Asia.

The year also saw a redefined direction of Icon Cancer Foundation, which operates as an independent registered charity with a mission to promote, initiate and support clinical trials and research, striving towards a brighter future for cancer patients and communities. The Foundation now acts as sponsor for Icon’s Investigator Initiated Trials and will support increased access to clinical trials across Australia. My special thanks to the Foundation’s supporters, whose generous donations allow us to make a lasting difference to cancer care.

I would like to acknowledge our entire research team at Icon who work tirelessly to care for our patients and their families. Their dedication and expertise are essential to the wellbeing of the patients in our care and to the translation of clinical trials into results that benefit the entire cancer care community.

Finally, my most important acknowledgement must be to clinical trial patients everywhere. Without the bravery and commitment of patients and their loved ones we cannot advance cancer treatments; they are our leaders and have the gratitude and admiration of the entire Icon community.

DR JOHN BASHFORD FRACP, FRCPA, MAICD

Director of Research

ICON ANNUAL RESEARCH REPORT 2021

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ICON ANNUAL RESEARCH REPORT 2021

EXECUTIVE MANAGER OF RESEARCH

FOREWORD

“Throughout 2021 and beyond, the team has continued to seize opportunities and offer more clinical trials to patients as close to home as possible.”

The last 12 months have been one of growth and new opportunities as we expand our clinical trials and research program. We have seen our portfolio grow with the introduction of research at Icon Cancer Centre in Hobart and the beginnings of a robust trials offering overseas in Singapore and Hong Kong.

Throughout 2021 and beyond, the team has continued to seize opportunities and offer more clinical trials to patients as close to home as possible.

We move forward in our IT research capabilities with the implementation of our new Clinical Trial Management System, RealTime. This new and enhanced IT system will be implemented across our research operations globally and will streamline trial feasibility, study start-up and trial operations.

It will also allow us to accurately capture trial timelines to effectively deliver our large trials portfolio and meet the ambitious growth ahead.

The research team also welcomed a redesign of our Study Start Up and Governance team and the newly created position of Global Study Start Up and Research Governance, providing the foundations for our unified global trials program.

We have also seen substantial growth in our Investigator Initiated Trials team where we have fostered new partnerships and new opportunities in developing Icon-sponsored clinical trials. In line with the growth of our unique Investigator Initiated Trials program, we are greatly anticipating the introduction of our own in-house skin cancer research program in FY23 led by some of the nation’s most experienced oncologists.

I would like to thank the entire research team for their dedication and congrate them for the many wins achieved in another year of unprecedented obstacles, where we continue to be impacted by COVID-19 and the floods experienced across Queensland and New South Wales. I look forward to more successes in 2022, which will no doubt see more growth and far-reaching opportunities for the benefit of cancer patients and their families.

SOPHIE MEPHAM PHD Executive Manager of Research Connect on LinkedIn

ICON ANNUAL RESEARCH REPORT 2021

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CONTENTS

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Our mission

10

Our global impact

12

2021 year in review

14

Impact - research in 2021

16

2021 highlights

18

Driving forward haematology research

20

New resources for breast cancer trials

24

Leading national Phase I program

26

Launching clinical trials in Hobart

30

A focus on investigator initiated trials

32

Tomorrow’s treatments today - John’s story

34

Research operations and evolution

36

Introducing trials in Singapore and Hong Kong

38

Governance and quality

40

Compounding and pharmacy capabilities

42

Future direction

44

With thanks

50

Appendices

52

Research partners

54

Principal investigators

56

2021 publications

61

Clinical trials registry

68

ICON ANNUAL RESEARCH REPORT 2021

“ I HAD THE CONFIDENCE IT WAS GOING TO BE ALRIGHT.” My doctor told me I was a good candidate for a new radiation treatment called focal brachytherapy as part of a clinical registry he was leading. I have a very close friend with advanced prostate cancer who has had fairly severe side effects from his treatment, both psychologically and physically. If focal brachytherapy wasn’t available to me, I would have said no to treatment rather than potentially facing those long-term side effects. Receiving this type of treatment felt like the right option for me personally … I was relieved and happy as I had the confidence it was going to be alright.

- NEVILLE BURGE, PATIENT

READ NEVILLE’S STORY HERE ICON ANNUAL RESEARCH REPORT 2021

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OUR MISSION Icon Group’s mission is to deliver the best care possible, to as many people as possible, as close to home as possible. Through a comprehensive end-to-end model, Icon provides the full spectrum of cancer care including haematology, medical oncology, radiation oncology, chemotherapy compounding, pharmacy management and clinical research.

Across the international network Icon saw over 2.5 million patient interactions in 2021 and is on target to move to four million annually by 2023. Icon Group is essential to the healthcare ecosystem and continues to innovate the way cancer care is delivered for the benefit of communities globally.

“ ICON GROUP IS ESSENTIAL TO THE HEALTHCARE ECOSYSTEM.” 10

ICON ANNUAL RESEARCH REPORT 2021

OUR VISION FOR RESEARCH With over 35 years’ experience, research

emerging treatments. This commitment

is part of Icon’s DNA. Icon’s international

is backed by international industry

network of clinicians believe clinical trials

partnerships, investment in dedicated

are critical to the provision of exceptional

research teams and clinical leadership

cancer care and continue to confidently

from highly respected researchers and

lead the way in operating Australia’s

specialists. Research at Icon aims to

largest private cancer clinical trials

provide more patients with opportunities

program.

previously not available to them by

Icon has a long-term commitment to increasing access to clinical trials and

bringing tomorrow’s treatments closer to today.

ICON ANNUAL RESEARCH REPORT 2021

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OUR GLOBAL IMPACT

Over 2.5 milli

MAINLAND CHINA

N loca

AUSTRALIA cancer centres pharmacies • 3 TGA compounding facilities • 1 drug stability testing and research laboratory • S everal cancer centres opening in 2022

HONG

• 3 4 • 7 3

NEW ZEALAND

VIETNAM

Integrated cancer centre opening 2022 SINGAPORE

•1

cancer centre •1 TGA compounding facility opening soon

SINGAPORE •6

cancer centres •1 health screening clinic •2 ASEAN outreach clinics •1 integrated cancer centre opening in 2022

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active trials

HONG KONG •2

•2

cancer centres specialist centres

MAINLAND CHINA

New research location

•5

Phase 1 research

cancer centres

VIETNAM •1

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oncology department management agreement

ICON ANNUAL RESEARCH REPORT 2021

Medical oncology resear

Radiation oncology rese Haematology research

Phase 1

Medical Oncology

Radiation Oncology

Haematology

Phase 1

Medical Oncology

Radiation Oncology

Haematology

ion patient interactions annually

RESEARCH LOCATIONS Adelaide (Tennyson), SA Auchenflower (Wesley), QLD Chermside, QLD East Melbourne (Freemasons), VIC Gold Coast Private, QLD

New research ation in 2022

Gold Coast University, QLD

G KONG

Hobart, TAS Moreland, VIC

300+ active

Mulgrave, VIC North Lakes, QLD

trials

Richmond, VIC Singapore

Compounding facility opening 2022

South Brisbane, QLD Southport, QLD Toowoomba, QLD Windsor Gardens, SA

AUSTRALIA

NEW RESEARCH LOCATIONS IN 2022 Cairns, QLD Canberra, ACT Greenslopes, QLD

rch

Hong Kong

earch

New drug stability and research lab

Townsville, QLD Wellington, NZ

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2021 YEAR IN REVIEW ACTIVE TRIALS

NEW TRIALS

300+ 35

500+ COMPOUNDING AND PHARMACY active trials

=10

512 105

PATIENTS ACTIVE ON CLINICAL TRIALS

278

patients recruited to Phase I clinical trials

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including trials external to Icon Group

patients recruited

44

35

142

trials or research projects in development or undergoing feasibility during 2021

new trials or research projects selected for participation and undergoing start-up

clinical trials open to recruitment in 2021

ICON ANNUAL RESEARCH REPORT 2021

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sites delivering research

79 articles published

68

active Principal Investigators

106% INCREASE FROM 2020 68 2021 33 2020

TUMOUR

IN 2021

TOP STREAMS

RECRUITING • Prostate cancer • Breast cancer • Renal cell cancer

ICON ANNUAL RESEARCH REPORT 2021

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ACCRUAL BY TRIAL PHASE

PHASE I

PHASE III

PHASE II

PHASE IV

OTHER

IMPACT RESEARCH IN 2021

ACCRUAL BY TRIAL SPONSOR

PHARMACEUTICAL COLLABORATIVE

ICON INVESTIGATOR INITIATED TRIALS

278

Total clinical accrual ACCRUAL BY SPECIALTY

23.16 Total clinical accrual monthly mean

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ICON ANNUAL RESEARCH REPORT 2021

MEDICAL ONCOLOGY HAEMATOLOGY

RADIATION ONCOLOGY

RESEARCH ACCRUAL BY PHASE OF TRIAL - JAN TO DEC 2021 30 30 25 30 25 20 25 20 15 20 15 10 15 10 5 10 5 0 5 0

JAN

FEB

MARCH

APRIL

MAY

JUNE

JULY

AUG

SEP

OCT

NOV

DEC

JAN

FEB

MARCH

APRIL

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JUNE

JULY

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SEP

OCT

NOV

DEC

RESEARCH ACCRUAL OF TRIAL - AUG JAN TO 2021NOV JAN FEB MARCH BY APRILSPONSOR MAY JUNE JULY SEPDECOCT

DEC

0

30 30 25 30 25 20 25 20 15 20 15 10 15 10 5 10 5 0 5 0 0

JAN

FEB

MARCH

APRIL

MAY

JUNE

JULY

AUG

SEP

OCT

NOV

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MARCH

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OCT

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MARCH

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JUNE

JULY

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SEP

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30 RESEARCH ACCRUAL BY PHASE OF SPECIALTY - JAN TO DEC 2021 30 25 30 25 20 25 20 15 20 15 10 15 10 5 10 5 0 5 0 0

ICON ANNUAL RESEARCH REPORT 2021

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2021 HIGHLIGHTS 18

ICON ANNUAL RESEARCH REPORT 2021

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DRIVING FORWARD

HAEMATOLOGY RESEARCH 2021 saw the renewed focus on expanding Icon’s haematology clinical trials program with the appointment of a dedicated Research Portfolio Lead, Yvette James. Yvette brings in-depth experience in oncology and haematology nursing as well as knowledge of trial management. With a dedicated resource working with the Haematology Research Clinical Lead, Dr Jason Butler, and alongside a recently established Haematology Research Committee, the haematology portfolio continues to mature.

Future focus will see the strengthening of current and new commercial and non-commercial sponsors, including our ongoing relationship with the Australasian Leukaemia and Lymphoma Group (ALLG). A renewed focus on internal promotion of Icon’s haematology expertise will also contribute to increased opportunities for research and registry involvement across Australia and beyond.

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ICON ANNUAL RESEARCH REPORT 2021

DR JASON BUTLER

YVETTE JAMES

MBBS, M.MED Sci (CLIN EPID), FRACP, FRCPA

Haematologist, Chair of Icon Haematology Research Committee

Research Portfolio Lead Haematology

Dr Butler has almost 20 years’ experience in the

Yvette holds a Masters of Advanced Practice Nursing

treatment and management of haematological

with a Grad Certificate in Oncology Nursing. With over 23

disorders. He completed a fellowship at the Bone

years’ clinical nurse experience and 18 years specialising

Marrow Transplant Unit, Royal Brisbane and Women’s

in oncology and haematology practice, Yvette holds

Hospital and has held a research posting at the

long-term industry relationships and extensive

Queensland Institute of Medical Research investigating

understanding of haematological trial management.

the role of bcl-2 in primary resistance in chronic myeloid leukaemia. Dr Butler holds memberships with

Connect on LinkedIn

leading haematology groups and sits on the board of Lymphoma Australia as Vice Chair and Director.

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HIGHLIGHTS Expansion of the Phase I Haematology Clinical Trials program

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Completion of a retrospective, observational study

at Icon Cancer Centre located

Enrolment of first patient to PHAROS PHI001 Phase I Relapsed / Refractory AML trial

at Wesley Hospital, Queensland,

Principal Investigator: Dr Joseph

Transplantation (ASCT) at Icon

Australia. Led by dedicated

Clarey. Co-Investigators: Dr

between 1996-2018. This paper was

and highly experienced

Raymond Banh, Dr Robert

presented at Blood 2021 Annual

Haematologists, Dr Robert

Hensen, A/Prof James Morton

Scientific Meeting and is awaiting

Hensen and Dr Joseph Clarey.

AM. For a full list of haematology

acceptance of publication by the

trials see Appendix here.

Internal Medicine Journal (IMJ).

ICON ANNUAL RESEARCH REPORT 2021

of all adults who underwent Autologous Stem Cell

OVERVIEW OF ASCT TRIAL FINDINGS • T his research was undertaken by Icon Haematology

- Transplant outcomes were benchmarked against

Fellow, Dr Karthik Nath, acknowledging the essential

the Australasian Bone Marrow Transplant Recipient

contribution of the late Noor Parker, Laboratory

Registry (ABMTRR), which collects data on

Director 1996 – 2020, and the support of the Wesley

haematopoietic stem cell transplantation through

Medical Research Clinical Research Grant 2020

transplant centres in Australasia. Icon’s ten-year OS

• Icon is the largest ASCT contributor in Queensland treating 40% of all South-East Queensland patients with excellent overall survival (OS) and Transplant Related Mortality (TRM), demonstrating the critical role of the private sector in the administration of this highly complex, specialised therapy • T he study explored the contribution and outcomes of patients undergoing ASCT within the private sector over a 23-year period: - T he Icon ASCT program is inclusive of patients aged

compared favourably against the ABMTRR over the same period for all disease subtypes: + Multiple Myeloma: 59% vs 36% + Diffuse Large B-Cell Lymphoma: 68% vs 46% + Follicular Lymphoma: 76% vs 53% + Mantle Cell Lymphoma: 62% vs 48% + NK Cell Lymphoma: 55% vs 40% The outcome of this review provides support for the administration of more novel forms of cellular

≥70 years, which has important implications for

immunotherapy for haematologic malignancies in the

transplant accessibility. In Australia, age limitations

private sector, including that of the rapidly expanding

are applied by some institutions in determining

field of chimeric antigen receptor (CAR) T-cell therapy.

eligibility for ASCT - In the last five years, 21% of Icon’s patients were ≥70 years, compared to 5% across Australasia. Low and acceptable TRM rates were demonstrated within this patient cohort

ICON ANNUAL RESEARCH REPORT 2021

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NEW RESOURCES FOR

BREAST CANCER TRIALS

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ICON ANNUAL RESEARCH REPORT

Medical Oncologist, A/Prof Nicole McCarthy continues to lead the way in breast cancer clinical trials. Helmed by A/Prof McCarthy the research team at Icon Cancer Centre within Wesley Hospital, Queensland is focused on driving a greater depth of trials for breast cancer patients. The upcoming introduction of a brand-new lead breast cancer Clinical Research Coordinator (CRC) will see the streamlining of the breast cancer research portfolio and a focus on patient recruitment and retention. The role will also enable greater promotion of Icon’s research capabilities to the local community, patients and industry sponsors.

HIGHLIGHTS In 2021, Icon Cancer Centre continued its tradition of involvement in a mixed portfolio of breast cancer research across multiple Icon Cancer Centre locations and both medical oncology and radiation oncology. The Icon Cancer Centre sites involved in breast cancer trials are: + Adelaide (Tennyson), SA + Gold Coast University Hospital, QLD + Hobart, TAS + Richmond, VIC + South Brisbane, QLD + Toowoomba, QLD + Wesley, QLD + Singapore In 2021, Icon had 19 breast cancer clinical trials recruiting patients and 22 breast cancer trials with

A/PROF NICOLE McCARTHY MBBS (Hons), MHSc, FRACP

Medical Oncologist A/Prof McCarthy has over 24 years of clinical experience, specialising in the treatment, management and research of breast cancers. She is the Chair of the

patients on active treatment or follow-up. The ratio of new breast cancer trials activated in 2021 compared to all indications was higher, with six new breast cancer clinical trials initiated and activated of the total 53 trials commenced in 2021. Accrual to breast cancer trials of patients with breast cancer was significant and contributed to 9% of Icon’s total clinical trial recruitment.

Breast Cancer Trials Medical Oncology Craft Group and

Significantly, four breast cancer patients were recruited

member of their Scientific Advisory Committee. She has

to Phase I clinical trials, reinforcing the vital role early

been a recipient of the Breast Cancer Research Trust

phase trials play in offering treatment opportunities for

Fellowship Grant and sits on breast cancer consumer

patients who have rare diagnoses or have exhausted

groups including the Kim Walter’s Choice Program and

other standard or investigational therapeutic options.

Breast Cancer Network of Australia.

ICON ANNUAL RESEARCH REPORT 2021

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LEADING NATIONAL PHASE I PROGRAM Icon operates Australia’s largest private Phase I clinical trials program, which saw 52% growth with the addition of Ashford Cancer Centre Research (ACCR) based at the Tennyson Centre in Adelaide, South Australia.

Icon’s Phase I trials are led by internationally recognised clinicians, A/Prof Jim Coward (South Brisbane, Qld) and Dr Gonzalo Tapia Rico ( Adelaide (Tennyson) and Windsor Gardens, SA) who treat a broad range of solid tumour malignancies and continue to amplify our impact and operate unparalleled, stable and growing private Phase I units.

The group continues to expand the Phase I portfolio, contributing 38% of the annual accrual across participating early phase locations at Queensland sites - South Brisbane, Southport, Wesley, Chermside and South Australia’s centres at Adelaide (Tennyson) and Windsor Gardens. This portfolio continues to thrive, with Icon’s ongoing relationships with sponsors including, but not limited to; AbbVie, Akesobio, Atridia, BeiGene and CStone. Notably 35 participants, one third of the annual accrual to Phase I trials, were from five Akesobio trials conducted across both the Icon Cancer Centre Adelaide (Tennyson) and Icon Cancer Centre South Brisbane clinics.

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ICON ANNUAL RESEARCH REPORT 2021

A/PROF JIM COWARD

DR GONZALO TAPIA RICO

BSc (Hons), MBBS, PhD, MRCP (UK), FRACP

MBBS, PhD, FRACP

Medical Oncologist, Icon Phase I Lead, Chair of Medical Oncology Research Committee

Medical Oncologist, Phase I Clinician – South Australia

With more than 20 years of clinical oncology experience,

and research in both his private practice and roles as

A/Prof Coward is heavily invested in providing cutting-

Clinical Senior Lecturer at the University of Adelaide

edge medicines through a growing Phase I portfolio.

and Clinical Director of Education at Icon Cancer Centre

In 2006, he was appointed as an MRC clinical fellow

Adelaide. He received his PhD in 2013 for research

at Barts Cancer Institute, London, where his research

exploring alternative classifications of molecular

on the effects of immunotherapy in advanced ovarian

subtypes in breast cancer. He holds several affiliations

cancer successfully translated to a clinical trial in

and memberships, including with the Australasian

patients with platinum resistant disease. A/Prof Coward

Gastro-Intestinal Trials Group (AGITG), European Society

was recently appointed as a member of the IQVIA

of Medical Oncology (ESMO) and Spanish Group of Breast

advisory board committee.

Cancer Research (GEICAM).

Dr Tapia Rico maintains a strong interest in clinical trials

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HIGHLIGHTS AT SOUTH BRISBANE • Plenary for Phase I Cantrixil (TRX-E-002-01) study: Principal Investigator, A/Prof Jim Coward - P ublished in Cancers and presented at the American Association for Cancer Research (AACR) conference, the study was found to prolong survival in advanced ovarian cancer by inducing ovarian cancer stem cells’ death and making the cells more sensitive to standard chemotherapy - A /Prof Coward to lead follow-up Phase II trial which aims to identify biomarkers on hidden stem cells and advance the development of new therapies targeting cancer stem cells treatments • O pen for recruitment Phase I trial - AK105-101: A Phase IA/IB Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK105 in Subjects With Advanced Solid Tumors. Principal Investigator: A/Prof Jim Coward

The Icon Cancer Centre sites involved in Phase I trials are Icon Cancer Centre Adelaide (Tennyson), Icon Cancer Centre South Brisbane and Icon Cancer Centre Windsor Gardens with the breakdown as follows: + Icon Cancer Centre Adelaide (Tennyson) — 44 42% + Icon Cancer Centre South Brisbane — 37 35% + Icon Cancer Centre Windsor Gardens — 15 14% + Icon Cancer Centre Southport — 6 5% + Icon Cancer Centre Wesley — 2 2% + Icon Cancer Centre Chermside — 1 1% • South Brisbane Clinical Research Coordinator Team Lead, Stephanie Airey was a finalist in Icon Group’s Annual Awards. Nominated by her peers, this prestigious recognition highlights Stephanie’s significant contribution to Icon’s Phase I program and the success of the group’s research capabilities, including guidance through the 2021 TGA Good Clinical Practice (GCP) inspection.

• In 2021, Icon recruited 105 participants to Phase I clinical trials, contributing 38% of the annual clinical trials accrual across early phase trial locations.

“ S urvival outcomes in ovarian cancer are poor, and sadly most patients with ovarian cancer will die with chemotherapy resistant disease.

Recent evidence suggests this may reflect the existence of ovarian cancer stem cells that remain dormant and resistant to existing treatment like chemotherapy. Our research has been investigating these stem cells and targeting these could provide the majority of women who are living with ovarian cancer hope of long-term survival.”

A/PROF JIM COWARD BSc (Hons), MBBS, PhD, MRCP (UK), FRACP

Medical Oncologist

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ICON ANNUAL RESEARCH REPORT 2021

HIGHLIGHTS AT ADELAIDE South Australia’s Phase I unit is supported by a full-

• Recruited 112 trial participants and identified 214

service research program offering trials across Phase

patients as potential trial participants across Icon

I – IV and operated by a dedicated research team, led

Adelaide centres

by Adelaide Director of Research, A/Prof Dusan Kotasek and Clinical Research Business Manager, Sue Yeend.

Adelaide added 20 new studies to Icon’s trial portfolio focusing on a wide range of cancer indications to improve access to emerging treatments.

• Early 2021 saw the opening of the fully equipped research unit at Icon Cancer Centre Windsor Gardens, with the first trial patient recruited at the centre in February • Opened seven new trials at Windsor Gardens, with 16%

• I con Cancer Centre Adelaide (Tennyson) was the first in the world to dose a patient on theFIH AK127-101 study: A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours • Opened the EARLI-001 diagnostic study involving a radically new technique, forcing cancer cells to produce synthetic biomarkers not found in the human body, which are then highly detectable and localisable in a PET scanner.

of Icon Adelaide patients recruited at Windsor Gardens

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ICON ANNUAL RESEARCH REPORT 2021

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LAUNCHING

CLINICAL TRIALS IN HOBART July 2021 saw the introduction of a clinical trials program at Icon Cancer Centre Hobart, the first private oncology clinical trials unit in Tasmania.

In its infancy, the trials program at Hobart, delivered by an experienced clinical research coordinator and seven investigators, has forged important partnerships with key industry and collaborative group sponsors and has opened several trials across a broad portfolio including breast, skin, urothelial, prostate, lung, colorectal and upper GI clinical trials. Medical Oncologist, A/Prof Louise Nott has been instrumental in the establishment of the research portfolio, and it is thanks to this strong leadership that Hobart has been the site selected for 20 studies during 2021, five of which were activated within the year and the remainder due in the first quarter of 2022.

This addition to the Tasmanian cancer care landscape will improve access to cancer care and further eliminate the need to travel interstate to access clinical trial opportunities.

A/PROF LOUISE NOTT BMedSci, MBBS(Hons), FRACP

Medical Oncologist A/Prof Nott is widely published and has acted as a Principal Investigator / Sub Investigator on over 50 oncology clinical trials across industry, collaborative and academic sectors. She holds an Honorary Associate position at Sydney Medical School and is a University Associate with the Menzies Research Institute in Tasmania.

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ICON ANNUAL RESEARCH REPORT 2021

HIGHLIGHTS • Second highest recruiting centre across Australia for the CANVACCS study - a survey examining patient perspectives on COVID-19 vaccination during the 2021 vaccine rollout, with 280 Hobart patients participating.

Future publications co-authored by A/Prof Nott on vaccine hesitancy amongst Australian patients with breast cancer are planned for 2022 • 2021 saw the first patient recruitment to the lidERA clinical trial, which aims to evaluate the efficacy and safety of giredestrant compared with standard adjuvant endocrine monotherapy in patients with estrogen receptor positive, HER2-negative early breast cancer.

TRIALS ACTIVATED IN 2021 ANZUP 1907 / RetroPSMA

MASC 03.18 / I-MAT

A retrospective study to identify clinical predictors of

A randomised placebo-controlled phase II trial of

early metastatic disease using PSMA PET imaging

adjuvant avelumab in early-stage Merkel cell carcinoma

CANVACCS

ORBIT-M

CANcer patients’ perspectives on corona virus

Optimal Response Biome for ImmunoTherapy

VACCination Survey

in Melanoma

GO42784 / TRIO045 / liDERA A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

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A FOCUS ON

INVESTIGATOR INITIATED TRIALS In March 2021 a dedicated Investigator Initiated Trials (IIT) team was formed to manage Icon’s growing global IIT portfolio. The appointment of an Investigator Initiated Trials and Grants Manager, Mel Grand, and a dedicated IIT Project Manager, Lloyd Smyth, has reinvigorated the focus of IITs across Icon, aligned processes and supported the establishment of a Group framework to deliver a quality international IIT program.

MEL GRAND

LLOYD SMYTH

Investigator Initiated Trials and Grants Manager

Investigator Initiated Trials Project Manager

Mel has over 20 years’ experience in the oncology

Lloyd is a qualified radiation therapist who brings

sector, having worked as a radiation therapist, project

experience in both academic and clinical research to the IIT

manager and clinical trials manager. She brings an

program. He has a strong interest in the use of innovative

extensive depth of clinical knowledge combined with

techniques to treat cancer, having previously completed

high level project management, including large trial

his PhD in the discipline of radiation biology through work

portfolios and the management of government grants,

at the Australian Synchrotron. Lloyd’s publication record

as well as a strong focus on quality and research

spans clinical and translational domains, and he brings

ethics and education.

skills in data and project management to support the development of the IIT portfolio.

Connect on LinkedIn Connect on LinkedIn

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ICON ANNUAL RESEARCH REPORT 2021

HIGHLIGHTS • Developed and implemented a new Icon IIT Framework, alongside a suite of resources including policies, procedures, and study management tools to continue to improve the quality of IITs • Streamlined the use of REDCap as the IIT study base and implemented RealTime Software Solutions to effectively track all trial activities and reporting, aligning the IIT portfolio with the global clinical trials program • Established the Icon Quality and Sponsor Oversight Committee (QSOC), providing quality oversight of the IIT program from a sponsor perspective • Initiated 16 new potential IITs and 67 patients recruited to Icon IITs

• Publications in 2021 include milestone prostate cancer trials focusing on the use of focal brachytherapy and PET screening: - Anderson E, Smyth LML, O’Sullivan R, Ryan A, Lawrentschuk N, Grummet J, See AW, et al. Focal low dose-rate brachytherapy for low to intermediate risk prostate cancer: preliminary experience at an Australian institution. Transl Androl Urol. 2021 Sep;10(9):3591–603.

- B owden P, See AW, So K, Lawrentschuk N, Moon D, Murphy DG, et al. 68Ga-PSMA-PET screening and transponder-guided salvage radiotherapy to the prostate bed alone for biochemical recurrence following prostatectomy: interim outcomes of a phase II trial. World J Urol. 2021 Nov 1;39(11):4117–25.

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TOMORROW’S TREATMENTS TODAY JOHN’S STORY Clinical trials are at the heart of all medical advances. For many patients they can offer new hope and opportunities when they have exhausted all current lines of treatments.

PINPOINT is an Icon Investigator Initiated Trial and was a first-of-its-kind study. The Phase II study found that patients can choose an upfront treatment which can lead to cancer control, without the side effects of hormone therapy and more aggressive forms of radiation therapy treatment. The study showed that by targeting radiation at the prostate bed alone, quality of life is preserved for at least three years following treatment.

Principal Investigator: Dr Pat Bowden, MBBS, FRANZCR, Radiation Oncologist

“ THIS TREATMENT HAS HELPED ME GET MY LIFE BACK.” 34

ICON ANNUAL RESEARCH REPORT 2021

HOW PINPOINT RADIATION TREATMENT GAVE JOHN THE STRENGTH TO CARRY ON Like many men, 64-year-old Armadale local John Healy’s

“I’m so thankful that I was able to receive this targeted,

prostate cancer diagnosis came following a commitment

non-invasive treatment through a trial. The thought of

to annual PSA testing. Going in to see his GP each year

dealing with the difficult side effects of other aggressive

had become second nature to John after eight years of

treatment options while already dealing with issues

regular blood tests, when an elevated PSA result in 2016

from my surgery meant there was no other alternative

sparked the shock discovery.

to consider.”

The news that he had prostate cancer was

The PINPOINT study is the first-of-its-kind to show

crushing for John, who had just lost his wife six

that patients can choose an upfront treatment which

months earlier to breast cancer and was raising

can lead to cancer control but without the side effects

his 14-year-old son alone.

of hormone therapy and more aggressive radiation

“It was devastating to face prostate cancer and the prospect of treatment. In that situation your life is on the line and you’re kind of vulnerable. I was scared, I’d just lost my wife who was my advisor and my life partner, and then I was told I had cancer,” John said.

John went on to have his prostate removed through a radical prostatectomy procedure, followed by threemonthly monitoring appointments to identify whether

therapy treatments. The study showed that by targeting radiation at the prostate bed alone – the region where the prostate was removed from – quality of life is preserved for at least three years following treatment.

For John, having the opportunity to receive the latest in radiation therapy treatment and contribute to the future of prostate cancer care through the PINPOINT study has been a critical part of his journey to recovery.

his cancer had returned. He says the experience was

“You feel like you’re contributing to an advancement in

terrifying, with the threat of his prostate cancer coming

the treatment for prostate cancer, while being able to

back looming heavily ahead of every appointment.

receive treatment available nowhere else. Research is

“It was a really tough time, not knowing what the future

critical for people with cancer.”

holds. I believed that surgery to remove my prostate

He says the most difficult part of his prostate cancer

would be the end of it. Six months after my surgery

journey has been the ongoing side effects he now faces

a scan picked up that my cancer had returned in the

following his radical prostatectomy.

prostate bed. I felt like I was back to square one.”

“It was explained to me, and I knew there was going

Still experiencing ongoing side effects from his

to be a consequence, but I wasn’t aware of other

surgery, John was grateful to learn that he was a

treatment options such as radiation therapy.

perfect candidate to receive non-invasive radiation

The lack of sexual function has been a very big void

therapy treatment through the Phase II PINPOINT study,

in my life but that’s the reality. However, this is much

delivered at Icon Cancer Centre in Victoria.

better than the alternative!”

As part of the PINPOINT trial, John was scanned with

Now, as he looks ahead to the future, John hopes to be

the latest cancer imaging technology (68Ga-PSMA-PET)

able to travel again soon.

to ensure that he would benefit most from treatment directly targeted to the prostate bed.

“I’m originally from England and am looking forward to getting back and seeing family. I’ve been

He was then implanted with tiny electronic

bringing up my son and hopefully will send him on

transponders, known as Calypso® radiofrequency

the road to his life. I’m so grateful. This treatment

transponders, to allow for real-time tracking of the

has helped me get my life back. I have enormous

prostate bed, ensuring accurate and focused radiation

gratitude that I can say, five years later that my

delivery which avoided nearby organs such as the

cancer is in remission.”

bladder and the bowel, and reducing long-term side effects such as incontinence, scar tissue, and damage to the bladder and bowel.

ICON ANNUAL RESEARCH REPORT 2021

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RESEARCH OPERATIONS AND EVOLUTION Alongside the 2020 leadership appointments, operations at research has evolved to meet growth and support a sustainable infrastructure for clinical trials.

This new organisational structure sees clinical research coordinators and clinical research assistants supported by an infrastructure of study start-up, regulatory management, administrative oversight and technical support from a combination of head office-based and cancer centre teams.

The structure and maintenance of core functions allows the clinical teams to focus on the care and treatment of our patients and the conduct of research protocols across all Icon locations.

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ICON ANNUAL RESEARCH REPORT 2021

ADAM STONELEY Senior Operations Manager – Research Innovation and Governance With 30 years’ experience working in the clinical trials and healthcare industry across the public and private sector, Adam brings extensive knowledge to the Group’s research division. Throughout his tenure at Icon, he has led research operations and introduced leading clinical data management systems and processes to deliver a quality, robust clinical trials service which can effectively evolve alongside growth.

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REBECCA CLARKE Senior Operations Manager – Research Coordination Rebecca has over 10 years’ experience in the clinical research space, having held numerous roles across quality, governance and operations. With a strong interest in Phase I-IV oncology trials and a dedication to improving the execution of trials, Rebecca leads Icon’s research coordination with efficiency. Managing an experienced team, she is focused on improving the planning and execution of Icon's national clinical trials program whilst maintaining the highest quality.

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HIGHLIGHTS • Research State Lead appointments to assist Icon

RealTime can be implemented across a large

centres across Australia in coordinating trial portfolios,

geographical scope and has the capability to

management, regulatory management, and liaison with

supplement other patient data subsets within Icon

business management and operations

Group's network

• Following the introduction of RealTime Software

• I nvestment in a dedicated Research Innovations team.

Solutions in 2020, 2021 saw the full roll-out of

This team work closely with the Research Governance

RealTime across Icon Group’s global clinical trials

and clinical teams to ensure there are technological

portfolio. This digital solution aligns the group’s

solutions and innovative applications to support

Clinical Trial Management System (CTMS) - tracking

efficient operations. Implementations include:

and managing trial planning, performing and reporting functions, and tracking deadlines and milestones across the entire global network. This system enables research teams across all Icon Group locations to have real-time documentation of clinical trial participant visits and milestones directly into a cloud based,

- Roll-out of DocuSign for efficient digital signatures - Centralised storage and sharing of secure online information through SiteDocs Portal - Protocol compliance and reliable financial recovery with RealTime CTMS.

secure, centralised database, improving efficiencies, quality and service ICON ANNUAL RESEARCH REPORT 2021

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INTRODUCING TRIALS IN

SINGAPORE AND HONG KONG While Icon’s doctors in Singapore have long been participating in clinical trials, these were operated using an outsource model.

With a global approach to cancer care, in 2021 Icon Group prioritised the evolution of research in Singapore and Hong Kong with the introduction of a dedicated clinical trials division including a new Director of Clinical Trials, Joanne Chio, to lead the ASEAN trials portfolio. Alongside experienced clinical research coordinators and dedicated oncologists, 2021 marked a year of establishing solid foundations to bring an in-depth level of trials to the region.

HIGHLIGHTS • In May 2021 an Icon Singapore Research Committee

months, including Icon’s first paediatric oncology trial

with committee members including Dr Tan Yew Oo,

(Y-mAbs 203) and the first in the private sector for

Dr Karmen Wong, Dr Patricia Kho, Dr Lee Guek Eng,

neuroblastoma. Principal Investigator: Dr LeLe Aung

Dr Robert Lim, Dr Daniel Chan and Dr LeLe Aung.

This committee has helped to enhance research collaboration across Icon sites and will continue to grow Icon’s regional reach across the ASEAN region, working closely with shared partners to continue to

• G rew from one to five Principal Investigators, totalling 67% of Singapore doctors participating in clinical trials as either Principal Investigators or Co-Investigators • Set-up foundations for an extensive trial portfolio in

improve access to clinical trials. It will also increase

Hong Kong. Partnered with BioAtla who have selected

collaboration with Icon’s mature research team in

Icon Cancer Centre Hong Kong as a site to conduct a

Australia and leverage established industry partners

leading immunotherapy lung cancer trial.

and seek international opportunities • A dded two new trial sites in Singapore. Icon Cancer Centre Farrer Park has been designated as trial headquarters with two new satellite sites established at Icon Cancer Centre Gleneagles and Mount Alvernia

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• L aunched ten clinical trials across the span of nine

was established, chaired by Dr Hsieh Wen-Son and

ICON ANNUAL RESEARCH REPORT 2021

DR HSIEH WEN-SON

JOANNE CHIO

BSc, MD, Internal Medicine, Medical Oncology (USA), Diplomate Internal Medicine and Medical Oncology ABIM (USA)

Director of Clinical Trials, ASEAN

Medical Oncologist, Chair Singapore Research Committee

Joanne brings over 10 years’ experience in the management and delivery of clinical trials programs within the public and pharmaceutical sectors, with an in-depth knowledge of the local oncology research

Dr Hsieh has a research interest in molecularly

landscape. In her previous public appointment, she

targeted cancer therapies, immunotherapy and

successfully grew the organisation’s trials portfolio with

molecular diagnostics. He has established a number

a strong focus on the development of Phase I oncology

of international studies involving centres in Singapore,

clinical trials. Her team managed over 250 trials and

Hong Kong, Korea, the Philippines, Myanmar and the

led several first-in-class early drug studies. She has a

United States, examining novel treatments and novel

strong interest in the delivery of effective educational

diagnostic tests for lymphoma and nasopharyngeal

solutions, enhancing data solutions and building

and hepatocellular carcinoma. He has authored over

partnerships to deliver robust clinical trials programs.

80 scientific articles, abstracts, and book chapters, and has been Principal Investigator of more than 30

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completed or ongoing clinical trials investigating novel treatments for a variety of cancers.

ICON ANNUAL RESEARCH REPORT 2021

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GOVERNANCE AND QUALITY 2021 saw a restructure and investment in Icon’s governance team to streamline study start-up framework and centralise support across feasibility, ethics and trial contracts.

Newly appointed Global Research Governance Manager, Tenille Baker has brought a new level of expertise to the Group’s global governance procedures and has introduced an independent research governance quality framework for efficient review, compliance, and approval of all clinical research activity across the global network.

TENILLE BAKER

ELIZA KEATING

Global Research Governance Manager

Research Quality Specialist

Tenille brings over 20 years’ experience in

Eliza started her career in academic research

administration, clinical trials and research across

institutions with a strong interest in the field of

both the public and private sector. She has previously

oncology. She progressed to a Data Manager role

held national research and business operational

before taking the position of Research Quality

and research associate positions with a focus on

Specialist at Icon in July 2021. Her attention to

trial compliance, standardised ethics procedures

detail, clinical experience and academic background

and audits, and quality trial tracking and archiving

reflects the skills required for maintaining regulatory

procedures. Tenille is a certified TransCelerate

standards and compliance for oncology and

GCP trainer.

haematology clinical trials. Eliza leads evolutions for quality programs and systems across Icon Group to

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meet international expansion.

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ICON ANNUAL RESEARCH REPORT 2021

HIGHLIGHTS • E stablished a central feasibility assessment of

• I ncreased uptake in GCP and regulatory compliance

clinical trials and overarching governance processes

through in-house 'train the trainer' program and a

and Standard Operating Procedures to standardise

brand new online GCP module, facilitated by Executive

research participation, safety, audits and quality

Manager, Sophie Mepham. More than 100 team

assurance

members were trained in GCP in 2021. Focus is now

• Renewed engagement of key clinical stakeholders to ensure Icon’s clinical trials program and culture aligns with the company’s strategic goals, expanding clinician support and ability to conduct trials • Voluntarily participated in a TGA Good Clinical Practice

on engaging more clinicians and research teams to participate in 2022 • The research quality team have plans to grow the global quality program through the implementation of an electronic quality management system.

(GCP) inspection demonstrating Icon’s commitment to quality assurance and elevating the Group’s reputation of conducting first-class clinical trials. Participation in this inspection came prior to the official rollout of the formal TGA program, set to begin in early 2022. TGA inspectors selected Icon as one of the few Australian test sites, which has allowed the team to benchmark current quality research systems and prepare for the mandatory GCP inspections.

ICON ANNUAL RESEARCH REPORT 2021

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COMPOUNDING AND PHARMACY CAPABILITIES Icon is uniquely positioned to deliver an end-to-end research model backed by the group’s compounding and pharmacy capabilities.

Holding long-standing relationships with hospitals, pharmaceutical and manufacturing, Icon provides a collaborative and connected ecosystem conducive to quality management of clinical trials and rigorous research projects.

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ICON ANNUAL RESEARCH REPORT 2021

COMPOUNDING

PHARMACY

Icon Group’s compounding arm, Slade Health assists

Icon Group provides a complete suite of management

hospitals across Australia with clinical trials through

services to support the operations of Epic Pharmacy

the delivery of compounding services from Slade’s

and Slade Pharmacy. Epic and Slade pharmacies have a

three TGA-licensed facilities which adhere to Good

long and extensive history in clinical trial involvement

Manufacturing Practice (GMP). Slade’s clinical trial

and proudly work with hospital partners and Icon’s

experience spans Phase I-IV studies, primarily in

cancer centres to manage the pharmaceutical

oncology and haematology.

components and associated costs of providing

Slade’s clinical trials service includes national trial coordination among the TGA-licensed compounding

investigational drug services for clinical trials in both inpatient and outpatient settings across Australia.

facilities to ensure relevant criteria is met for the

The Group’s pharmacies support a range of clinical

compounding of investigational products. Each

trials from Phase I to Phase IV, covering a diverse

compounding facility has dedicated trials staff who

array of clinical indications including solid tumours,

oversee the management and segregated storage

cardiovascular, haematology, neurological, respiratory

of clinical trial drugs in validated and monitored

and gastrointestinal disorders. Most trials are

equipment.

commercially sponsored with some involvement in

Slade supports the administrative work required in

unsponsored collaborative research studies.

clinical trials by providing relevant manufacturing

All pharmacies follow Good Clinical Practice in

records and maintaining training documentation to

the handling of investigational products, with a

guarantee compliance with Good Clinical Practice.

requirement that all pharmacy staff handling trial

With validated couriers, Slade also assures the safe

products have a current GCP certificate, which includes

and secure cold chain or ambient transport of clinical

the requirements stipulated by the TGA, and the Society

trial products to hospitals on time.

of Hospital Pharmacists’ SHPA’s Standard of Practice in clinical trials for pharmacy services.

HIGHLIGHTS • 248 clinical trials across three Slade Health TGA licensed compounding facilities - 4 0 for Epic, Slade and Icon pharmacies - 5 8 for NSW public hospitals - 150 for direct hospital pharmacy customers • Over 90% oncology/haematology; remaining in autoimmune, neurodegenerative indications • 20% Phase I clinical trials, 80% Phase II-IV • A pproximately 3,000 compounded sterile clinical trial products annually.

Experienced clinical trials pharmacists from the Group’s Pharmacy Practice Unit (PPU) provide support to pharmacy staff including trial documentation, policies, training and administrative guidance on pharmacy costs, contracts and indemnification. As part of a quality assurance program, the PPU audits the clinical trial pharmacies annually, assessing training, policies and procedures, trial documentation, facilities and equipment.

HIGHLIGHTS • 2 3 pharmacies delivering clinical trials • 4 94 active trials at the end of 2021. 164 of these are trials within Icon centres, with the remainder external to the group i.e. hospital partners • 173 clinical trials opened in the calendar year.

ICON ANNUAL RESEARCH REPORT 2021

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FUTURE DIRECTION 44

ICON ANNUAL RESEARCH REPORT 2021

ICON ANNUAL RESEARCH REPORT 2021

45

FUTURE DIRECTION Icon’s research portfolio will continue to forge new ground and lead the way in private oncology trials.

With an established global framework backed by a comprehensive oncology offering, Icon is well positioned to deliver clinical trials to as many patients as possible, as close to home as possible. 2022 and beyond will focus on increasing industry partnerships, growing the investigator network and establishing innovative solutions that will enable Icon to turn the dial on oncology clinical trials and reduce the growing cancer burden.

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ICON ANNUAL RESEARCH REPORT 2021

INVESTIGATOR INITIATED TRIALS 2022 will see a focus on growing Icon’s Investigator

With extensive engagement from the Group’s highly

Initiated Trials (IITs) program across the international

experienced radiation oncologists, radiation

network by 50%, with an aim to activate four new

therapists, medical physicists, oncology nurses,

IITs within the calendar year and expand trials within

multidisciplinary referrer network and industry

medical oncology and haematology, and across

collaborators, Icon is looking to harness this knowledge

Singapore. Further partnership opportunities are

beyond cancer care. The next few years will see an

underway to develop innovative, progressive IITs, and

increase in technical research and innovation, pushing

a continual focus on quality assurance will ensure the

the limits of radiation technology and studying its

success of a robust IIT offering.

potential benefits in other healthcare disciplines and

LEADING THE WAY IN RADIATION MEDICINE Icon Group currently operates one of the largest

diseases. The use of AI and adaptive technologies are already being used in Icon led IITs to potentially improve outcomes in common conditions such as Parkinson’s disease and other diseases.

private radiation oncology services in Australia and are

Icon Group Board Advisor, Radiation Oncologist Prof

frequent early adopters of the latest radiation therapy

Sandro Porceddu continues to support Icon’s radiation

technologies. Icon’s research offering will continue to

medicine portfolio, bringing over 20 years’ international

leverage the Group’s radiation oncology experience

experience in the management of head and neck

including Icon’s unique centralised functions: remote

cancer, skin cancer and lymphoma. He has published

radiation training and planning, an internationally

over 170 clinical research articles, is a regularly

recognised medical physics team and an in-house

invited speaker at major cancer conferences such as

enterprise projects management office. This mature

the American Society of Clinical Oncology (ASCO) and

oncology ecosystem allows the expansion of clinical

European Society of Medical Oncology (ESMO), and has

trials not only within the confines of radiation oncology

Chaired the Trans Tasman Radiation Oncology Group

but extends the Group’s reach and capabilities beyond

(TROG). Prof Porceddu’s consultation and unparalleled

the treatment and research of cancers, focusing on a

clinical experience will drive forward the vision of

broader radiation medicine lens.

Icon’s radiation medicine capabilities and provide international growth opportunities.

“ T he last 10 years alone has seen a continual acceleration in radiation therapy technology and techniques. With strong clinical leadership and investment in research, Icon is well-positioned to be at the forefront of the next generation of radiation medicine, reinventing and expanding its potential in healthcare. Excellence in clinical research and innovation translates into excellence in clinical care delivery.”

PROF SANDRO PORCEDDU BSc, MBBS (Hons), FRANZCR, MD

Radiation Oncologist ICON ANNUAL RESEARCH REPORT 2021

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THERANOSTICS In late 2021 Icon formed a collaboration with Dr Jones and Partners, a clinician owned and operated medical imaging organisation servicing South Australia and Alice Springs. This partnership marks the beginning of a comprehensive theranostics clinical trial imaging and treatment program for patients across South Australia.

Future focus will include the development of national theranostics and subsequent research projects, further contributing to hyper personalised cancer treatments.

A SPOTLIGHT ON SKIN CANCER RESEARCH Radiation Oncologist, Prof Gerald Fogarty joined Icon in 2021, bringing over 20 years of radiation oncology and clinical research experience. Prof Fogarty is a leading clinician specialising in the treatment and management of skin cancers and benign skin conditions and is at the forefront of utilising the latest in radiation therapy technologies. He has authored over 180 publications and is a member of peak organisations including Melanoma and Skin Cancer Trials (MASC), Australasian Brachytherapy

“ O ne in two Australians will be diagnosed with some form of skin cancer before the age of 70.

Radiation therapy brings tissue conservation to the treatment algorithm and helps deliver better survivorship. However, despite this being our national cancer, there is little in the way of level one evidence to justify radiation therapy in the treatment of malignant and benign diseases of skin. We need to invest in national research programs that will allow clinicians to create this evidence, especially using new technologies in radiation therapy.”

PROF GERALD FOGARTY

Group (ABG), Australasian Merkel Cell Carcinoma Interest Group (AMIGOs) and Australia and New Zealand Health and Neck Cancer Society (ANZHNCS). Under his leadership and expertise Icon will establish an extensive skin cancer research portfolio, including a focus on Investigator Initiated Trials with an aim to improve access to new and emerging treatments and improve patient outcomes across Australia.

STABILITY AND RESEARCH LAB In March 2022 under the Slade Health brand, Icon Group opened a state-of-the-art specialist Drug Stability Testing and Research Laboratory in Sydney at Slade’s Mt Kuring-gai TGA licensed facility. This laboratory is the first-of-its-kind in Australia with the capability of generating the robust scientific data required to demonstrate and prolong stability and safety of compounded drugs. This lab conducts a range of studies from physiochemical testing of products to cell culture and in-depth biological assays. The potential to extend shelf-life of compounded drugs, which often need to be administered within 24 hours, will minimise wastage and increase flexibility and access to treatments, especially for regional communities. Research undertaken in this laboratory

BSc, MBBS, PhD, FRANZCR

will ultimately help remove some of the systemic barriers

Radiation Oncologist

within cancer care infrastructure by improving the ability to deliver the latest, most innovative treatments to regional and remote locations.

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ICON ANNUAL RESEARCH REPORT 2021

GLOBAL PARTNERSHIPS

Leveraging the Group’s comprehensive cancer care

Future strategy will focus on fostering long-term

service, Icon’s research teams are also in discussion

industry partnerships and forging new relationships

with leading pharmaceutical groups to offer an end-

to further Icon’s research impact. Building on the

to-end clinical trial service from compounding through

Group’s long-standing global partnership with Varian

to real-world clinical and pharmacy drug data and to

Medical Systems, in April 2022 a five-year research

expand involvement in Phase IV post-marketing trials.

and professional services agreement was signed.

Icon will continue to seek opportunities with sponsors,

Through this agreement, Icon will participate in clinical

pharmaceutical companies, academic institutions and

and technical research programs, product evaluation

advocacy groups to advance clinical trials and design

projects and clinical consultations with Varian to offer

comprehensive, innovative research programs.

clinical expertise and industry perspectives throughout product development. The first project between the two organisations will focus on the use of Artificial Intelligence (AI) in contouring to reduce the time it takes to plan radiation therapy treatments. Contouring involves outlining the tumour and nearby organs to deliver precise radiation therapy to the tumour site and avoid healthy tissue. AI contouring enables high quality Organs at Risk (OAR) contouring and standardisation with AI-powered algorithms. This is designed to help simplify the radiation therapy planning workflow.

2022 will also see the launch of a Varian HyperArc Registry with Icon sites contributing to this global data set. This registry will collect and analyse a robust set of data during and following the course of radiation treatment for patients treated with HyperArc, providing an extensive data platform to enable clinical research and the evolution of HyperArc technology. This will be the first of many research collaborations which have

EXPANSION IN ASIA The next few years will see a focus on expanding the clinical trials portfolio in Singapore, Hong Kong and Mainland China. In line with the launch of the new integrated cancer centre at Mt Alvernia Hospital in Singapore in late 2022, a second clinical trials regional headquarters will be established on-site. This will further extend Icon’s clinical research capabilities including technical research and ability to offer a wider range of clinical trials. An increase in cross collaboration and industry networking will also be a focus for 2022 to allow the introduction of more trials in the region.

The Singapore research team is also on target to launch a clinical trials app in 2022 to support clinicians to introduce research into their practice and help facilitate patient trial recruitment.

the capacity to advance cancer treatment across a wide range of tumour streams.

ICON ANNUAL RESEARCH REPORT 2021

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WITH THANKS

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ICON ANNUAL RESEARCH REPORT 2021

ACKNOWLEDGEMENTS In another year of uncertainties Icon would like to

All funds raised for ICF support the delivery and

extend a warm thank you to all the doctors and research

execution of IITs including trial management,

teams for their ongoing dedication to the promotion

recruitment, data collection and publication, and

and delivery of clinical trials. Thank you to our sponsors

ongoing trial patient support including access to

and partners for continuing to work collaboratively

transport, accommodation and clinical research

to increase access to clinical trials and help reduce

coordinators and allied health professionals.

the growing global cancer burden. We also extend a special thanks and best wishes to our patients, whose participation in clinical trials makes it possible to discover groundbreaking new treatments.

We warmly acknowledge the valued support of donors to

Together we continue to provide hope and opportunity to patients today and into the future.

Learn more about Icon Cancer Foundation at iconcancerfoundation.org.

Icon Cancer Foundation (ICF), an independent not-forprofit registered charity whose mission is to promote, initiate and support clinical trials and research, striving towards a brighter future for cancer patients and communities. ICF is committed to improving patient access to new and emerging treatments by raising awareness of and sponsoring Investigator Initiated Trials (IITs).

Community fundraising is crucial to the delivery of IITs, as they are not sponsored by large pharmaceutical companies and involve ongoing costs and resources to deliver vital and often unique research to advance medicine.

ICON ANNUAL RESEARCH REPORT 2021

51

“ When I was offered this trial, there was not a d I thought, if this trial could help me in anyway, it. I knew there was no cure, but I always said t long enough to see my grandchildren grow up here, and happily watching my five grandchild Without this trial, I simply wouldn’t be here.”

DAWN NORRIS

APPENDICES

Patient

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ICON ANNUAL RESEARCH REPORT 2021

doubt in my mind. , I was willing to do that I wanted to live . I’m now 70, still dren live their lives.

ICON ANNUAL RESEARCH REPORT 2021

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RESEARCH PARTNERS Icon Group is proud to work with over 200 collaborators including Clinical Research Organisations (CROs), commercial and non-commercial organisations (including the pharmaceutical industry, hospitals, and universities), industry vendors and service providers. We understand that making a difference in reducing the global cancer burden is a collaborative effort and continue to partner with new organisations who share common values in order to play a leading role in turning the dial on cancer care.

COLLABORATORS AND VENDORS

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ICON ANNUAL RESEARCH REPORT 2021

SPONSORS AND CLINICAL RESEARCH ORGANISATIONS ( CRO )

ICON ANNUAL RESEARCH REPORT 2021

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PRINCIPAL INVESTIGATORS MEDICAL ONCOLOGY

56

Principal Investigators

Title

Icon Cancer Centre Locations

Dr Carolyn Bampton MBBS, FRACP

Medical Oncologist

Adelaide (Tennyson) (SA)

Dr Sarwan Bishnoi MBBS, MD, FRACP

Medical Oncologist

Adelaide (Tennyson) (SA)

Dr Daniel Chan Boon Yeow MBBS (Hons), MRCP (UK), FAMS (Medical Oncology), FRCP (UK)

Medical Oncologist

Singapore

Dr Kerry Cheong MBBS(Hons), FRACP

Medical Oncologist

Adelaide (Tennyson) (SA)

A/Prof Jim Coward BSc (Hons), MBBS, PhD, MRCP (UK), FRACP

Medical Oncologist

Chermside and South Brisbane (QLD)

A/Prof Simon Durrant MBBS, MRCS, LRCP, FRACP, FRCPath

Medical Oncologist and Clinical Haematologist

Chermside and Wesley (QLD)

Dr Paul Eliadis (AM) MBBS, BSc (Med), FRACP, FRCPA

Medical Oncologist and Clinical Haematologist

Wesley (QLD)

Dr Jeffrey Goh MBBS, FRACP

Medical Oncologist

Chermside and Greenslopes (QLD)

Dr David Grimes MBBS (Qld), FRACP

Medical Oncologist

North Lakes and Wesley QLD

Dr Keith Horwood MBBS (Hons) FRACP

Medical Oncologist

Southport (QLD)

Dr Amy Hsieh MBBS, FRACP

Medical Oncologist

Adelaide (Windsor Gardens) (SA)

Dr Hsieh Wen-Son BSc (USA), MD (USA), Internal Medicine (USA), Medical Oncology (USA), Diplomate Internal Medicine and Medical Oncology ABIM (USA)

Medical Oncologist

Singapore

Dr Mohammed Islam MBBS, FRACP

Medical Oncologist

Southport (QLD)

Dr Vikram Jain MBBS, FRACP

Medical Oncologist

South Brisbane (QLD)

A/Prof Dusan Kotasek MBBS (Hons), FRACP

Medical Oncologist

Adelaide (Tennyson) (SA)

Dr Lee Guek Eng BSc, MBBS, MRCP, MMed

Medical Oncologist

Singapore

ICON ANNUAL RESEARCH REPORT 2021

Principal Investigators

Title

Icon Cancer Centre Locations

Dr Agnieszka Malczewski MBBS, FRACP, MSc

Medical Oncologist

Chermside, North Lakes and Wesley (QLD)

A/Prof Nicole McCarthy MBBS (Hons), MHSc, FRACP

Medical Oncologist

Wesley (QLD)

Dr Anna Mislang MBBS, FRACP

Medical Oncologist

Adelaide (Tennyson) (SA)

Dr Cristina Moldovan MBBS, FRACP

Medical Oncologist

Hobart (TAS)

A/Prof Louise Nott BMedSci, MBBS(Hons), FRACP

Medical Oncologist

Hobart (TAS)

Dr Meena Okera MBBS(Hons), FRACP

Medical Oncologist

Adelaide (Tennyson) (SA)

Dr Francis Parnis MBBS, FRACP

Medical Oncologist

Adelaide (Tennyson) (SA)

Dr Dainik Patel MBBS, FRACP

Medical Oncologist

Adelaide (Tennyson) (SA)

Dr Nimit Singhal MBBS, FRACP

Medical Oncologist

Adelaide (Tennyson) (SA)

A/Prof Michael Slancar MD, FRACP

Medical Oncologist

Southport (QLD)

Dr Brian Stein MBBS(Hons), FRACP

Medical Oncologist

Adelaide (Tennyson) (SA)

Dr Adam Stirling MBBS(Hons), FRACP

Medical Oncologist

Chermside, North Lakes and Wesley (QLD)

Dr Hsiang Tan MBBS, FRACP

Medical Oncologist

Adelaide (Tennyson) (SA)

Dr Tan Yew Oo MBBS, FRCP (Canada), FACP (USA), FRACP (Aus), FRCP (UK), FRCP (Glasg), FAMS (Medical Oncology), Diplomate of American Board of Internal Medicine, Haematology and Medical Oncology

Medical Oncologist

Singapore

Dr Gonzalo Tapia Rico MBBS, PhD, FRACP

Medical Oncologist

Adelaide (Tennyson) (SA)

A/Prof Paul Vasey MBChB, MSc(Clin.Pharm), MD, MRCP(UK), FRACP

Medical Oncologist

Toowoomba and Wesley (QLD)

Dr Karmen Wong MBBS (AUS), MRCP (UK), FRCP (Glasg), MMed (Int Med), FAM

Medical Oncologist, Icon Singapore Medical Director

Singapore

ICON ANNUAL RESEARCH REPORT 2021

57

PRINCIPAL INVESTIGATORS HAEMATOLOGY

58

Principal Investigators

Title

Icon Cancer Centre Locations

Dr Raymond Banh MBBS, FRACP, FRCPA

Clinical Haematologist

Redland, South Brisbane and Wesley (QLD)

Dr Jason Butler MBBS, M.MED Sci (CLIN EPID), FRACP, FRCPA

Clinical Haematologist

South Brisbane (QLD)

Dr Stanley Cheung MBBS, PhD, MRCP, FRACP, FHKCP, FHKAM, FRCP (Glasg), AFRACMA

Clinical Haematologist

Adelaide (Tennyson) (SA)

Dr Joseph Clarey MBBS, FRACP, FRCPA

Clinical Haematologist

Chermside, Mackay and Wesley (QLD)

A/Prof Simon Durrant MBBS, MRCS, LRCP, FRACP, FRCPath

Medical Oncologist and Clinical Haematologist

Chermside and Wesley (QLD)

Dr Paul Eliadis (AM) MBBS, BSc (Med), FRACP, FRCPA

Medical Oncologist and Clinical Haematologist

Wesley (QLD)

Dr Stephen Fanning MBBS, MSc, FRACP, FRCPA

Clinical Haematologist

Wesley (QLD)

Dr Robert Hensen MBBS, FRACP, FRCPA

Clinical Haematologist

Chermside, North Lakes and South Brisbane and Wesley (QLD)

Dr Matthew Hourigan MBBS (Hons), FRACP, FRCPA

Clinical Haematologist

Greenslopes, Redland and Wesley (QLD)

Dr Ian Irving MBBS, FRACP, FRCPA

Clinical Haematologist; Icon Group Medical Director

Mackay and Wesley (QLD)

Dr Akash Kalro MBBS, MD, FRCPA, FRACP

Clinical Haematologist

Adelaide (Tennyson) (SA)

Dr Edward Morris BMBS, DM, FRACP, FRCPA

Clinical Haematologist

Townsville (QLD)

A/Prof James Morton (AM) MBBS, BSci(Med), FRACP, FRCPA, GAICD

Clinical Haematologist

South Brisbane (QLD)

A/Prof Kerry Taylor MBBS(Hons), FRACP, FRCPA

Clinical Haematologist

South Brisbane (QLD)

Dr Nick Wickham MA, MRCP, FRCPath, FRACP, FRCPA, GAICD

Clinical Haematologist

Adelaide (Windsor Gardens) (SA)

ICON ANNUAL RESEARCH REPORT 2021

PRINCIPAL INVESTIGATORS RADIATION ONCOLOGY Principal Investigators

Title

Icon Cancer Centre Locations

Mr Trent Aland BASc, MSc, MBA, PhD in Medical Physics

National Director of Physics (AU)

South Brisbane Corporate Office (QLD)

Dr Patrick Bowden MBBS, FRANZCR

Radiation Oncologist

Canberra (ACT), Freemasons, Moreland, Mulgrave, Richmond (VIC)

Dr Michael Dally MB, ChB, BSc, FRANZCR

Radiation Oncologist

Freemasons, Mulgrave and Richmond (VIC), Hobart (TAS)

A/Prof Matthew Foote BSc, MBBS (Hons), FRANZCR

Radiation Oncologist

Greenslopes (QLD)

A/Prof Kumar Gogna MBBS, DCH, FRCP, FRANZCR

Radiation Oncologist

Greenslopes and Redland (QLD)

A/Prof Jim Jackson MBBS, FRANZCR, PhD

Radiation Oncologist

Gold Coast Private Hospital (QLD)

Dr Eric Khoo MBBS, FRANZCR

Radiation Oncologist

Gold Coast Private Hospital and Gold Coast University Hospital (QLD)

Dr Dominic Lunn BSc (Hons), MBBS (Hons), FRANZCR, DipPallMed (Clinical)

Radiation Oncologist

Gold Coast Private Hospital, Gold Coast University Hospital and Redland (QLD)

Dr Penny Mackenzie MBBS (Hons), BSc, FRANZCR

Radiation Oncologist

Toowoomba (QLD)

Dr Luke McGhee BSc, MBBS (Hons)

Radiation Oncologist

Cairns (Liz Plummer) (QLD)

Dr Lekshmi Nair MBBS, FRANZCR

Radiation Oncologist

Toowoomba (QLD)

Dr Andrew Oar BSc, MBBS, MIPH, FRANZCR

Radiation Oncologist

Gold Coast Private Hospital and Gold Coast University Hospital (QLD)

A/Prof Mark Pinkham BM, BCh, MA(Hons)(Oxon), FRANZCR

Radiation Oncologist

Greenslopes and North Lakes (QLD)

Dr Ariyanto Pramana BSc (Med), MBBS (Hons), FRANZCR

Radiation Oncologist

Cairns (QLD)

A/Prof David Pryor BSc, MBBS, FRANZCR

Radiation Oncologist

Greenslopes (QLD)

Dr Andrew See MBBS, FRANZCR

Radiation Oncologist

Freemasons, Moreland, Mulgrave and Richmond (VIC)

ICON ANNUAL RESEARCH REPORT 2021

59

60

Principal Investigators

Title

Icon Cancer Centre Locations

Dr Kevin So MBBS, BMedSc(Hons), FRANZCR

Radiation Oncologist

Freemasons, Moreland, Mulgrave and Richmond (VIC)

Dr Amy Yuen Meei Teh BSc (Med), MBBS (Hons), FRANZCR

Radiation Oncologist

Gosford and Wahroonga (NSW)

Dr Vivien Tse MBBS, MSc, MRCP (UK), FRCR (UK), FRANZCR

Radiation Oncologist

Toowoomba (QLD)

Dr Dinesh Vignarajah MBBS, FRANZCR

Radiation Oncologist

Maroochydore (QLD)

ICON ANNUAL RESEARCH REPORT 2021

2021 PUBLICATIONS 1. ( 68)Ga-PSMA-PET screening and transponder-guided

A, Gartlan KH, Curley C, Olver SD, Chang K, Butler JP,

salvage radiotherapy to the prostate bed alone for

Misra A, Subramoniapillai E, Morton AJ, Durrant S,

biochemical recurrence following prostatectomy:

Henden AS, Moore J, Ritchie D, Gottlieb D, Cooney J,

interim outcomes of a phase II trial

Paul SK, Hill GR.

Authorship: Bowden P, See AW, So K, Lawrentschuk N, Moon D, Murphy DG, Rao R, Crosthwaite A, King

7. A retrospective analysis of the investigative practices

D, Haxhimolla H, Grummet J, Ruljancich P, Gyomber

of acute limb ischaemia presenting with an unknown

D, Landau A, Campbell N, Frydenberg M, Smyth LML,

aetiology.

Nolan S, Gwini SM, McKenzie DP.

Authorship: Nath K, Reyaldeen R, Mack K, Sistla L, Palamuthusingam D, Zahir SF, Dave R, Muller J,

2. [(177)Lu]Lu-PSMA-617 versus cabazitaxel in patients

McCann A.

with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial

8. A Retrospective Cross-Sectional Cohort Trial

Authorship: Hofman MS, Emmett L, Sandhu S,

Assessing the Prevalence of MTHFR Polymorphisms

Iravani A, Joshua AM, Goh JC, Pattison DA, Tan TH,

and the Influence of Diet on Platinum Resistance in

Kirkwood ID, Ng S, Francis RJ, Gedye C, Rutherford

Ovarian Cancer Patients.

NK, Weickhardt A, Scott AM, Lee ST, Kwan EM, Azad

Authorship: Phillips-Chavez C, Coward J, Watson M,

AA, Ramdave S, Redfern AD, Macdonald W, Guminski

Schloss J.

A, Hsiao E, Chua W, Lin P, Zhang AY, McJannett MM, Stockler MR, Violet JA, Williams SG, Martin AJ, Davis ID; TheraP Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group.

9. A djuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer Authorship: Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja

3. A case of IVIg responsive paraneoplastic SOX1

E, Fielding A, Balmaña J, Domchek SM, Gelmon KA,

peripheral neuropathy in a male with breast

Hollingsworth SJ, Korde LA, Linderholm B, Bandos

carcinoma

H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki

Authorship: Beer R, O’Gorman C, Horwood K, Blum S.

Z, Huzarski T, Ganz PA, Lucas PC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG,

4. A Comprehensive Study of the Epidemiology of

Costantino JP, Arahmani A, Wolmark N, McFadden E,

Haematological Malignancies in North Queensland

Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer

Authorship: Nath K, Boles R, Emeto TI, Adegboye OA,

CE Jr; OlympiA Clinical Trial Steering Committee and

Castellanos ME, Alele FO, Pearce J, Ewart B, Ward K,

Investigators (McCarthy N).

Lai HC, Morris E, Hodges G, Irving I. 10. A djuvant systemic treatment for high-risk resected 5. A phase 2 study of anastrozole in patients with

non-cutaneous melanomas: What is the evidence?

oestrogen receptor and/progesterone receptor

Authorship: Tapia Rico G, Yong CH, Herrera

positive recurrent/metastatic granulosa cell

Gómez RG.

tumours/sex-cord stromal tumours of the ovary: The PARAGON/ANZGOG 0903 trial

11. AGITG MASTERPLAN: a randomised phase II study of

Authorship: Banerjee SN, Tang M, O’Connell RL,

modified FOLFIRINOX alone or in combination with

Sjoquist K, Clamp AR, Millan D, Nottley S, Lord R,

stereotactic body radiotherapy for patients with

Mullassery VM, Hall M, Gourley C, Bonaventura T, Goh

high-risk and locally advanced pancreatic cancer

JC, Sykes P, Grant PT, McNally O, Alexander L, Kelly

Authorship: Oar A, Lee M, Le H, Wilson K, Aiken C,

C, Carty K, Divers L, Bradshaw N, Edmondson RJ,

Chantrill L, Simes J, Nguyen N, Barbour A, Samra J,

Friedlander M; PARAGON investigators.

Sjoquist KM, Moore A, Espinoza D, Gebski V, Yip S, Chu J, Kneebone A, Goldstein D.

6. A phase 3 double-blind study of the addition of tocilizumab vs placebo to cyclosporin/methotrexate

12. A n MRD-stratified pediatric protocol is as

GVHD prophylaxis

deliverable in adolescents and young adults as

Authorship: Kennedy GA, Tey SK, Buizen L, Varelias

children with ALL ICON ANNUAL RESEARCH REPORT 2021

61

2021 PUBLICATIONS CONTINUED Authorship: Greenwood M, Trahair T, Sutton R,

J, Stockler MR, Mileshkin L; Australia New Zealand

Osborn MP, Kwan J, Mapp S, Howman R, Anazodo A,

Gynaecological Oncology Group (ANZGOG).

Wylie BR, D’Rozario J, Hertzberg M, Irving I, Yeung DT, Coyle L, Jager A, Engeler DM, Venn NC, Frampton C, Wei AH, Bradstock KF, Dalla-Pozza L.

18. Clinically significant localised prostate cancer: deciding what will provide the best clinical outcomes Authorship: Woo HH, Teh A.

13. A ssessing tumor centrality in lung stereotactic ablative body radiotherapy (SABR): the effects of variations in bronchial tree delineation and potential

lymphoedema and quality of life deficits after

for automated methods

axillary surgery: a prospective cohort study.’

Authorship: Ghandourh W, Dowling J, Chlap P, Oar A,

Authorship: Boyages J, Shah C, Vicini FA.

Jacob S, Batumalai V, Holloway L. 14. A ustralia and New Zealand Transplant and Cellular

20. C oncurrent ibrutinib plus venetoclax in relapsed/ refractory mantle cell lymphoma: the safety run-in

Therapies COVID-19 vaccination consensus position

of the phase 3 SYMPATICO study

statement

Authorship: Wang M, Ramchandren R, Chen R,

Authorship: Hamad N, Ananda-Rajah M, Gilroy

Karlin L, Chong G, Jurczak W, Wu KL, Bishton M,

N, MacIntyre R, Gottlieb D, Ritchie D, Harrison S,

Collins GP, Eliadis P, Peyrade F, Lee Y, Eckert K,

Kennedy G, Watson AM, Greenwood M, Doocey R,

Neuenburg JK, Tam CS.

Perera T, Spencer A, Wong E, O’Brien T, Shaw P, Conyers R, Milliken S, Bardy P, Larsen S, Ho PJ, Lai H, Bajel A, Butler J, Tiley C, D’Rozario J, Johnston A, Cochrane T, Mills T, Irving I, Pullon H, Purtill D. 15. C haracterisation of in-room leakage and scattered

21. C oncurrent use of nivolumab and radiotherapy for patients with metastatic non-small cell lung cancer and renal cell carcinoma with oligometastatic disease progression on nivolumab Authorship: Ansari J, Farrag A, Ali A, Abdelgelil M,

radiation for the Varian Halcyon linear accelerator.

Murshid E, Alhamad A, Ali M, Ansari H, Hussain S,

Authorship: Caravani K, Murry R, Healy B.

Glaholm J.

16. C irculating tumor DNA dynamics and recurrence

22. C utaneous squamous cell carcinoma metastatic

risk in patients undergoing curative intent resection

to the axilla and groin: Outcomes and prognostic

of colorectal cancer liver metastases: A prospective

factors.

cohort study

Authorship: Bucknell NW, Gyorki DE, Bressel M,

Authorship: Tie J, Wang Y, Cohen J, Li L, Hong W,

Estall V, Webb A, Henderson M, Chua MS, Rischin D,

Christie M, Wong HL, Kosmider S, Wong R, Thomson

Tiong A.

B, Choi J, Fox A, Field K, Burge M, Shannon J, Kotasek D, Tebbutt NC, Karapetis C, Underhill C, Haydon A, Schaeffer J, Ptak J, Tomasetti C, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. 17. C linical activity of durvalumab for patients with

23. D eveloping clinical indicators for oncology: the inaugural cancer care indicator set for the Australian Council on Healthcare Standards Authorship: Segelov E, Carrington C, Aranda S, Currow D, Zalcberg JR, Heriot AG, Mileshkin L,

advanced mismatch repair-deficient and repair-

Coutsouvelis J, Millar JL, Collopy BT, Emery JD,

proficient endometrial cancer. A nonrandomized

Zhang P, Cooper S, O’Kane C, Wale J, Hancock SJ,

phase 2 clinical trial

Sulkowski A, Bashford J.

Authorship: Antill Y, Kok PS, Robledo K, Yip S, Cummins M, Smith D, Spurdle A, Barnes E, Lee YC, Friedlander M, Baron-Hay S, Shannon C, Coward J, Beale P, Goss G, Meniawy T, Lombard J, Andrews

62

19. C omment on: ‘Increases in arm volume predict

ICON ANNUAL RESEARCH REPORT 2021

24. D isseminated enterovirus infection in a patient treated with Obinutuzumab Authorship: McNeil T, Hannah R, Hui CH, Qiao M.

25. E ffect of a Remotely Delivered Weight Loss

33. I mplementing a prospective surveillance and

Intervention in Early-Stage Breast Cancer:

early intervention model of care for breast

Randomized Controlled Trial.

cancer-related lymphedema into clinical practice:

Authorship: Reeves MM, Terranova CO, Winkler EAH,

application of the RE-AIM framework

McCarthy N, Hickman IJ, Ware RS, Lawler SP, Eakin

Authorship: Koelmeyer L, Gaitatzis K, Ridner SH,

EG, Demark-Wahnefried W.

Boyages J, Nelms J, Hughes TM, Elder E, French J, Ngui N, Hsu J, Stolldorf D.

26. E nhancing Checkpoint Inhibitor Therapy in Solid Tissue Cancers: The Role of Diet, the Microbiome &

34. L envatinib plus Pembrolizumab or Everolimus for

Microbiome-Derived Metabolites

Advanced Renal Cell Carcinoma

Authorship: Malczewski AB, Ketheesan N, Coward

Authorship: Motzer R, Alekseev B, Rha SY, Porta C,

JIG, Navarro S.

Eto M, Powles T, Grünwald V, Hutson TE, Kopyltsov E, Méndez-Vidal MJ, Kozlov V, Alyasova A, Hong SH,

27. E pigenetic Regulation of miR-92a and TET2 and

Kapoor A, Alonso Gordoa T, Merchan JR, Winquist

Their Association in Non-Hodgkin Lymphoma.

E, Maroto P, Goh JC, Kim M, Gurney H, Patel V, Peer

Authorship: Elliott EK, Hopkins LN, Hensen R,

A, Procopio G, Takagi T, Melichar B, Rolland F, De

Sutherland HG, Haupt LM, Griffiths LR.

Giorgi U, Wong S, Bedke J, Schmidinger M, Dutcus

28. E quity should know no borders: The role of Australasian radiation oncologists in supporting radiation oncology services in low- and middle-

CE, Smith AD, Dutta L, Mody K, Perini RF, Xing D, Choueiri TK; CLEAR Trial Investigators.

35. M aintenance treatment with rucaparib for recurrent

income countries in the Asia-Pacific

ovarian carcinoma in ARIEL3, a randomized phase 3

Authorship: Hassan S, Oar A, Ward I, Koh ES,

trial: The effects of best response to last platinum-

Shakespeare TP, Yap ML.

based regimen and disease at baseline on efficacy

29. Focal low dose-rate brachytherapy for low to intermediate risk prostate cancer: preliminary experience at an Australian institution Authorship: Anderson E, Smyth LML, O’Sullivan R, Ryan A, Lawrentschuk N, Grummet J, See AW. 30. H epatitis B in haematology patients receiving intravenous immunoglobulin: highlighting a core issue.

Authorship: Nath K, Wong T, Ahluwalia A, Colquhoun S, Clark PJ, Taylor K, Cherian S. 31. I maging of patients with multiple myeloma and associated plasma cell disorders: consensus practice statement by the Medical Scientific Advisory Group to Myeloma Australia.

Authorship: Creeper K, Augustson B, Kusel K, Fulham MJ, Ho J, Quach H, Mollee P, Weber N, Talaulikar D, Johnston A, Murphy N, Joshua D, Ward C, Ling S, Gibson J, Szer J, Harrison S, Zannettino A, Jaksic W, Lee C, Spencer A, Kalff A, Szabo F, Romeril K, Chan H, Gibbs S, Horvath N, Prince HM. 32. I mplementation of 3D conformal radiotherapy technology at the National Cancer Centre Mongolia: A successful Asia-Pacific collaborative initiative Authorship: Koh ES, Gogna NK, Minjgee M, Tsegmed U, Gonchig O, Vanchinbazar E, Erdenetuya Y, Yap ML, Shelton N, Ochoa C, Ceylan A, Lowe T, Heng SM, Scott A, Oar A, Ward I.

and safety Authorship: Oaknin A, Oza AM, Lorusso D, Aghajanian C, Dean A, Colombo N, Weberpals JI, Clamp AR, Scambia G, Leary A, Holloway RW, Amenedo Gancedo M, Fong PC, Goh JC, O’Malley DM, Armstrong DK, Banerjee S, García-Donas J, Swisher EM, Cameron T, Maloney L, Goble S, Ledermann JA, Coleman RL. 36. M aximum Tolerated Dose and Anti-Tumor Activity of Intraperitoneal Cantrixil (TRX-E-002-1) in Patients with Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer: Phase I Study Results Authorship: Coward JI, Barve MA, Kichenadasse G, Moore KN, Harnett PR, Berg D, Garner JS, Dizon DS. 37. M odelling of a novel technique to improve the visualisation of implanted fiducial markers for intrafraction MV imaging of prostate VMAT targets Authorship: Aland T, Jones M, Aho J, Kairn T, Trapp J. 38. N eoadjuvant Radiotherapy Dose Escalation in Locally Advanced Rectal Cancer: a Systematic Review and Meta-analysis of Modern Treatment Approaches and Outcomes Authorship: Hearn N, Atwell D, Cahill K, Elks J, Vignarajah D, Lagopoulos J, Min M. ICON ANNUAL RESEARCH REPORT 2021

63

2021 PUBLICATIONS CONTINUED 39. N ivolumab plus Cabozantinib versus Sunitinib for

expanded access study in Australia and India.

Advanced Renal-Cell Carcinoma

Authorship: Loi S, Karapetis CS, McCarthy N,

Authorship: Choueiri TK, Powles T, Burotto M,

Oakman C, Redfern A, White M, Khasraw M, Doval

Escudier B, Bourlon MT, Zurawski B, Oyervides

DC, Gore V, Alam M, Binko J, Lu DR, Kim S, Boyle F.

Juárez VM, Hsieh JJ, Basso U, Shah AY, Suárez C, Hamzaj A, Goh JC, Barrios C, Richardet M, Porta C, Kowalyszyn R, Feregrino JP, Żołnierek J, Pook D,

Halcyon linear accelerator using a PTW Octavius

Kessler ER, Tomita Y, Mizuno R, Bedke J, Zhang J,

4D device

Maurer MA, Simsek B, Ejzykowicz F, Schwab GM,

Authorship: Aland T, Jarema T, Trapp JV, Kairn T.

Apolo AB, Motzer RJ; CheckMate 9ER Investigators.

40. N ovel 5-point 18-FDG-PET/CT visual scoring

46. P ersonalizing Conservative Lymphedema Management Using Indocyanine Green-Guided

system for assessing treatment response in

Manual Lymphatic Drainage

patients with oesophageal or gastro-oesophageal

Authorship: Koelmeyer LA, Thompson BM, Mackie H,

junction carcinoma

Blackwell R, Heydon-White A, Moloney E, Gaitatzis K,

Authorship: Cong E, Oar AJ, Lee MT, Chicco A, Lin M,

Boyages J, Suami H.

Yap J, Lin P, Ho Shon I. 41. O utcomes Following Hypofractionated Stereotactic

47. P hysical activity and exercise in adults diagnosed with primary brain cancer: a systematic review

Radiotherapy to the Cavity After Surgery for

Authorship: Sandler CX, Matsuyama M, Jones TL,

Melanoma Brain Metastases.

Bashford J, Langbecker D, Hayes SC.

Authorship: Gallo J, Garimall S, Shanker M, Castelli J, Watkins T, Olson S, Huo M, Foote MC, Pinkham MB. 42. O utcomes with Partial Breast Irradiation vs. Whole

48. P lanned withdrawal of dexamethasone after pomalidomide low dose dexamethasone induction for lenalidomide refractory multiple myeloma (ALLG MM14)

Breast Irradiation: a Meta-Analysis

Authorship: Kalff A, Khong T, Ramachandran M, Ho

Authorship: Shah C, Jia X, Hobbs BP, Tendulkar RD,

PJ, Mollee P, D’Rozario J, Taylor K, Estell J, Norton

Sittenfeld SMC, Al-Hilli Z, Arthur DW, Keisch ME,

S, Kemp R, Mitchell AJ, Reynolds J, Kennedy N,

Khan AJ, Shaitelman SF, Boyages J, Wazer D, Kundu

Quach H, Spencer A.

N, Vicini FA. 43. P albociclib for Residual High-Risk Invasive HR-

49. P ralatrexate in relapsed/refractory T-cell lymphoma: a retrospective multicenter study

Positive and HER2-Negative Early Breast Cancer-

Authorship: Bhurani M, Admojo L, Van Der Weyden

The Penelope-B Trial

C, Twigger R, Bazargan A, Quach H, Zimet A, Coyle L,

Authorship: Loibl S, Marmé F, Martin M, Untch M,

Lindsay J, Radeski D, Hawkes E, Kennedy G, Irving I,

Bonnefoi H, Kim SB, Bear H, McCarthy N, Melé Olivé

Gutta N, Trotman J, Yeung J, Dunlop L, Hua M, Giri P,

M, Gelmon K, García-Sáenz J, Kelly CM, Reimer T, Toi

Yuen S, Panicker S, Moreton S, Khoo L, Scott A,

M, Rugo HS, Denkert C, Gnant M, Makris A, Koehler

Kipp D, McQuillan A, McCormack C, Dickinson M,

M, Huang-Bartelett C, Lechuga Frean MJ, Colleoni

Prince HM.

M, Werutsky G, Seiler S, Burchardi N, Nekljudova V, von Minckwitz G. 44. P albociclib plus letrozole as treatment for

50. P rospective surveillance model in the home for breast cancer-related lymphoedema: a feasibility study

postmenopausal women with hormone receptor-

Authorship: Koelmeyer LA, Moloney E, Boyages J,

positive/human epidermal growth factor receptor

Sherman KA, Dean CM.

2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate: An

64

45. P atient-specific quality assurance on a Varian

ICON ANNUAL RESEARCH REPORT 2021

51. P rostate cancer GTV delineation with biparametric MRI and (68)Ga-PSMA-PET: comparison of expert

contours and semi-automated methods

Authorship: Lim KHT, Kong HL, Chang KTE, Tan DSW,

Authorship: Hearn N, Blazak J, Vivian P, Vignarajah

Tan IBH, Mohamad F, Soh SY, Pang BN, Soo RA, Choo

D, Cahill K, Atwell D, Lagopoulos J, Min M.

SP, Hsieh WS, Aung L.

52. R adiation protection in radiotherapy is

59. R educing axial truncation artefacts in iterative

too conservative

cone-beam CT for radiation therapy using a priori

Authorship: Rijken J, Jeffries C, Baldock C.

pre-conditioned information Authorship: Cai M, Byrne M, Archibald-Heeren B,

53. R andomized phase 3 ALCANZA study of brentuximab

Metcalfe P, Rosenfeld A, Wang Y.

vedotin vs physician’s choice in cutaneous T-cell lymphoma: final data.

60. R epeatability of hypoxia dose painting by numbers

Authorship: Horwitz SM, Scarisbrick JJ, Dummer

based on EF5-PET in head and neck cancer

R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani

Authorship: Wright P, Arnesen MR, Lønne PI,

PL, Bechter O, Eradat H, Pinter-Brown L, Akilov

Suilamo S, Silvoniemi A, Dale E, Minn H, Malinen E.

OE, Geskin LJ, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J,

61. R eport of the ACPSEM radiation oncology medical

Taylor K, Dalle S, Stadler R, Lisano JM, Bunn V, Little

physics workforce modelling project task group.

M, Prince HM.

Authorship: Crowe S, Aland T, Fog L, Greig L, Hamlett L, Lydon J, Waterhouse D, Doromal D,

54. R andomized Trial of Radiation Therapy with Weekly

Sawers A, Round H.

Cisplatin or Cetuximab in Low-Risk HPV-Associated Oropharyngeal Cancer (TROG 12.01) - A Trans-

62. R esponse of factor X deficiency to darutumumab in

Tasman Radiation Oncology Group Study

the treatment of AL amyloidosis: a novel finding

Authorship: Rischin D, King M, Kenny L, Porceddu

Authorship: Mar E, Taylor K, Mollee P.

S, Wratten C, Macann A, Jackson JE, Bressel M, Herschtal A, Fisher R, Fua T, Lin C, Liu C, Hughes BGM, McGrath M, McDowell L, Corry J. 55. R apid Access Palliative Radiation Therapy Clinics:

63. R esponse to brentuximab vedotin versus physician’s choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis

The Evidence Is There, but Where Are the Clinics? An

Authorship: Kim YH, Prince HM, Whittaker S, Horwitz

Australian and New Zealand Perspective

SM, Duvic M, Bechter O, Sanches JA, Stadler R,

Authorship: Roos D, James M, Lah M, Pope K,

Scarisbrick J, Quaglino P, Zinzani PL, Wolter P,

Shorthouse A, Govindaraj R, Holt T.

Eradat H, Pinter-Brown LC, Ortiz-Romero PL, Akilov OE, Trotman J, Taylor K, Weichenthal M, Walewski

56. R eal-world incidence of symptomatic skeletal

J, Fisher D, McNeeley M, Gru AA, Brown L, Palanca-

events and bone-modifying agent use in

Wessels MC, Lisano J, Onsum M, Bunn V, Little M,

castration-resistant prostate cancer - an

Trepicchio WL, Dummer R.

Australian multi-centre observational study Authorship: Anton A, Wong S, Shapiro J, Weickhardt

64. R EZOLVE (ANZGOG-1101): A phase 2 trial of

A, Azad A, Kwan EM, Spain L, Gunjur A, Torres J,

intraperitoneal bevacizumab to treat symptomatic

Parente P, Parnis F, Goh J, Semira MC, Gibbs P, Tran

ascites in patients with chemotherapy-resistant,

B, Pezaro C.

epithelial ovarian cancer Authorship: Sjoquist KM, Espinoza D, Mileshkin

57. R eal-world use of first-generation antiandrogens: impact on patient outcomes and subsequent

L, Ananda S, Shannon C, Yip S, Goh J, Bowtell D, Harrison M, Friedlander ML.

therapies in metastatic castration-resistant prostate cancer

65. R ucaparib maintenance treatment for recurrent

Authorship: Kelly R, Anton A, Wong S, Shapiro J,

ovarian carcinoma: the effects of progression-free

Weickhardt A, Azad A, Kwan EM, Spain L, Muthusamy

interval and prior therapies on efficacy and safety in

A, Torres J, Parente P, Parnis F, Goh J, Joshua A,

the randomized phase III trial ARIEL3

Pook D, Baenziger O, Gibbs P, Tran B.

Authorship: Clamp AR, Lorusso D, Oza AM, Aghajanian C, Oaknin A, Dean A, Colombo N,

58. R ecommended testing algorithms for NTRK gene fusions in pediatric and selected adult cancers: Consensus of a Singapore Task Force.

Weberpals JI, Scambia G, Leary A, Holloway RW, Amenedo Gancedo M, Fong PC, Goh JC, O’Malley DM, ICON ANNUAL RESEARCH REPORT 2021

65

2021 PUBLICATIONS CONTINUED Armstrong DK, Banerjee S, García-Donas J, Swisher

measurements and Monte Carlo simulations

EM, Cameron T, Goble S, Coleman RL, Ledermann JA.

Authorship: Rijken J, Towns S, Healy B.

66. S hould Lutetium-prostate specific membrane

73. T he Risk of Subclinical Breast Cancer-Related

antigen radioligand therapy for metastatic prostate

Lymphedema by the Extent of Axillary Surgery and

cancer be used earlier in men with lymph node only

Regional Node Irradiation: A Randomized Controlled

metastatic prostate cancer?

Trial

Authorship: Yaxley WJ, McBean R, Wong D, Grimes D,

Authorship: Boyages J, Vicini FA, Shah C, Koelmeyer

Vasey P, Frydenberg M, Yaxley JW.

LA, Nelms JA, Ridner SH.

67. S tereotactic body radiotherapy in the management

74. T he utilization of allied and community health

of hepatocellular carcinoma: An Australian multi-

services by cancer patients living in regional and

institutional patterns of practice review

remote geographical areas in Australia

Authorship: Liu HY, Lee YD, Sridharan S, Choong ES,

Authorship: Parikh DR, Diaz A, Bernardes C, De Ieso

Le H, Wang W, Khor R, Chu J, Oar A, Mott R, Smart

PB, Thachil T, Kar G, Stevens M, Garvey G.

J, Jenkins T, Anderson N, Cross S, Loo KF, Wigg A, Stuart K, Pryor D.

75. T herapeutic implications of immune-profiling and EGFR expression in salivary gland carcinoma

68. S urvey of germline variants in cancer-associated

Authorship: Guazzo E, Cooper C, Wilkinson L,

genes in young adults with colorectal cancer.

Feng S, King B, Simpson F, Porceddu S, Panizza B,

Authorship: Mikaeel RR, Young JP, Li Y, Smith E,

Coward JIG.

Horsnell M, Uylaki W, Tapia Rico G, Poplawski NK, Hardingham JE, Tomita Y, Townsend AR, Feng J,

76. Treatment outcomes for patients with metastatic

Zibat A, Kaulfuß S, Müller C, Yigit G, Wollnik B, Price

castrate-resistant prostate cancer following

TJ.

docetaxel for hormone-sensitive disease Authorship: Schmidt A, Anton A, Shapiro J, Wong

69. Talazoparib monotherapy in metastatic castration-

S, Azad A, Kwan E, Spain L, Muthusamy A, Torres

resistant prostate cancer with DNA repair

J, Parente P, Parnis F, Goh J, Joshua AM, Pook D,

alterations (TALAPRO-1): an open-label, phase 2

Gibbs P, Tran B, Weickhardt A.

trial Authorship: de Bono JS, Mehra N, Scagliotti GV,

77. U nmet needs in breast cancer survivors

Castro E, Dorff T, Stirling A, Stenzl A, Fleming MT,

are common, and multidisciplinary care is

Higano CS, Saad F, Buttigliero C, van Oort IM, Laird

underutilised: the Survivorship Needs Assessment

AD, Mata M, Chen HC, Healy CG, Czibere A, Fizazi K.

Project Authorship: Vuksanovic D, Sanmugarajah J, Lunn D,

70. T he first real-time intrafraction target position

Sawhney R, Eu K, Liang R.

monitoring in pancreas SBRT on an Elekta linear accelerator

78. Varian Ethos online adaptive radiotherapy for

Authorship: Arumugam S, Pavey D, Oar A, Holloway

prostate cancer: Early results of contouring

L, Sidhom M, Lee M.

accuracy, treatment plan quality, and treatment time.

71. T he Modernization of Radiation Therapy Services in

Authorship: Byrne M, Archibald-Heeren B, Hu Y,

Cambodia: A Model of International Collaboration

Teh A, Beserminji R, Cai E, Liu G, Yates A, Rijken J,

Authorship: Eav S, Mel M, Ath V, Shelton N, Rogl K,

Collett N, Aland T.

Newman G, Ward I, Yap ML. 79. Weight Gain and Lymphedema After Breast Cancer 72. T he need to update NCRP 151 data for 10 MV linear accelerator bunker shielding based on new

66

ICON ANNUAL RESEARCH REPORT 2021

Treatment: Avoiding the Catch-22?

Authorship: Boyages J, Cave AE, Naidoo D, Ee CCL.

“Without the bravery and commitment of patients and their loved ones we cannot advance cancer treatments; they are our leaders and have the gratitude and admiration of the entire Icon community.”

DR JOHN BASHFORD FRACP, FRCPA, MAICD

Icon Group Director of Research

ICON ANNUAL RESEARCH REPORT 2021

67

TRIALS REGISTER 2021 68

ICON ANNUAL RESEARCH REPORT 2021

FOR A FULL LIST OF CURRENT ICON TRIALS VISIT: AUSTRALIA | SINGAPORE

ICON ANNUAL RESEARCH REPORT 2021

69

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - OPEN TO RECRUITMENT

MEDICAL ONCOLOGY

70

Abbrev. Title

Protocol Title

M19-037

A Phase 1 First-in Human, Multi-Center, Open Label, Dose-Escalation Study to Determine the Safety,Tolerability and Pharmacokinetics of ABBV-927 and ABBV-368 with and without ABBV-181 in Subjects with Locally Advanced or Metastatic Solid Tumors

M19-345

A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination with ABBV-181 in Subjects with Locally Advanced or Metastatic Solid Tumors

ADG116-1003

A Phase 1b, Open-Label, Dose Escalation and Expansion Study of ADG116, ADG116 Combined with Toripalimab (Anti-PD-1 Antibody), ADG116 Combined with ADG106 (Anti-CD137 Antibody) in Patients with Advanced/Metastatic Solid Tumors

AK112-101

A Phase 1a/1b, Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK112 in Subjects with Advanced Solid Tumors

AK114-102

A Phase 1a, Multicentre, Open Label, Dose-escalating Study to Evaluate the Safety, Pharmacokinetics and Anti Tumor Activity of AK114 in Subjects with Advanced or Metastatic Solid Tumors

AK117-101

A Phase 1, multicenter, open-label, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, and antitumor activity of AK117 in subjects with relapsed / refractory advanced or metastatic solid tumors or lymphomas

AK119-102

A Phase 1a/1b, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics, and antitumor activity of AK119 in combination with AK104 in subjects with advanced or metastatic solid tumors.

AK127-101

A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of AK127 in Combination with AK104 in Subjects with Advanced or Metastatic Solid Tumors

DESTINY PanTumor02 D967VC00001

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors

SHR-1701-001AUS

Phase 1, Open-Label, Multicenter, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety and Tolerability of SHR-1701 in Subjects with Advanced Solid Tumors

OPEN TO RECRUITMENT — AUSTRALIA

Indication

Sponsor

Location

Advanced malignancies

Abbvie

Icon Cancer Centre South Brisbane

Advanced malignancies

Abbvie

Icon Cancer Centre South Brisbane

Advanced malignancies

Adagene

Icon Cancer Centre Adelaide (Tennyson)

Advanced malignancies

AkesoBio

Icon Cancer Centre South Brisbane, Icon Cancer Centre Adelaide (Tennyson)

Advanced malignancies

Akesobio

Icon Cancer Centre Adelaide (Tennyson)

Advanced malignancies

Akesobio

Icon Cancer Centre South Brisbane, Icon Cancer Centre Adelaide (Tennyson)

Advanced malignancies

Akesobio

Icon Cancer Centre South Brisbane, Icon Cancer Centre Adelaide (Tennyson)

Advanced malignancies

Akesobio

Icon Cancer Centre Adelaide (Tennyson)

Advanced malignancies

AstraZeneca

Icon Cancer Centre South Brisbane

Advanced malignancies

Atridia

Icon Cancer Centre South Brisbane

ICON ANNUAL RESEARCH REPORT 2021

71

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - OPEN TO RECRUITMENT

OPEN TO RECRUITMENT — AUSTRALIA

72

Abbrev. Title

Protocol Title

SHR2002-102

A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection in Combination With SHR-1316 in Patients With Advanced Malignant Tumors

BGB-290-103

Phase 1b Study to Assess the Safety, Tolerability, and Clinical Activity of BGB-290 in Combination with Temozolomide (TMZ) in Subjects with Locally Advanced or Metastatic Solid Tumors

BGB-A317- 15025-101

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB 15025 alone and in Combination with AntiPD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors

BGB-A317- 290-LTE1

An Open-Label, Multicenter, Long-term Extension Study of Tislelizumab-Containing Treatment and/or Pamiparib-Containing Treatment in Patients With Advanced Malignancies

CL001_559

A Phase 1 First In Human, Multicenter, Open-Label Study to determine the safety, tolerability, pharmacokinetics, and Recommended Phase 2 Dose of Ccx559 in subjects with solid tumors

TQB2928-I-01

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TQB2928 Injection in Patients with Advanced Solid Tumors or Hematological Malignancies

DB1303-O-1001

This study is a Multicenter, open label, none randomized First in human Phase1/2 study to assess the safety, tolerability, PK, PD and preliminary antitumor activity of DB1303 in subjects with advanced solid malignant tumours.

FPT155-001

A Phase 1a/1b Study of FPT155 in Patients with Advanced Solid Tumours

Ragnar 42756493CAN2002

A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and Selected FGFR Gene Alterations.

MAX-10181-001

A Phase I study of MAX-10181 given orally to patients with advanced solid tumors

ABILITY MDNA11-01

Trial designed to assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of MDNA11 in patients with advanced solid tumors

Indication

Sponsor

Location

Advanced malignancies

Atridia

Icon Cancer Centre South Brisbane

Advanced malignancies

BeiGene

Icon Cancer Centre South Brisbane

Advanced malignancies

Beigene

Icon Cancer Centre Windsor Gardens

Advanced malignancies

BeiGene

Icon Cancer Centre Wesley

Advanced malignancies

ChemoCentryx

Icon Cancer Centre Windsor Gardens

Advanced malignancies

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Icon Cancer Centre Adelaide (Tennyson)

Advanced malignancies

DB3

Icon Cancer Centre South Brisbane

Advanced malignancies

Five Prime

Icon Cancer Centre South Brisbane

Advanced malignancies

Janssen

Icon Cancer Centre South Brisbane

Advanced malignancies

MaxiNovel

Icon Cancer Centre South Brisbane

Advanced malignancies

Medicenna

Icon Cancer Centre South Brisbane

ICON ANNUAL RESEARCH REPORT 2021

73

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - OPEN TO RECRUITMENT

OPEN TO RECRUITMENT — AUSTRALIA

74

Abbrev. Title

Protocol Title

SUCCEED MG010-001

A Phase II, two-arm, open label, randomised, multi-centre study to assess the safety, tolerability and efficacy of MG010 in combination with sorafenib in subjects with solid tumours who have failed existing treatments.

CANVACCS

CANcer patients' perspectives on coronavirus VACCination Survey (CANVACCS) research project

CK-301-101

A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects with Advanced Cancers

CN1-101

A Phase I, Open Label, Multi-Center, Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN1 in Patients with Advanced Solid Tumors or B-cell Lymphoma

YH003002

A Multicenter, Open-Label, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of YH003 in combination with Toripalimab (anti-PD-1 mAb) in Subjects with Advanced Solid Tumors

RLY-4008-101

A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

ABSK043-101

A Phase 1, Open-Label Study of ABSK043 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor

PATINA ANZ1701 / AFT-38

A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/ HER2-Positive Metastatic Breast Cancer

DESTINY-Breast12 D9673C00007

An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously Treated Advanced/Metastatic HER2-Positive Breast Cancer

EMBER J2J-MC-JZLA

A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination with Anticancer Therapies for Patients with ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers

Indication

Sponsor

Location

Advanced malignancies

Metagone Biotech

Icon Cancer Centre South Brisbane

Advanced malignancies

Monash University

Icon Cancer Centre Hobart

Advanced malignancies

Novotech

Icon Cancer Centre South Brisbane

Advanced malignancies

Novotech

Icon Cancer Centre South Brisbane

Advanced malignancies

Novotech

Icon Cancer Centre South Brisbane

Advanced malignancies

Relay

Icon Cancer Centre South Brisbane

Advanced malignancies

Abbisko

Icon Cancer Centre South Brisbane

Breast Cancer

ANZBCTG

Icon Cancer Centre Wesley

Breast Cancer

AstraZeneca

Icon Cancer Centre Wesley

Breast Cancer

Eli Lilly

Icon Cancer Centre Adelaide (Tennyson)

ICON ANNUAL RESEARCH REPORT 2021

75

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - OPEN TO RECRUITMENT

OPEN TO RECRUITMENT — AUSTRALIA

76

Abbrev. Title

Protocol Title

IMPassion030/ Alexandra BIG 16-05/AFT-27/ WO39391

A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination with Standard Adjuvant Anthracycline / Taxane-Based Chemotherapy versus Chemotherapy Alone in Patients with Operable Triple Negative Breast Cancer.

lidERA GO42784 TRIO045

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating The Efficacy And Safety Of Adjuvant Gdc-9545 Compared With Physician’s Choice Of Adjuvant Endocrine Monotherapy In Patients With Estrogen Receptor−Positive, Her2-Negative Early Breast Cancer

OP-1250-001

A Phase I/II Open-label, First-in-Human, Multicenter, Dose Escalation and Dose Expansion Study of OP-1250 Monotherapy in Adult Subjects With Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer

OP-1250-002

A Phase 1 Dose Escalation and Dose Expansion Open-label, Multicenter, Study of OP-1250 in Combination with the CDK4/6 Inhibitor Palbociclib in Adult Subjects with Advanced or Metastatic HR-positive, HER2-negative Breast Cancer

CUPISCO MX39795

A Phase II, Randomized, Active-Controlled, Multi-Center Study Comparing The Efficacy And Safety Of Targeted Therapy Or Cancer Immunotherapy Guided By Genomic Profiling Versus Platinum-Based Chemotherapy In Patients With Cancer Of Unknown Primary Site Who Have Received Three Cycles Of Platinum Double

RINGSIDE AL-DES-01

A Phase 2/3, Randomised, Multicenter Study to Evaluate AL102 in Patients with Progressing Desmoid Tumours

ATTEND IRFMN-EN-7556

Phase III Double-Blind Randomized Placebo Controlled Trial of Atezolizumab in Combination with Paclitaxel and Carboplatin in Women with Advanced/Recurrent Endometrial Cancer

ASPEN-03 AT148003

A Phase 2 Study Of ALX148 In Combination With Pembrolizumab In Patients With Advanced Head And Neck Squamous Cell Carcinoma (ASPEN-03)

ASPEN-04 AT148004

A Phase 2 Study Of ALX148 In Combination With Pembrolizumab And Chemotherapy In Patients With Advanced Head And Neck Squamous Cell Carcinoma ( ASPEN-04)

NORTH CP-MGA271-06

A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination with Retifanlimab or Tebotelimab in the First-Line Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Indication

Sponsor

Location

Breast Cancer

Roche

Icon Cancer Centre Adelaide (Tennyson), Icon Cancer Centre Wesley

Breast Cancer

Roche

Icon Cancer Centre Hobart, Icon Cancer Centre Adelaide (Tennyson), Icon Cancer Centre Wesley

Breast Cancer

Olema

Icon Cancer Centre Wesley

Breast Cancer

Olema

Icon Cancer Centre Wesley

Cancer of unknown primary

Roche

Icon Cancer Centre Chermside

Desmoid tumours

Ayala

Icon Cancer Centre Adelaide (Tennyson)

Endometrial Cancer

ANZGOG

Icon Cancer Centre Chermside

Head and Neck Cancer

ALX Oncology

Icon Cancer Centre Adelaide (Tennyson)

Head and Neck Cancer

ALX Oncology

Icon Cancer Centre Adelaide (Tennyson)

Head and Neck Cancer

MacroGenics, Inc

Icon Cancer Centre Southport

ICON ANNUAL RESEARCH REPORT 2021

77

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - OPEN TO RECRUITMENT

OPEN TO RECRUITMENT — AUSTRALIA

78

Abbrev. Title

Protocol Title

BGB-900-105

Phase 1/1b Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) in Patients with Unresectable Lo

RELATIVITY CA224-104

A Phase 2 Randomized Double-blind Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy as First Line Treatment for Participants with Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

COSTAR Lung 213410

A Randomized, Parallel-group Treatment, Phase 2/3, Open-label, 3-arm Study Comparing Efficacy of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Male and Female Participants Aged 18 Years and Older With Advanced Non-small Cell Lung Cancer Who Have Progressed on P

B.FAST BO29554

A Phase 2/3 Multicentre Study evaluating the efficacy and safety of multiple targeted therapies as treatments for patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harbouring actionable somatic mutations detected in blood . (B-Fast:

RTN2 TROG 08.09

A Randomised Trial of Post-operative Radiation Therapy Following Wide Excision of Neurotropic Melanoma of the Head and Neck

Y H003004

A Study to Assess YH003 in Combination With Toripalimab(Anti-PD-1 mAb) Injection in Patients With Cancers

HBI-8000-303

A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI 8000 Combined with Nivolumab versus Placebo with Nivolumab in Patients with Unresectable or Metastatic Melanoma Not Previously Treated with PD-1 or PD-L1 Inhibitors

PIVOT-12 20-214-29/ CA045-22

A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence

ORBIT-M

Microba-ORBIT-m_Optimized Response Biome for Immuno Therapy Treatment

I-MAT I-MAT

A randomised placebo-controlled phase II trial of adjuvant avelumab in early stage Merkel cell carcinoma

Indication

Sponsor

Location

Lung Cancer

Beigene

Icon Cancer Centre South Brisbane, Icon Cancer Centre Windsor Gardens

Lung Cancer

Bristol Myers-Squibb

Icon Cancer Centre South Brisbane

Lung Cancer

GSK

Icon Cancer Centre South Brisbane, Icon Cancer Centre Adelaide (Tennyson)

Lung Cancer

Roche

Icon Cancer Centre Adelaide (Tennyson)

Melanoma

ANZMTG

Icon Cancer Centre Toowoomba

Melanoma

Eucure

Icon Cancer Centre Wesley

Melanoma

HUYA

Icon Cancer Centre Wesley

Melanoma

Nektar

Icon Cancer Centre Wesley

Melanoma

Microba

Icon Cancer Centre Hobart

Merkel Cell Cancer

MASC

Icon Cancer Centre Hobart

ICON ANNUAL RESEARCH REPORT 2021

79

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - OPEN TO RECRUITMENT

OPEN TO RECRUITMENT — AUSTRALIA

80

Abbrev. Title

Protocol Title

DREAM3R CTC 0231 ALTG18/001

Durvalumab (MEDI4736) with Chemotherapy as First Line Treatment in Advanced Pleural Mesothelioma - A Phase 3 Randomised Trial.

EMBRACE CTC0160

Phase II clinical trial of the PARP inhibitor, olaparib, in HR-deficient metastatic breast and relapsed ovarian cancer in patients without germline mutations in BRCA1 and BRCA2

ICON-9

An international Phase III randomised trial of cediranib & olaparib maintenance in patients with relapse platinum sensitive ovarian cancer

ANZUP1907

A retrospective study to identify clinical predictors of early metastatic disease using PSMA PET imaging.

RADIANT BAY 88-8223 / 20510

A Phase 4, randomized, open-label, multicenter efficacy and safety study of standard dose of radium-223 dichloride vs. standard doses of novel anti-hormonal therapy (NAH) in patients with bone dominant metastatic castration resistant prostate cancer progressing on/after one line of NAH.

ePAD Prostate

Electronic CRPC Australian Database

Checkmate-7DX CA2097DX

A Phase 3 Randomized, Double-Blind Study of Nivolumab or Placebo in Combination with Docetaxel, in Men with Metastatic Castration-resistant Prostate Cancer (CheckMate 7DX: CHECKpoint pathway and nivoluMAB clinical Trial Evaluation 7DX)

Statins-Lipidomics

Statins in Metastatic Castration-Resistant Prostate Cancer-A multi-centre, open label trial of simvastatin in addition to docetaxel chemotherapy for metastatic castrationresistant prostate cancer

PROCADE HC1119-CS-03

A Multinational Phase 3, Randomized, Double-Blind, Non-inferiority, Efficacy and Safety Study of Oral HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

AMPLITUDE 67652000PCR3002

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metast

Indication

Sponsor

Location

Mesothelioma

ALTG

Icon Cancer Centre Chermside, Icon Cancer Centre Wesley

Ovarian Cancer

ANZGOG

Icon Cancer Centre Wesley

Ovarian Cancer

ANZGOG

Icon Cancer Centre South Brisbane

Prostate Cancer

ANZUP

Icon Cancer Centre Hobart

Prostate Cancer

Bayer

Icon Cancer Centre South Brisbane, Icon Cancer Centre Adelaide (Tennyson)

Prostate Cancer

BioGrid

Icon Cancer Centre Adelaide (Tennyson)

Prostate Cancer

Bristol Myers-Squibb

Icon Cancer Centre Chermside

Prostate Cancer

Chris O’Brien Lifehouse

Icon Cancer Centre Adelaide (Tennyson)

Prostate Cancer

HINOVA

Icon Cancer Centre Southport

Prostate Cancer

Janssen

Icon Cancer Centre Chermside, Icon Cancer Centre Adelaide (Tennyson)

ICON ANNUAL RESEARCH REPORT 2021

81

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - OPEN TO RECRUITMENT

OPEN TO RECRUITMENT — AUSTRALIA

82

Abbrev. Title

Protocol Title

FUZOPRO SHR3162-III-305

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined with Abiraterone Acetate and Prednisone (AA-P) versus Placebo Combined with AA-P as First-Line Treatment in Patients with Metastatic CastrationResistant P

RAVES TROG 08.03

A Phase III Multi-centre Randomised Trial Comparing Adjuvant Radiotherapy (RT) With Early Salvage RT in Patients With Positive Margins or Extraprostatic Disease Following Radical Prostatectomy.

Real-PRO

Registry-based Study of Enzalutamide vs Abiraterone assessing cognitive function in Elderly Metastatic Castration-Resistant Prostate Cancer

UniCAB ANZUP1802

A Phase II Trial Of Single Agent Cabozantinib In Patients With Locally Advanced Or Metastatic Non-Clear Cell Renal Cell Carcinoma Post Immunotherapy Or Who Are Unsuitable For Immunotherapy

Checkmate-914 CA209914

A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

KRAB 2018.158

Kidney canceR Australian registry and Biobank

C-POST R2810-ONC-1788

A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma

iTestis 2017.372

Bioinformatics for Testis Cancer

Tropics-04 IMMU-132-13

A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cancer

Indication

Sponsor

Location

Prostate Cancer

Jiangsu Hengrui Medicine

Icon Cancer Centre Adelaide (Tennyson)

Prostate Cancer

TROG

Icon Cancer Centre Toowoomba

Prostate Cancer

Walter & Eliza Hall Institute

Icon Cancer Centre Adelaide (Tennyson)

Renal Cell Cancer

ANZUP

Icon Cancer Centre Adelaide (Tennyson)

Renal Cell Cancer

Bristol Myers-Squibb

con Cancer Centre Chermside

Renal Cell Cancer

Walter & Eliza Hall Institute

Icon Cancer Centre Adelaide (Tennyson)

Skin Cancer

Regeneron

Icon Cancer Centre Southport, Icon Cancer Centre Adelaide (Tennyson)

Testicular Cancer

Walter & Eliza Hall Institute

Icon Cancer Centre Adelaide (Tennyson)

Urothelial Cance

Gilead

Icon Cancer Centre Adelaide (Tennyson), Icon Cancer Centre Wesley

ICON ANNUAL RESEARCH REPORT 2021

83

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - OPEN TO RECRUITMENT

OPEN TO RECRUITMENT — SINGAPORE

84

Abbrev. Title

Protocol Title

HER2Real D9673R00005

A Multicountry, Multicentre, Noninterventional Retrospective Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2positive Unresectable or Metastatic Breast Cancer.

DESTINY-Breast06 D9670C00001

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting.

KRYSTAL-10 849-010

A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy.

TROPION-LUNG01 DS1602-A-U301

Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations.

LIQUIK-01 PXL 252853

LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC).

INSIGHT-2 MS2000950031

A Phase II, two arm study to investigate Tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapy

KRYSTAL-12 849-012

A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation.

AY-mAbs203

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor in Combination With Irinotecan and Temozolomide in Patients With High-Risk Neuroblastoma With Primary Refractory Disease or in First Relapse. An International, Single-Arm, Multicenter Phase 2 Trial.

Tropics-04 IMMU-132-13

A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cance

Indication

Sponsor

Location

Breast Cancer

AstraZeneca

Icon Cancer Centre Farrer Park

Breast Cancer

AZ Daiichi Snkyo

Icon Cancer Centre Gleneagles

Colorectal Cancer

Mirati

Icon Cancer Centre Farrer Park

Lung Cancer

AZ Daiichi Snkyo

Icon Cancer Centre Farrer Park

Lung Cancer

Lucence

Icon Cancer Centre Farrer Park

Lung Cancer

Merck

Icon Cancer Centre Farrer Park

Lung Cancer

Mirati

Icon Cancer Centre Farrer Park

Neuroblastoma

Y-mAbs Therapeutics

Icon Cancer Centre Mount Alvernia

Urothelial Cancer

Gilead

Icon Cancer Centre Farrer Park

ICON ANNUAL RESEARCH REPORT 2021

85

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

86

Abbrev. Title

Protocol Title

C-550-01

A Phase 1/2, Open-Label, Multi-Arm Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination with AGEN2034 in Subjects with Metastatic or Locally Advanced Solid Tumors, and Expansion into Select Solid Tumors

AK104-101

A Phase 1a/1b multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, pharmacokinetics, and antitumor activity of AK104 in subjects with advanced solid tumors

AK105-101

A Phase 1a/1b Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK105 in Subjects with Advanced Solid Tumors.

AB154CSP0001

A Phase 1 Study to Evaluate the Safety and Tolerability of AB154 Monotherapy and Combination Therapy in Participants with Advanced Malignancies

BGB-900-103

A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Sitravatinib in Combination with Tislelizumab in Patients with Advanced Solid Tumors.

CS1002-101

A Phase Ia/Ib, Open-Label, Dose-Escalation and Dose-Expansion Study of the AntiCTLA- 4 Monoclonal Antibody as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody in Subjects with Advanced Solid Tumors

CS1003-101

A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects with Advanced Solid Tumors

INMB-001

Phase 1 Open-Label, Dose Escalation Study of INB03 in Patients with Metastatic Cancer with Increased Inflammatory Biomarkers in Peripheral Blood

MK-1308-001

A Phase 1 Open Label, Multi-Arm, Multicenter Study of MK-1308 in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

MK-7684-001

A Phase 1 Trial of MK-7684 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Indication

Sponsor

Location

Advanced malignancies

Agenus

Icon Cancer Centre South Brisbane

Advanced malignancies

Akesobio

Icon Cancer Centre South Brisbane

Advanced malignancies

Akesobio

Icon Cancer Centre South Brisbane, Icon Cancer Centre Adelaide (Tennyson)

Advanced malignancies

Arcus Biosciences

Icon Cancer Centre South Brisbane

Advanced malignancies

BeiGene

Icon Cancer Centre Chermside

Advanced malignancies

CStone

Icon Cancer Centre Adelaide (Tennyson)

Advanced malignancies

CStone

Icon Cancer Centre South Brisbane

Advanced malignancies

INmune

Icon Cancer Centre South Brisbane

Advanced malignancies

Merck

Icon Cancer Centre Adelaide (Tennyson)

Advanced malignancies

Merck

Icon Cancer Centre Adelaide (Tennyson)

ICON ANNUAL RESEARCH REPORT 2021

87

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

88

Abbrev. Title

Protocol Title

XNW7201-1-02

A Phase I, Open-Label, Multi-Center, Non-Randomized, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of XNW7201 in Subjects with Advanced Solid Tumors.

INTR@PID BTC-055 MS200647-0055

A Phase II, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine plus Cisplatin With and Without M7824 as a First-line Treatment of Biliary Tract Cancer.

POTOMAC D419JC00001

A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG-Na??ve Non-Muscle-Invasive Bladder Cancer Patients (POTOMAC)

JAVELIN100 B9991001

A Phase 3, Multicenter, Multinational, Randomized, Open-Label, Parallel-Arm Study, of Avelumab*(MSB0010718C) Plus Best Supportive Care Versus Best Supportive Care Alone As A Maintenance treatment in patients with locally advanced or metastatic urothelial cancer whose disease did not progress after c

PENELOPE B GBG78_BIG1-13

Phase III Study evaluating palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in patients with hormone-receptor-positive, HER2-normal primary breast cancer withy high relapse risk after neoadjuvant chemotherapy

CAPItello-291 D3615C00001

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor

OLYMPIA D081CC00006

A randomised, double-blind, parallel group, placebo-controlled multi-centre phase III study to assess the efficiacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA 1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitiv

RAPPER BCRC122

Review Of Australian Prescribing Practices Of Eribulin

SOFT IBCSG 24-02/BIG 2-02

A phase III trial evaluating the role of Ovarian Function Suppression and the role of exemestane as adjuvant therapies for post menopausal women with endocrine responsive Breast Cancer

HER2CLIMB ONT 380-206

Phase 2 Randomized, Double-Blinded, Controlled Study of ONT-380 vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma

Indication

Sponsor

Location

Advanced malignancies

Sinovent

Icon Cancer Centre South Brisbane

Biliary Tract Cancer

Merck

Icon Cancer Centre Wesley

Bladder Cancer

AstraZeneca

Icon Cancer Centre Wesley

Bladder Cancer

Pfizer

Icon Cancer Centre Adelaide (Tennyson), Icon Cancer Centre Wesley

Breast Cancer

ANZBCTG

Icon Cancer Centre Wesley

Breast Cancer

Astra Zeneca

Icon Cancer Centre Adelaide (Tennyson), Icon Cancer Centre Wesley

Breast Cancer

AstraZeneca

Icon Cancer Centre Wesley

Breast Cancer

BCRC-WA

Icon Cancer Centre Adelaide (Tennyson)

Breast Cancer

BCT

Icon Cancer Centre Wesley

Breast Cancer

Cascadian

Icon Cancer Centre Wesley

ICON ANNUAL RESEARCH REPORT 2021

89

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

90

Abbrev. Title

Protocol Title

I3Y-MC-JPCP

An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability when Receiving Abemaciclib for Patients with Previously Treated Hormone ReceptorPositive, HER2-Negative, Metastatic Breast Cancer

MONARCH2 I3Y-MC-JPBL

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant with or without Abemaciclib, a CDK4/6 Inhibitor, for Women with Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

MONARCH-E I3Y-MC-JPCF

A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Re

Keynote-119 MK-3475-119

A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab versus Single Agent Chemotherapy per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC)

MONALEESA-2 CLEE011A2301

A randomized double-blind, placebo-controlled study of LEE011 in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease

PALOMA3 A5481023

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (Faslodex(R)) With or Without PD-0332991 (Palbociclib) Goserelin in Women with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Whose Disease Progressed After Prior Endocrine Therapy

TRIO22 A5481008

A Randomized, Multicenter, Double-Blind Phase 3 Study of PD-0332991 (Oral CDK 4/6 Inhibitor) plus letrozole versus placebo plus letrozole for the Treatment of Postmenopausal Women with ER (+), HER2 (-) Breast Cancer who have not received any prior Systemic Anti-cancer Treatment for Advanced Disease.

APHINITY BO25126

A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer

IPATunity170 CO41101

A phase III, double-blind, placebo-controlled, randomized study of Ipatasertib in combination with Atezolizumab and Paclitaxel as a treatment for patients with locally advanced unresectable or metastatic Triple-Negative Breast Cancer

Indication

Sponsor

Location

Breast Cancer

Eli Lilly

Icon Cancer Centre Adelaide (Tennyson)

Breast Cancer

Eli Lilly

Icon Cancer Centre Adelaide (Tennyson), Icon Cancer Centre Wesley

Breast Cancer

Eli Lilly

Icon Cancer Centre Adelaide (Tennyson)

Breast Cancer

Merck

Icon Cancer Centre Wesley

Breast Cancer

Novartis

Icon Cancer Centre Adelaide (Tennyson)

Breast Cancer

Pfizer

Icon Cancer Centre Southport

Breast Cancer

Pfizer

Icon Cancer Centre Wesley

Breast Cancer

Roche

Icon Cancer Centre Wesley

Breast Cancer

Roche

Icon Cancer Centre Adelaide (Tennyson)

ICON ANNUAL RESEARCH REPORT 2021

91

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

92

Abbrev. Title

Protocol Title

KAITLIN BO28407

A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines As Adjuvant Therapy In Patients With Operable HER2-Positive Primary Breast Cancer

PERUSE MO28047

A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2-positive advanced (metastatic or locally recurrent) breast cancer.

NATALEE TRIO033

A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer

NUTMEG COGNO 16/01

A Randomized Phase II Study of NivolUmab and TeMozolomide vs Temozolomide in newly diagnosed Elderly Glioblastoma

AK104-201-AU

A Phase 2, multicenter, single-arm, open-label study to evaluate the efficacy and safety of AK104 in subjects with recurrent or metastatic cervical cancer

FRESCO-2 2019-013GLOB1

A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer

PHAEDRA ANZGOG1601

A Phase II trial of DuRvalumab (Medi 4736) in Advanced Endometrial Cancer ???PHAEDRA???

INTRIGUE DCC-2618-03002

A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumors after Treatment with Imatinib

TrilynX Debio1143SCCHN-301

A randomized, double-blind placebo-controlled, Phase 3 study of Debio 1143 in combination with platinum-based chemotherapy and standard fractionation intensitymodulated radiotherapy in patients with locally advanced squamous cell carcinoma of the head an

IMvoke010 WO40242

A Phase III, multicenter, randomized, double-blind, placebo-controlled study of atezolizumab (anti-PD-L1 antibody) as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced Squamous Cell Carcinoma of the Head and Neck

COSMIC 312 XL184-312

A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy

Indication

Sponsor

Location

Breast Cancer

Roche

Icon Cancer Centre Wesley

Breast Cancer

Roche

Icon Cancer Centre Wesley

Breast Cancer

TRIO

Icon Cancer Centre Wesley

Central Nervous System Neoplasms

COGNO

Icon Cancer Centre Wesley

Cervical Cancer

Akesobio

Icon Cancer Centre Chermside, Icon Cancer Centre Adelaide (Tennyson)

Colorectal Cancer

Hutchison MediPharma

Icon Cancer Centre South Brisbane

Endometrial Cancer

ANZGOG

Icon Cancer Centre South Brisbane

Gastrointestinal Stromal tumours

Deciphira

Icon Cancer Centre Adelaide (Tennyson)

Head and Neck Cancer

Debio

Icon Cancer Centre Adelaide (Tennyson)

Head and Neck Cancer

Roche

Icon Cancer Centre Adelaide (Tennyson)

Hepatocellular Carcinoma

Exelixis

Icon Cancer Centre Adelaide (Tennyson)

ICON ANNUAL RESEARCH REPORT 2021

93

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

94

Abbrev. Title

Protocol Title

ADAURA D5164C00001

A Phase III, Double-blind, Randomized, Placebo-Controlled Multi-centre, study to assess the efficacy and safety of AZD9291 versus Placebo, in Patients with Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, fol

Illuminate-301 2125-MEL301

A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with PD 1 Refractory Melanoma

Keynote-716 MK-3475716

Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study

APOLLO-1 CBT-501

A phase 1/2 open label, multi-center dose escalation and expansion study of combination immunotherapy APL-501 (anti-PD-1) or nivolumab with APL-101 (c-Met inhibitor) in locally advanced or metastatic hepatocellular carcinoma and renal cell carcinoma

VELIA M13-694

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP inhibitor) in Subject with Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

SORAYA IMGN853-0417

A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

JAVELIN200 B9991009

A Phase 3, Multicenter, Randomized, Open-Label Study Of Avelumab (MSB0010718C) Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum-Resistant/Refractory Ovarian Cancer

CanStem111P

A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma.

CL-SBP-101-03

A Phase 1a/1b Dose Escalation and Expansion Study of SBP-101 in Combination with Nab-Paclitaxel and Gemcitabine in Subjects with Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

ENZAMET ANZUP1304

Randomised phase 3 trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer

Indication

Sponsor

Location

Lung Cancer

Astra Zeneca

Icon Cancer Centre Adelaide (Tennyson)

Melanoma

Idera

Icon Cancer Centre Wesley

Melanoma

Merck

Icon Cancer Centre Adelaide (Tennyson)

Multiple Myeloma

CBT Pharmaceuticals

Icon Cancer Centre Adelaide (Tennyson)

Ovarian Cancer

Abbvie

Icon Cancer Centre South Brisbane

Ovarian Cancer

Novotech

Icon Cancer Centre Wesley

Ovarian Cancer

Pfizer

Icon Cancer Centre Wesley

Pancreatic Cancer

Boston BioMed

Icon Cancer Centre South Brisbane

Pancreatic Cancer

Panbela

Icon Cancer Centre Adelaide (Tennyson)

Pancreatic Cancer

ANZUP

Icon Cancer Centre Adelaide (Tennyson)

ICON ANNUAL RESEARCH REPORT 2021

95

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

96

Abbrev. Title

Protocol Title

9785-CL-0123

A Phase 2 Open-label Extension Study for Subjects with Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

PROpel D081SC00001

A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men with Metastatic Castration- resistant Prostate Cancer

SHR3680-002

A Phase 1 Trial of SHR3680 with or without Shr3162 in Subjects with Metastatic Castration-Resistant Prostate Cancer.

ARASENS 17777 / 1841788

A randomized, double–blind, placebo–controlled Phase III study of darolutamide (ODM–201) versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastatic hormone–sensitive prostate cancer

Darolutamide ROS 20321

An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies

Checkmate-9KD CA2099KD

A Phase 2 Study of Nivolumab in Combination with Either Rucaparib, Docetaxel, or Enzalutamide in Men with Castration-resistant Metastatic Prostate Cancer (CheckMate 9KD: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9KD)

ProstateBowelPrepStudy

The effectiveness of an anti-flatulent diet to achieve favourable bowel conditions in prostate cancer patients undergoing Radiation Therapy.

ACIS 56021927PCR3001

A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cance

PREVALENCE 64091742PCR0002

Biomarker Study to Determine Frequency of DNA-repair Defects in Men with Metastatic Prostate Cancer

EMBARK MDV3100-13

A phase 3, Randomized, Efficacy and safety study of Enzalutamide plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men with high-risk nonmetastatic Prostate Cancer progressing After Definitive Therapy

PLATO MDV3100-10

A Phase 4, Randomized, Double Blind, Placebo Controlled Study of Continued Enzalutamide Treatment Beyond Progression in Patients With Chemotherapy Naive Metastatic Castration Resistant Prostate Cancer

Indication

Sponsor

Location

Prostate Cancer

Astellas

Icon Cancer Centre Adelaide (Tennyson)

Prostate Cancer

Astra Zeneca

Icon Cancer Centre Adelaide (Tennyson)

Prostate Cancer

Atridia

Icon Cancer Centre South Brisbane

Prostate Cancer

Bayer

Icon Cancer Centre Adelaide (Tennyson)

Prostate Cancer

Bayer

Icon Cancer Centre Adelaide (Tennyson)

Prostate Cancer

Bristol-Myers Squibb

Icon Cancer Centre Chermside

Prostate Cancer

Icon Cancer Foundation

Icon Cancer Centre (Australia)

Prostate Cancer

Janssen

Icon Cancer Centre Adelaide (Tennyson)

Prostate Cancer

Janssen

Icon Cancer Centre Adelaide (Tennyson)

Prostate Cancer

Medivation

Icon Cancer Centre Southport

Prostate Cancer

Medivation

Icon Cancer Centre South Brisbane

ICON ANNUAL RESEARCH REPORT 2021

97

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

98

Abbrev. Title

Protocol Title

PROSPER MDV3100-14

PROSPER: A Multinational, phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safet Study of Enzalutamide in Patients with nonmetastatic CastrationResistant Prostate Cancer

TALAPRO-1 MDV3800-06

A Phase 2, Open-Label, 2-Arm, Response Rate Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Who Previously Received Taxane-Based Chemotherapy and Progressed on at Least 1 Novel Hormonal Agent (Enzalutamide and/or Abiraterone Acetate/Prednisone)

TALAPRO-2 C3441021

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Talazoparib in Combination with Physician's Choice of Enzalutamide or Abiraterone Acetate/ Prednisone in Metastatic Castration-Resistant Prostate Cancer with DNA Damage Repair Deficiencies

IPATential CO39303

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer

KEYPAD ANZUP1601

A phase 2 trial of pembrolizumab and denosumab in advanced clear-cell renal cell carcinoma (ccRCC) progressing after a VEGF-TKI

UNISoN ANZUP1602

Phase II Sequential Treatment Trial of Single Agent Nivolumab, then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602)

CLEAR E7080-G000-307

A Multicenter, Open-label, Randomised, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Advanced Renal Cell Carcinoma

EISAIE7080-G000-218

A Randomized, Open-Label (formerly Double-Blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targe

COSMIC-313 XL184-313

A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk

Keynote-564 MK-3475564

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy

Indication

Sponsor

Location

Prostate Cancer

Medivation

Icon Cancer Centre Southport, Icon Cancer Centre Adelaide (Tennyson), Icon Cancer Centre Wesley

Prostate Cancer

Medivation

Icon Cancer Centre Wesley

Prostate Cancer

Pfizer

Icon Cancer Centre Wesley

Prostate Cancer

Roche

Icon Cancer Centre Adelaide (Tennyson)

Renal Cell Cancer

ANZUP

Icon Cancer Centre Wesley

Renal Cell Cancer

ANZUP

Icon Cancer Centre Adelaide (Tennyson)

Renal Cell Cancer

Eisai

Icon Cancer Centre Chermside

Renal Cell Cancer

Eisai

Icon Cancer Centre Adelaide (Tennyson)

Renal Cell Cancer

Exelixis

Icon Cancer Centre Chermside

Renal Cell Cancer

Merck

Icon Cancer Centre Adelaide (Tennyson)

ICON ANNUAL RESEARCH REPORT 2021

99

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

100

Abbrev. Title

Protocol Title

Keynote-B61 MK3475-B61

A Phase 2, Single-arm, Open-label Clinical Trial of Pembrolizumab Plus Lenvatinib in Participants with First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (nccRCC) (KEYNOTE-B61)

PIVOT9 17-214-09 / CA045002

A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined with Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients with Previously Untreated Advanced Renal Cell Carcinoma

IMmotion010 WO39210

A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy

IMmotion151 WO29637

A Phase III, Open-Label, Randomiozed study of Atezolizumab (Anti-PD-L1 antibody) in Combination with Bevacizumab versus Sunitinib in Patients with untreated advanced renal cell Carcinoma

IMmotion250 WO41994

A Phase III, Multicenter, Randomized, Open-label Study of Atezolizumab in Combination with Cabozantinib in Patients with Renal Cell Carcinoma who Experienced Disease progression During or After Check Point Inhibitor Treatment

R2810-ONC-1540

A Phase 2 study of REGN2810, a fully human monoclonal antibody to Programmed Death – 1 (PD-1), in patients with advanced cutaneous Squamous Cell Carcinoma

COSMIC-401 XL184-401

A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Cabozantinib (XL184) at 60 mg/Day Compared to 140 mg/Day in Progressive, Metastatic Medullary Thyroid Cancer Patients

Checkmate-901 CA209901

A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer

PIVOT-10 18-214-10 / CA045-012

A Phase 2, randomized, non-comparative, open-label study of NKTR-214 in combination with nivolumab and of chemotherapy in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients with low PD L1 expression

IMvigor130 WO30070

A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (AntiPD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

SAUL MO29983

An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

Indication

Sponsor

Location

Renal Cell Cancer

MSD

Icon Cancer Centre Adelaide (Tennyson)

Renal Cell Cancer

Nektar

Icon Cancer Centre Adelaide (Tennyson)

Renal Cell Cancer

Roche

Icon Cancer Centre Adelaide (Tennyson)

Renal Cell Cancer

Roche

Icon Cancer Centre Chermside

Renal Cell Cancer

Roche

Icon Cancer Centre Chermside

Skin Cancer

Regeneron

Icon Cancer Centre Adelaide (Tennyson)

Thyroid Cancer

Exelixis

Icon Cancer Centre Adelaide (Tennyson)

Urothelial Cancer

Bristol-Myers Squibb

Icon Cancer Centre Chermside

Urothelial Cancer

Nektar

Icon Cancer Centre Adelaide (Tennyson)

Urothelial Cancer

Roche

Icon Cancer Centre Adelaide (Tennyson)

Urothelial Cancer

Roche

Icon Cancer Centre Chermside

ICON ANNUAL RESEARCH REPORT 2021

101

MEDICAL ONCOLOGY

CLINICAL TRIALS REGISTER

MEDICAL ONCOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — SINGAPORE

102

Abbrev. Title

Protocol Title

CBYL719X2402 BYLieve

A Phase II, multicenter, open-label, three-cohort, non-comparative study to assess the efficacy and safety of alpelisib plus fulvestrant or letrozole in patients with PIK3CA mutant, hormone receptor (HR+) positive, HER2-negative advanced breast cancer (aBC), who have progressed on or after prior treatments

CAPItello-290 D3614C00001

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.

RIGHT Choice CLEE011A3201C

A Phase II Randomized Study of the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Physician Choice Chemotherapy in Premenopausal or Perimenopausal Patients With Hormone Receptor-positive/ HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer.

Checkmate-74W CA20974W

A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination with Trans-arterial ChemoEmbolization (TACE) in Patients with Intermediate-stage Hepatocellular Carcinoma (HCC).

Y-mAbs202

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission. An International, Open-Label,Uncontrolled, Single-Arm, Multicenter, Phase 2 Trial.

SKYSCRAPER-08/YO42138

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Patients With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma.

Indication

Sponsor

Location

Breast Cancer

Novartis Pharmaceuticals

Icon Cancer Centre Farrer Park

Breast Cancer

AstraZeneca

Icon Cancer Centre Farrer Park

Breast Cancer

Novartis

Icon Cancer Centre Farrer Park

Hepatocellular Carcinoma

Brstol-Myers Squibb

Icon Cancer Centre Farrer Park

Neuroblastoma

Y-mAbs

Icon Cancer Centre Mount Alvernia

Oesophageal Carcinoma

Roche

Icon Cancer Centre Farrer Park

ICON ANNUAL RESEARCH REPORT 2021

103

CLINICAL TRIALS REGISTER

HAEMATOLOGY TRIALS - OPEN TO RECRUITMENT

HAEMATOLOGY

104

Abbrev. Title

Protocol Title

ALLG AML M22

A randomized, multi-arm study platform to compare the efficacy of experimental therapies versus standard of care in subjects with acute myeloid leukemia in first complete remission.

PHI-101

A Prospective, Phase la/b, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the FLT3 Inhibitor, PHI-101, Alone in Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Aplastic Anaemia Registry

Aplastic Anaemia Registry

WAMM ALLG NHL33

An ALLG Window Study of Acalabrutinib plus Rituximab followed by R-DHAOx+ASCT in fit Mantle Cell Lymphoma

Mangrove BGB-3111-306

A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Study Drug plus Rituximab Versus Bendamustine plus Rituximab in Patients with Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

BRUIN-MCL-321 LOXOBTK-20019

A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma

CANOVA M13-494

A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared with Pomalidomide and Dexamethasone in Subjects with t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

Myeloma 1000

Myeloma 1000 Project

MRDR Database

Myeloma and Related Disease Registry

COMMANDS ACE-536MDS-002

A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) versus Epoetin Alfa for the Treatment of Anemia due to IPSS-R Very low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in ESA Na??ve Subjects Who Require Red Blood Cell Transfusions

MDS Database

A retrospective/prospective study of patients with Myelodysplasia in South Australia – diagnostic phenotype, outcome and the risk of iron overload.

SRA-MMB-352-4365 GSUS-352-4365

Extended Access of Momelotinib for Subjects with Primary Myelofibrosis (PMF) or Postpolycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

OPEN TO RECRUITMENT — AUSTRALIA

Indication

Sponsor

Location

Acute Myeloid Leukaemia

ALLG

Icon Cancer Centre Wesley

Acute Myeloid Leukaemia

Pharos

Icon Cancer Centre Wesley

Aplastic anaemia

Monash University

Icon Cancer Centre South Brisbane

Mantle Cell Lymphoma

ALLG

Icon Cancer Centre Wesley

Mantle Cell Lymphoma

BeiGene

Icon Cancer Centre Wesley

Mantle Cell Lymphoma

Loxo

Icon Cancer Centre Wesley

Multiple Myeloma

Abbvie

Icon Cancer Centre Wesley

Multiple Myeloma

Monash University

Icon Cancer Centre Adelaide (Tennyson)

Multiple Myeloma

Icon Cancer Centre South Brisbane, Icon Cancer Centre Adelaide (Tennyson)

Myelodysplastic Syndrome

Celgene

Icon Cancer Centre Wesley

Myelodysplastic Syndrome

Royal Adelaide Hospital

Icon Cancer Centre Adelaide (Tennyson)

Myelofibrosis

Astellas

Icon Cancer Centre Wesley

ICON ANNUAL RESEARCH REPORT 2021

105

HAEMATOLOGY

CLINICAL TRIALS REGISTER

HAEMATOLOGY TRIALS - OPEN TO RECRUITMENT

OPEN TO RECRUITMENT — AUSTRALIA

106

Abbrev. Title

Protocol Title

MANIFEST-2 CPI 0610-04

A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

PXS5505-MF-101

A phase 1/2a study to evaluate safety, pharmacokinetic and pharmacodynamic dose escalation and expansion study of PXS-5505 in patients with primary, postpolycythemia vera or post-essential thrombocythemia myelofibrosis

TL-895-201

A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects with Relapsed/ Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis

KRT-232-101

An Open-Label, Phase 2a/2b Study of KRT-232 in Subjects With Primary Myelofibrosis (PMF), Post???Polycythemia Vera MF (post???PV-MF), Or Post???Essential Thrombocythemia MF (post???ET-MF) Who Have Failed Prior Treatment with a JAK Inhib

ZN-d5-001

Phase 1 First in Human Dose -Escalation Study of ZN-d5 as a Single Agent in Subjects with Non-Hodgkin Lymphoma or Acute Myeloid Leukemia

ESCALADE D8227C00001

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤70 Years With Previously Untreated Non-GCB DLBCL

GCT3013-05

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma

PNH Registry M07-001

Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry

OPEN TO RECRUITMENT — SINGAPORE

Abbrev. Title

Protocol Title

ELM-2 R1979-ONC-1625

An open-label study to assess the anti-tumor activity and safety of REGN1979 , an Anti-CD20 X Anti-CD3 bispecific antibody, in patients with relapsed or refractory follicular lymphoma

Indication

Sponsor

Location

Myelofibrosis

Constellation Pharmaceuticals

Icon Cancer Centre Wesley

Myelofibrosis

Pharmaxis

Icon Cancer Centre Adelaide (Tennyson)

Myelofibrosis

Telios

Icon Cancer Centre Wesley

Myeloproliferative Neoplasms

Kartos

Icon Cancer Centre Wesley

Non-Hodgkin's Lymphoma

Zentalis

Icon Cancer Centre Adelaide (Tennyson)

Non-Hodgkin's Lymphoma

AstraZeneca

Icon Cancer Centre South Brisbane

Non-Hodgkin's Lymphoma

Genmab

Icon Cancer Centre South Brisbane

Paroxysmal Nocturnal Hemoglobinuria

Alexion

Icon Cancer Centre Wesley

Indication

Sponsor

Location

Follicular Lymphoma

Regeneron

Icon Cancer Centre Farrer Park

ICON ANNUAL RESEARCH REPORT 2021

107

HAEMATOLOGY

CLINICAL TRIALS REGISTER

HAEMATOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

108

Abbrev. Title

Protocol Title

ALLGM13

High Dose Cytarabine and Fludarabine Without Anthracycline for Patients with Core Binding Factor Acute Myeloid Leukaemia

CLL14 BO25323

A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions

ASCEND ACE-CL-309

A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia

ASSURE D8220C00008

A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects with Chronic Lymphocytic Leukemia

Alpine BGB-3111-305

A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared with Ibrutinib in Patients with Relapsed / Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sequoia BGB-3111-304

An International, Phase 3, Open-label, Randomized Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

ALLGCML7

A phase II study of efficacy and safety of Pegasys in patients with Chronic Myeloid Leukaemia in PCR +ve complete or near complete cytogenetic remission on Glivec at 600mg daily or maximum tolerated dose

TWISTER ALLG CML8

A Phase II study of withdrawal of imatinib therapy in adult patients with chronic phase chronic myeloid leukaemia in stable complete molecular remission

SHINE PCI-32765MCL3002

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

SYMPATICO PCYC-1143-CA

Phase 3 study of ibrutinib in combination with venetoclax in subjects with mantle cell lymphoma (MCL)

Indication

Sponsor

Location

Acute Myeloid Leukaemia

ALLG

Icon Cancer Centre South Brisbane

Chronic Lymphocytic Leukaemia

Roche

Icon Cancer Centre Adelaide (Tennyson)

Chronic Lymphocytic Leukemia

Acerta Pharma

Icon Cancer Centre South Brisbane

Chronic Lymphocytic Leukemia

AstraZeneca

Icon Cancer Centre Wesley

Chronic Lymphocytic Leukemia

BeiGene

Icon Cancer Centre Wesley

Chronic Lymphocytic Leukemia

BeiGene

Icon Cancer Centre Wesley

Chronic Myeloid Leukaemia

ALLG

Icon Cancer Centre South Brisbane

Chronic Myeloid Leukaemia

ALLG

Icon Cancer Centre South Brisbane

Mantle Cell Lymphoma

Janssen

Icon Cancer Centre South Brisbane

Mantle Cell Lymphoma

Pharmacyclics

Icon Cancer Centre Wesley

ICON ANNUAL RESEARCH REPORT 2021

109

HAEMATOLOGY

CLINICAL TRIALS REGISTER

HAEMATOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

110

Abbrev. Title

Protocol Title

ALLGMM14

A prospective randomised Phase II study of single agent pomalidomide maintenance versus combination pomalidomide and low dose dexamethasone maintenance following induction with the combination of pomalidomide and low dose dexamethasone in patients with relapsed and refractory myeloma previously trea

ALLGMM17

A multicentre single arm study of carfilzomib-thalidomide-dexamethasone (CarTD) for newly diagnosed transplant-eligible multiple myeloma (TE NDMM) patients refractory to initial bortezomib-based induction therapy

VCDD AMARC_03-16

A randomized phase 2 study of bortezomib, cyclophosphamide and dexamethasone induction (VCD) compared with VCD and daratumumab induction followed by daratumumab maintenance (VCDD) for the initial treatment of transplant ineligible patients with multiple myeloma.

DREAMM8 207499

A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GSK2857916 in Combination with Pomalidomide and Low-Dose Dexamethasone (GSK2857916+Pd) versus Pomalidomide plus Bortezomib and LowDose Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple

MAIA 54767414MMY3008

A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy

POLLUX 54767414MMY3003

Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma

C16019

A phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients with Multiple myeloma (NDMM) following induction therapy and autologous stem cell transplant (ASCT)

IMROZ EFC12522

A Phase 3 randomized, open-label, multicenter study assessing the clinical benefit of isatuximab (SAR650984) in combination with bortezomib (Velcade??), lenalidomide (Revlimid??) and dexamethasone versus bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma not

ALLGMDS4

A Randomised Phase II study comparing the efficacy of 5azacitidine alone versus combination therapy with lenalidomide and 5azacitidine in patients with higher risk myelodysplastic syndromes (MDS) and low marrow blast count acute myeloid leukaemia (AML).

Indication

Sponsor

Location

Multiple Myeloma

ALLG

Icon Cancer Centre South Brisbane

Multiple Myeloma

ALLG

Icon Cancer Centre Wesley

Multiple Myeloma

AMaRC

Icon Cancer Centre South Brisbane

Multiple Myeloma

GSK

Icon Cancer Centre Wesley

Multiple Myeloma

Janssen

Icon Cancer Centre Adelaide (Tennyson)

Multiple Myeloma

Janssen

Icon Cancer Centre South Brisbane

Multiple Myeloma

Millenium

Icon Cancer Centre South Brisbane

Multiple Myeloma

Sanofi

Icon Cancer Centre South Brisbane

Myelodysplastic Syndrome

ALLG

Icon Cancer Centre South Brisbane

ICON ANNUAL RESEARCH REPORT 2021

111

HAEMATOLOGY

CLINICAL TRIALS REGISTER

HAEMATOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

112

Abbrev. Title

Protocol Title

ENHANCE 3674-0013

Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination with Azacitidine versus Azacitidine Plus Placebo in Treatment-naive Patients with Higher Risk Myelodysplastic Syndrome

INSPIRE MDS 04-30

A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician???s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent

PANTHER P-3001

A Phase 3, Randomized, Controlled, Open-Label, Clinical Study of Pevonedistat Plus Azacitidine versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or LowBlast Acute Myelogenous Leukemia

B-MIND MOR208C204

A Phase II/III, Randomised, Multicentre Study of MOR00208 with Bendamustine versus Rituximab with Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT)

BGB-3111-LTE1

An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients with B-cell Malignancies

ALL NHL14

Trial of rituximab versus a watch and wait strategy in patients with advanced stage, asymptomatic, non-bulky follicular lymphoma (grades 1, 2 and 3a)

PRIMA ALLG NHL16

A multicentre, phase III, open-label, randomized study in patients with advanced follicular lymphoma evaluating the benefit of maintenance therapy with Rituximab (MabThera(R)) after induction of response with chemotherapy plus Rituximab in comparison with no maintenance therapy

CHRONOS 4 806946/17833

A Phase III, randomized, double-blind, controlled, multicentre study of intravenous PI3K inhibitor Copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in patients with relapsed indolent non-Hodgkin’s lymphoma (iNH

Rosewood BGB-3111-212

An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined with Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/Refractory Follicular Lymphoma

GO29781

An Open-Label, Multicenter, Phase I/Ib Trial Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of BTCT4465A As A Single Agent And Combined With Atezolizumab In Patients With Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma And Chronic Lymphocytic Leukaemia

Indication

Sponsor

Location

Myelodysplastic Syndrome

Forty-Seven

Icon Cancer Centre South Brisbane

Myelodysplastic Syndrome

OncoNova

Icon Cancer Centre Wesley

Myelodysplastic Syndrome

Takeda

Icon Cancer Centre Wesley

Non-Hodgkin's Lymphoma

MorphoSys

Icon Cancer Centre South Brisbane

Non-Hodgkin's Lymphoma

Beigene

Icon Cancer Centre Adelaide (Tennyson)

Non-Hodgkin's Lymphoma

ALLG

Icon Cancer Centre Adelaide (Tennyson)

Non-Hodgkin's Lymphoma

ALLG

Icon Cancer Centre Wesley

Non-Hodgkin's Lymphoma

Bayer

Icon Cancer Centre Adelaide (Tennyson)

Non-Hodgkin's Lymphoma

BeiGene

Icon Cancer Centre South Brisbane, Icon Cancer Centre Wesley

Non-Hodgkin's Lymphoma

Genentech

Icon Cancer Centre Wesley

ICON ANNUAL RESEARCH REPORT 2021

113

HAEMATOLOGY

CLINICAL TRIALS REGISTER

HAEMATOLOGY TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

114

Abbrev. Title

Protocol Title

SELENE PCI32765FLR3001

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination with Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Previously Trea

C25003

A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

GO29365

A Phase Ib/II Study Evaluating The Safety, Tolerability And Anti-Tumor Activity Of Polatuzumab Vedotin In Combination With Rituximab (R) Or Obinutuzumab (G) Plus Bendamustine (B) In Relapsed Or Refractory Follicular Or Diffuse Large B-Cell Lymphoma

POLARIX GO39942

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

ECHELON-2 SGN35-014

A Randomized , double-blind, placebo-controlled, phase 3 study of Brentuximab Vedotin and CHP (A+CHP) versus CHOP in the frontline treatm,ent of patients with CD30-positive mature T-cell lymphomas

TG1701-101

A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton’s Tyrosine Kinase Inhibitor, in Patients with B-Cell Malignancies.

Indication

Sponsor

Location

Non-Hodgkin's Lymphoma

Janssen

Icon Cancer Centre South Brisbane

Non-Hodgkin's Lymphoma

Millenium

Icon Cancer Centre South Brisbane

Non-Hodgkin's Lymphoma

Roche

Icon Cancer Centre Adelaide (Tennyson)

Non-Hodgkin's Lymphoma

Roche

Icon Cancer Centre Adelaide (Tennyson)

Non-Hodgkin's Lymphoma

Seattle Genetics

Icon Cancer Centre Wesley

Non-Hodgkin's Lymphoma

TG Therapeutics, Inc.

Icon Cancer Centre Adelaide (Tennyson)

ICON ANNUAL RESEARCH REPORT 2021

115

CLINICAL TRIALS REGISTER

RADIATION ONCOLOGY/MEDICINE TRIALS - OPEN TO RECRUITMENT

RADIATION ONCOLOGY/MEDICINE

116

Abbrev. Title

Protocol Title

ALLG AML M22

A randomized, multi-arm study platform to compare the efficacy of experimental therapies versus standard of care in subjects with acute myeloid leukemia in first complete remission.

PHI-101

A Prospective, Phase la/b, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the FLT3 Inhibitor, PHI-101, Alone in Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Aplastic Anaemia Registry

Aplastic Anaemia Registry

WAMM ALLG NHL33

An ALLG Window Study of Acalabrutinib plus Rituximab followed by R-DHAOx+ASCT in fit Mantle Cell Lymphoma

Mangrove BGB-3111-306

A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Study Drug plus Rituximab Versus Bendamustine plus Rituximab in Patients with Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

BRUIN-MCL-321 LOXOBTK-20019

A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma

CANOVA M13-494

A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared with Pomalidomide and Dexamethasone in Subjects with t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

Myeloma 1000

Myeloma 1000 Project

MRDR Database

Myeloma and Related Disease Registry

COMMANDS ACE-536MDS-002

A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) versus Epoetin Alfa for the Treatment of Anemia due to IPSS-R Very low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in ESA Na??ve Subjects Who Require Red Blood Cell Transfusions

MDS Database

A retrospective/prospective study of patients with Myelodysplasia in South Australia – diagnostic phenotype, outcome and the risk of iron overload.

SRA-MMB-352-4365 GSUS-352-4365

Extended Access of Momelotinib for Subjects with Primary Myelofibrosis (PMF) or Postpolycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

OPEN TO RECRUITMENT — AUSTRALIA

Indication

Sponsor

Location

Acute Myeloid Leukaemia

ALLG

Icon Cancer Centre Wesley

Acute Myeloid Leukaemia

Pharos

Icon Cancer Centre Wesley

Aplastic anaemia

Monash University

Icon Cancer Centre South Brisbane

Mantle Cell Lymphoma

ALLG

Icon Cancer Centre Wesley

Mantle Cell Lymphoma

BeiGene

Icon Cancer Centre Wesley

Mantle Cell Lymphoma

Loxo

Icon Cancer Centre Wesley

Multiple Myeloma

Abbvie

Icon Cancer Centre Wesley

Multiple Myeloma

Monash University

Icon Cancer Centre Adelaide (Tennyson)

Multiple Myeloma

Icon Cancer Centre South Brisbane, Icon Cancer Centre Adelaide (Tennyson)

Myelodysplastic Syndrome

Celgene

Icon Cancer Centre Wesley

Myelodysplastic Syndrome

Royal Adelaide Hospital

Icon Cancer Centre Adelaide (Tennyson)

Myelofibrosis

Astellas

Icon Cancer Centre Wesley

ICON ANNUAL RESEARCH REPORT 2021

117

RADIATION ONCOLOGY/ MEDICINE

CLINICAL TRIALS REGISTER

RADIATION ONCOLOGY/MEDICINE TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

118

Abbrev. Title

Protocol Title

DCIS TROG 07.01

A Randomised Phase III Study of Radiation Doses and Fractionation Schedules in Nonlow Risk Ductal Carcinoma In Situ (DCIS) of the Breast

STARS TROG 08.06

A Randomised Comparison of Anastrozole Commenced Before and Continued During Adjuvant Radiotherapy for Breast Cancer Versus Anastrozole and Subsequent Antioestrogen Therapy Delayed Until After Radiotherapy.

SUPREMO TROG 11.01

Selective use of postoperative radiotherapy after mastectomy

HART TROG 14.04

Deep Inhalation Breath Hold for reduction of cardiac toxicity in patients with left sided breast cancer undergong radiotherapyTherapy

VESPA

A Phase II pilot study to investigate the feasibility, safety, acceptability and potential efficacy of vaginal oestriol in preventing vaginal stenosis.

ORATORII

A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery

TROG12.01

A Randomised Trial of Weekly Cetuximab and Radiation versus Weekly Cisplatin and Radiation in Good Prognosis Locoregionally Advanced HPV-Associated Oropharyngeal Squamous Cell Carcinoma

PEARL CTC 0145/ALTG 13/008

A randomised phase 3 trial of Palliative care early in advanced lung cancers

P_LUNG TROG 11.03 CNS

A Randomised Phase III Trial of High Dose Palliative Radiotherapy (HDPRT) Versus Concurrent Chemotherapy + HDPRT (C-HDPRT) in Patients with Good Performance Status, Locally Advanced/Small Volume Metastatic Non Small Cell Lung Cancer (NSCLC) Not Suitable for Radical Chemo-Radiotherapy

CROSSPET

Phase II post neoadjuvant CROSS-chemoradiation PET scan as predictor of response and survival in patients with localised oesophageal cancer

Split Course

A single arm, prospective Phase II study of Split-Course Pelvic Radiotherapy for Locally Progressive, Castrate Resistant Prostate Cancer

Indication

Sponsor

Location

Breast Cancer

TROG

Icon Cancer Centre Toowoomba

Breast Cancer

TROG

Icon Cancer Centre Toowoomba

Breast Cancer

TROG

Icon Cancer Centre Toowoomba

Breast Cancer

TROG

Icon Cancer Centre Gold Coast

Gynaecological Cancer

Icon Cancer Foundation

Icon Cancer Centre Gold Coast

Head and Neck Cancer

Consortium

Icon Cancer Centre Gold Coast

Head and Neck Cancer

TROG

Icon Cancer Centre Gold Coast

Lung Cancer

ALTG

Icon Cancer Centre Gold Coast

Lung Cancer

TROG

Icon Cancer Centre Cairns,Icon Cancer Centre Gold Coast, Icon Cancer Centre Toowoomba

Oesophago Gastric Cancer

Icon Cancer Foundation

Icon Cancer Centre Gold Coast

Prostate Cancer

Princess Alexandra Hospital

Icon Cancer Centre Greenslopes

ICON ANNUAL RESEARCH REPORT 2021

119

RADIATION ONCOLOGY/ MEDICINE

CLINICAL TRIALS REGISTER

RADIATION ONCOLOGY/MEDICINE TRIALS - CLOSED TO RECRUITMENT

CLOSED TO RECRUITMENT — AUSTRALIA

120

Abbrev. Title

Protocol Title

ENZARAD ANZUP1303

Randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer

PINPOINT

Phase II Trial Harnessing PSMA-PET And Calypso® Real-Time Tracking To Precisely Locate And Treat Recurrent Prostate Cancer

TRANSFORM

Ablative Stereotactic Radiotherapy as an alternative to systemic treatment in men with oligometastatic prostate cancer and controlled primary disease. A prospective Phase II study measuring toxicity, disease control and freedom from escalation in systemic therapy

Indication

Sponsor

Location

Prostate Cancer

ANZUP

Icon Cancer Centre Gold Coast, Icon Cancer Centre Adelaide (Tennyson), Icon Cancer Centre Toowoomba

Prostate Cancer

Icon Cancer Foundation

Icon Cancer Centre Richmond

Prostate Cancer

Icon Cancer Foundation

Icon Cancer Centre Richmond

ICON ANNUAL RESEARCH REPORT 2021

121

ICON GROUP HEAD OFFICE Level 1, 22 Cordelia Street South Brisbane QLD 4101 Australia T +61 7 3737 4500 E research@icon.team icongroup.global

122

ICON ANNUAL RESEARCH REPORT 2021