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

Phase 3

Active, not recruiting

• Conditions: Melanoma
• Interventions: Drug: Nivolumab + Relatlimab; Drug: rHuPH20

• Registration Number: NCT05625399
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-22
• Study Start: 2023-03-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-08-04
• Study Completion: 2027-11-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nivolumab + Relatlimab FDC SC	rHuPH20	-
Nivolumab + Relatlimab FDC IV	Nivolumab + Relatlimab	-
Nivolumab + Relatlimab FDC SC	Nivolumab + Relatlimab	-

Primary Outcome Measures

Name	Time	Method
Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab	Up to 28 days
Cavgd28 of Relatlimab	Up to 28 days
Trough serum concentration at steady state (Cminss) of Nivolumab	Up to 4 months
Cminss of Relatlimab	Up to 4 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	Up to approximately 3 years
Trough serum concentration at Day 28 after the first dose (Cmind28) of Nivolumab and Relatlimab	Up to 28 days
Peak serum concentration after the first dose (Cmax1) of Nivolumab and Relatlimab	Up to 28 days
Time to Cmax1 (Tmax1) of Nivolumab and Relatlimab	Up to 28 days
Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) per RECIST v1.1	Up to approximately 3 years
Peak serum concentration at steady state (Cmaxss) of Nivolumab and Relatlimab	Up to 4 months
Disease Control Rate (DCR) by BICR per RECIST v1.1	Up to approximately 3 years
Time to Response (TTR), by BICR per RECIST v1.1	Up to approximately 3 years
DOR by Investigator per RECIST v1.1	Up to approximately 3 years
Time-averaged serum concentration at steady state (Cavgss) of Nivolumab and Relatlimab	Up to 4 months
Duration of Response (DOR) by BICR per RECIST v1.1	Up to approximately 3 years
Objective Response Rate (ORR) by Investigator per RECIST v1.1	Up to approximately 3 years
TTR by Investigator per RECIST v1.1	Up to approximately 3 years
Change from Baseline in Functional Assessment of Cancer Therapy - Melanoma Subscale (FACT-MS)	Up to approximately 3 years
DCR by Investigator per RECIST v1.1	Up to approximately 3 years
Progression Free Survival (PFS) by BICR and Investigator per RECIST v1.1	Up to approximately 3 years
Overall Survival	Up to approximately 3 years

Trial Locations

Locations (149)

Local Institution - 0125; 🇺🇸 Phoenix, Arizona, United States

Local Institution - 0189; 🇺🇸 Springdale, Arkansas, United States

Local Institution - 0098; 🇺🇸 Los Angeles, California, United States

Local Institution - 0093; 🇺🇸 Orange, California, United States

Local Institution - 0123; 🇺🇸 Stanford, California, United States

Local Institution - 0113; 🇺🇸 Englewood, Colorado, United States

Local Institution - 0114; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0146; 🇺🇸 Baltimore, Maryland, United States

Local Institution - 0071; 🇺🇸 Rochester, Minnesota, United States

Local Institution - 0013; 🇺🇸 Omaha, Nebraska, United States

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