Icon Group Annual Research Report 2020

ICON ANNUAL RESEARCH REPORT 2020 ICON ANNUAL RESEARCH REPORT 2020

1

2

ICON ANNUAL RESEARCH REPORT 2020

CHIEF EXECUTIVE OFFICER

FOREWORD

“At Icon we are committed to placing patients at the heart of everything we do, and this threads through how we approach research.”

Despite floods, fires and a global health crisis, Icon Group has continued to deliver life-saving treatments to patients across our international network.

In a year of unprecedented challenges, the Icon team stepped up to not only ensure patients continued to have access to the care they needed, but also rose to the challenge and forged ahead on our mission to deliver more care to more people.

Across all aspects of the Group – cancer care, compounding, pharmacy and research we collectively focussed on making a lasting difference. With the introduction of new cancer centres domestically and across our Asia footprint, we introduced new communities to Icon’s world-class care. We also expanded our pharmacy and compounding offerings, and continued to invest in maturing our research remit, further extending our commitment to patient-centred, comprehensive care.

We are proud to offer Australia’s largest private oncology clinical trials program. Icon continues to lead the way in Phase I through to Phase IV trials, as well as unique investigator-initiated trials across haematology, medical oncology and radiation oncology. With a long-standing experienced research team, we are well positioned to expand our research infrastructure to bring more clinical trials to patients across our global network in the months and years to come.

Research plays a paramount role in improving cancer care today and tomorrow. At Icon we are committed to placing patients at the heart of everything we do, and this threads through how we approach research. Our doctors are passionate about clinical trials, our multidisciplinary teams work together to deliver unique Icon investigator-initiated research, and we strive to build and maintain industry partnerships all with the aim of improving patient outcomes and reducing the global cancer burden. Together we are providing much needed hope to patients and their families across continents and I cannot be prouder of what the Icon team has and will continue to achieve for a brighter tomorrow.

Mark Middleton

Connect on LinkedIn

ICON ANNUAL RESEARCH REPORT 2020

3

4

ICON ANNUAL RESEARCH REPORT 2020

DIRECTOR OF RESEARCH

FOREWORD

“My special thanks to our wonderful patients whose determination to do better and go further for themselves, their families, supporters, and the broader community remains our primary inspiration.”

The past year has been a transformative one for research at Icon Group.

It has been a year for meeting unexpected challenges and rising to them with new solutions, innovations and fresh faces. Despite the challenges of COVID-19, 2020 saw a record year for clinical trial recruitment, a restructure to best take forward the opportunities presented by the transfer of functions from the Icon Cancer Foundation into the group’s research division, and a comprehensive external review by Professor Nik Zeps to inform our forward strategic planning.

Our year began with the loss of our founding Laboratory Director, Noor Parker and the retirement of our founding Icon Research Executive Manager, Fiona Jonker. Their role in both clinical research and service was immense, and I acknowledge their significant contribution which has set a solid foundation for our continued success.

Subsequently we have welcomed Sophie Mepham PhD as the Group’s Executive Manager of Research and Deb Taylor as Director of Cellular Therapy Laboratory. Sophie brings a wealth of practical and governance experience from her previous senior roles at Peter MacCallum Cancer Institute and the NHS, and Deb similarly from her longstanding leadership role at Mater Group.

I am delighted to see the energy and freshness of thought both have brought to their roles.

My thanks go to all our people across Icon Group who have worked creatively and with absolute commitment to our goals of delivering innovation and research to the highest quality. My thanks also extend to our committed Icon Cancer Foundation donors whose generous support underpins many of our research activities.

Dr John Bashford

ICON ANNUAL RESEARCH REPORT 2020

5

6

ICON ANNUAL RESEARCH REPORT 2020

EXECUTIVE MANAGER OF RESEARCH

FOREWORD

“The research team has undergone a significant restructure over the last six months to ensure we are ready for our expansion.”

It has been a privilege to take up the role of Executive Manager of Research at Icon in May of 2020 and have the opportunity to lead a team of passionate and driven researchers and doctors. Icon has already demonstrated itself to be the leader in delivering oncology clinical trials in the private sector and I look forward to driving growth in the trials we have available, opening clinical trials at more centres across our national network, and increasing international opportunities as we move into 2021.

The research team has undergone a significant restructure over the last six months to ensure we are ready for our expansion, which will see us open sites at North Lakes in Brisbane’s northern suburbs, Sydney, Canberra, Hobart, Adelaide, Singapore and more! We will be increasing our capabilities in Phase I trials as well as expanding our haematology trials portfolio and continuing our important global industry relationship with Varian for radiation oncology studies led by doctors at Icon.

Our clinical trials program continues to be supported by the highest quality pharmacy program through both our experienced Icon, Slade and Epic pharmacy teams. With dedicated clinical trial pharmacists and our own compounding pharmacy units, this further strengthens our trial capabilities with a holistic and supportive ecosystem which places Icon in a unique position to drive research forward and bring more care to where it is needed.

I would like to thank the entire research team for their dedication and congratulate them for the many wins achieved in a year of unprecedented obstacles. I look forward to more successes in 2021 which will no doubt see more growth and far-reaching opportunities for the ongoing benefit of cancer patients and their families.

Sophie Mepham PhD

Connect on LinkedIn

ICON ANNUAL RESEARCH REPORT 2020

7

CONTENTS

8

Our Mission

10

Our Impact

12

Icon Group geographical footprint

12

Research at Icon - scope of service

14

Industry partnerships and collaborations

16

The year at a glance

18

Key Highlights

20

Strategy

22

Growth

23

Innovation

24

Impact

26

2021 and Beyond

30

Acknowledgements

32

Appendices

34

Clinical Trials Register

36

Icon Research Committees

92

Principal Investigators

93

Principal Investigator Publications 2020

96

ICON ANNUAL RESEARCH REPORT 2020

“CLINICAL TRIALS HAVE BEEN LIFE-CHANGING FOR ME.” “This opportunity has helped me get my life back and changed my outlook. My tumours have decreased in size and the majority of my side effects have virtually disappeared. I truly can’t believe I am still here, and without research I wouldn’t have had the chance. Now I can look to the future. Don’t just accept one person’s advice. If it means the chance for a longer life, explore absolutely every avenue you can and don’t be afraid to ask lots of questions.”

MAREE SMEAL, PATIENT

READ MAREE’S STORY HERE ICON ANNUAL RESEARCH REPORT 2020

9

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. This vision underpins the research division with a clear goal to provide research opportunities and access to clinical trials to as many people as possible, as close to home as possible.

ICON GROUP Icon Group is Australia’s largest dedicated provider of cancer care with a growing reach into Asia. The Group is built on a strong but simple vision to deliver the best care possible, to as many people as possible, as close to home as possible.

Our integrated, end-to-end service model leverages the strengths of a diverse, multidisciplinary team to achieve this mission.

Our businesses encompass all aspects of quality cancer care, including treatment delivery, pharmacy, clinical resarch and chemotherapy compounding.

With a strong focus on innovation and investment in technologybased solutions, as well as partnerships with peak international bodies, Icon is proudly at the forefront of addressing the global cancer burden.

10

ICON ANNUAL RESEARCH REPORT 2020

ICON GROUP’S RESEARCH Icon Group operates Australia’s largest private cancer clinical trials program with a growing reach across the global Icon network. With research a relatively uncommon practice in a private healthcare setting, Icon is extremely proud of the depth and experience within our dedicated research arm that has been operating for over 25 years. We provide patients and clinicians with access to national and international clinical trials across medical oncology, haematology and radiation oncology, including the nation’s largest Phase I program, trials sponsored by the pharmaceutical industry, along with collaborative studies undertaken in partnership with various universities and industry groups.

Icon has been an active contributor in several milestone trials that have seen significant advancements in cancer drugs including the ground-breaking trial that changed the use of Herceptin in HER2-positive breast cancer patients. We also conduct and have contributed to a number of significant radiation oncology trials including TRANSFORM – the single largest study of its kind in the world. This trial focussed on stereotactic radiation therapy as an alternative to systemic treatment in men with oligometastatic prostate cancer, a game changer for patients with advanced prostate cancer. SHRINC was also an important radiation oncology investigator-initiated trial assessing the use of stereotactic hypofractionated radiation therapy for multiple (310) cerebral metastases.

Icon is committed to further extending our research partnerships and activities to continue to provide more patients and clinicians with access to new and emerging advances in cancer treatment.

ICON ANNUAL RESEARCH REPORT 2020

11

OUR IMPACT Australia/New Zealand Sites Adelaide Mulgrave North Lakes Auchenflower Cairns Redland Canberra Revesby Richmond Chermside East Melbourne Rockingham Geelong South Brisbane Southport Gold Coast x 2 Springfield Gosford Toowoomba Greenslopes Townsville Hobart Mackay Wahroonga Warrnambool Maroochydore Midland Wellington Moreland Windsor Gardens

ICON GROUP GEOGRAPHICAL FOOTPRINT

Singapore Sites Farrer Park Mt Elizabeth x2 Gleneagles Novena Mt Alvernia Orchard

12

Hong Kong Sites Central x2 Tsim Sha Tsui x2 Mainland China Sites Chongqing Jiangxian Fengcheng Qingdao Vietnam Ho Chi Minh (Management Agreement) Chemotherapy Compounding sites Mt Waverley Geebung Mt Kuring-gai

Pharmacy Sites Auchenflower x 3 Ballan Box Hill Brisbane Waters Brunswick Burnside Camberwell Canberra x 2 Chermside Currumbin East Melbourne x 2 Epping Forster Frankston Geelong Greenslopes Hobart x 2 Hollywood Hunter Valley Hurstville Kempsey Launceston Lismore Mackay Maitland Merewether Midland Mornington

Mt Lawley Mulgrave Murdoch x2 Newcastle x2 Noble Park North Gosford North Lakes Northern Beaches Port Macquarie x2 Richmond Robina Rockingham Sandgate South Brisbane Southport Spring Hill x 2 Sunshine Coast Taree Tennyson Toowoomba x2 Toronto Townsville x 2 Uraween Warragul Westmead Whyalla Windsor Gardens

Outreach Clinics Hanoi, Vietnam Ho Chi Minh, Vietnam Under construction or announced Concord, Australia Moorabbin (Holmesglen), Australia

ICON ANNUAL RESEARCH REPORT 2020

Maitland, Australia Mildura, Australia

Sanmenxia, China

Existing centres Under construction or announced Clinic locations hosted by Icon doctors Clinic locations hosted by Icon doctors

ICON ANNUAL RESEARCH REPORT 2020

13

RESEARCH AT ICON SCOPE OF SERVICE

Cairns

Townsville Mackay

Maroochydore Toowoomba

Maitland

Midland Rockingham

IN DEVELOPMENT

Mildura

Canberra

Adelaide IN DEVELOPMENT Windsor Gardens

Auchenflower Chermside Gold Coast Greenslopes North Lakes Redland South Brisbane Springfield

Gosford Revesby Wahroonga Concord IN DEVELOPMENT

East Melbourne Mulgrave Geelong Richmond Moreland Warrnambool Moorabbin (Holmesglen)

Hobart

14

ICON ANNUAL RESEARCH REPORT 2020

IN DEVELOPMENT

Southport, QLD

Gold Coast, QLD

Toowoomba, QLD

Greenslopes, QLD

Townsville, QLD

Moreland, VIC

Windsor Gardens, SA

Haematology

East Melbourne (Freemasons), VIC

Haematology

South Brisbane, QLD

Radiation Oncology

Chermside, QLD

Radiation Oncology

Richmond, VIC

Medical Oncology

Cairns, QLD

Medical Oncology

Redland, QLD

Phase 1

Auchenflower, QLD

Phase 1

Haematology

Radiation Oncology

Medical Oncology

Phase 1

RESEARCH LOCATIONS

Tennyson, SA

Mulgrave, VIC North Lakes, QLD

Haematology

Radiation Oncology

Medical Oncology

Phase 1

NEW RESEARCH LOCATIONS IN 2021

Canberra, ACT

Hong Kong

Hobart, TAS

Singapore

Moreland, VIC

Wellington

Mulgrave, VIC

ICON ANNUAL RESEARCH REPORT 2020

15

INDUSTRY PARTNERSHIPS AND COLLABORATIONS

Icon Group is proud to work with over 200 collaborators including Contract Research Organisations (CROs), commercial and noncommercial organisations (including the pharmaceutical industry, hospitals, and universities), industry vendors and service providers.

16

ICON ANNUAL RESEARCH REPORT 2020

We understand that making a difference

The University of Queensland (UQ) and

in reducing the global cancer burden is a

Queensland University of Technology (QUT)

collaborative effort and continue to partner with

Icon continues to collaborate with leading

new organisations who share common values in order to play a leading role in changing the face of cancer care.

MAJOR PARTNERSHIPS AND COLLABORATIONS Clinical Oncology Society of Australia (COSA) Icon collaborated with COSA for their Annual Scientific Meeting through facilitation of the PreConference Workshop ‘Tele-trials, the new norm?’.

In line with the virtual theme the workshop was also made available via Icon’s digital platforms to participants around the world. This split presentation model provided opportunities to a wide variety of industry partners and participants to gain the most out of these resources in a platform that works for them.

Queensland universities, UQ and QUT to provide work-integrated learning placements to undergraduate students interested in pursuing a career in research.

Varian Medical Systems Icon Group are proud to have a global partnership with radiation oncology industry leaders, Varian Medical Systems (Varian). This partnership has extended to research with the intention to establish an improved process for identification, prioritisation and support of Icon Investigator-Initiated projects that align with Varian’s values and vision to further advance radiation therapy techniques.

Wesley Medical Research Icon and Wesley Medical Research (in Queensland) have a longstanding relationship

Queensland Institute of Medical Research

and are currently collaborating on a

(QIMR) Berghofer

retrospective analysis of survival outcomes

In 2019, Icon Group signed a Memorandum of Understanding (MOU) with QIMR Berghofer. The MOU better enables Icon and QIMR Berghofer to translate cutting-edge research into clinical practice, with key areas of interest including new ways of diagnosing cancer and sharing information that could be used to genetically sequence cancers.

following autologous haematopoietic stem cell transplantation (ASCT) in the private sector. Icon Cancer Centre performs the highest number of ASCT in Australasia with most transplants performed at The Wesley Hospital. This analysis will audit survival outcomes post-ASCT performed at Icon Cancer Centre, including the development of a comprehensive database to ensure the high quality of clinical outcomes.

ICON ANNUAL RESEARCH REPORT 2020

17

THE YEAR AT A GLANCE LAUNCHED A

45

TRIALS OR RESEARCH PROJECTS SELECTED FOR PARTICIPATION AND UNDERGOING START-UP AT ICON

COVID-19 HOME TESTING STUDY. THE FIRST STUDY IN AUSTRALIA TO EXPLORE SELF-TESTING IN A CANCER POPULATION.

HIGHEST GLOBAL RECRUITERS OF THE POTOMAC TRIAL

18

ICON ANNUAL RESEARCH REPORT 2020

135

PATIENTS ON PHASE I TRIALS

700 +

PATIENTS ON ACTIVE TRIALS

105

166

ACTIVE STUDIES WITH PATIENTS CURRENTLY IN TREATMENT AND FOLLOW-UP

CLINICAL TRIALS OPEN FOR RECRUITMENT

34

NEW TRIALS

250

TOTAL ACTIVE TRIALS

55

AUSTRALIA’S

TRIALS OR RESEARCH PROJECTS IN DEVELOPMENT OR UNDERGOING FEASIBILITY

LARGEST PHASE I PRIVATE CLINICAL TRIALS PROGRAM

ACQUISITION OF

50%

ASHFORD CANCER CENTRE RESEARCH + INCREASED RESEARCH CAPACITY BY 50% ICON ANNUAL RESEARCH REPORT 2020

19

KEY HIGHLIGHTS STRATEGY ◊ E volution of research steering committees ◊ N ew executive and strategic appointments ◊ Good Clinical Practice training

GROWTH ◊ Five new centres participating in trials ◊ A shford Cancer Centre Research acquisition ◊ Introduction of new digital solutions ◊ I ncrease in tele-trials and new remote access to clinical trials program

INNOVATION ◊ P harmacy and compounding integration and governance ◊ COVID-19 home testing trial ◊ I nception of a dedicated research innovations and operations team

IMPACT ◊ T RANSFORM trial: changing the face of radiation therapy ◊ 3 3% increase in research accrual ◊ World’s highest recruiter for POTOMAC trial

20

ICON ANNUAL RESEARCH REPORT 2020

ICON ANNUAL RESEARCH REPORT 2020

21

STRATEGY EXECUTIVE MANAGER RESEARCH APPOINTED

GOOD CLINICAL PRACTICE TRAINING

In May 2020, Sophie Mepham, PhD was appointed

Icon continues to expand and build on our

to lead the department in the role of Executive

high levels of Good Clinical Practice (GCP) and

Manager of Research. Sophie is committed to

regulatory compliance through our in-house GCP

expanding research to facilitate clinical trials

Train the Trainer program, facilitated by Sophie

across the Icon Group global network. Her

Mepham, GCP. Currently Icon has 15 team

innovative and quality-focussed approach and

members certified as TransCelerate GCP trainers

passion for research has brought new levels of

with this number set to increase in 2021.

excitement to the team, setting a clear strategy for continual growth and maturity.

NEW APPOINTMENTS AND TEAMS

EVOLUTION OF RESEARCH STEERING COMMITTEES The evolution of the Group’s research committees helps to guide, monitor, evaluate

2020 saw the restructure of several research

and oversee all research activities. These

teams to meet business goals and continued

committees are split based on medical specialty

expansion of clinical trials. This included the

including haematology, radiation oncology

introduction of new key roles including:

and medical oncology. They are focussed on

◊ Cell Therapy Laboratory Director ◊ Research Quality Specialist ◊ Clinical Research Coordinator Team Leads ◊ Clinical Research Assistants

ensuring research activities optimally support Icon’s mission and vision as well as approving and monitoring the implementation of research activities to foster a robust research portfolio for Icon Cancer Centre patients. This is including, but not limited to, Icon’s Investigator-Initiated research and research sponsored by both commercial and non-commercial partners

Appointment of Sophie Mepham as Executive Manager of Research has brought new levels of excitement to the team with a focus on innovation and quality.

22

ICON ANNUAL RESEARCH REPORT 2020

and organisations. These committees include a Committee Chair(s) and up to 15 medical practitioners representing various tumour streams, as well as representation from the Icon Research Executive Manager and teams.

GROWTH ACCR ACQUISITION

NEW DIGITAL SOLUTIONS

Icon’s research experienced significant growth

COVID-19 brought unprecedented changes for

in 2020 with the acquisition of Ashford Cancer

the research industry. Icon adapted quickly to

Centre Research (ACCR). ACCR commenced

meet the needs of the business and has used this

clinical trials in January 1998. Since that time,

opportunity to implement new digital technologies

it has grown to become a major clinical and

and streamline organisational process

research trial facility centre with more than

implementation, both contributing to building

35 active clinical trials focussed on a wide

strong foundations for business expansion.

range of tumour types. ACCR’s dedicated team of oncologists, haematologists and research coordinators have extensive experience in the management and coordination of clinical trials with a strong history of Phase I participation.

In 2020 Icon implemented the following digital solutions to increase efficiencies: ◊ TrialsDocs/SiteDocs Portal Preparing research sites for the e-clinical era to allow remote Investigator site file documentation

REMOTE ACCESS TO CLINICAL TRIALS

review and source data verification. ◊ Devena Solutions A utomating Icon’s clinical trial workflows

COVID-19 created an opportunity to invest further

increasing ease and efficiency in research

in telehealth and tele-trials. Telehealth visits

feasibility and start-up processes.

were increasingly utilised by our investigators and research coordination team to allow trials to continue without exposing patients to unnecessary risks. Icon’s Remote Access to Clinical Trials (ReACT) program also continues to provide direct access to research opportunities for patients close to their communities, covering both metropolitan and rural areas throughout Australia.

◊ RealTime Software Solutions I con’s clinical trial management system tracking clinical trials, clinics, investigators and patients to provide enhanced reporting capabilities. ◊ Slope Tracks Icon’s incoming and outgoing use of laboratory kits, patient devices and other equipment relevant to research protocol increasing inventory accuracy and efficiencies. ◊ DocuSign Facilitating e-signatures for efficient research documentation to reduce feasibility and meet on-trial documentation timelines.

ICON ANNUAL RESEARCH REPORT 2020

23

INNOVATION NEW RESEARCH INNOVATIONS AND OPERATIONS TEAM Icon’s research restructure saw the inception of a new team. The Research Innovations and Operations Team (RIOT) has been created to focus on the growth and support of Icon’s research portfolio. This new team is managed by Adam Stoneley who has over 25 years’ experience in the implementation and management of trials across both the public and private sector. RIOT consists of a growing number of research project leads and clinical research project officers who throughout 2020 have prioritised the review and implementation of industry leading digital technologies and organisation processes to establish a solid foundation for growth.

24

ICON ANNUAL RESEARCH REPORT 2020

RESEARCH PHARMACIES As part of Icon Group’s integrated approach to cancer care, the Group provides a complete suite of pharmacy management services to support the operations of Icon Cancer Centre, Epic and Slade pharmacies, as well as Slade Health TGA-licensed manufacturing services.

Icon’s Pharmacy Practice Unit oversees the governance and management of the Group’s pharmacy operations.

During COVID-19 restrictions, our research pharmacies displayed herculean levels of adaptability and strength. Working swiftly to set new policies and procedures to allow for the continuation of patient drug delivery and return was monumental in keeping clinical research running throughout the pandemic. Innovative solutions including sustainable transport options and the digitalisation of processes were also positive opportunities to have arisen from the challenging year.

COVID-19 HOME TESTING STUDY Sponsored by Sonic Healthcare Icon launched a COVID-19 home testing study at Icon centres in Wahroonga (NSW), South Brisbane, North Lakes and Wesley (QLD) and Richmond (VIC). A Phase II prospective study looking at the feasibility and efficacy of selfcollected nasopharyngeal specimens for COVID-19 detection in an Australian oncology population. This was the first study in Australia to explore the feasibility of self-testing for COVID-19 in a cancer population and is Icon’s first entirely virtual study, using e-consent and REDCap’s automated data capture.

“We know that for many cancer patients, moving around in the community can not only expose patients to COVID-19 but also viruses such as the common cold.

At-home testing is an important way Icon can protect patients from viral infection at a time when they are most vulnerable and reduce the risk of COVID-19 for patients and team members within our centres.”

DR JOHN BASHFORD, ICON DIRECTOR OF RESEARCH

ICON ANNUAL RESEARCH REPORT 2020

25

IMPACT RESEARCH IN 2020 A C C R U A L BY T R I A L P H A S E

A C C R U A L BY T R I A L S P O N S O R

PHASE I

PHASE III

PHARMACEUTICAL

PHASE II

PHASE IV

C O L L A B O R AT I V E

ICON I N V E S T I G AT O R I N I T I AT E D T R I A L S

OTHER

A C C R U A L BY S P E C I A LT Y

MEDICAL ONCOLOGY H A E M AT O L O G Y

PATIENT ACCRUAL PER PHASE FROM 2016 TO 2020 Since 2016 Icon has continued to see an increase in trial participants across Phase I – Phase IV trials.

PHASE I

PHASE III

PHASE II

PHASE IV

2016-2017 FY

26

2 0 1 7- 2 0 1 8 F Y

ICON ANNUAL RESEARCH REPORT 2020

2018-2019 FY

2019-2020 FY

R A D I AT I O N ONCOLOGY

PATIENT ACCRUAL PER PHASE DURING 2020 Accrual to Phase I clinical trials remained steady during 2020 and contributed to approximately 33% of research participant accrual and addressed the much-needed opportunity of third and fourth treatment lines for patients as well as providing therapy for patients with rare diagnoses unmet by traditional clinical trials.

RESEARCH ACCRUAL BY PHASE OF TRIAL - JAN TO DEC 2020 PHASE I

PHASE II

PHASE III

PHASE IV

OTHER

25

20

ACCRUAL

15

10

5

0 Jan-20

Feb-20

Mar-20

Apr-20

May-20

Jun-20

Jul-20

Aug-20

Sep-20

Oct-20

Nov-20

Dec-20

MONTH

RESEARCH ACCRUAL BY SPONSOR OF TRIAL - JAN TO DEC 2020 C O L L A B O R AT I V E

I C O N I N V E S T I G AT O R - I N I T I AT E D T R I A L S

PHARMACEUTICAL

25

20

ACCRUAL

15

10

5

0 Jan-20

Feb-20

Mar-20

Apr-20

May-20

Jun-20

Jul-20

Aug-20

Sep-20

Oct-20

Nov-20

Dec-20

MONTH

ICON ANNUAL RESEARCH REPORT 2020

27

MILESTONES IN RADIATION THERAPY LIBERATE LIBERATE is an Icon Investigator-Initiated Trial which aims to provide proof of concept that focal brachytherapy minimises side effects that are commonly seen in treating the whole prostate for men with low to intermediate risk prostate cancer. LIBERATE is the only clinical registry monitoring patients who have undergone focal brachytherapy helping to ensure quality assurance and measure rates of success and side effects. This study is led by Radiation Oncologist, Dr Andrew See in collaboration with Urologic Surgeon, A/Prof Jeremy Grummet from Epworth Healthcare.

TRANSFORM Led by Principal Investigator, Radiation Oncologist, Dr Patrick Bowden, TRANSFORM was a prospective Phase II study concluding high-tech precision stereotactic radiation therapy (SBRT) can prevent treatment escalation for more than two years and improve the prognosis of advanced prostate cancer patients with early metastatic cancer. TRANSFORM was published in the International Journal of Cancer and is the single

“The results of this study demonstrate the importance of innovation in cancer care and how new techniques can add enormously to the cancer journey and have the potential to improve quality and duration of life.”

largest study of its kind in the world, with over 200 enrolled patients.

28

ICON ANNUAL RESEARCH REPORT 2020

DR PATRICK BOWDEN, RADIATION ONCOLOGIST

“RESEARCH IS FUNDAMENTAL IN THE TREATMENT OF CANCER.” “Research is fundamental in the treatment of cancer. Joining the LIBERATE registry and contributing to evidence of focal brachytherapy for the benefit of future patients has been a very good thing.”

ANDREW DALTON, PATIENT

READ ANDREW’S STORY HERE

ICON ANNUAL RESEARCH REPORT 2020

29

2021 AND BEYOND Icon’s research will continue to redesign itself to meet the needs of our patients and our industry. We are moving toward a globally focussed infrastructure which will ensure Icon continues to lead the way in providing research opportunities to as many patients as possible, as close to home as possible. The evolutions within the research team better represents all facets of research that we conduct and allows for improved management and quality on an international scale.

30

RESEARCH EXPANSION

PHASE I CLINICAL TRIALS

Icon Group are committed to providing research

Over the last year, accrual to Phase I clinical

opportunities across our global footprint. In 2021,

trials grew, contributing to approximately 33%

the group will introduce a Director of Clinical Trials

of the group’s research participant accrual.

in Singapore to spearhead the establishment

With the introduction of ACCR, Icon now boasts

of research sites in Singapore and Hong Kong,

the nation’s largest Phase I cancer clinical trial

providing a strong foundation for additional

program across both the public and private sector.

opportunities across Asia. Icon will also continue

Our primary Phase I unit in South Brisbane has

domestic growth, establishing research at Icon

secured additional office space to allow for future

centres in North Lakes, Canberra and Hobart with

expansion of the team, which will only amplify

several more in the pipeline.

the expected growth in this area. The Group looks

ICON ANNUAL RESEARCH REPORT

forward to expanding our Phase I capabilities across more of our Australia and international research sites throughout 2021.

Medical Oncologist A/Prof Jim Coward has been instrumental in setting up Icon’s Phase I clinical trial program, the first trial of which commenced in 2016 to determine the safety and feasibility of weekly intra-peritoneal administration of Cantrixil to women with persistent or recurrent ovarian cancer, fallopian tube cancer or primary

“Phase I clinical trials offer new and promising treatments with the potential to extend someone’s life. The need to integrate early phase trials into a patient’s journey is paramount, and some of the results we have seen in Phase I trials is nothing short of astonishing”

peritoneal cancer. This was a pioneer trial led by Principal Investigator A/Prof Coward which laid the foundations and infrastructure for Icon’s highly successful Phase I oncology program. This further

A/PROF JIM COWARD, MEDICAL ONCOLOGIST, PHASE I LEAD CLINICIAN

places Icon on the international map as a leader in delivering cutting-edge oncology medicine. Results of the trial will be published in 2021.

NEW ELECTRONIC MEDICAL RECORD Icon is furthering their global partnership with Varian through the adoption of a new and improved electronic medical record for both medical oncology and radiation oncology. This platform includes functionality for patient reported outcomes, improving collation and utilisation, as well as a wealth of additional functionality that will benefit Icon Cancer Centre as a whole.

SHARED INVESTIGATOR PLATFORM ( SIP ) INTEGRATION PILOT Icon will be included in a SiteDocs/SIP integration pilot, whereby research documentation can be shared between Icon sites and sponsors automatically, dramatically reducing administration timelines and any lag in research information sharing between sites and sponsors.

This is projected to improve the timeliness of trial start up administration, implementation of required procedural changes, ethics applications and quality of data.

31

ACKNOWLEDGEMENTS Icon would like to thank all the research team

development of new and improved medications for

and doctors for their dedication to clinical trials

patients in Icon’s care via clinical trials.

in what has been an unprecedented year of challenges for the entire healthcare industry. We also extend our greatest thanks to our clinical trial patients, families and carers who support the evolution of cancer treatment and provide endless inspiration every day.

unique Icon Investigator-Initiated trials and also help to support patients on clinical trials who may have otherwise not been able to participate.

This includes transport and accommodation support along with access to personal cancer care

We also warmly acknowledge the much-valued

coordinators and allied health services to ensure

support of donors to Icon Cancer Foundation, a

patients achieve the best possible outcome from

not-for-profit health promoting charity which

their trial.

is dedicated to improving patient access to medication through clinical trials.

Founded in 1990 as the HOCA Research Centre, the Foundation has long supported the

32

Foundation funds also contribute to setting up

ICON ANNUAL RESEARCH REPORT 2020

“I don’t see myself as a great philanthropist or martyr, but if the trial can not only help me out but is also a path to getting this treatment accepted to help other people, that makes me feel really good.”

COLIN METCHER, PATIENT

READ COLIN’S STORY HERE

ICON ANNUAL RESEARCH REPORT 2020

33

APPENDICES

“Clinical research and clinical care go hand in hand. Research has always been in Icon’s DNA. Through testing new treatments, and taking new approaches to care we are helping to improve quality of life and striving to increase accessibility to people in their own communities, giving patients and families more time, more opportunities and most importantly, more hope.”

DR JOHN BASHFORD, DIRECTOR OF RESEARCH

34

ICON ANNUAL RESEARCH REPORT 2020

ICON ANNUAL RESEARCH REPORT 2020

35

MEDICAL ONCOLOGY Abbrev. Title

Title

Description

IL6 PT

A Prospective Observational Study

This study aims to investigate

Assessing The Role of IL-6 On

whether the IL-6 protein is

The Platelet Protective Effects of

responsible for protecting platelets

Paclitaxel-based Chemotherapy

in people receiving paclitaxel.

in Patients with Epithelial Ovarian Cancer

Vitamin D

Analysing compliance with Calcium

This observational study will examine

and Vitamin D supplementations

rates of compliance with calcium and

in patients receiving bone

vitamin D doses prescribed to cancer

resorption agents

patients who may benefit from taking these supplements due to the type of cancer treatment drugs they have been given.

CLINICAL TRIALS REGISTER

ICON-INITIATED TRIALS OPEN TO ACCRUAL

Non-BCRA PARP

36

Outcome of poly ADP ribose

To describe the response of olaparib

polymerase inhibitors

in patients with non-germline

and subsequent systemic

BRCA andhomologous recombinant

chemotherapy in BRCA1/2 mutant

deficient high grade serous

and homologous recombinant

ovarian, fallopian tube and primary

deficient gynaecological cancers

peritoneal cancers.

Disease Type

Sponsor

Location

Ovarian Cancer

Icon Cancer Foundation

Icon Cancer Centre South Brisbane, Wesley, Chermside, Southport (QLD)

Basket

Icon Cancer Foundation

Icon Cancer Centre South Brisbane, Wesley, Chermside, Southport (QLD)

Ovarian, fallopian tube or primary

Peter MacCallum Cancer Institute

Icon Cancer Centre South Brisbane (QLD)

peritoneal cancer

ICON ANNUAL RESEARCH REPORT 2020

37

HAEMATOLOGY Abbrev. Title

Title

Description

Bone Marrow Transplant

A retrospective analysis of

This project will address significant

survival outcomes following

gaps around clinical outcomes post

autologous haematopoietic

autologous transplantation in the

stem cell transplantation in

private sector.

the private sector

SERENITY

Risk factors for developing breast

This study aims to identify which

implant associated lymphoma

patients with breast implants may be at high risk of developing breast implant associated lymphoma and to provide recommendations of which patients with breast implants should be priority for screening activities.

Lymphodema 3D

Evaluating the reliability and

This is a method comparison study

Scanner

sensitivity of a hand held dual

with measurements taken at one-

camera 3D scanner in measuring

time point involving tape measure

secondary lymphoedema

and 3D imaging software completed

CLINICAL TRIALS REGISTER

ICON-INITIATED TRIALS OPEN TO ACCRUAL

by two trained assessors.

38

ICON ANNUAL RESEARCH REPORT 2020

Disease Type

Sponsor

Location

Autologous haematopoietic stem

Wesley Medical Research and Icon

Icon Cancer Centre Wesley (QLD))

cell transplantation (ASCT)

Cancer Foundation

Lymphoma

Icon Institute of Innovation and

All Australia Icon Cancer Centre locations

Research Pty Ltd; Griffith University

Lymphoedema

Icon Cancer Foundation

Icon Cancer Centre Chermside (QLD)

ICON ANNUAL RESEARCH REPORT 2020

39

RADIATION ONCOLOGY Abbrev. Title

Title

Description

SHRINC

A Phase II Prospective Trial of

The purpose of this study is to

Stereotactic Hypofractionated

investigate whether improved

RadIation for Multiple (3-10)

radiation planning technology that

cerebral metastases

conforms to the shape and size of

including Neurological and

the cancer, can be used to treat

Cognitive assessment.

multiple sites of cancer within the brain, and at the same time protect and preserve your brain (memory and cognitive) function.

LIBERATE

Clinical registry of focal low dose

This observational study will examine

rate brachytherapy in men with

rates of compliance with calcium and

biopsy confirmed low-intermediate

vitamin D doses prescribed to cancer

risk prostate cancer

patients who may benefit from taking these supplements due to the type of cancer treatment drugs they have been given.

CLINICAL TRIALS REGISTER

ICON-INITIATED TRIALS OPEN TO ACCRUAL

ERUPT

40

External Beam Radiotherapy and

This study will aim to measure the

Urethral strictures in prostate

incidence of urethral strictures

cancer treatment

that develop after external beam radiotherapy for prostate cancer.

Dupuytren’s

Radiation therapy in the treatment

The research will consist of a

of Dupuytren’s Contracture: a

retrospective audit of medical records

single institution’s experience

relating to patient’s previously treated for Dupuytren’s Contracture at an Australian radiation oncology treatment centre.

Bowen Project

Evaluation of plan quality and

Study aims to conduct a planning

treatment delivery times of

study to assess quality and treatment

HyperArc, CyberKnife and Gamma

delivery times of each of the three

Knife stereotactic radiosurgery for

modalities in the treatment of

multiple brain metastases

multiple brain metastases.

Disease Type

Sponsor

Location

Brain cancer

Integrated Clinical Oncology Network

Icon Cancer Centre Richmond (VIC) and

Pty Ltd (ICON)

Icon Cancer Centre Hobart (TAS)

Icon Cancer Foundation

Icon Cancer Centre Richmond and

Basket

Freemasons (VIC)

Prostate cancer

Icon Cancer Foundation

Icon Cancer Centre Toowoomba (QLD)

Dupuytren’s contracture

Sunshine Coast University Hospital and

Icon Cancer Centre Maroochydore (QLD)

Integrated Clinical Oncology Network Pty Ltd (ICON)

Basket

The Harley Street Clinic (UK) and

Icon Cancer Centre Bowen (NZ)

Integrated Clinical Oncology Network Pty Ltd (ICON)

ICON ANNUAL RESEARCH REPORT

41

RADIATION ONCOLOGY CONTINUED

Abbrev. Title

Title

Description

PINPOINT

Phase II Trial Harnessing PSMA-PET

The purpose of this study is to

and CalypsO® Real-time Tracking

assess the use of Prostate-Specific

To Precisely Locate And Treat

Membrane Antigen (PSMA) PET/

Recurrent Prostate Cancer

CT scans to identify if men with increased Prostate Specific Antigen (PSA) in the blood have prostate cancer cells in the prostate bed alone, elsewhere in the body, or both.

The second phase of the study will evaluate the effectiveness of using the Calypso (Registered Trademark) tracking system for radiation therapy.

PROSPER-82

A Prospective Phase II Trial

Aims to use Intensity Modulated

Investigating SpaceOAR® Hydrogel

Radiotherapy (IMRT), following the

in Patients with Prostate Cancer

insertion of SpaceOAR®, to dose

Receiving Dose Escalated

escalate men undergoing treatment

Radiotherapy to 82Gy

for clinically localised prostate cancer, aiming to treat to doses of 82Gy in 41 fractions.

CLINICAL TRIALS REGISTER

ICON-INITIATED TRIALS OPEN TO ACCRUAL

TREMOR

42

Safety and effectiveness of

The aim of this study is to test the

frameless linac-based stereotactic

efficacy and safety of frameless

radiosurgery on tremor in

linac-based stereotactic radiosurgical

patients with essential tremor or

thalamotomy, utilising an indirect

Parkinson’s disease

coordinate-based approach.

Disease Type

Sponsor

Location

Prostate cancer

Epworth Medical Foundation

Icon Cancer Centre Richmond and Freemasons (VIC)

Prostate cancer

Epworth Medical Foundation

Icon Cancer Centre Richmond and Freemasons (VIC)

Essential tremor or Parkinson’s

Icon Institute of Innovation and

Icon Cancer Centre Richmond and

related tremor

Research (IIIR)

Freemasons (VIC)

ICON ANNUAL RESEARCH REPORT

43

UNSPECIFIED Abbrev. Title

Title

Description

COVID-19

The feasibility and efficacy of

This study will assess the feasibility

Screening Study

self-collected nasopharyngeal

and uptake of self-directed

specimens for COVID-19

testing for COVID-19 and other

detection in an Australian

seasonal respiratory viruses among

oncology population

patients undergoing treatment for their cancer.

BRACE

A Phase II trial evaluating exercise

The aim of this study is to determine

for patients with brain cancer -

the suitability and safety of an

determining the feasibility and

18-week exercise program for people

safety of an 18-week individualised

with brain cancer and to test whether

exercise program

the program improves quality of life,

CLINICAL TRIALS REGISTER

ICON-INITIATED TRIALS OPEN TO ACCRUAL

well-being and physical health.

44

ICON ANNUAL RESEARCH REPORT 2020

Disease Type

Sponsor

Location

Basket

Icon Cancer Foundation and Sonic

Icon Cancer Centre South Brisbane,

Healthcare

Wesley, North Lakes (QLD) Icon Cancer Centre Richmond (VIC) and Icon Cancer Centre Wahroonga (NSW)

Brain & central nervous system

Icon Cancer Foundation

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD)

ICON ANNUAL RESEARCH REPORT 2020

45

MEDICAL ONCOLOGY Abbrev. Title

Title

Description

RAGNAR –

A Phase II Study of Erdafitinib

The purpose of this study is to

42756493CAN2002

in Subjects With Advanced Solid

evaluate the efficacy of erdafitinib

Tumors and FGFR Gene Alterations

in terms of overall response rate (ORR) in participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) mutations and gene fusions.

AK112-101

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

AK104-101

46

A Phase Ia/Ib Multicenter,

This study is to characterise the

Open-label, Dose-escalation,

safety, tolerability, pharmacokinetics

and Dose-expansion Study

(PK), immunogenicity,

to Evaluate the Safety,

pharmacodynamics (PD) and

Pharmacokinetics, & Antitumor

anti-tumor activity of AK104 as a

Activity of AK104 in Subjects

single agent in adult subjects with

with Advanced Solid Tumors

advanced solid tumor malignancies.

A Phase I/Ib, Multicenter,

This Phase I trial is evaluating the

Open-label, Dose-escalation and

effectiveness and safety of a novel

Dose-expansion Study to Evaluate

immunotherapy (AK112) for the

the Safety, Pharmacokinetics,

treatment of patients with advanced

and Antitumor Activity of AK112

solid tumours.

in Subjects with Select Advanced Solid Tumors

AK117-101

A Phase I, Multicenter, Open-

This Phase I trial is trying to

label, Dose Escalation and Dose

understand how safe and tolerable

Expansion Study to Evaluate the

a new targeted therapy is (AK117)

Safety, Pharmacokinetics, and

for the treatment of adults with

Antitumor Activity of AK117 in

advanced cancers that have spread

Subjects with Relapsed/Refractory

to other parts of the body and

Advanced or Metastatic Solid

have not responded/able to have

Tumors or Lymphomas

other treatment.

Disease Type

Sponsor

Location

Solid tumors

Janssen Research & Development, LLC

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD)

Solid tumors

Akeso (Akesobio Australia Pty Ltd)

Icon Cancer Centre South Brisbane (QLD)

Solid tumors

Akeso (Akesobio Australia Pty Ltd)

Icon Cancer Centre South Brisbane (QLD) and Icon Cancer Centre Adelaide (SA)

Solid tumors

Akeso (Akesobio Australia Pty Ltd)

Icon Cancer Centre South Brisbane (QLD) and Icon Cancer Centre Adelaide (SA)

ICON ANNUAL RESEARCH REPORT

47

MEDICAL ONCOLOGY CONTINUED

Abbrev. Title

Title

Description

AK119-102

A Phase Ia/1b, Multicenter, Open-

This is a first-in-human (FIH),

Label, Dose-Escalation and

Phase Ia/Ib, Multicentre, Open-Label,

Dose-Expansion Study to Evaluate

Dose-Escalation and Dose-Expansion

the Safety, Pharmacokinetics,

Study to Evaluate the Safety,

and Anti-tumor Activity of AK119

Pharmacokinetics, and Anti-tumour

in Combination With AK104

Activity of AK119 (Anti-CD73) in

in Subjects With Advanced or

Combination with AK104 in Subjects

Metastatic Solid Tumors

with Advanced or Metastatic Solid Tumours.

BGB-900-103

A Phase Ib Study to Assess

This Phase I trial is combining an

the Safety, Tolerability,

oral drug (Sitravatinib) with an

Pharmacokinetics, and

immuno-oncology drug (Tislelizumab)

Preliminary Antitumor Activity

for the treatment of patients with

of Sitravatinib in Combination

locally advanced or metastatic

With Tislelizumab in Patients

Non-small Cell Lung Cancer (NSCLC),

With Advanced Solid Tumors

Renal Cell Carcinoma (RCC) or

BGB-900-105

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

Ovarian Cancer (OC).

48

Phase I/Ib Study Investigating

The primary objectives of this

Safety, Tolerability, PK and

study are to assess the safety

Antitumor Activity of Anti-TIGIT

and tolerability, to determine the

Monoclonal Antibody BGB-A1217

maximum tolerated dose (MTD) or

in Combination With Anti-PD-1

maximum administered dose (MAD)

Monoclonal Antibody Tislelizumab

and to determine the recommended

in Patients With Advanced

Phase II dose (RP2D) of BGB-A1217

Solid Tumours

in combination with tislelizumab in participants with advanced solid tumours.

BGB-290-103

A Phase Ib Study to Assess the

The primary objective of this

Safety, Tolerability and Clinical

study is to determine the safety

Activity of BGB-290 in Combination

and tolerability of pamiparib, the

With Temozolomide (TMZ) in

maximum tolerated dose (MTD) or

Subjects With Locally Advanced or

maximum administered dose (MAD)

Metastatic Solid Tumours

for pamiparib combined with TMZ, to select the recommended Phase II dose (RP2D) and schedule of pamiparib in combination with TMZ, and to determine the antitumor activity of pamiparib in combination with TMZ.

Disease Type

Sponsor

Location

Solid tumors

Akeso (Akesobio Australia Pty Ltd)

Icon Cancer Centre South Brisbane (QLD) and Icon Cancer Centre Adelaide (SA)

Solid tumors

BeiGene

Icon Cancer Centre South Brisbane, Chermside, and Wesley (QLD)

Solid tumors

BeiGene

Icon Cancer Centre South Brisbane, Chermside, and Wesley (QLD) and Icon Cancer Centre Windsor Gardens (SA)

Solid tumors

BeiGene

Icon Cancer Centre South Brisbane (QLD)

ICON ANNUAL RESEARCH REPORT

49

MEDICAL ONCOLOGY CONTINUED

Abbrev. Title

Title

Description

CN1-101

A Phase I, Open Label, Multi-center,

This Phase I trial is testing a new

Dose Escalation Clinical Study to

intravenous treatment for people

Evaluate the Safety, Tolerability,

with advanced solid cancers or

Pharmacokinetics, and Preliminary

B-cell lymphoma.

Efficacy of CN1 in Patients with Advanced Solid Tumors or B-cell Lymphoma

CK-301-101

A Phase I, Open-label, Multicentre,

CK-301 (cosibelimab) is a fully

Dose-escalation Study of CK-301

human monoclonal antibody of

Administered Intravenously as

IgG1 subtype that directly binds to

a Single Agent to Subjects With

Programmed Death-Ligand 1 (PD-

Advanced Cancers

L1) and blocks its interactions with the Programmed Death-1 (PD-1) and B7.1 receptors. The primary objectives of this study are to assess the safety, tolerability and efficacy of CK-301 single agent to subjects with selected recurrent or metastatic cancers.

CS1003-101

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

when administered intravenously as a

50

A Phase Ia/Ib, Open-Label,

This Phase I trial is evaluating the

Multiple-Dose, Dose-Escalation

safety and effectiveness of a new

and Expansion Study of the

biological drug (CS1003) in patients

Anti-PD-1 Monoclonal Antibody

with advanced cancers.

CS1003 in Subjects With Advanced Solid Tumours

MAX-10181-001

A Phase I Study of MAX-10181

This is a multicentre, first-in-human,

Given Orally to Patients With

non-randomised, open-label, single-

Advanced Solid Tumour

arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumour.

FPT155-001

A Phase I Safety and Tolerability

This Phase I trial is evaluating the

Study of FPT155 in Patients With

safety and recommended dose of a

Advanced Solid Tumours

new intravenous drug (FPT155) in patients with advanced solid cancers (except primary Central Nervous System cancers).

Disease Type

Sponsor

Location

Solid tumors

Curon Biopharmaceutical (Australia)

Icon Cancer Centre South Brisbane (QLD)

Co Pty Ltd

Solid tumors

Checkpoint Therapeutics, Inc

Icon Cancer Centre South Brisbane (QLD)

Solid tumors

CStone Pharmaceuticals

Icon Cancer Centre South Brisbane, Chermside, and Wesley (QLD) and Icon Cancer Centre Adelaide (SA)

Solid tumors

Maxinovel Pty Ltd

Icon Cancer Centre South Brisbane (QLD)

Solid tumors

Five Prime Therapeutics, Inc

Icon Cancer Centre South Brisbane (QLD)

ICON ANNUAL RESEARCH REPORT

51

MEDICAL ONCOLOGY CONTINUED

Abbrev. Title

Title

Description

SHR-1701-001AUS

A Phase I, Open-Label,

This is a two-part, open-label,

Multicentre, Non-Randomised,

multicenter, non-randomised,

Dose Escalation/Expansion

dose escalation, Phase I study of

Study to Evaluate the Safety,

repeated doses of SHR-1701 in

Tolerability, Pharmacokinetics,

subjects with advanced solid

Pharmacodynamics and

tumors who have failed current

Immunogenicity of SHR-1701

standard anti-tumor therapies.

in Subjects With Advanced Solid Tumours

XNW7201-1-02

A Phase I/II, open label, Multicentre

This purpose of this study is to

study to assess the safety,

determine the safety, tolerability

tolerability, and efficacy of MG010

and efficacy of MG010 in

in combination with sorafenib in

combination with sorafenib in

subjects with solid tumours who

patients with solid tumors who

have failed existing treatments

have failed existing treatments.

A Phrase I, Open-label, Multicentre,

This Phase I trial is evaluating the

Non-Randomised, Does Escalation

effectiveness, safety and tolerance

Study to Evaluate the Safety,

for a targeted therapy (XNW7201) to

Tolerability and Pharmacokinetic

treat patients with locally advanced

Profile of XNW7201 in Subjects

or metastatic solid tumours.

With Advanced Solid Tumours

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

SUCCEED

52

YH003002

A Multicentre, Open-Label,

This is a Phase I/II, multicentre,

Phase I/II Dose Escalation and

open-label study of YH003 in

Expansion Study to Evaluate the

combination with Toripalimab

Safety, Tolerability, Efficacy and

(anti-PD-1 mAb). The study is

Pharmacokinetics of YH003 in

comprised of a dose escalation part

Combination With Toripalimab

(Part I) exploring escalating doses

(Anti-PD-1 mAb) in Subjects With

of YH003 in combination with fixed

Advanced Solid Tumours

dose toripalimab in subjects with advanced solid tumours (Part I), followed by an expansion part (Part II) with three expansion cohorts.

Disease Type

Sponsor

Location

Solid tumors

Atridia Pty Ltd

Icon Cancer Centre South Brisbane (QLD)

Solid tumors

Metagone Biotech Australia Pty Ltd

Icon Cancer Centre South Brisbane (QLD)

Solid tumors

Sinovent Pty Ltd

Icon Cancer Centre South Brisbane (QLD)

Solid tumors

Eucure (Beijing) Biopharma Co. Ltd

Icon Cancer Centre South Brisbane (QLD)

ICON ANNUAL RESEARCH REPORT

53

MEDICAL ONCOLOGY CONTINUED

Abbrev. Title

Title

Description

PATINA

A Randomised, Open Label, Phase

This Phase III trial is trying to show

III Trial to Evaluate the Efficacy and

the benefit of adding a chemotherapy

Safety of Palbociclib + Anti-HER2

drug (palbociclib) to anti-HER2

Therapy + Endocrine Therapy Vs.

therapy plus endocrine therapy in

Anti-HER2 Therapy + Endocrine

the treatment of HER 2+ breast

Therapy After Induction Treatment

cancer that has spread to other

for Hormone Receptor Positive

parts of the body.

(HR+)/HER2-positive Metastatic Breast Cancer

EMBRACE study

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

IMpassion030

54

A Phase III, Multicenter,

This Phase III trial is comparing

Randomised, Open-Label Study

the safety and effectiveness of an

Comparing Atezolizumab (Anti PD-

immunotherapy drug (Atezolizumab)

L1 Antibody) in Combination With

and a chemotherapy drug (Paclitaxel),

Adjuvant Anthracycline/Taxane-

given in combination with the

Based Chemotherapy Versus

investigator's choice of standard

Chemotherapy Alone in Patients

chemotherapy, for the treatment of

With Operable Triple Negative

stage II or stage III triple negative

Breast Cancer

breast cancer (TNBC).

Phase II clinical trial of the PARP

This Phase II trial is evaluating an

inhibitor, olaparib, in HR-deficient

oral drug (Olaparib) in the treatment

metastatic breast and relapsed

of HR-deficient metastatic breast

ovarian cancer in patients without

cancer and relapsed ovarian cancer

germline mutations in BRCA1

without BRCA1 and BRCA2 mutations.

and BRCA2

CAPItello-291

A Phase III Double-blind

This Phase III trial is trying to

Randomised Study Assessing the

understand whether it is more

Efficacy and Safety of Capivasertib

or less effective to use hormone

+ Fulvestrant Versus Placebo

therapy alone or in combination

+ Fulvestrant as Treatment for

with a targeted cancer drug for the

Locally Advanced (Inoperable)

treatment of advanced HR+/HER2-

or Metastatic Hormone Receptor

breast cancer that has gotten worse

Positive, Human Epidermal Growth

or come back on prior treatment.

Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor

Disease Type

Sponsor

Location

Breast cancer

Pfizer

Icon Cancer Centre Wesley (QLD)

Breast cancer

Hoffmann-La Roche

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD) and Icon Cancer Centre Adelaide (SA)

Breast cancer

University of Sydney/Cancer Australia

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD)

Breast cancer

AstraZeneca

Icon Cancer Centre Wesley (QLD) and Icon Cancer Centre Adelaide (SA)

ICON ANNUAL RESEARCH REPORT

55

MEDICAL ONCOLOGY CONTINUED

Abbrev. Title

Title

Description

NATALEE

A Phase III Multicenter,

A Phase III multicentre, randomised,

Randomised, Open-label Trial to

open-label trial to evaluate efficacy

Evaluate Efficacy and Safety of

and safety of ribociclib with endocrine

Ribociclib With Endocrine Therapy

therapy as adjuvant treatment in

as an Adjuvant Treatment in

patients with HR+/HER2- Early

Patients With Hormone Receptor-

Breast Cancer.

positive, HER2-negative Early Breast Cancer (New Adjuvant Trial With Ribociclib

KEYPAD

Denosumab and Pembrolizumab

This Phase II trial is evaluating the

in Clear Cell Renal Carcinoma: a

combination of an immunotherapy

Phase II Trial

(Pembrolizumab) and a targeted therapy (Denosumab) for the treatment of advanced clear cell

NUTMEG

A Randomised Phase II Study of

This Phase II trial is comparing

NivolUmab and TeMozolomide

the effect of a chemotherapy

vs Temozolomide Alone in Newly

drug (Temozolomide) alone and in

Diagnosed Elderly Patients

combination with an immunotherapy

With Glioblastoma

drug (Nivolumab) for the treatment of elderly patients with a newly

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

renal cell carcinoma (ccRCC).

56

diagnosed glioblastoma.

TALAPRO-2

A Phase III, Randomised, Double-

This Phase III trial is comparing

Blind, Placebo-Controlled Study of

the benefits of combining two

Talazoparib with Enzalutamide in

targeted therapies (Talazoparib

Metastatic Castration-Resistant

and enzalutamide) in comparison

Prostate Cancer

to using enalutamide alone for the treatment of patients with metastatic castration-resistant prostate cancer.

CheckMate 7DX

A Phase III Randomised,

This Phase III trial will evaluate

Double-blind Study of Nivolumab

the safety and effectiveness of an

or Placebo in Combination

immunotherapy (nivolumab), given

with Docetaxel in Men with

in combination with a chemotherapy

Metastatic Castration-resistant

(docetaxel), in men with advanced

Prostate Cancer

castration-resistant prostate cancer that has gotten worse after secondgeneration hormone therapy.

Disease Type

Sponsor

Location

Breast cancer

Novartis Pharmaceuticals

Icon Cancer Centre Wesley (QLD)

Renal cell carcinoma

Merck

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD)

Brain & central nervous system

University of Sydney

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD)

Prostate cancer

Pfizer

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD)

Prostate cancer

Bristol-Myers Squibb (BMS)

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD)

ICON ANNUAL RESEARCH REPORT

57

MEDICAL ONCOLOGY CONTINUED

Abbrev. Title 20510

Title

Description

A Phase IIII, Randomised, open-

This study will assess whether

label, multicenter efficacy and

Radium-223 dichloride is more

safety study of standard dose of

efficient and safer treatment than

radium-223 dichloride vs. standard

novel anti-hormonal (NAH) therapy

doses of novel anti-hormonal

in patients with prostate cancer.

therapy (NAH) in patients with bone dominant metastatic castration resistant prostate cancer (mCRPC) progressing on/after one line of NAH

A Phase III, Open-label,

The purpose of this study is to

Randomised Study of Nivolumab

determine whether an investigational

Combined With Ipilimumab, or With

immunotherapy nivolumab in

Standard of Care Chemotherapy,

combination with ipilimumab or in

Versus Standard of Care

combination with standard of care

Chemotherapy in Participants With

chemotherapy is more effective

Previously Untreated Unresectable

than standard of care chemotherapy

or Metastatic Urothelial Cancer

alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

Checkmate 914

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

CheckMate901

58

A Phase III Randomised,

This Phase III trial is trying to

Double-Blind Study of Nivolumab

determine whether the combination

Monotherapy or Nivolumab

of two immunotherapy drugs

Combined With Ipilimumab vs

(nivolumab and ipilimumab) is

Placebo in Participants With

effective in preventing cancer

Localised Renal Cell Carcinoma

recurrence in patients with renal cell

Who Underwent Radical or Partial

carcinoma, who have had part or all

Nephrectomy and Who Are at High

of their kidney removed.

Risk of Relapse

CONTACT-03

A Phase III, Multicentre,

This is a Phase III, multicentre,

Randomised, Open-Label Study

Randomised, open-label study

to Evaluate the Efficacy and

designed to evaluate the efficacy

Safety of Atezolizumab Given in

and safety of atezolizumab given in

Combination With Cabozantinib

combination with cabozantinib versus

Versus Cabozantinib Alone in

cabozantinib alone in participants

Patients With Inoperable, Locally

with inoperable, locally advanced, or

Advanced, or Metastatic Renal

metastatic renal cell carcinoma (RCC)

Cell Carcinoma Who Experienced

who experienced radiographic tumour

Radiographic Tumour Progression

progression during or after Immune

During or After Immune Checkpoint

Checkpoint Inhibitor (ICI) treatment

Inhibitor Treatment

in the metastatic setting.

Disease Type

Sponsor

Location

Prostate cancer

Bayer AG

Icon Cancer Centre South Brisbane (QLD)

Urothelial cancer

Bristol-Myers Squibb

Icon Cancer Centre South Brisbane, Chermside, Wesley (QLD)

Renal cell

Bristol-Myers Squibb

Icon Cancer Centre South Brisbane, Chermside, and Wesley (QLD)

Renal cell

Hoffmann-La Roche

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD)

ICON ANNUAL RESEARCH REPORT

59

MEDICAL ONCOLOGY CONTINUED

Abbrev. Title

Title

Description

COSMIC-313

A Randomised, Double-blind,

This Phase III trial is combining

Controlled Phase III Study of

a targeted cancer treatment and

Cabozantinib in Combination with

immunotherapy treatment to see how

Nivolumab and Ipilimumab Versus

this combination impacts survival

Nivolumab and Ipilimumab in

outcomes for people whose renal cell

Previously Untreated Advanced or

carcinoma (a type of cancer) has

Metastatic Renal Cell Carcinoma of

spread to other parts of the body.

Intermediate or Poor Risk

ICON9

International Phase III Randomised

This Phase III trial is comparing

Study to Evaluate the Efficacy of

maintenance therapy with two oral

Maintenance Therapy With Olaparib

drugs (Olaparib and Cediranib),

and Cediranib or Olaparib Alone

versus Olaparib as a maintenance

in Patients With Relapsed Ovarian

therapy alone, in patients with

Cancer Following a Response to

relapsed ovarian cancer.

SORAYA

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

Platinum-based Chemotherapy

60

A Phase III, Single Arm Study of

This study is designed to evaluate the

Mirvetuximab Soravtansine in

efficacy and safety of mirvetuximab

Platinum-Resistant, Advanced

soravtansine (MIRV) in patients with

High-Grade Epithelial Ovarian,

platinum-resistant high-grade serous

Primary Peritoneal, or Fallopian

epithelial ovarian cancer, primary

Tube Cancers With High Folate

peritoneal, or fallopian tube cancer,

Receptor-Alpha Expression

whose tumours express a high-level of Folate Receptor-Alpha (FRα).

IL6PT-1

A Prospective Observational Study

This study aims to investigate

Assessing The Role of IL-6 On

whether the IL-6 protein is

The Platelet Protective Effects of

responsible for protecting platelets

Paclitaxel-based Chemotherapy

in people receiving paclitaxel.

in Patients with Epithelial Ovarian Cancer

AtTEnd

Phase III Double-blind Randomised

This Phase III trial will evaluate

Placebo Controlled Trial of

whether it is more or less effective

Atezolizumab in Combination

to use an immunotherapy, in

With Paclitaxel and Carboplatin in

combination with chemotherapy,

Women With Advanced/Recurrent

to treat women with advanced or

Endometrial Cancer

recurrent endometrial cancer.

Disease Type

Sponsor

Location

Renal cell

Exelixis

Icon Cancer Centre South Brisbane, Chermside, Wesley (QLD)

Ovarian cancer

University College, London

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD)

Ovarian cancer

ImmunoGen, Inc

Icon Cancer Centre South Brisbane, Chermside, Wesley (QLD)

Ovarian cancer

Icon Cancer Foundation

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD)

Cervical & endometrial cancer

Mario Negri Institute for

Icon Cancer Centre South Brisbane,

Pharmacological Research

Chermside, Wesley (QLD)

ICON ANNUAL RESEARCH REPORT

61

MEDICAL ONCOLOGY CONTINUED

Abbrev. Title

Title

Description

AK104-201-AU

A Phase II, Multicenter, Single-

This Phase II trial is trying to

arm, Open-label Study to Evaluate

determine how safe and tolerable

the Efficacy and Safety of AK104

the biological therapy, AK104, is for

in Subjects with Recurrent or

the treatment of patients who have

Metastatic Cervical Cancer

cervical cancer that has spread or come back following prior treatment.

INTR@PID BTC 055

A Phase II, Multicenter,

Study consists of an open-label,

Randomised, Placebo-controlled

safety run-in part and a randomised,

Study of Gemcitabine Plus Cisplatin

double-blind, placebo-controlled

with and without M7824 as a

Phase II/3 part. In the Phase II/3

First-line Treatment of Biliary

part, the study will evaluate whether

Tract Cancer

bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve metastatic BTC compared to placebo, gemcitabine and cisplatin.

C-POST

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

participants with locally advanced or

62

A Randomised, Placebo-Controlled,

This Phase III trial is comparing

Double-Blind Study of Adjuvant

survival outcomes for patients with

Cemiplimab Versus Placebo After

high-risk cutaneous squamous

Surgery and Radiation Therapy in

cell carcinoma who are treated

Patients With High-Risk Cutaneous

with adjuvant immunotherapy

Squamous Cell Carcinoma

(cemiplimab), compared to those who are treated with a placebo, after surgery and radiotherapy.

CUPISCO

A Phase II, Randomised, Active-

This study will compare the efficacy

Controlled, Multi-Center Study

and safety of molecularly-guided

Comparing the Efficacy and Safety

therapy versus standard platinum-

of Targeted Therapy or Cancer

containing chemotherapy in

Immunotherapy Guided by Genomic

participants with poor-prognosis

Profiling Versus Platinum-Based

cancer of unknown primary site

Chemotherapy in Patients With

(CUP; non-specific subset) who have

Cancer of Unknown Primary Site

achieved disease control after 3

Who Have Received Three Cycles of

cycles of first-line platinum-based

Platinum Doublet Chemotherapy

induction chemotherapy.

Disease Type

Sponsor

Location

Cervical & endometrial cancer

Akeso (Akesobio Australia Pty Ltd)

Icon Cancer Centre South Brisbane, Chermside, Wesley (QLD) and Icon Cancer Centre Adelaide (SA)

Hepatobiliary cancer

Skin cancer

EMD Serono Research & Development

Icon Cancer Centre South Brisbane,

Institute, Inc; Merck

Chermside, and Wesley (QLD)

Regeneron Pharmaceuticals; Sanofi

Icon Cancer Centre Southport, Gold Coast (QLD) and Icon Cancer Centre Adelaide (SA)

Unknown primary cancer

Hoffmann-La Roche

Icon Cancer Centre South Brisbane, Chermside, and Wesley (QLD)

ICON ANNUAL RESEARCH REPORT

63

MEDICAL ONCOLOGY CONTINUED

Abbrev. Title

Title

Description

HBI-8000-303

A Multicentre, Randomised, Double-

This is a multicentre, randomised,

Blind Phase III Study of HBI-8000

double-blind, placebo-controlled

Combined With Nivolumab Versus

Phase III study of HBI-8000 or

Placebo With Nivolumab in Patients

Placebo combined with nivolumab.

With Unresectable or Metastatic

Randomization of eligible patients

Melanoma Not Previously Treated

who are not adolescents or patients

With PD-1 or PD-L1 Inhibitors

with new, progressive brain metastasis will be stratified by PD-L1 expression (positive, ≥5% expression level versus negative, <5% expression level) and LDH (normal versus elevated). Adolescents and patients with new, progressive brain metastasis will be Randomised in a separate stratum.

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

PIVOT-12

64

A Phase III, Randomised,

The main purpose of this study

Open-label Study to Compare

is to compare the efficacy of

Adjuvant Immunotherapy of

bempegaldesleukin plus nivolumab

Bempegaldesleukin Combined

versus nivolumab in patients with

With Nivolumab Versus Nivolumab

completely resected Stage IIIA/B/C/D,

After Complete Resection of

or Stage IV cutaneous melanoma who

Melanoma in Patients at High

are at high risk for recurrence.

Risk for Recurrence

Disease Type

Sponsor

Location

Malignant melanoma

HUYA Bioscience International

Icon Cancer Centre Wesley (QLD)

Malignant melanoma

Nektar Therapeutics

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD)

ICON ANNUAL RESEARCH REPORT

65

HAEMATOLOGY Abbrev. Title

Title

Description

ASSURE

A Phase IIIb, Multicenter, Open-

This Phase III trial is evaluating the

label, Single-arm Study of

safety and effectiveness of a targeted

Acalabrutinib (ACP-196) in Subjects

therapy in patients with chronic

with Chronic Lymphocytic Leukemia

lymphocytic leukaemia.

A Study of Zanubrutinib (BGB-3111)

This study is designed to compare the

Versus Ibrutinib in Participants

overall response rate of zanubrutinib

With Relapsed/Refractory Chronic

versus ibrutinib in participants

Lymphocytic Leukemia

with relapsed/refractory chronic

ALPINE

lymphocytic leukemia or small lymphocytic lymphoma.

A Safety and Pharmacokinetic

This is a Phase I/IB dose-escalation

Study of BTCT4465A

study of BTCT4465A (Mosunetuzumab)

(Mosunetuzumab) as a Single

administered as a single agent and

Agent and Combined With

in combination with atezolizumab

Atezolizumab in Non-Hodgkin's

in participants with relapsed or

Lymphoma (NHL) and Chronic

refractory B-cell NHL and CLL. The

Lymphocytic Leukemia (CLL)

study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

GO29781

66

B-MIND

A Phase II/III, Randomised,

This is a randomised, two-arm,

Multicentre Study of Tafasitamab

multicentre, open-label Phase II/III

With Bendamustine Versus

efficacy and safety study of Tafasitamab

Rituximab With Bendamustine

in combination with BEN versus RTX in

in Patients With Relapsed

combination with BEN given to adult

or Refractory Diffuse Large

patients who have relapsed after or are

B-Cell Lymphoma (R-R DLBCL)

refractory to at least one but no more

Who Are Not Eligible for High-

than three prior systemic therapies

Dose Chemotherapy (HDC)

and have failed, or are not candidates

and Autologous Stem-Cell

for HDC and ASCT, and have thus

Transplantation (ASCT)

exhausted their therapeutic options of demonstrated clinical benefit. At least one prior therapy line must have included a CD20-targeted therapy.

Disease Type

Sponsor

Location

Chronic lymphocytic leukaemia

AstraZeneca

Icon Cancer Centre South Brisbane, Chermside, and Wesley (QLD)

Chronic lymphocytic leukaemia

BeiGene

Icon Cancer Centre South Brisbane (QLD)

Chronic lymphocytic leukaemia

Genentech, Inc

Icon Cancer Centre South Brisbane, Chermside, and Wesley (QLD)

B-Cell lymphoma

MorphoSys AG

Icon Cancer Centre South Brisbane, Chermside, Wesley, and Southport (QLD)

ICON ANNUAL RESEARCH REPORT

67

HAEMATOLOGY CONTINUED

Abbrev. Title

Title

Description

CANOVA

A Phase III, Multicenter,

A study designed to evaluate the

Randomised, Open Label Study of

safety and efficacy of venetoclax

Venetoclax and Dexamethasone

plus dexamethasone (VenDex)

Compared with Pomalidomide and

compared with pomalidomide

Dexamethasone in Subjects with

plus dexamethasone (PomDex)

T (11;14)-positive Relapsed or

in participants with t (11;14)-

Refractory Multiple Myeloma

positive relapsed or refractory multiple myeloma.

Myeloma and Related

Myeloma and Related

The Myeloma and Related Diseases

Diseases Registry

Diseases Registry

Registry (MRDR) is an ongoing register of patients with a new diagnosis of multiple myeloma, plasmacytoma, plasma cell leukaemia or monoclonal gammopathy of

DREAMM7

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

undetermined significance (MGUS).

68

A Multicentre, Open-Label,

This is a Phase III, randomised,

Randomised Phase III Study

open-label study designed to evaluate

to Evaluate the Efficacy and

safety and efficacy of belantamab

Safety of the Combination of

mafodotin in combination with

Belantamab Mafodotin, Bortezomib,

bortezomib/dexamethasone (Arm A)

and Dexamethasone (B-Vd)

versus daratumumab in combination

Compared With the Combination

with bortezomib/dexamethasone

of Daratumumab, Bortezomib

(Arm B) in the participants with

and Dexamethasone (D-Vd) in

relapsed recurrent multiple myeloma.

Participants With Relapsed/ Refractory Multiple Myeloma

DREAMM8

A Phase III, Multicentre,

This study will evaluate the efficacy

Open-Label, Randomised Study

and safety of belantamab mafodotin

to Evaluate the Efficacy and

in combination with pomalidomide

Safety of Belantamab Mafodotin

and dexamethasone (Arm A)

in Combination With Pomalidomide

compared with that of combination

and Dexamethasone (B-Pd) Versus

of pomalidomide, bortezomib

Pomalidomide Plus Bortezomib

and dexamethasone (Arm B) in

and Dexamethasone (PVd) in

participants with relapsed/refractory

Participants With Relapsed/

multiple myeloma (RRMM).

Refractory Multiple Myeloma

Disease Type

Sponsor

Location

Multiple myeloma

AbbVie

Icon Cancer Centre South Brisbane, Chermside, Wesley, Southport, and Townsville (QLD)

Multiple myeloma

Janssen-Cilag Pty Limited

Icon Cancer Centre South Brisbane, Chermside, Wesley, Southport (QLD) Icon Cancer Centre Adelaide (SA)

Multiple myeloma

GlaxoSmithKline

Icon Cancer Centre Adelaide (SA)

Multiple myeloma

GlaxoSmithKline

Icon Cancer Centre South Brisbane, Chermside, and Wesley (QLD)

ICON ANNUAL RESEARCH REPORT

69

HAEMATOLOGY CONTINUED

Abbrev. Title

Title

Description

ROSEWOOD

An International, Phase II,

This Phase II trial is evaluating

Open-label, Randomised Study

Obinutuzumab alone and in

of BGB-3111 Combined with

combination with a new oral drug

Obinutuzumab Compared with

(BGB-3111) for the treatment of

Obinutuzumab Monotherapy

non-Hodgkin follicular lymphoma

in Relapsed/Refractory

that has got worse or not responded

Follicular Lymphoma

to prior treatment.

A Phase III, Open-label,

Anemia is considered to be one of the

Randomised Study to Compare

most prevalent cytopenias in patients

the Efficacy and Safety of

who have myelodysplastic syndromes,

Luspatercept (ACE-536) Versus

an umbrella term used to describe

Epoetin Alpha for the Treatment of

disorders relating to the ineffective

Anemia Due to IPSS-R Very Low,

production of red blood cells, white

Low or Intermediate Risk Due to

blood cells, and/or platelets. The goal

Myelodysplastic Syndrome (MDS)

of this study is to assess the safety

ESA in Native Subjects Who Require

and efficacy of luspatercept versus

Red Blood Cell Transfusions

epoetin alfa in anemic patients who are categorized as International Prognostic Scoring SystemRevised (IPSS-R) very low, low, or intermediate risk Myelodysplastic syndrome (MDS), are Erythropoiesis-

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

COMMANDS

70

stimulating agent naïve, and require constant red blood cell transfusions.

ENHANCE

A Randomised, Double-blind,

The primary objective of this

Multicentre Study Comparing

study is to evaluate the efficacy

Magrolimab in Combination With

of magrolimab in combination

Azacitidine Versus Azacitidine

with azacitidine compared to that

Plus Placebo in Treatment-

of azacitidine plus placebo in

naïve Patients With Higher Risk

previously untreated participants

Myelodysplastic Syndrome

with intermediate/high/very high-risk myelodysplastic syndrome (MDS)

by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).

Disease Type

Sponsor

Location

Follicular lymphoma

BeiGene

Icon Cancer Centre South Brisbane and Wesley (QLD)

Myelodysplastic syndrome

Acceleron Pharma Inc

Icon Cancer Centre South Brisbane, Chermside, Wesley and Southport (QLD)

Myelodysplastic syndrome

Gilead Sciences

Icon Cancer Centre South Brisbane (QLD)

ICON ANNUAL RESEARCH REPORT

71

HAEMATOLOGY CONTINUED

Abbrev. Title

Title

Description

AMLM22/D2

A Randomised, Multi-arm Study

This Phase II trial is comparing the

Platform to Compare the Efficacy

safety and effectiveness of a new,

of Experimental Therapies Versus

experimental treatment Molibresib

Standard of Care in Subjects with

and standard of care in patients with

Acute Myeloid Leukemia in First

acute myeloid leukaemia in complete

Complete Remission

first remission.

An Open-label, Phase IIa/IIb

This Phase II trial is evaluating an oral

Study of KRT-232 in Subjects

drug (KRT-232) for the treatment of

with Primary Myelofibrosis, Post–

patients with myelofibrosis who are

polycythemia Vera Myelofibrosis, Or

no longer benefiting their current

Post–essential Thrombocythemia

treatment with a JAK inhibitor.

KRT-232-101

Myelofibrosis who have Failed Prior

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

Treatment with a JAK Inhibitor

72

ICON ANNUAL RESEARCH REPORT 2020

Disease Type

Sponsor

Location

Acute myeloid leukaemia

The Australasian Leukaemia &

Icon Cancer Centre South Brisbane,

Lymphoma Group (ALLG)

Chermside, and Wesley (QLD)

Sierra Oncology, Inc

Icon Cancer Centre South Brisbane,

Myelofibrosis

Chermside, and Wesley (QLD)

ICON ANNUAL RESEARCH REPORT 2020

73

RADIATION ONCOLOGY Abbrev. Title

Title

Description

SPAR

A clinical trial comparing

The primary purpose of this trial is

Simvastatin to placebo, in addition

to compare the effect of simvastatin

to standard chemotherapy and

with placebo on the effectiveness

radiotherapy, in preoperative

and side effects of pre-operative

treatment for patients with

chemoradiotherapy treatment

rectal cancer

prior to rectal cancer surgery, and on the body's inflammatory response to cancer.

EXPERT

A prospective, single arm,

This Phase II study aims to

Multicentre study of post

investigate whether PET scan

neoadjuvant chemoradiation

performed after the completion

PET as predictor of pathological

of chemotherapy and radiation

response in patients with localised

can predict response of

oesophageal cancer

oesophageal cancer.

Examining Personalised

The purpose of this study is to see

Radiation Therapy for Low-Risk

whether a specialised laboratory test

Early Breast Cancer

(Prosigna (PAM50) Assay) of breast cancer tissue can be used to choose

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

CROSSPET

74

women who can safely avoid radiation therapy because there is a low risk of the cancer coming back.

MAGMA

The Multi-arm Glioblastoma

A multi-arm multi-stage, multicentre,

Australasia Trial

Phase III (MAMS) platform trial that aims to assess hypotheses against a common standard-of-care control arm for the management of people with glioblastoma.

Disease Type

Sponsor

Location

Rectal adenocarcinoma, or

The Australasian Gastro-Intestinal

Icon Cancer Centre Gold Coast (Qld)

high-grade dysplasia

Trials Group (AGITG)

Gastrointestinal cancer

South Eastern Sydney Local

Icon Cancer Centre Cairns and Gold

Health District

Coast (QLD) and Icon Cancer Centre Mulgrave (VIC)

Breast cancer

Glioblastoma

Breast Cancer Trials, Australia

Icon Cancer Centre Mulgrave and

and New Zealand

Richmond (VIC)

The Cooperative Trials Group for

Icon Cancer Centre Gold Coast (QLD)

Neuro-Oncology (COGNO)

ICON ANNUAL RESEARCH REPORT

75

RADIATION ONCOLOGY CONTINUED

Abbrev. Title

Title

Description

MASTERPLAN

MASTERPLAN: A Randomised Phase

This is a prospective, multicentre

II Study of MFOLFIRINOX And

randomised, Phase II clinical trial

Stereotactic Radiotherapy (SBRT)

to evaluate safety and activity of

for Pancreatic Cancer With High

stereotactic body radiotherapy

Risk and Locally Advanced Disease

(SBRT) in addition to chemotherapy in patients with high-risk and borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). High risk defined as any patient with tumour >4cm, extrapancreatic extension or node positive disease.

A Phase II Randomised Trial

This study will compare radiation

for Early-stage Squamous Cell

therapy with a new surgical treatment

Carcinoma of the Oropharynx:

called transoral robotic surgery

Radiotherapy vs Trans-oral

(TORS). TORS is a new surgical

Robotic Surgery

approach using a robot to assist the surgeon in removing the tumour, potentially with fewer side effects than older surgical techniques.

OUTRUN

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH OPEN TO ACCRUAL

ORATOR2

76

A Randomised Phase II Trial of

The aim of this study is to compare

Osimertinib With or Without

the effects of Osimertinib alone

Stereotactic Radiosurgery for

versus SRS plus Osimertinib on

EGFR Mutated Non-Small Cell

intra-cranial disease control in

Lung Cancer (NSCLC) With

EGFR mutated NSCLC with brain

Brain Metastases

metastases diagnosed or developed while on first line EGFR tyrosine kinase inhibitors.

DISL-HiCaP

Darolutamide Augments Standard

The purpose of this study is to

Therapy for Localised Very

determine the effectiveness of

High-Risk Cancer of the Prostate

darolutamide as part of adjuvant

(ANZUP1801): A Randomised Phase

androgen deprivation therapy (ADT)

III Double-blind, Placebo-controlled

with a luteinising hormone releasing

Trial of Adding Darolutamide to

hormone analogue (LHRHA) in men

Androgen Deprivation Therapy and

having radiation therapy for localised

Definitive or Salvage Radiation in

prostate cancer at very high risk of

Very High Risk, Clinically Localised

recurrence.

Prostate Cancer

Disease Type

Sponsor

Location

Pancreatic cancer

Australasian Gastro-Intestinal Trials

Icon Cancer Centre Gold Coast (QLD)

Group; Trans-Tasman Radiation Oncology Group; Australian Government Department of Health and Ageing

Squamous cell carcinoma

Lawson Health Research Institute

Icon Cancer Centre Gold Coast (QLD)

Lung cancer

Trans-Tasman Radiation

Icon Cancer Centre Greenslopes and

Oncology Group

North Lakes (QLD)

University of Sydney

Icon Cancer Centre Gold Coast (QLD) and

Prostate cancer

Icon Cancer Centre Adelaide (SA)

ICON ANNUAL RESEARCH REPORT

77

MEDICAL ONCOLOGY Abbrev. Title

Title

Description

RESONATE

A compRehEnSive Oral aNti-cAncer

This pilot randomised control trial

medicaTion FramEwork

will evaluate the effectiveness of a patient support package aimed at educating and supporting newly initiated OAM patients at Icon Cancer Centre’s.

Metabolomics in Enhancing

The long-term clinical aim is to

Responses in Cancer

utilise the metabolome as a predictive

ImmunoTherapy in Melanoma

biomarker for patients undergoing immunotherapy treatment, with the goal of reversing metabolomic changes associated with the non-responder phenotype.

CLINICAL TRIALS REGISTER

ICON-INITIATED RESEARCH UNDER REVIEW AND IN DEVELOPMENT

MERIT-M

78

Disease Type

Sponsor

Location

Basket

Integrated Clinical Oncology Network

TBC

Pty Ltd (ICON)

Melanoma

Uniting Health Care

Icon Cancer Centre Wesley, South Brisbane, Chermside and North Lakes (QLD)

ICON ANNUAL RESEARCH REPORT

79

RADIATION ONCOLOGY Abbrev. Title

Title

Description

POCAHONTAS

Up Front Total Eradication Therapy

The POCAHONTAS trial will be the

vs Stereotactic Ablation of PSMA

first to prospectively assess upfront

PET Persistent Metastases in Men

SABR versus delayed SABR, in concert

with CSPCa (4-10) Managed with

with best systemic therapy, for

Best Systemic therapy

poly-metastatic (4 – 10 metastases), hormone-sensitive prostate cancer.

The optimal combination of SABR and systemic therapy identified standard-of-care treatment in a future Phase III trial.

ERASE

Evaluation of Response Adapted

Only 20% of patients with advanced

SABR in advanced mElanoma

melanoma on combined ICIs

receiving immunotherapy

achieve a complete response (CR).

The development of anatomical and biological adapted SBRT in combination with immune checkpoint inhibitors in the early management of these patients may increase these response rates, inducing

CLINICAL TRIALS REGISTER

ICON-INITIATED RESEARCH UNDER REVIEW AND IN DEVELOPMENT

in this trial will be tested against

80

an environment for sustained progression free survival and prolonged survival.

Varian HyperArc Registry

HyperArc Registry Study

The objective of the HyperArc Registry will be to provide a data platform to enable clinical research regarding treatments involving HyperArc and to advance patient care.

Disease Type

Sponsor

Location

Prostate cancer

Integrated Clinical Oncology

TBC

Network Pty Ltd (ICON) and Varian Medical Systems

Melanoma

Integrated Clinical Oncology

TBC

Network Pty Ltd (ICON) and Varian Medical Systems

Basket

Integrated Clinical Oncology

TBC

Network Pty Ltd (ICON) and Varian Medical Systems

ICON ANNUAL RESEARCH REPORT

81

MEDICAL ONCOLOGY Abbrev. Title

Title

AMPLITUDE

A Phase III Randomised, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone (AA-P) and ADT versus Abiraterone Acetate and Prednisone and ADT in Subjects with Metastatic Castration Sensitive Prostate Cancer

CP-MGA271-06

A Phase II 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

FRESCO-2

A Global Multicenter Randomised Placebo-Controlled Phase III 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

M19-345

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH UNDER REVIEW AND IN DEVELOPMENT

(mCSPC) with DNS-repair Gene Defects

82

A Phase I 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

COSTAR-213410

A Randomised, Open Label Phase II/III Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Nonsmall Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)

ACT001-AU-004

A Phase II, open label, multicenter study assessing the safety and efficacy ofACT001 in combination with whole brain radiation therapy (WBRT) for brain metastases from solid tumors

Description

Disease Type

Sponsor

The purpose of the study is to determine if the combination of niraparib

Prostate cancer

Janssen Research

with Abiraterone Acetate (AA) plus prednisone compared with AA plus

& Development, LLC

prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic CastrationSensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).

This is an open-label, non-randomised study of approximately 80 patients.

Squamous cell

Enrollment into each cohort will occur independently, with 50 programmed

carcinoma

MacroGenics

cell death ligand 1 (PD-L1)-positive patients enrolled in the retifanlimab cohort, and 30 PD-L1-negative patients enrolled in the tebotelimab cohort.

This is a global, randomised, double-blind, placebo-controlled, multicenter

Colorectal cancer

Hutchison

Phase III clinical trial to compare the efficacy and safety of fruquintinib

Medipharma

plus best supportive care (BSC) versus placebo plus BSC in patients

Limited

with refractory metastatic colorectal cancer (mCRC). 687 subjects will be Randomised to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.

The study will determine the recommended Phase II dose (RP2D) of

Solid tumours

AbbVie

Lung cancer

GlaxoSmithKline

Solid tumours

Accendatech Au

ABBV-151 administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-151 alone and in combination with budigalimab. The study will consist of 2 Phases: dose escalation and dose expansion.

This is a multi-center, parallel group treatment, Phase II open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced Nonsmall cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

The aim of this study is to evaluate the safety and tolerability of 800mg per day of ACT001 in combination with WBRT in the setting of brain metastases

Pty Ltd

from solid tumors.

ICON ANNUAL RESEARCH REPORT

83

MEDICAL ONCOLOGY CONTINUED

Abbrev. Title

Title

CA224-104

A Phase II Randomised 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)

A Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Efficacy of SHR-1501 in Combination With SHR-1316 in Patients With Advanced Malignancies

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH UNDER REVIEW AND IN DEVELOPMENT

SHR-1501-I-101

84

“I ENCOURAGE ALL PATIENTS TO ACCEPT THE OPPORTUNITY WITH BOTH HANDS.”

ICON ANNUAL RESEARCH REPORT 2020

Description

Disease Type

Sponsor

The purpose of this study is to assess the safety profile of nivolumab plus

Lung cancer

Bristol-Myers

relatlimab in combination with platinum doublet chemotherapy (PDCT)

Squibb

and to determine if nivolumab plus relatlimab in combination with PDCT improves progression free survival (PFS) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

The purpose of this study is to evaluate the safety and tolerability of SHR-

Basket (all

Jiangsu HengRui

1501 in combination with SHR-1316 in patients with advanced malignancies

advanced cancer)

Medicine Co. Ltd

and to provide a recommended dose (RP2D) for subsequent clinical studies.

“The effort that goes into improving cancer treatment is phenomenal. I have been on a trial for nearly three years and have felt well enough to enjoy each day.

If given the opportunity to participate in a trial, I encourage all patients to accept the opportunity with both hands.”

JENNIFER WALDON, PATIENT

ICON ANNUAL RESEARCH REPORT 2020

85

HAEMATOLOGY Abbrev. Title

Title

DREAMM7

A Multicentre, Open-Label, Randomised Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma

DREAM3R

DuRvalumab (MEDI4736) with chEmotherapy as first line treatment in

ESCALADE-ACE-LY-312

Phase III, Randomised, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Subjects ≤65 Years With Previously Untreated Non-Germinal Center DLBCL

GCT3013-05

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

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH UNDER REVIEW AND IN DEVELOPMENT

advanced pleural Mesothelioma - A Phase III Randomised trial

86

MANIFEST-2

A Phase III, Randomised, Double-blind, Active-Control Study of CPI0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

TL-895-201

A Phase II, Open-label, Multicentre Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis

Description

Disease Type

Sponsor

This is a Phase III, randomised, open-label study designed to evaluate safety

Multiple myeloma

GlaxoSmithKline

The purpose of this study is to see whether adding durvalumab to standard

Malignant pleural

PrECOG, LLC;

chemotherapy will improve overall survival (OS) in patients with malignant

mesothelioma

AstraZeneca;

and efficacy of belantamab mafodotin in combination with bortezomib/ dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

pleural mesothelioma MPM.

Thoracic Oncology Group Australasia (TOGO); University of Sydney

Phase III randomised, double-blind, placebo-controlled, study assessing

B-cell lymphoma

Acerta Pharma BV

B-cell lymphoma

Genmab

Myelofibrosis

Constellation

the efficacy and safety of acalabrutinib plus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤65 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.

The purpose of this trial is to evaluate the efficacy of epcoritamab (GEN3013 DuoBody®-CD3xCD20) compared to investigator’s choice of chemotherapy in patients with relapsed, refractory diffuse large B-Cell Lymphoma who have failed or are ineligible for High-dose chemotherapy followed by autologous stem cell transplantation.

A Phase III, randomised, blinded study comparing CPI-0610 and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not

Pharmaceuticals

been exposed previously to Janus kinase inhibitors (JAKi). CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

Evidence suggests that inhibition of both BET and JAK pathways can result in synergistic reduction of disease and overall improvement in the prognosis of MF.

This study evaluates TL-895, a potent, orally available and highly selective

Myelofibrosis

Telios Pharma, Inc

irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis.

Participants must be relapsed/refractory (e.g. having failed prior therapy), intolerant, or ineligible to receive JAKi treatment.

ICON ANNUAL RESEARCH REPORT

87

HAEMATOLOGY CONTINUED

Abbrev. Title

Title

BGB-3111-306

A Phase III Randomised, Open-Label, Multicentre Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

WAMM-NHL33

An ALLG Window study of Acalabrutinib plus Rituximab followed by

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH UNDER REVIEW AND IN DEVELOPMENT

R-DHAOx+ASCT in fit Mantle Cell Lymphoma

88

Description

Disease Type

Sponsor

This is a randomised study to compare the efficacy and safety of

Mantle cell

BeiGene

zanubrutinib plus rituximab versus bendamustine plus rituximab in

lymphoma

previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.

The trial aims to improve treatment for people with newly

Mantle cell

The Australasian

diagnosed mantle cell lymphoma (MCL).

lymphoma

Leukaemia and Lymphoma Group

ICON ANNUAL RESEARCH REPORT

89

RADIATION ONCOLOGY Abbrev. Title

Title

ORATOR3

A Phase II Randomised Trial for HPV-Negative Oropharyngeal

AVATAR

Stereotactic Radiotherapy for Oligoprogressive ER-positive Breast Cancer

CLINICAL TRIALS REGISTER

ADDITIONAL CLINICAL RESEARCH UNDER REVIEW AND IN DEVELOPMENT

Squamous Cell Carcinoma: Radiotherapy vs. Trans-Oral Surgery

90

ICON ANNUAL RESEARCH REPORT 2020

Description

Disease Type

Sponsor

The purpose of this study is to compare standard radiation therapy (RT)

Squamous cell

London Regional

(with added chemotherapy if your doctor determines it is necessary)

carcinoma

Cancer Program

Breast cancer

Peter MacCallum

with a surgical treatment called transoral surgery to compare these two treatments to see if there is any difference in cancer outcomes, side effects and quality of life.

The primary objective of this study is to describe the time to change in systemic therapy after stereotactic radiotherapy (SRT) in patients with

Cancer Centre

ER-positive HER2-negative advanced breast cancer receiving an aromatase inhibitor (AI) in combination with a CDK 4/6 inhibitor who have up to 5 sites of oligoprogressive disease.

ICON ANNUAL RESEARCH REPORT 2020

91

ICON RESEARCH COMMITTEES MEDICAL ONCOLOGY, HAEMATOLOGY AND RADIATION ONCOLOGY

Medical Oncology Committee

Radiation Oncology Committee

The newly named Icon Medical Oncology

The Icon Radiation Oncology Research Committee

Research Committee has been in existence

was established early 2018 to meet the varied

since 2006. With the separation of the medical

governance needs of the growing mix of radiation

oncology and haematology research governance

oncology clinical trials versus technical and allied

in August 2020, the committee has been able

health projects across several Icon Cancer Centre

to better devote more time and attention to the

locations. An additional role of this committee

increasing predominance of Phase I medical

includes reviewing and assessing requests from

oncology trials. Committee members include

external healthcare organisations to have Icon

some of Icon Cancer Centre’s most prolific and

Cancer Centre as service providers for radiation

active investigators, Medical Oncologists, A/Prof

oncology services.

Jim Coward and Dr Jeffery Goh. ◊ A/Prof Nicole McCarthy - Medical Oncologist

Chair

Haematology Committee The Icon Haematology Research Committee was created mid-2020. This research committee was formed from the division of the prior dual medical oncology and haematology research committee to focus more efficiently on the needs of the haematologist and drive growth in both participant accrual and new trial activity for the clinical haematology portfolio. This newly formed committee permitted the inclusion of additional haematologists with a passion, expertise and interest in clinical trials. ◊ Dr Jason Butler - Haematologist - Chair

92

ICON ANNUAL RESEARCH REPORT 2020

◊ Dr Amy Teh - Radiation Oncologist – Co-Chair ◊ Trent Aland PhD - National Director of Medical

Physics – Co-Chair

2021 EVOLUTIONS In 2021 Icon’s Singapore team will launch a research committee with Medical Oncologist, Dr Hsieh Wen-Son as Chair.

PRINCIPAL INVESTIGATORS MEDICAL ONCOLOGY

Principal Investigators

Title

Icon Cancer Centre Locations

A/Prof Jim Coward

Medical Oncologist

South Brisbane and

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

Chermside (QLD)

A/Prof Simon Durrant

Medical Oncologist and

MBBS, MRCS, LRCP, FRACP, FRCPath

Clinical Haematologist

Dr Paul Eliadis AM

Medical Oncologist and

MBBS, BSc (Med), FRACP, FRCPA

Clinical Haematologist

Dr Jeffrey Goh

Medical Oncologist

MBBS, FRACP

Dr Vikram Jain

Wesley and Chermside (QLD)

Wesley (QLD)

Chermside and Greenslopes (QLD)

Medical Oncologist

South Brisbane (QLD)

Medical Oncologist

Wesley, North Lakes and

MBBS, FRACP

Dr Agnieszka Malczewski MBBS, FRACP, MSc

A/Prof Nicole McCarthy

Chermside (QLD)

Medical Oncologist

Wesley (QLD)

Medical Oncologist

Hobart (TAS)

Medical Oncologist

Southport (QLD)

Medical Oncologist

Wesley, Chermside and North

MBBS (Hons), MHSc, FRACP

Dr Cristina Moldovan MBBS, FRACP

A/Prof Michael Slancar MD, FRACP

Dr Adam Stirling MBBS(Hons), FRACP

A/Prof Paul Vasey

Lakes (QLD)

Medical Oncologist

Wesley and Toowoomba (QLD)

MBChB, MSc(Clin.Pharm), MD, MRCP(UK), FRACP

ICON ANNUAL RESEARCH REPORT 2020

93

PRINCIPAL INVESTIGATORS HAEMATOLOGY

Principal Investigators

Title

Icon Cancer Centre Locations

Dr Raymond Banh

Clinical Haematologist

South Brisbane, Wesley

MBBS, FRACP, FRCPA

Dr Ian Bunce

and Redland (QLD)

Clinical Haematologist

OAM, RFD, ED, MBBS(Qld), FRACP, FRCPA

Dr Joseph Clarey

Chermside and Wesley (QLD)

Clinical Haematologist

MBBS, FRACP, FRCPA

Wesley, Mackay and Chermside (QLD)

A/Prof Simon Durrant

Medical Oncologist and Clinical

MBBS, MRCS, LRCP, FRACP, FRCPath

Haematologist

Dr Paul Eliadis AM

Medical Oncologist and Clinical

MBBS, BSc (Med), FRACP, FRCPA

Haematologist

Dr Robert Hensen

Clinical Haematologist

MBBS, FRACP, FRCPA

Wesley and Chermside (QLD)

Wesley (QLD)

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

Dr Matthew Hourigan

Clinical Haematologist

MBBS (Hons), FRACP, FRCPA

Greenslopes (QLD)

Dr Ian Irving

Clinical Haematologist; Icon

MBBS, FRACP, FRCPA

Group Medical Director

Wesley and Mackay (QLD)

A/Prof James Morton AM

Clinical Haematologist; Icon

South Brisbane and

MBBS, BSci (Med), FRACP, FRCPA, GAICD

Group Director of Haematology

Chermside (QLD)

A/Prof Kerry Taylor

Clinical Haematologist

South Brisbane (QLD)

MBBS(Hons), FRACP, FRCPA

94

Wesley, Redland and

ICON ANNUAL RESEARCH REPORT 2020

PRINCIPAL INVESTIGATORS RADIATION ONCOLOGY

Principal Investigators

Title

Icon Cancer Centre Locations

Mr Trent Aland

National Director of Medical

South Brisbane Corporate

BASc, MSc, MBA, PhD in Medical Physics

Physics

Office (QLD)

Dr Patrick Bowden

Radiation Oncologist

Freemasons, Mulgrave,

MBBS, FRANZCR

Richmond and Moreland (VIC), Canberra (ACT)

Dr Michael Dally

Radiation Oncologist

MB, ChB, BSc, FRANZCR

A/Prof Kumar Gogna

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

Radiation Oncologist

Greenslopes and Redland (QLD)

Radiation Oncologist

Gold Coast Private Hospital,

MBBS, DCH, FRCP, FRANZCR

A/Prof Jim Jackson MBBS, FRANZCR

Gold Coast University Hospital, North Lakes and Greenslopes (QLD)

Dr Eric Khoo

Radiation Oncologist

MBBS, FRANZCR

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

Dr Dominic Lunn

Radiation Oncologist

BSc (Hons), MBBS (Hons), FRANZCR, DipPallMed (Clinical)

Dr Andrew Oar

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

Radiation Oncologist

BSc, MBBS, MIPH, FRANZCR

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

A/Prof Mark Pinkham

Radiation Oncologist

BM, BCh, MA(Hons)(Oxon), FRANZCR

Dr Andrew See MBBS, FRANZCR

North Lakes and Greenslopes (QLD)

Radiation Oncologist

Freemasons, Mulgrave, Richmond and Moreland (VIC)

ICON ANNUAL RESEARCH REPORT 2020

95

PRINCIPAL INVESTIGATOR PUBLICATIONS 2020 1. U se of Prostate-specific Membrane Antigen

7. A 14-year Retrospective Analysis of Indications

Positron-emission Tomography/Ct in Response

and Outcomes of Autologous Haemopoietic Stem

Assessment Following Upfront Chemohormonal

Cell Transplantation in Regional Queensland: A

Therapy in Metastatic Prostate Cancer

Single-centre Experience

Authorship: Anton A, Kamel Hasan O, Ballok Z,

Authorship: Hamilton EM, Nath KD, Vangaveti VN,

Bowden P, Costello AJ, Harewood L, Corcoran

McCutchan AD, Marsh JL, Birchley AJ, Casey JM,

NM, Dundee P, Peters JS, Lawrentschuk N, Troy

McNamara C, Lai HC, Morris ES, Hodges G, Irving IM.

A, Webb D, Chan Y, See A, Siva S, Murphy D, Hofman MS, Tran B.

8. E valuation of a New GPU-enabled VMAT Multicriteria Optimisation Plan Generation Algorithm

2. P imasertib Versus Dacarbazine in Patients

Authorship: Spalding M, Walsh A, Aland T.

with Unresectable NRAS-Mutated Cutaneous Melanoma: Phase II, Randomised, Controlled

9. A ustralasian Gastrointestinal Trials Group (AGITG)

Trial with Crossover

and Trans-Tasman Radiation Oncology Group

Authorship: Lebbé C, Dutriaux C, Lesimple T,

(TROG) Guidelines for Pancreatic Stereotactic

Kruit W, Kerger J, Thomas L, Guillot B, Braud F,

Body Radiation Therapy (SBRT)

Garbe C, Grob JJ, Loquai C, Ferraresi V, Robert

Authorship: Oar A, Lee M, Le H, Hruby G, Dalfsen

C, Vasey P, Conry R, Isaacs R, Espinosa E,

R, Pryor D, Lee D, Chu J, Holloway L, Briggs

Schueler A, Massimini G, Dréno B.

A, Barbour A, Chander S, Ng SP, Samra J, Shakeshaft J, Goldstein D, Nguyen N, Goodman

3. D isruption of Glycogen Utilization Markedly

KA, Chang DT, Kneebone A.

Improves the Efficacy of Carboplatin against Preclinical Models of Clear Cell Ovarian Carcinoma

10. A Systematic Literature Review Assessing

Authorship: Khan T, He Y, Kryza T, Harrington

If Genetic Biomarkers Are Predictors For

BS, Gunter JH, Sullivan MA, Cuda T, Rogers

Platinum-based Chemotherapy Response In

R, Davies CM, Broomfield A, Gough M, Wu AC,

Ovarian Cancer Patients

McGann T, Weroha SJ, Haluska P, Forbes JM,

Authorship: Phillips-Chavez C, Watson M,

Armes JE, Barry SC, Coward JI, Jagasia N, Chetty

Coward J, Schloss J.

N, Snell CE, Lourie R, Perrin LC, Hooper JD. 4. A Consensus Statement On The Use Of

11. Fractionated Stereotactic Body Radiotherapy For Up To Five Prostate Cancer Oligometastases:

Biosimilar Medicines In Haematology In Australia

Interim Outcomes Of A Prospective Clinical Trial

Authorship: Gregory GP, Carrington C, Cheah CY,

Authorship: Bowden P, See AW, Frydenberg M,

Hawkes EA, Irving IM, Siderov J, Opat S.

Haxhimolla H, Costello AJ, Moon D, Ruljancich P, Grummet J, Crosthwaite A, Pranavan G, Peters

5. E valuation of a New Hybrid VMAT-IMRT MultiCriteria Optimization Plan Generation Algorithm

JS, So K, Gwini SM, McKenzie DP, Nolan S, Smyth LML, Everitt C.

Authorship: Spalding M, Walsh A, Clarke H, Aland T.

12. I s Prospective MRI Mapping of The Changes in the Volume of the Prostate Gland in Prostate

6. Q uality And Access - Early Experience of

Cancer Patients Undergoing 6 Months of

Implementing a Virtual Stereotactic Chart

Neo-adjuvant Androgen Deprivation Therapy A

Round Across a National Network

Step Towards A Trial to Determine Those Who

Authorship: Fitzgerald R, Pryor D, Aland T,

May Benefit from Treatment Intensification or

Anderson L, Knesl M, Fong A, Lunn D, Oar A,

Extended Duration?

Jackson J, Foote M.

Authorship: Christie DR, Sharpley CF, Mitina N, MacAteer E, Jackson JE, Lunn D.

96

ICON ANNUAL RESEARCH REPORT

13. C linical and Dosimetric Risk Stratification for

19. U nmet needs in breast cancer survivors

Patients at High-risk of Feeding Tube Use During

are common, and multidisciplinary care

Definitive IMRT For Head And Neck Cancer

is underutilised: the Survivorship Needs

Authorship: Jackson JE, Anderson NJ, Wada

Assessment Project

M, Schneider M, Poulsen M, Rolfo M, Fahandej

Authorship: Vuksanovic D, Sanmugarajah J,

M, Gan H, Joon DL, Khoo V.

Lunn D, Sawhney R, Eu K, Liang R.

14. R esults from the Safety Run-In Period of

20. D aratumumab, lenalidomide, and

The Sympatico Study Evaluating IBRUTINIB

dexamethasone in relapsed/refractory

In Combination with VENETOCLAX in Patients

myeloma: a cytogenetic subgroup analysis

with Relapsed/Rrefractory Mantle Cell

of POLLUX

Lymphoma

Authorship: Kaufman JL, Dimopoulos MA,

Authorship: M. Wang R. Ramchandren R. Chen

White D, Benboubker L, Cook G, Leiba M,

L. Karlin G. Chong W. Jurczak K. Wu M. Bishton

Morton J, Joy Ho P, Kim K, Takezako N, Moreau

G. Collins P. Eliadis F. Peyrade K. Freise J.

P, Sutherland HJ, Magen H, Iida S, Kim JS,

Sukbuntherng Y. Lee E. Dobkowska V. Fedorov

Miles Prince H, Cochrane T, Oriol A, Bahlis

J. Neuenburg C. Tam.

NJ, Chari A, O’Rourke L, Trivedi S, Casneuf T, Krevvata M, Ukropec J, Kobos R, Avet-Loiseau

15. Validation of the preconfigured Varian Ethos

H, Usmani SZ, San-Miguel J.

Acuros XB Beam Model for treatment planning dose calculations: A dosimetric study Authorship: Hu Y, Byrne M, Archibald-Heeren B, Collett N, Liu G, Aland T. 16. T herapeutic implications of immune-profiling and EGFR expression in salivary gland carcinoma Authorship: Guazzo E, Cooper C, Wilkinson L, Feng S, King B, Simpson F, Porceddu S, Panizza B, Coward JIG. 17. M icrobiome-derived metabolome as a potential predictor of response to cancer immunotherapy Authorship: Malczewski AB, Navarro S, Coward JI, Ketheesan N. 18. P ralatrexate in relapsed/refractory T-cell lymphoma: a retrospective multicenter study Authorship: Bhurani M, Admojo L, Van Der Weyden C, Twigger R, Bazargan A, Quach H, Zimet A, Coyle L, Lindsay J, Radeski D, Hawkes E, Kennedy G, Irving I, Gutta N, Trotman J, Yeung J, Dunlop L, Hua M, Giri P, Yuen S, Panicker S, Moreton S, Khoo L, Scott A, Kipp D, McQuillan A, McCormack C, Dickinson M, Prince HM.

97

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

98

ICON ANNUAL RESEARCH REPORT 2020