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)

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIITreatmentActive18 and over3475-177
NCI-2015-02241, 163238, 2015-002024-89, NCT02563002

Trial Description

Summary

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)

compared to current SOC chemotherapy.

Eligibility Criteria

Inclusion Criteria:

Locally confirmed dMMR or MSI-H stage IV colorectal carcinoma

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

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

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Merck and Company Inc

    Trial Sites

    U.S.A.

    California
    Los Angeles

    UCLA / Jonsson Comprehensive Cancer Center

    Zev Aryeh Wainberg
    Principal Investigator

    USC / Norris Comprehensive Cancer Center

    Heinz-Josef Lenz
    Principal Investigator

    Orange

    UC Irvine Health/Chao Family Comprehensive Cancer Center

    Jason Adam Zell
    Principal Investigator

    Palo Alto

    Stanford Cancer Institute

    Sigurdis Haraldsdottir
    Principal Investigator

    Colorado
    Aurora

    University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Christopher Hanyoung Lieu
    Principal Investigator

    Christopher Hanyoung Lieu
    Principal Investigator

    Connecticut
    New Haven

    Yale University

    Howard S. Hochster
    Principal Investigator

    Hawaii
    Honolulu

    University of Hawaii Cancer Center

    Jared Acoba
    Principal Investigator

    Illinois
    Chicago

    University of Chicago Comprehensive Cancer Center

    Manish R. Sharma
    Principal Investigator

    Maryland
    Baltimore

    Johns Hopkins University/Sidney Kimmel Cancer Center

    Luis Alberto Diaz
    Principal Investigator

    Massachusetts
    Boston

    Brigham and Women's Hospital

    Robert James Mayer
    Principal Investigator

    Dana-Farber Cancer Institute

    Robert James Mayer
    Principal Investigator

    Michigan
    Ann Arbor

    University of Michigan Comprehensive Cancer Center

    Mark M. Zalupski
    Principal Investigator

    New York
    Bronx

    Montefiore Medical Center-Weiler Hospital

    Lakshmi Rajdev
    Principal Investigator

    Buffalo

    Roswell Park Cancer Institute

    Patrick McKay Boland
    Principal Investigator

    North Carolina
    Durham

    Duke University Medical Center

    Michael A. Morse
    Principal Investigator

    Ohio
    Cleveland

    Case Comprehensive Cancer Center

    Michael James McNamara
    Principal Investigator

    Columbus

    Ohio State University Comprehensive Cancer Center

    Richard Miles Goldberg
    Principal Investigator

    Oregon
    Portland

    OHSU Knight Cancer Institute

    Gina Maria Vaccaro
    Principal Investigator

    Pennsylvania
    Philadelphia

    Fox Chase Cancer Center

    Michael John Hall
    Principal Investigator

    Pittsburgh

    University of Pittsburgh Cancer Institute (UPCI)

    James Jinhak Lee
    Principal Investigator

    Texas
    Dallas

    UT Southwestern/Simmons Cancer Center-Dallas

    Muhammad Shaalan Beg
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT02563002

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.