A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

Study Overview
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Brief Summary
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The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.

Official Title
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A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for Nivolumab + Relatlimab Fixed-dose Combination Subcutaneous Versus Nivolumab + Relatlimab Fixed-dose Combination Intravenous and Nivolumab Subcutaneous Versus Nivolumab Intravenous in Participants With Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Drug: relatlimab+nivolumab
* Drug: relatlimab+nivolumab+rHuPH20
* Drug: nivolumab
* Drug: nivolumab+rHuPH20


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma Exclusion Criteria: Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs) Other protocol-defined inclusion/exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Metastatic Melanoma<br> | Drug: relatlimab+nivolumab<br>* Specified dose on specified days<br>* Other names: Opdualag;Drug: relatlimab+nivolumab+rHuPH20<br>* Specified dose on specified days<br>|
| Experimental: Cohort 2: Resected Melanoma<br> | Drug: nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Drug: nivolumab+rHuPH20<br>* Specified dose on specified days<br>* Other names: BMS-986298;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that prefer subcutaneous (SC) route of administration as assessed by Question 7 of the Patient Experience and Preference Questionnaire (PEPQ) |  | At Cycle 4 Day 1 (each cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events (AEs) |  | Up to approximately 2.5 years | 
| Number of participants with Serious AEs (SAEs) |  | Up to approximately 2.5 years | 
| Number of participants with treatment-related AEs |  | Up to approximately 2.5 years | 
| Number of participants with AEs leading to discontinuation |  | Up to approximately 2.5 years | 
| Number of participants with Immune-mediated AEs (IMAEs) |  | Up to approximately 2.5 years | 
| Number of participants with other events of special interest (OESIs) |  | Up to approximately 2.5 years | 
| Number of participants with injection/infusion-related AEs |  | Up to approximately 2.5 years | 
| Number of deaths |  | Up to approximately 2.5 years | 
| Number of participants with laboratory abnormalities |  | Up to approximately 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient preference, Nivolumab Relatlimab IV, Nivolumab Relatimab SC, Melanoma, rHuPH20, FDC IV, FDC SC, Adjuvant, Metastatic, Switch, Nivolumab, Relatlimab