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

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

Clinicaltrials.gov identifier:
NCT04895722

Treatment
Stage 4 colorectal cancer

Study Contact Information:

For additional information, please contact:

Merck Clinical Trials toll free Number: 1-888-577-8839 
or email: Trialsites@merck.com


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 () ( IV) Colorectal Cancer.

This is phase 2, multi-arm, , 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     
This Study is Open To:

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

  • has 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 for the disease.
This Study is Not Open To:

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