A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05625399
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab + Relatlimab — DRUG
    Specified dose on specified days
  • rHuPH20 — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

Key Dates

Start date
Mar 6, 2023
Status verified
May 2026
Primary completion
Aug 4, 2025
Completion
Nov 18, 2027

Study Design

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

Arms

  • Experimental: Nivolumab + Relatlimab FDC SC
  • Active Comparator: Nivolumab + Relatlimab FDC IV

Primary Outcome Measure

Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab [ Time Frame: Up to 28 days ]

Locations (15)

FacilityCityStateZIPSite coordinators
Local Institution - 0125PhoenixArizona85013-
Local Institution - 0189SpringdaleArkansas72762-
Local Institution - 0098Los AngelesCalifornia90025-
Local Institution - 0093OrangeCalifornia92868-3201-
Local Institution - 0123StanfordCalifornia94305-
Local Institution - 0113EnglewoodColorado80113-
Local Institution - 0114JacksonvilleFlorida32224-
Local Institution - 0146BaltimoreMaryland21201-
Local Institution - 0071RochesterMinnesota55905-
Local Institution - 0013OmahaNebraska68130-
Local Institution - 0169ClevelandOhio44195-
Local Institution - 0139EastonPennsylvania18045-
Local Institution - 0124PhiladelphiaPennsylvania19107-
Local Institution - 0122MurrayUtah84107-
Local Institution - 0115FairfaxVirginia22031-

Related coverage on Hipa.ai

Find similar trials in Phoenix, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Local Institution - 0125· Phoenix, AZLocal Institution - 0189· Springdale, ARLocal Institution - 0098· Los Angeles, CALocal Institution - 0093· Orange, CALocal Institution - 0123· Stanford, CALocal Institution - 0113· Englewood, CO

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