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Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177 / KEYNOTE-177)

Trial Status: Closed to Accrual

In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.

Inclusion Criteria

  • Locally confirmed dMMR or MSI-H stage IV colorectal carcinoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start
  • Life expectancy of at least 3 months
  • Measurable disease
  • Female participants of childbearing potential must be willing to use adequate contraception for the course of the study starting with the first dose of study medication through 180 days after the last dose of SOC therapy or 120 days after the last pembrolizumab dose
  • Male participants must agree to use adequate contraception for the course of the study starting with the first dose of study medication through 180 days after the last dose of SOC therapy or 120 days after the last pembrolizumab dose
  • Adequate organ function

Exclusion Criteria

  • Has received prior systemic therapy for Stage IV colorectal cancer. May have received prior adjuvant chemotherapy for colorectal cancer as long as it was completed at least 6 months prior to randomization on this study
  • Currently participating and receiving treatment in another study, or participated in a study of an investigational agent and received treatment, or used an investigational device within 4 weeks of randomization
  • Active autoimmune disease that has required systemic treatment in past 2 years
  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization on this study
  • Radiation therapy within 4 weeks prior to randomization on this study and not recovered to baseline from adverse events due to radiation therapy
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization on this study
  • Has received prior therapy with an immune checkpoint inhibitor (e.g., anti-programmed cell death [PD]-1, anti-PD ligand 1 [L1], anti-PD-L2 agent, or anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4] agent, etc.)
  • Another malignancy that is progressing or requires active treatment with the exception of non-melanomatous skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma
  • Received a live vaccine within 30 days of planned start of study medication
  • Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or C
  • Known history of, or any evidence of interstitial lung disease or active, non-infectious pneumonitis
  • Known history of active tuberculosis (Bacillus tuberculosis [TB])
  • Active infection requiring systemic therapy
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of SOC or 120 days after the last dose of pembrolizumab

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: COMPLETED
Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL

Hawaii

Honolulu
Queen's Medical Center
Status: CLOSED_TO_ACCRUAL
University of Hawaii Cancer Center
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: APPROVED

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: COMPLETED
Brigham and Women's Hospital
Status: COMPLETED
Dana-Farber Cancer Institute
Status: COMPLETED

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: CLOSED_TO_ACCRUAL

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: COMPLETED
Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL
New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

North Carolina

Durham
Duke University Medical Center
Status: COMPLETED

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Oregon

Portland
OHSU Knight Cancer Institute
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Merck and Company Inc

  • Primary ID 3475-177
  • Secondary IDs NCI-2015-02241, 163238, 2015-002024-89, KEYNOTE-177, MK-3475-177
  • Clinicaltrials.gov ID NCT02563002