A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.

Official Title
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A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection

Conditions
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Melanoma

Intervention / Treatment
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* Biological: Nivolumab/rHuPH20
* Biological: Nivolumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins Complete resection performed within 12 weeks prior to randomization or treatment assignment Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 Exclusion Criteria: History of uveal or mucosal melanoma Untreated/unresected CNS metastases or leptomeningeal metastases Active, known or suspected autoimmune disease Serious or uncontrolled medical disorder 4 weeks prior to screening Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible Prior immunotherapy treatments for any prior malignancies are not permitted 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Subcutaneous Nivolumab<br> | Biological: Nivolumab/rHuPH20<br>* Specified dose on specified days<br>* Other names: BMS-986298;|
| Active Comparator: Arm B: Intravenous Nivolumab<br> | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 15 months | 
| Number of participants with serious adverse events (SAEs) |  | Up to 15 months | 
| Number of participants with treatment-related AEs |  | Up to 15 months | 
| Number of participants with treatment-related SAEs |  | Up to 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Cancer, rHuPH20, OPDIVO®