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.
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:
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:
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)
- Experimental: Nivolumab + Relatlimab FDC SC
- Active Comparator: Nivolumab + Relatlimab FDC IV
- Nivolumab + Relatlimab (BMS-986213 / Opdualag / ):
Specified dose on specified days - rHuPH20:
Specified dose on specified days
Quelle: ClinicalTrials.gov
