Studying a Combination of Three Drugs to Treat Previously Untreated Metastatic Colorectal Cancer which Is MSI-High and Has a BRAF V600E Mutation
https://www.facingourrisk.org/research-clinical-trials/study/252/comparing-three-drugs-in-patients-with-metastatic-colorectal-cancer-who-have-not-had-prior-treatment
Clinicaltrials.gov identifier:
NCT05217446 (https://clinicaltrials.gov/show/NCT05217446)
Treatment
Study for metastatic colorectal cancer that has not yet been treated
Study Contact Information:
For additional information, please contact:
Pfizer CT.gov Call Center at 1-800-718-1021 or by email clinicaltrials.gov_inquiries@pfizer.com
About the Study
This study is being done to learn about the effects of using three study medicines together as treatment for metastatic colorectal cancer that has been previously untreated.
What the Study Involves
Participants will be randomly selected (by chance) and placed into one of two groups.
- Group 1: People will receive a combination of treatments: Braftovi (encorafenib) orally, Erbitux (cetuximab) injected IV, and Keytruda (prembrolizumab) injected IV.
- Group 2: People will receive pembrolizumab (Keytruda) injected into the vein.
Study Sites
Arizona
- Phoenix
Mayo Clinic Building - Phoenix - Phoenix
Mayo Clinic Hospital - Scottsdale
Mayo Clinic
California
- Los Angeles
Keck Hospital of USC - Los Angeles
Keck School of Medicine - Los Angeles
LAC USC Medical Center - Los Angeles
USC/Norris Comprehensive Cancer Center/Investigational Drug Services - Pasadena
Keck Hospital of USC Pasadena
Florida
- Miami Beach
Mount Sinai Cancer Center - Miami
University of Miami Hospital and Clinics, Sylvester Cancer Center - Plantation
University of Miami Hospital and Clinics, Sylvester Cancer Center
Minnesota
- Rochester
Mayo Clinic Cancer Center Outpatient Pharmacy - Rochester
Mayo Clinic
New York
- New York
Columbia University Medical Center
Tennessee
- Germantown
The West Clinic, West Cancer Center
Texas
- Houston
MD Anderson Cancer Center
This Study is Open To:
Patients 16 years or older with metastatic colorectal cancer who:
- have had tumor testing of tissue or blood that shows a BRAF V600E mutation
- have had tumor testing that confirms microsatellite instability (MSI-High)
- have a tumor that can be measured in size
- have not received prior treatments for metastatic disease
This Study is Not Open To:
People who:
- have disease that has spread to the central nervous system (CNS)
- have a decreased ability to fight infections and other diseases
- have an active autoimmune disease requiring continued treatment in the past two years
- have clinically significant heart disease
- have received a vaccine within 30 days of planned start date for the study
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.