A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

Study Overview
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Brief Summary
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The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

Official Title
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A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Biological: Nivolumab
* Biological: Nivolumab + Relatlimab Fixed Dose Combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and < 18 years of age must have a Lansky/Karnofsky performance score ≥ 80% Complete resection must be performed within 90 days prior to randomization All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization Tumor tissue must be provided for biomarker analyses Exclusion Criteria: History of ocular melanoma Untreated/unresected CNS metastases or leptomeningeal metastases Active, known, or suspected autoimmune disease Participants with serious or uncontrolled medical disorder Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening History of myocarditis, regardless of etiology. Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Nivolumab Plus Relatlimab<br>Combination | Biological: Nivolumab + Relatlimab Fixed Dose Combination<br>* Specified dose on specified days<br>* Other names: Opdualag;|
| Experimental: Arm B: Nivolumab<br>Monotherapy | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-Free Survival (RFS) time per Investigator assessment |  | Approximately 52 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Approximately 90 months | 
| Distant Metastasis-Free Survival (DMFS) time per Investigator assessment |  | Approximately 90 months | 
| Incidence of Adverse Events (AEs) |  | 30 days from participant's last dose | 
| Severity of AEs |  | 30 days from participant's last dose | 
| Incidence of Serious Adverse Events (SAEs) |  | 30 days from participant's last dose | 
| Severity of SAEs |  | 30 days from participant's last dose | 
| Incidence of AEs leading to discontinuation (DC) |  | 30 days from participant's last dose | 
| Severity of AEs leading to DC |  | 30 days from participant's last dose | 
| Incidence of immune-mediated AEs (IMAEs) |  | 135 days from participant's last dose | 
| Severity of IMAEs |  | 135 days from participant's last dose | 
| Incidence of drug related AEs |  | 30 days from participant's last dose | 
| Severity of drug related AEs |  | 30 days from participant's last dose | 
| Incidence of deaths |  | 30 days from participant's last dose | 
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests |  | 30 days from participant's last dose | 
| Incidence of clinically significant changes in clinical laboratory values: Chemistry tests |  | 30 days from participant's last dose | 
| Progression-Free Survival 2 (PFS2) |  | Approximately 52 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Relatlimab, Nivolumab, Opdivo