Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

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)

Protocol: OSU-15298

Full Title

A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)

Purpose

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.

Are you eligible?

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

Colon Cancer Rectal Cancer Gastrointestinal Cancers