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Studying a Combination of Three Drugs to Treat Previously Untreated Metastatic Colorectal Cancer with Certain Tumor Markers

Clinicaltrials.gov identifier:
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  [email protected]


Studying a Combination of Three Drugs to Treat Previously Untreated Metastatic Colorectal Cancer which Is MSI-High and Has a BRAF V600E Mutation

About the Study

This study is being done to learn about the effects of using three study medicines together as treatment for 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 colorectal cancer who:

  • have had tumor testing of tissue or blood that shows a BRAF V600E mutation
  • have had tumor testing that confirms ()
  • have a tumor that can be measured in size
  • have not received prior treatments for 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