LaBahn Pancreatic Cancer Program's Purple Post: Volume 2 Issue 2

VOLUME 2 ISSUE 2 | JULY 2022

PURPLE POST LABAHN PANCREATIC CANCER PROGRAM NEWSLETTER

Left to right: Ryan Ugalde, Kay Kays, Manny Garcia, Judy Green, Dr. Michael Gordon, Ron Brefka, Dr. Vivian Pearlman, Michael Francis, Stan Vitkas, Kathy Lee, Janet Bor, Johnny Ringo, Dan Winkelman, Roger Caplinger, Craig Hellmers, attendees at the recent Power of Us event in Phoenix, AZ.

T

he beautiful Wisconsin summer is upon us! In this issue of the Purple Post, we are shining a spotlight on our team of investigators that help support clinical trials for pancreatic cancer. Many may have heard of the term

"clinical trial” or even participated in one. Clinical trials are studies which are performed in humans and represent a culmination of prior work to identify better ways to treat diseases. In general, clinical trials often represent the cutting edge of cancer care, and patients who participate in clinical trials have access to treatments before they are widely available. Clinical trials are conducted with strict adherence to protocols, to ensure the safety of the participants as well as the high quality of the information being collected. This requires a dedicated team of specialists who oversee a wide range of activities, from regulatory oversight to monitoring of adverse events and toxicities. In this issue, Dr. Ben George, who is the Director of the Medical College of Wisconsin Clinical Trials Office, shares the accomplishments of the last year and identifies future areas of interest. Haley Heaviland, one of the clinical research coordinators, gives a behind the scenes look at what goes into monitoring a clinical trial.

In addition, we are pleased to announce that we have been selected to participate in the PANCAN Precision Promise Adaptive Clinical trial which will offer patients with metastatic pancreatic cancer unique opportunities to receive novel therapeutics. And finally, summer is synonymous with the great American pastime of baseball. We were fortunate to participate in the annual Seena Magowitz Foundation’s “Dinner on the Diamond” which celebrated pancreatic cancer survivors and raised funds for pancreatic cancer research and clinical trials. This summer, I hope that you are finding time to relax, reconnect with friends and family, and enjoy the beautiful weather.

Susan Tsai, MD, MHS- Director, LaBahn Pancreatic Cancer Program

READ INSPIRING STORIES FROM 5+ YEAR PANCREATIC CANCER SURVIVORS BY VISITING: https://bit.ly/5yrPts

IN THIS ISSUE @MCWPancProgram

2 MCW CLINICAL TRIALS OFFICE

CLINICAL RESEARCH

3 COORDINATORS AT MCW

4 CURRENT CLINICAL TRIALS

5 PRECISION PROMISE 6 DINNER ON THE DIAMOND

7 PATIENT SUPPORT SERVICES

7 TEAM MEMBER SPOTLIGHT

Purple Post The Purple Post Newsletter is a publication by the LaBahn Pancreatic Cancer Program to provide patients, family, and loved ones with informative and current topics at the Medical College of Wisconsin. Issue are published every February, June, and October.

Art + Production Lori Keiser, BS, MA Melissa Mena, BS, CCRC Editing Beth Krzywda, APNP LaBahn Pancreatic Cancer Program Director Susan Tsai, MD, MHS LaBahn Pancreatic Cancer Program 8701 W Watertown Plank Rd Wauwatosa, WI 53226 mcwpancreas@mcw.edu © Copyright 2022 LaBahn Pancreatic Cancer Program All rights reserved. No part of this publication may be reproduced by any means, prints, electronic, or any other, without prior written permission of the publisher.

For questions, comments, or to submit an idea for an upcoming newsletter, please contact us at mcwpancreas@mcw.edu or 414955-1423.

Follow us: @MCWPancreasProgram @MCWPancProgram

CLINICAL TRIALS AND THE FUTURE OF CANCER CARE By: Ben George, MD, Jennifer Bollmer, and Lori Keiser Clinical trials are research studies that involve people. They are often the final step in a long process of testing new therapies or therapeutic strategies. Clinical trials are considered essential to improve the care of all patients with cancer, as many treatments used today are the result of past clinical trials.

In 2012, at the Clinical Trials Office (CTO) was established at MCW’s Clinical Cancer Center to provide a centralized infrastructure for the development, enhancement, and execution of cancer clinical trials.

Members of the solid tumor early phase clinical trials team at MCW

There are currently over 130 full-time staff working in the CTO, with the plan to expand to over 150 staff members by 2023. Each disease team has dedicated staff to help with the regulatory and financial aspects of the trial, and the CTO has additional staff members to help with education and quality assurance. CTO staff are integral to ensure that clinical trials are conducted with a high level of scientific and ethical oversight. This helps to ensure that the trial is safe and has accurate and meaningful results.

In 2021, 103 patients at the Medical College of Wisconsin were enrolled into National Clinical Trials Network clinical trials. These are large clinical trials which are conducted across many centers across the country and often set the standard of care for oncology practice. In addition, in the last year, 132 patients (22%) were enrolled in precision medicine trials. These trials utilized targeted therapies which are tailored to vulnerabilities that may be present in the tumor. In addition, there were 143 earlyphase interventional treatment trial participants compared to 81 in 2017. Early-phase trials represent novel therapeutics which have had evidence of being effective in the laboratory or in animals and are just beginning to be tested in humans.

Over the past five years, the CTO has experienced tremendous growth as evidenced by the following statistics: Treatment accrual increased 49% Total interventional accrual increased 26% Early phase treatment accrual increased 77% The CTO has ambitious plans and will be focused on 6 major efforts. Specific areas of interest include: 1) increasing the total number of treatment trials and trial participants since its inception in 2012, 2) increasing the focus on precision oncology clinical programs, 3) addressing disparities in clinical trial research by planning clinical trial education centers in underserved areas of the Milwaukee community, 4) increasing the relationships with similar academic institutions acrossthe country. 5) increasing the enrollment into trials designed and led by MCW investigators., and lastly 6) expanding early phase (first in human) and cellular immunotherapy programs at MCW. Pancreatic Cancer Program Updates | Volume 2, Issue 2 | Page 2

BEHIND THE S C E N E S CLINICAL RESEARCH COORDINATORS AT MCW By: Haley Heaviland, Clinical Research Coordinator III Pictured Above: Barb Dion, Haley Heaviland, Kati Hallada, Megan Memmell

In the Clinical Trials Office (CTO), many people work behind the scenes on clinical trials, but to patients, there is one person that serves as the face of the CTO- the clinical research coordinators (CRC) or clinical research nurses (CRN). A patient’s first interaction with us often begins with the study informed consent.

This discussion may be the only interaction with us, or depending on the protocol we may see patients frequently over the course of a trial. During the trial we may meet with patients for questionnaires, assessments, exchanging diaries, returning medications or specimens, scheduling appointments or a check-in. Considering that your CRC or CRN may play quite a big part of your clinic visit, it maybe surprising to learn that the time spent in clinic accounts for 10% or less of their work.

RESPONSIBILITIES OF THE CRC: Reviewing proposed trials and assessing potential resources needed such as labs, imaging, and locations Educating nurses and health care team on the protocols for the trials Creating tip sheets for clinical staff working on the trials Developing calendars to monitor a patient's progress Meeting with patients to obtain informed consent for trial participation Reviewing patient eligibility for a trial Tracking a patient's progress throughout the trial to ensure appointments and therapies occur at the right times Entering data from labs, visits, and treatment into a centralized database for the trial Monitoring for patient safety and deviations from the trial protocols so they can then report to committees overseeing the trial

As you can see, coordinators have many responsibilities but at the end of the day, they are here to help patients through clinical trials safely and effectively. They work tirelessly with a variety of people to support research and advance new therapies and technologies. The role is often behind the scenes, but vital in treating patients with pancreatic cancer.

Pictured Above: Gastrointestinal/Gentiourinary Cancer coordinators & assistants

Pancreatic Cancer Program Updates | Volume 2, Issue 2 | Page 3

CURRENT Clinical Trials TRIALS FOR LOCALIZED PANCREATIC CANCER SOFT TRIAL GOAL: To determine how to best give radiation therapy prior to surgery.

Study Design: Patients with resectable, borderline resectable, or locally advanced pancreatic cancer are eligible. Patients are randomized to either a long course of preoperative chemotherapy and radiation given together over about 5.5 weeks or a shorter course of preoperative therapy with a higher dose of radiation given over about 1.5 weeks or 5 total treatments.

PANC TRIAL GOAL: To learn more about how to best adjust the chemotherapy which is given before surgery (neoadjuvant chemotherapy) to maximize its effectiveness.

Study Design: Patients with resectable and borderline resectable pancreatic cancer are eligible.

This utilizes serial monitoring of a tumor marker (CA 19-9) in the blood and radiographic imaging, to guide changes to neoadjuvant chemotherapy to optimize the ability to receive all neoadjuvant therapy and surgery.

PANCREAS TRIAL GOAL: To determine if specific molecular characteristics of the tumor predicts responsiveness to chemotherapy.

Study Design: Patients with resectable and borderline resectable pancreatic cancer are eligible.

Tumor samples will be taken for molecular profiling.

The molecular characteristics of the tumor will help determine the type of chemotherapy that is given for neoadjuvant therapy.

TRIALS FOR METASTATIC PANCREATIC CANCER ECOG-GIANT GOAL: To determine which of two chemotherapy treatment combinations, Gemcitabine and Nabpaclitaxel (GnP) or 5-Flurouracil, Leucovorin, and Liposomal Irinotecan (Naliri), is more effective at improving overall survival in patients over the age of 70 years with metastatic pancreatic cancer.

Study Design: Patients with metastatic pancreatic cancer who have not previously undergone therapy are eligible. Patients are randomly assigned to receive GnP or Naliri.

FAETH-THERAPUTICS GOAL: To determine if dietary changes (via amino acid restriction) may be an effective strategy to treat multiple types of cancer.

Study Design: Patient with metastatic pancreatic cancer who have not previously undergone therapy are eligible. All subjects will receive NEAAR (nonessential amino acid restricted) medical food in addition to standard of care FDA-approved chemotherapy consisting of Gemcitabine and Nabpaclitaxel. Each week, NEAAR medical food will be consumed 5 consecutive days followed by 2 days of usual diet.

For more information and to see the most up-to-date list of clinical trials at MCW, scan the QR code with your smartphone or visit: https://www.froedtert.com/researc h/clinical-trials/cancer

Pancreatic Cancer Program Updates | Volume 2, Issue 2 | Page 4

Precision Promise

PANCREATIC CANCER ACTION NETWORK'S NEW ADAPTIVE CLINICAL TRIAL

Pancreatic Cancer Action Network, or PanCAN, has a new and exciting clinical trial opportunities for patients with metastatic pancreatic cancer. Its Precision Promise adaptive clinical trial is a pioneering effort to fast-track new treatment options to accelerate the access to new and promising therapeutics.

PanCAN is bringing together leading experts and stakeholders – researchers, clinicians, industry, and pancreatic cancer thought-leaders – to make this historic initiative possible.

Precision Promise was created because traditional clinical trial designs are often slow to evaluate new treatment options for pancreatic cancer patients. The design of the Precision Promise adaptive clinic trial will more efficiently test new therapies by reducing the number of patients needed and requiring less time than traditional clinical trials. This adaptive clinical trial tests multiple new drugs and combinations, comparing them to standard of care therapy in patients with metastatic pancreatic cancer. It is also designed to allow for multiple investigational therapies to be tested at the same time. Precision Promise will be a central hub for data collection, collaboration, and clinical advancement for research in pancreatic cancer.

PanCAN is collaborating with a consortium of leading institutions across the United States to design and manage pancreatic cancer research and clinical trials. Through a competitive, peer-reviewed process, Froedtert & the Medical College of Wisconsin has been selected as one of the sites and will be opening enrollment in the Precision Promise adaptive clinical trial in near future. Patients with metastatic pancreatic cancer who have never previously been treated or have had only one prior treatment may be eligible. Stay tuned for the official announcement of the trial activation.

PanCAN's Precision Promise allows researchers to do the following so treatments can be developed more quickly and efficiently Learn Faster

Collaborate with Nationwide Leaders

Collect Data

Pancreatic Cancer Program Updates | Volume 2, Issue 2 | Page 5

Dinner on the Diamond By: Melissa Mena

I’m a survivor.”

Words that echoed throughout Chase

The Seena Magowitz Foundation hosted the Power of US Event in Phoenix as a celebration of survivors of pancreatic cancer. This event gathered physicians, scientists, ambassadors, health care providers, survivors and supporters to collaborate on the latest research and pancreas cancer care.

The Power of US reflects the synergy of this special event. Several MCW patients attended in person while a greater number of MCW patients were among those on a dedicated website highlighting long term survivors and their inspiring stories (see link on page 1).

Many attendees showed up dressed to fit the attire "Western" theme sporting plaid, jeans, or cowboy boots. We first gathered at the entrance of Chase field where we were greeted by tour guides.

Pictured Above: MCW patients and survivors Ron Brefka (left) & Roger Caplinger (right)

They walked us through the stadium, bringing us behind the scenes to show off a "Honus" Wagner's T206 Baseball card, sold in 2021 for over 6.6 million dollars. We ended the tour in the dugout where guests posed for pictures and explored the bench from the player's perspective.

As a spectator, its not often that you get to see so many survivors in one place. You know the commonly reported statistics for pancreatic cancer survivors and feel lucky you get to meet any. But in Arizona, I met 31 survivors, many of which were over five years out from their diagnosis. Even more shocking was meeting those diagnosed with metastatic disease, deemed long-term survivors, like Elise Roth Tedeschi. She was diagnosed in 2012 at age 43 with stage four disease. She is now 10 years out with no evidence of disease. I was stunned when I ate dinner with another survivor, Manny Garcia, diagnosed at age 26. While most patients are diagnosed in their later years, it's not unheard of to come across someone young with the disease.

Manny enrolled into a clinical trial where he received an experimental combination of chemotherapy. He is now three years out from his original stage four diagnosis.

Over dinner, the survivors took turns recanting their journeys to the audience. It was awe-inspiring and a privilege to hear.

While they spoke of different experiences, a theme presented consistently in their stories- having hope, keeping positive and working together in the fight against pancreatic cancer.

Share your storY

bit.ly/smstoryshare Pictured Above: Manny Garcia (left) & Dr. Michael Gordon (right)

Pictured Above: Dan Winkelman (left) & Teona Ducre (right) Pancreatic Cancer Program Updates | Volume 2, Issue 2 | Page 6

SUPPORTIVE CARE FOR CANCER PATIENTS At Froedtert & the Medical College of Wisconsin, we believe in treating the whole patient, not simply their disease. Our Cancer Network provides access to a full range of support services that address the physical, emotional, social, and spiritual needs of patients and their families. Below is a list of services available to patients. Scan the QR code below to learn more about these services.

S E R V I C E S

Small Stones Wellness Center

24 Hour Clinic Adolescent & Young Adult cancer Program Art Therapy Cancer Support Groups and Classes Cancer Rehabilitation Child Life Services Counseling and Emotional Support Fertility Preservation Home Care and Hospice Jeffery C. Siegel Quality of Life Center

Nutrition Palliative Care Small Stones Wellness Center Social Services

MORE INFORMATION

www.froedtert.com/cancer/support

LABAHN PANCREATIC CANCER TEAM SPOTLIGHT What is your role at MCW and how long have you been a part of the team?

I am Clinical Research Coordinator III and the Team Lead for the GI/GU team aka The Rolling Stones. I joined the team in August 2014 as a Clinical Research Assistant II. I have worked in some aspect of research for MCW since 2007 when I started at MCW in the Biomedical Resource Center.

What do you enjoy most about the work that you do?

Being a small part of the effort to raise the bar for overall survival for cancer patients in general and pancreas cancer patients specifically. I have lost several loved ones to cancer but am also incredibly fortunate that my dad, my sister and myself are all long-term cancer survivors (and all had treatment or surgery at MCW). I also feel really privileged to be working with a truly inspiring group of dedicated and motivated health care professionals in the pancreas program and on my team in the CTO.

Haley Heaviland, ALB, CCRP Clinical Research Coordinator III

What are some of you interests and hobbies outside of work?

My wife and I love to travel, especially places we can hike, snorkel, get out on the ocean, or see wildlife in their natural habitat. Alaska and Mexico are our two favorite places to go. In the last couple of years I’ve developed a houseplant collection both at home and at work and have somehow become plant lady in our office taking care of about 40 plants around our offices on breaks/lunches/after hours. I have three very adorable but naughty cats which tends to make having plants in the office a little easier than having plants at home.

Pancreatic Cancer Program Updates | Volume 2, Issue 2 | Page 7