A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03470922
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Relatlimab — BIOLOGICAL
    Specified dose on specified day
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab monotherapy in treating unresectable melanoma or melanoma that has spread.

Key Dates

Start date
Apr 11, 2018
Status verified
Aug 2025
Primary completion
Jan 25, 2021
Completion
Dec 15, 2030

Study Design

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

Arms

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

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomization to date of first documented tumor progression or death (up to approximately 33 months) ]

Locations (22)

FacilityCityStateZIPSite coordinators
Local Institution - 0010TucsonArizona85724-5024-
Local Institution - 0020Los AngelesCalifornia90095-
Coastal Integrative Cancer CareSan Luis ObispoCalifornia93401-
Local Institution - 0116Santa BarbaraCalifornia93105-
Local Institution - 0012Washington D.C.District of Columbia20007-
Local Institution - 0013JacksonvilleFlorida32224-
Local Institution - 0117OrlandoFlorida32806-
Local Institution - 0007TampaFlorida33612-
Local Institution - 0038AtlantaGeorgia30342-
Local Institution - 0016ChicagoIllinois60611-
Local Institution - 0114Fort WayneIndiana46804-
Local Institution - 0077BaltimoreMaryland21237-
Local Institution - 0120BaltimoreMaryland21287-
Local Institution - 0014BostonMassachusetts02215-
Local Institution - 0134BostonMassachusetts02215-
Local Institution - 0015Ann ArborMichigan48109-
Local Institution - 0009MinneapolisMinnesota55407-
Local Institution - 0011RochesterMinnesota55905-
Local Institution - 0018CharlotteNorth Carolina28204-
Local Institution - 0019AllentownPennsylvania18103-
Local Institution - 0076DallasTexas75246-
Local Institution - 0008HoustonTexas77030-

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