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Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008)

NCT04895722 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2026-03-30

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.

Conditions

Interventions

BIOLOGICAL

Pembrolizumab

400 mg or 200 mg pembrolizumab administered via IV infusion.

BIOLOGICAL

Pembrolizumab/Quavonlimab

Co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) fixed-dose combination (FDC) administered via IV infusion.

BIOLOGICAL

Pembrolizumab/Favezelimab

Co-formulated pembrolizumab/favezelimab (200 mg/800 mg) FDC administered via IV infusion

BIOLOGICAL

Pembrolizumab/Vibostolimab

Co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) FDC administered via IV infusion

BIOLOGICAL

MK-4830

800 mg MK-4830 administered via IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2025-05-21
Completion
2026-08-13
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Colombia
  • Costa Rica
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Guatemala
  • Hungary
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04895722 on ClinicalTrials.gov