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

ClinicalTrials.gov ID: NCT05625399

Public ClinicalTrials.gov record NCT05625399. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 5:33 PM EDT

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Official title

A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05625399
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Bristol-Myers Squibb; Industry
Enrollment: 579 participants

Conditions and interventions

Conditions

Melanoma

Interventions

Nivolumab + Relatlimab Drug
rHuPH20 Drug

Drug

Eligibility (public fields only)

Age range: 12 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 5, 2023
Primary completion: Aug 3, 2025
Completion: Nov 17, 2027
Last update posted: Aug 25, 2026

2023 – 2027

United States locations

U.S. sites: 15
U.S. states: 12
U.S. cities: 15

Facility	City	State	ZIP	Site status
Local Institution - 0125	Phoenix	Arizona	85013	—
Local Institution - 0189	Springdale	Arkansas	72762	—
Local Institution - 0098	Los Angeles	California	90025	—
Local Institution - 0093	Orange	California	92868-3201	—
Local Institution - 0123	Stanford	California	94305	—
Local Institution - 0113	Englewood	Colorado	80113	—
Local Institution - 0114	Jacksonville	Florida	32224	—
Local Institution - 0146	Baltimore	Maryland	21201	—
Local Institution - 0071	Rochester	Minnesota	55905	—
Local Institution - 0013	Omaha	Nebraska	68130	—
Local Institution - 0169	Cleveland	Ohio	44195	—
Local Institution - 0139	Easton	Pennsylvania	18045	—
Local Institution - 0124	Philadelphia	Pennsylvania	19107	—
Local Institution - 0122	Murray	Utah	84107	—
Local Institution - 0115	Fairfax	Virginia	22031	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 134 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05625399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 25, 2026 · Synced Sep 3, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05625399 live on ClinicalTrials.gov.

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