Combined Pembrolizumab & Quavonlimab (MK-1308A) Versus Other Treatments in People With MSI-High or dMMR Stage IV Colorectal Cancer

About the Study

The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus four other treatments in patients with Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic (stage IV) Colorectal Cancer.

This is phase 2, multi-arm, randomized, open-label study.  Participants are placed into one of the five study groups by chance. All study participants will know which medication they are receiving during the study. 

What the Study Involves

Participants in this study will receive one of the following five therapies for up to approximately 2 years.    

• Pembrolizumab intravenously (IV) every 6 weeks
• Co-formulated pembrolizumab/quavonlimab via IV every 6 weeks
• Co-formulated pembrolizumab/favezelimab via IV every 3 weeks
• Co-formulated pembrolizumab/vibostolimab via IV every 3 weeks
• Pembrolizumab plus MK-4830 via IV every 3 weeks

Study participants will be followed for up to 39 months.

Study Locations

Florida

• Orange City
  Mid Florida Cancer Center
  Contact: Study Coordinator: 407-353-1915     

Georgia

• Athens
  University Cancer & Blood Center, LLC (Site 1521)       
  Contact: Study Coordinator: 706-353-5006     

Illinois

• Chicago
  University of Chicago Medical Center-Medicine - Section of Hematology/Oncology       
  Contact: Study Coordinator: 855-702-8222     

Pennsylvania

• Pittsburgh
  UPMC Hillman Cancer Center        
  Pittsburgh, Pennsylvania
  Contact: Study Coordinator: 412-692-4724     

Tennessee

• Nashville
  Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center
  Contact: Study Coordinator: 800-811-8480     

Texas     

• Temple
  Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology
  Contact: Study Coordinator: 254-724-3179     

Washington

• Tacoma
  Northwest Medical Specialties          
  Contact: Study Coordinator: 253-428-8700     

People age 18 years or older who meet the following criteria:

• has Stage IV Colorectal Cancer
• has locally confirmed dMMR/MSI-H
• is able to provide a tumor tissue sample that has not previously been exposed to radiation

Either one of the following two criteria also needs to be met:

1. has previously been treated for cancer and the disease progressed. Prior treatment must have included a specific set of therapeutic agents to be considered eligible for this study. The study team will review the lists of required agents with the patient during enrollment.  
2. Cancer has not been treated, including no prior chemotherapy or immunotherapy for the disease.

People with the following are not eligible for the study:

• a known additional cancer that is progressing or has required active treatment within the past 2 years
• an active autoimmune disease that has required systemic treatment in past 2 years
• acute or chronic pancreatitis
• significant heart disease
• an infection requiring therapy (e.g., tuberculosis, known viral or bacterial infections, Hepatitus B, Hepatitus C, etc.)
• Human Immunodeficiency Virus (HIV) infection