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

NCT05625399 · tracked via the Priya Life Science USA tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2023-03-06

Last updated

2026-08-26

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

Nivolumab + RelatlimabAll Nivolumab trials (104) →All Relatlimab trials (11) →rHuPH20 →

Nivolumab + Relatlimab: Specified dose on specified days

rHuPH20: Specified dose on specified days

Study 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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

Inclusion Criteria * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to \< 18 years of age). * Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system. * Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). * Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and \< 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent). * Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition). Exclusion Criteria * Participants must not have ocular melanoma. * Participants must not have a history of myocarditis, regardless of etiology. * Participants must not have a condition requiring systemic treatment with either corticosteroids (\>10 milligrams \[mg\] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale — Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale — Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale — Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Adjusted Trough Relatlimab Serum Concentration at Steady-State (Cminss-Rela) on Natural Logarithmic Scale — Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.

Trial sites (149)

Facility	City	Region
Local Institution - 0125	Phoenix	Arizona
Local Institution - 0189	Springdale	Arkansas
Local Institution - 0098	Los Angeles	California
Local Institution - 0093	Orange	California
Local Institution - 0123	Stanford	California
Local Institution - 0113	Englewood	Colorado
Local Institution - 0114	Jacksonville	Florida
Local Institution - 0146	Baltimore	Maryland
Local Institution - 0071	Rochester	Minnesota
Local Institution - 0013	Omaha	Nebraska
Local Institution - 0169	Cleveland	Ohio
Local Institution - 0139	Easton	Pennsylvania
Local Institution - 0124	Philadelphia	Pennsylvania
Local Institution - 0122	Murray	Utah
Local Institution - 0115	Fairfax	Virginia
Local Institution - 0050	Coffs Harbour	New South Wales
Local Institution - 0175	Orange	New South Wales
Local Institution - 0172	Port Macquarie	New South Wales
Local Institution - 0118	Wagga Wagga	New South Wales
Local Institution - 0184	Waratah	New South Wales
Local Institution - 0033	Westmead	New South Wales
Local Institution - 0055	Wollstonecraft	New South Wales
Local Institution - 0090	Birtinya	Queensland
Local Institution - 0008	Bendigo	Victoria
Local Institution - 0059	Box Hill	Victoria
Local Institution - 0154	Heidelberg	Victoria
Local Institution - 0030	Melbourne	Victoria
Local Institution - 0109	Traralgon	Victoria
Local Institution - 0106	Nedlands	Western Australia
Local Institution - 0161	Nedlands	Western Australia
Local Institution - 0027	Graz	Austria
Local Institution - 0029	Salzburg	Austria
Local Institution - 0168	Sankt Pölten	Austria
Local Institution - 0037	Vienna	Austria
Local Institution - 0072	Brussels	Belgium
Local Institution - 0078	Charleroi	Belgium
Local Institution - 0016	Liège	Belgium
Local Institution - 0177	Fortaleza	Ceará
Local Institution - 0180	Vitória	Espírito Santo
Local Institution - 0107	Belo Horizonte	Minas Gerais

+ 109 more sites — see the full list on the official registry below.

More Bristol-Myers Squibb trials in the USA

A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS). Recruiting

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy Recruiting

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1) Recruiting

A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants Recruiting

A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy Active, not recruiting

Other trials for the same condition

Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067 Recruiting

A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051) Recruiting

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma Active, not recruiting

Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer Recruiting

A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05625399 on ClinicalTrials.gov ↗ ← All trials in the USA