The Colorectal Cancer Alliance (Alliance) and the Global Coalition for Adaptive Research (GCAR) have joined forces to transform how clinical trials are conducted for colorectal cancer through KLEOS. KLEOS is a cost-effective, adaptive clinical trial platform designed to accelerate the evaluation of new investigational therapies, reduce barriers, and create new opportunities to bring drug development in colorectal cancer into curative windows.
Colorectal cancer is the deadliest cancer in people under age 50 and the second leading cause of cancer death in the United States. KLEOS was created to address the urgent need for more effective therapies through a modern, collaborative approach to clinical research.
KLEOS LEADERSHIP TEAM
CLINICAL/SCIENTIFIC LEADERSHIP
Aparna Parikh, MD (MGH, Harvard)
Chris Lieu, MD (University of Colorado)
Emil Lou, MD, PhD (University of Minnesota)
John Marshall, MD (Georgetown, Alliance)
Kristen Ciombor, MD, MSCI (Vanderbilt)
Pashtoon Kasi, MD, MS (City of Hope)
Scott Kopetz, MD, PhD (MD Anderson)
Colorectal Cancer
Alliance
Michael Sapienza, MM
Tina Zeff
Jamee Telford
Vishal Sandesara, MBA
Kim Newcomer
GCAR
Meredith Buxton, PhD, MPH
Robert F. Murray, MBA
ABOUT THE TRIAL
KLEOS is a multicenter, open-label Phase 2 adaptive clinical trial platform currently under development. KLEOS is designed to rapidly evaluate investigational therapies for individuals with colorectal cancer.
The platform will enroll participants to one of four sub-protocols:
- Neoadjuvant
- Perioperative
- Minimal Residual Disease (MRD)
- Refractory
Unlike traditional clinical trials that evaluate a single therapy, KLEOS is designed as an ongoing platform capable of evaluating multiple investigational therapies simultaneously over time. New treatment arms can be introduced as investigational therapies emerge, while predefined interim analyses guide decision-making throughout the life of the study.
By leveraging a shared infrastructure and adaptive design, KLEOS is intended to accelerate the evaluation of investigational therapies, improve operational efficiency, and generate high-quality clinical evidence to inform rapid clinical decision-making for future patients.
POWERED BY COLLABORATION
POWERED BY COLLABORATION
KLEOS is sponsored by the Global Coalition for Adaptive Research (GCAR) in collaboration with the Colorectal Cancer Alliance and leading gastrointestinal oncology investigators.
GCAR is a nonprofit research organization specializing in adaptive platform trials and master protocols. Through innovative trial design, global operations, regulatory expertise, and comprehensive trial oversight, GCAR is advancing more efficient approaches to clinical research. The Colorectal Cancer Alliance, a leading nonprofit dedicated to ending colorectal cancer, brings deep expertise, strong relationships across the colorectal cancer community, and leadership in patient advocacy, research, and education to help accelerate progress.
Together, this collaboration is advancing a first-of-its-kind model for accelerating colorectal cancer research.