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)

Part of paid clinical trials in Orange City, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04895722
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    400 mg or 200 mg pembrolizumab administered via IV infusion.
  • Pembrolizumab/Quavonlimab — BIOLOGICAL
    Co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) fixed-dose combination (FDC) administered via IV infusion.
  • Pembrolizumab/Favezelimab — BIOLOGICAL
    Co-formulated pembrolizumab/favezelimab (200 mg/800 mg) FDC administered via IV infusion
  • Pembrolizumab/Vibostolimab — BIOLOGICAL
    Co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) FDC administered via IV infusion
  • MK-4830 — BIOLOGICAL
    800 mg MK-4830 administered via IV infusion

Study Details

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.

Key Dates

Start date
Jun 25, 2021
Status verified
May 2026
Primary completion
May 21, 2025
Completion
Aug 13, 2026

Study Design

Enrollment
302 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A - Pembrolizumab/Quavonlimab
    Participants in Cohort A receive co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) every 6 weeks (Q6W) for up to approximately 2 years.
  • Active Comparator: Cohort A - Pembrolizumab
    Participants in Cohort A receive pembrolizumab 400 mg intravenously (IV) Q6W for up to approximately 2 years.
  • Experimental: Cohort B - Pembrolizumab/Quavonlimab
    Participants received co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.
  • Experimental: Cohort B - Pembrolizumab Plus MK-4830
    Participants receive pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.
  • Experimental: Cohort B - Pembrolizumab/Favezelimab
    Participants receive co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.
  • Experimental: Cohort B - Pembrolizumab/Vibostolimab
    Participants receive co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.
  • Active Comparator: Cohort B - Pembrolizumab
    Participants in Cohort B receive pembrolizumab 400 mg IV Q6W for up to approximately 2 years.

Primary Outcome Measure

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 46 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
Mid Florida Cancer Center ( Site 1519)Orange CityFlorida32763-
University Cancer & Blood Center, LLC ( Site 1521)AthensGeorgia30607-
University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal PChicagoIllinois60637-
Icahn School of Medicine at Mount Sinai ( Site 1528)New YorkNew York10029-
Hematology Oncology Associates of Rockland ( Site 1525)NyackNew York10960-
UPMC Hillman Cancer Center ( Site 1516)PittsburghPennsylvania15232-
The West Clinic, PLLC dba West Cancer Center ( Site 1576)GermantownTennessee38138-
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509)NashvilleTennessee37232-
UT Southwestern Medical Center ( Site 1551)DallasTexas75390-
Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549)TempleTexas76508-
Northwest Medical Specialties, PLLC ( Site 1546)TacomaWashington98405-

Related coverage on Hipa.ai

Find similar trials in Orange City, FL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Mid Florida Cancer Center· Orange City, FLUniversity Cancer & Blood Center, LLC· Athens, GAUniversity of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P· Chicago, ILIcahn School of Medicine at Mount Sinai· New York, NYHematology Oncology Associates of Rockland· Nyack, NYUPMC Hillman Cancer Center· Pittsburgh, PA

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