Melanoma
Conditions
Keywords
Nivolumab, Relatlimab, FDC, Melanoma, rHuPH20, OPDUALAG
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.
Interventions
Specified dose on specified days
DRUGrHuPH20
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab | Up to 28 days |
| Trough serum concentration at steady state (Cminss) of Nivolumab | Up to 4 months |
| Cavgd28 of Relatlimab | Up to 28 days |
| Cminss of Relatlimab | Up to 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Peak serum concentration at steady state (Cmaxss) of Nivolumab and Relatlimab | Up to 4 months |
| Time-averaged serum concentration at steady state (Cavgss) of Nivolumab and Relatlimab | Up to 4 months |
| Duration of Response (DOR) by BICR per RECIST v1.1 | Up to approximately 3 years |
| Disease Control Rate (DCR) by BICR per RECIST v1.1 | Up to approximately 3 years |
| Time to Response (TTR), by BICR per RECIST v1.1 | Up to approximately 3 years |
| Objective Response Rate (ORR) by Investigator per RECIST v1.1 | Up to approximately 3 years |
| Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) per RECIST v1.1 | Up to approximately 3 years |
| DCR by Investigator per RECIST v1.1 | Up to approximately 3 years |
| TTR by Investigator per RECIST v1.1 | Up to approximately 3 years |
| Progression Free Survival (PFS) by BICR and Investigator per RECIST v1.1 | Up to approximately 3 years |
| Overall Survival | Up to approximately 3 years |
| Number of Participants with Adverse Events (AEs) | Up to approximately 3 years |
| Change from Baseline in Functional Assessment of Cancer Therapy - Melanoma Subscale (FACT-MS) | Up to approximately 3 years |
| DOR by Investigator per RECIST v1.1 | Up to approximately 3 years |
| Trough serum concentration at Day 28 after the first dose (Cmind28) of Nivolumab and Relatlimab | Up to 28 days |
| Peak serum concentration after the first dose (Cmax1) of Nivolumab and Relatlimab | Up to 28 days |
| Time to Cmax1 (Tmax1) of Nivolumab and Relatlimab | Up to 28 days |
Countries
Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Finland, France, Germany, Israel, Italy, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed