A Study of EDP1503 in Patients With Colorectal or Triple Negative Breast Cancer or Cancer That Came Back After Treatment with a Checkpoint Inhibitor
https://www.facingourrisk.org/research-clinical-trials/study/116/a-study-of-edp1503-in-patients-with-colorectal-cancer-breast-cancer-or-checkpoint-inhibitor-relapsed-tumors
Clinicaltrials.gov identifier:
NCT03775850 (https://clinicaltrials.gov/show/NCT03775850)
Treatment
Study Contact Information:
Principal Investigator: Johanna Bendell, MD
Sarah Cannon Research Institute
by phone 844-710-6157 or by email
About the Study
Medicines that affect bacteria in the stomach and intestines may assist immunotherapy agents like pembrolizumab (Keytruda) in treating cancer. This study will look at the effect of a drug, EDP1503 on enhancing the anti-cancer response when used with pembrolizumab, in patients with advanced metastatic colorectal carcinoma, triple-negative breast cancer, or cancers that have recurred after a type of immunotherapy known as an immune checkpoint inhibitor. NOTE: This this study is no longer enrolling patients.
Type of Study
This is a Phase 1/2 non-randomized, open-label study. Patients will be assigned to one of three groups based on their type of cancer. All patients will know which group they are assigned to and the medications that they are receiving.
- Group A will enroll patients with microsatellite stable (MSI-Stable) colorectal cancer
- Group B will enroll patients with triple negative breast cancer
- Group C will enroll patients with an MSI-High cancer that recurred or progressed after treatment with an immune checkpoint inhibitor
What the Study Entails
All patients in this study will receive EDP1503 orally for a period of 14 days, following which they will be given a combination of EDP1503 orally and the immunotherapy agent pembrolizumab. Pembrolizumab will be administered intravenously once every 3 weeks.
Participants will be followed for 2 years.
Study Sites
For more information at all sites contact Sarah Cannon Research Institute by phone 844-710-6157 or by email
Arkansas
- Rogers: Highlands Oncology Group
Florida
- Sarasota: Florida Cancer Specialists
Oklahoma
- Oklahoma City: Stephenson Cancer Center
Tennessee
- Chattanooga: Tennessee Oncology, PLLC
- Nashville: Tennessee Oncology
This Study is Open To:
NOTE: This this study is no longer enrolling patients.
This Study is Not Open To:
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.