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Active, Not Recruiting

NCT Number: NCT05625399

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0050, Coffs Harbour, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nivolumab + Relatlimab

Drug

Specified dose on specified days

Other names: BMS-986213, Opdualag

rHuPH20

Drug

Specified dose on specified days

Primary outcomes

  1. Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab

    Time frame: Up to 28 days

  2. Trough serum concentration at steady state (Cminss) of Nivolumab

    Time frame: Up to 4 months

  3. Cavgd28 of Relatlimab

    Time frame: Up to 28 days

  4. Cminss of Relatlimab

    Time frame: Up to 4 months

Secondary outcomes

  1. Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) per RECIST v1.1

    Time frame: Up to approximately 3 years

  2. Trough serum concentration at Day 28 after the first dose (Cmind28) of Nivolumab and Relatlimab

    Time frame: Up to 28 days

  3. Peak serum concentration after the first dose (Cmax1) of Nivolumab and Relatlimab

    Time frame: Up to 28 days

  4. Time to Cmax1 (Tmax1) of Nivolumab and Relatlimab

    Time frame: Up to 28 days

  5. Peak serum concentration at steady state (Cmaxss) of Nivolumab and Relatlimab

    Time frame: Up to 4 months

  6. Time-averaged serum concentration at steady state (Cavgss) of Nivolumab and Relatlimab

    Time frame: Up to 4 months

  7. Duration of Response (DOR) by BICR per RECIST v1.1

    Time frame: Up to approximately 3 years

  8. Disease Control Rate (DCR) by BICR per RECIST v1.1

    Time frame: Up to approximately 3 years

  9. Time to Response (TTR), by BICR per RECIST v1.1

    Time frame: Up to approximately 3 years

  10. Objective Response Rate (ORR) by Investigator per RECIST v1.1

    Time frame: Up to approximately 3 years

  11. DOR by Investigator per RECIST v1.1

    Time frame: Up to approximately 3 years

  12. DCR by Investigator per RECIST v1.1

    Time frame: Up to approximately 3 years

  13. TTR by Investigator per RECIST v1.1

    Time frame: Up to approximately 3 years

  14. Progression Free Survival (PFS) by BICR and Investigator per RECIST v1.1

    Time frame: Up to approximately 3 years

  15. Overall Survival

    Time frame: Up to approximately 3 years

  16. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 3 years

  17. Change from Baseline in Functional Assessment of Cancer Therapy - Melanoma Subscale (FACT-MS)

    Time frame: Up to approximately 3 years

  18. Number of participants with serious adverse events (SAEs)

    Time frame: Up to approximately 3 years

  19. Number of participants with AEs leading to discontinuation

    Time frame: Up to approximately 3 years

  20. Number of participants with immune-mediated adverse events (IMAEs)

    Time frame: Up to approximately 3 years

  21. Number of participants with other events of special interest (OESIs)

    Time frame: Up to approximately 3 years

  22. Number of deaths

    Time frame: Up to approximately 3 years

  23. Number of participants with laboratory abnormalities

    Time frame: Up to approximately 3 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Halozyme Therapeutics

Registry information

Official study 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

Acronym: RELATIVITY-127

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Nov 22, 2022
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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