A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

Part of paid clinical trials in La Jolla, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05665595
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab/Vibostolimab — BIOLOGICAL
    Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 17 administrations
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab 25 mg/mL administered as IV infusion for up to 17 administrations

Study Details

The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

Key Dates

Start date
Jan 19, 2023
Status verified
Oct 2025
Primary completion
Mar 6, 2024
Completion
Sep 26, 2025

Study Design

Enrollment
1,594 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab/Vibostolimab
    Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).
  • Active Comparator: Pembrolizumab
    Participants receive 200 mg pembrolizumab via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).

Primary Outcome Measure

Recurrence-Free Survival (RFS) [ Time Frame: Up to approximately 13 months ]

Locations (30)

FacilityCityStateZIPSite coordinators
Moores Cancer Center ( Site 0116)La JollaCalifornia92093-0698-
The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)Los AngelesCalifornia90025-
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131)Los AngelesCalifornia90095-
California Pacific Medical Center - Pacific Campus ( Site 0111)San FranciscoCalifornia94115-
UCSF Medical Center at Mission Bay ( Site 0130)San FranciscoCalifornia94158-
The Melanoma & Skin Cancer Institute ( Site 0120)EnglewoodColorado80113-
Georgetown University Medical Center ( Site 0144)Washington D.C.District of Columbia20007-
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)MiamiFlorida33136-
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124)TampaFlorida33612-
Northwestern Memorial Hospital ( Site 0109)ChicagoIllinois60611-
Advocate Medical Group-Oncology ( Site 0102)Park RidgeIllinois60068-
University of Iowa-Holden Comprehensive Cancer Center ( Site 0107)Iowa CityIowa52242-
Henry Ford Hospital ( Site 0133)DetroitMichigan48202-
Comprehensive Cancer Centers of Nevada ( Site 0142)Las VegasNevada89169-
R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132)Lake SuccessNew York11042-
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146)MineolaNew York11501-
Icahn School of Medicine at Mount Sinai ( Site 0118)New YorkNew York10029-
Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113)New YorkNew York10016-
Weill Cornell Medical College ( Site 0115)New YorkNew York10065-
Levine Cancer Institute ( Site 0138)CharlotteNorth Carolina28204-
Sanford Fargo Medical Center ( Site 0127)FargoNorth Dakota58102-
Children's Hospital of Pittsburgh ( Site 0141)PittsburghPennsylvania15224-
UPMC Hillman Cancer Center ( Site 0135)PittsburghPennsylvania15232-
Sanford Cancer Center ( Site 0125)Sioux FallsSouth Dakota57104-
The West Clinic, PLLC dba West Cancer Center ( Site 0119)GermantownTennessee38138-
St. Jude Children's Research Hospital ( Site 0106)MemphisTennessee38105-
Vanderbilt University Medical Center ( Site 0139)NashvilleTennessee37232-
University of Texas MD Anderson Cancer Center ( Site 0145)HoustonTexas77030-
Inova Schar Cancer Institute ( Site 0103)FairfaxVirginia22031-
University of Wisconsin Hospital and Clinics ( Site 0108)MadisonWisconsin53792-

Related coverage on Hipa.ai

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By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Moores Cancer Center· La Jolla, CAThe Angeles Clinic and Research Institute - West Los Angeles Office· Los Angeles, CAUCLA Hematology/Oncology - Westwood (Building 100)· Los Angeles, CACalifornia Pacific Medical Center - Pacific Campus· San Francisco, CAUCSF Medical Center at Mission Bay· San Francisco, CAThe Melanoma & Skin Cancer Institute· Englewood, CO

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