A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma (RELATIVITY-127)

• ClinicalTrials.gov Identifier: NCT05625399
• Recruitment Status: Recruiting
• First Posted: November 22, 2022
• Last Update Posted: May 13, 2024
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: November 15, 2022
• First Posted Date: November 22, 2022
• Last Update Posted Date: May 13, 2024
• Actual Study Start Date: March 6, 2023
• Estimated Primary Completion Date: February 28, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 15, 2022)

• Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab [ Time Frame: Up to 28 days ]
• Trough serum concentration at steady state (Cminss) of Nivolumab [ Time Frame: Up to 4 months ]
• Cavgd28 of Relatlimab [ Time Frame: Up to 28 days ]
• Cminss of Relatlimab [ Time Frame: Up to 4 months ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 15, 2022)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
• 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: 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Melanoma

Intervention

• Drug: Nivolumab + Relatlimab
  Specified dose on specified days
  Other Names:

  • BMS-986213
  • Opdualag
• Drug: rHuPH20
  Specified dose on specified days

Study Arms

• Experimental: Nivolumab + Relatlimab FDC SC
  Interventions:

  • Drug: Nivolumab + Relatlimab
  • Drug: rHuPH20
• Active Comparator: Nivolumab + Relatlimab FDC IV
  Intervention: Drug: Nivolumab + Relatlimab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 1, 2023): 570
• Original Estimated Enrollment (submitted: November 15, 2022): 814
• Estimated Study Completion Date: February 28, 2025
• Estimated Primary Completion Date: February 28, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com; 855-907-3286; Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Finland, France, Germany, Israel, Italy, Mexico, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT05625399
• Other Study ID Numbers: CA224-127; 2022-000575-39 ( EudraCT Number ); U1111-1274-0193 ( Registry Identifier: WHO )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: See Plan Description
• Access Criteria: See Plan Description
• URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: May 2024