In partnership with leading physicians and researchers in gynecologic and medical oncology, GCAR is sponsoring the development and implementation of an adaptive platform trial for ovarian cancer — Ovarian CanceRx™. This innovative platform trial is designed to rapidly test new treatment regimens for patients with newly diagnosed advanced ovarian cancer or recurrent platinum resistant disease. Multiple interventions will be tested against standard of care with interventions entering and exiting the trial over time based on a decision algorithm. Its unique design will allow patients that develop drug resistance to re-enroll in different study arms, which will provide patients more options for their care. It also is designed to serve as a distinctive, information rich platform of longitudinal data with opportunities to explore tumor molecular genetics and characterization.
Ovarian cancer is a global problem affecting women of all ages. While ovarian cancer is a rare disease, accounting for only 1.7% of all cancers in women in the U.S. between 2013 and 2017, it accounted for almost 7% of cancer deaths in that period. There are nearly 300,000 new cases of ovarian cancer diagnosed yearly worldwide. Ovarian cancer is the 5th leading cause of cancer related deaths in women and accounts for more deaths than any other cancer of the female reproductive system. An estimated 1 in 78 women will develop ovarian cancer during her lifetime.
Even with the numerous randomized control trials in ovarian cancer, there still remains an unmet need in this field.
Patients with ovarian cancer have not benefited from new therapeutics in the same way that patients with other types of cancer because:
The traditional randomized control trials have been challenged by diversity of ovarian cancer subtypes as they are usually based on a “one size fits all” design and are not equipped to accommodate the complexities of the ovarian cancer subtypes. There is also an inherent inefficiency of trial designs in clinical research approaches to recruit and study enough patients to generate meaningful longitudinal data. Given the challenges of the traditional trials, master protocols and, and more specifically adaptive platform trials, provide a unique perspective to develop new facets in ovarian cancer research.
Ovarian CanceRx will identify science-driven treatment options for women with newly diagnosed or recurrent ovarian cancer. Ovarian CanceRx uses an adaptive clinical trial infrastructure by which multiple drugs and drug combinations can be tested simultaneously against the standard of care treatment options in order to rapidly develop and deliver new therapeutics to patients suffering from ovarian cancer.
Building on GCAR’s experience developing and executing master protocol and platform trials, GCAR is working with a committed group of leading gynecologic oncologists, researchers, and academics for Ovarian CanceRx.
|Beth Y. Karlan, MD|
Director, Cancer Population Genetics
UCLA, Jonsson Comprehensive Cancer Center
Professor and Vice Chair, Department of OB/GYN,
David Geffen School of Medicine
|Chair, Steering Committee|
|Ursula A. Matulonis, MD|
Chief, Division of Gynecologic Oncology
Dana-Farber Cancer Institute
Professor of Medicine, Harvard Medical School
|Chair, Arm Selection Committee|
|Lynda D. Roman, MD|
Associate Professor of Obstetrics and Gynecology
Division Chief, Gynecologic Oncology
Keck School of Medicine of USC
|Chair, Clinical Leadership|
|Anil K. Sood, MD|
Professor and Vice-Chair for Translational Research in the Departments of Gynecologic Oncology and Cancer Biology
The University of Texas MD Anderson Cancer Center
|Chair, Translational Leadership|
|Andrew W. Lo, PhD|
Charles E. and Susan T. Harris Professor, Finance
Director, Laboratory for Financial Engineering
MIT Sloan School of Management
|Chair, Financial Innovation and Strategy|
|Ashik Mohan, MS|
|Co-Chair, Financial Innovation and Strategy|
|Kathleen Moore, MD, MS|
Professor of Gynecologic Oncology, Department of Obstetrics and Gynecology
University of Oklahoma Health Sciences Center
|Co-Chair, Arm Selection Committee|
|David M. O’Malley, MD|
Professor, Department of Obstetrics and Gynecology
Director, Division of Gynecologic Oncology
Director, Clinical Research
The Ohio State University Comprehensive Cancer Center, The James
|Co-Chair, Clinical Leadership|
|Kunle Odunsi, MD, PhD|
Director, Comprehensive Cancer Center
Biological Sciences Division Dean for Oncology
University of Chicago Medicine
|Co-Chair, Translational Leadership|