Hoosier Cancer Research Network recently opened a cancer clinical trial for subjects with advanced colorectal cancer. The study, known as GI14-186, involves the study drug called pembrolizumab, given in combination with mFOLFOX6, a standard chemotherapy regimen for advanced colorectal cancer. The study is currently open to accrual at the Indiana University Melvin and Bren Simon Cancer Center, The Ohio State University, and Winship Cancer Institute of Emory University.

Cancer cells often create proteins called PD-1 that act as signals to turn off part of the immune system that recognizes cancer as foreign. Pembrolizumab blocks this signal and allows the immune system to recognize and attack these cancer cells.

The use of pembrolizumab in combination with mFOLFOX6 is investigational. This means that the FDA has not approved this combination of drugs for this type of cancer. This study will allow researchers to know whether adding pembrolizumab to the usual chemotherapy drugs makes the treatment work better, the same, or worse than the usual approach.

Participants in this study must have advanced colorectal cancer, and have not had prior systemic therapy for advanced or metastatic disease. Additional criteria must be met to be eligible for this study.

Increased awareness and screening have helped reduce the rate of new diagnoses, with rates falling by an average of 3.1 percent each year for the past 10 years. In addition, nearly three-quarters of all colorectal cancers are diagnosed when the disease is localized or regional, with relatively high five-year survival rates. However, for the 20 percent of colorectal cancer cases that involve metastatic disease, five-year survival drops to just 13 percent.

Safi Shahda, MD, (pictured) assistant professor of clinical medicine in the Division of Hematology/Oncology at the Indiana University School of Medicine and sponsor investigator of this study, hopes this study will help researchers learn what role immunotherapy and chemotherapy used in combination might have in treating advanced disease.

“Perhaps we may not see a great benefit when we use single drugs, but we need to find the right combination,” Dr. Shahda said. “While this is a small study, we’re hoping it will provide us with a lot of knowledge, especially in terms of correlative as well as translational studies that are already built into this clinical trial.”

See clinicaltrials.gov (study #NCT02375672) for more information about this trial, including full eligibility requirements.

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has initiated more than 150 trials in a variety of cancer types and supportive care, resulting in more than 300 publications. More than 4,600 subjects have participated in Hoosier Cancer Research Network clinical trials.