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Trial record 1 of 1 for:    CA224-127
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A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma (RELATIVITY-127)

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ClinicalTrials.gov Identifier: NCT05625399
Recruitment Status : Recruiting
First Posted : November 22, 2022
Last Update Posted : December 4, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Nivolumab + Relatlimab Drug: rHuPH20 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 6, 2023
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : February 28, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab + Relatlimab FDC SC Drug: Nivolumab + Relatlimab
Specified dose on specified days
Other Names:
  • BMS-986213
  • Opdualag

Drug: rHuPH20
Specified dose on specified days
Active Comparator: Nivolumab + Relatlimab FDC IV Drug: Nivolumab + Relatlimab
Specified dose on specified days
Other Names:
  • BMS-986213
  • Opdualag


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05625399


Contacts
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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 #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05625399    
Other Study ID Numbers: CA224-127
2022-000575-39 ( EudraCT Number )
U1111-1274-0193 ( Registry Identifier: WHO )
First Posted: November 22, 2022    Key Record Dates
Last Update Posted: December 4, 2023
Last Verified: December 2023
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Nivolumab
Relatlimab
FDC
 Melanoma
rHuPH20
OPDUALAG
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Nivolumab
Relatlimab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action