A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05002569
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

Key Dates

Start date
Oct 19, 2021
Status verified
Dec 2025
Primary completion
Dec 16, 2024
Completion
Apr 2, 2025

Study Design

Enrollment
1,093 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Nivolumab Plus Relatlimab
    Combination
  • Experimental: Arm B: Nivolumab
    Monotherapy

Primary Outcome Measure

Recurrence Free Survival (RFS) [ Time Frame: Approximately 27.5 Months ]

Locations (43)

FacilityCityStateZIPSite coordinators
Local Institution - 0176BirminghamAlabama35249-
Local Institution - 0164SpringdaleArkansas72762-
Local Institution - 0200Los AngelesCalifornia90025-
Local Institution - 0185Palo AltoCalifornia94304-
Local Institution - 0162San FranciscoCalifornia94115-
Saint John's Cancer InstituteSanta MonicaCalifornia90404-
Local Institution - 0138AuroraColorado80045-
Local Institution - 0166Washington D.C.District of Columbia20007-
Local Institution - 0243MiamiFlorida33136-
Washington University School Of MedicineMiamiFlorida33136-
Local Institution - 0179PensacolaFlorida32504-
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient CenterTampaFlorida33612-
Local Institution - 0148AtlantaGeorgia30342-
Local Institution - 0191AtlantaGeorgia30322-
Local Institution - 0202ChicagoIllinois60611-
Local Institution - 0177PeoriaIllinois61615-
Local Institution - 0223Fort WayneIndiana46804-
University of Iowa-Holden Comprehensive Cancer CenterIowa CityIowa52242-
Local Institution - 0178WestwoodKansas66205-
Dana-Farber Cancer Institute-MelanomaBostonMassachusetts02215-
Local Institution - 0258Ann ArborMichigan48109-
Local InstitutionGrand RapidsMichigan49503-
Local Institution - 0133MinneapolisMinnesota55407-
Local Institution - 0139HackensackNew Jersey07601-
Local Institution - 0206MorristownNew Jersey07960-
Icahn School Of Medicine At Mount SinaiNew YorkNew York10029-
Local Institution - 0140New YorkNew York10016-
Local Institution - 0210New YorkNew York10065-
Local Institution - 0130CharlotteNorth Carolina28204-
Local Institution - 0145DurhamNorth Carolina27710-
Local Institution - 0141ClevelandOhio44195-
MetroHealth Medical CenterClevelandOhio44109-
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive CColumbusOhio43210-
Local Institution - 0267AllentownPennsylvania18103-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Local Institution - 0125PittsburghPennsylvania15232-
Local Institution - 0171CharlestonSouth Carolina29425-
Local Institution - 0147GermantownTennessee38138-
Local Institution - 0183NashvilleTennessee37232-
Local Institution - 0146AustinTexas78731-
Local Institution - 0163DallasTexas75246-
Local Institution - 0172HoustonTexas77030-
Local Institution - 0137FairfaxVirginia22031-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Local Institution - 0176· Birmingham, ALLocal Institution - 0164· Springdale, ARLocal Institution - 0200· Los Angeles, CALocal Institution - 0185· Palo Alto, CALocal Institution - 0162· San Francisco, CASaint John's Cancer Institute· Santa Monica, CA

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