A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection

Study Overview
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Brief Summary
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The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.

Official Title
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A Randomized, Double-Blind, Parallel, Phase 1 Study to Compare the Pharmacokinetics of BMSCHO1-Nivolumab Process D to Nivolumab Process C After Complete Resection of Stage IIIa/b/c/d or Stage IV Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed stage IIIa/b/c/d or stage IV melanoma Complete resection of Stage III disease that is documented on the surgical and pathology reports or complete resection of Stage IV disease with margins negative for disease that is documented on the pathology report Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: Prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured Any significant acute or chronic medical illness that is uncontrolled History of ocular/uveal melanoma Active, known or suspected autoimmune disease Systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease. 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A (Process C)<br> | Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|
| Experimental: Arm B (Process D)<br> | Drug: 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 |
| --- | --- | --- |
| Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h) |  | Over the dosing interval at Week 1 and Week 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | Over the dosing interval at Week 1 and Week 17 | 
| Observed serum concentration at the end of a dosing interval (Ctau) |  | Over the dosing interval at Week 1 and Week 17 | 
| Time of maximum observed plasma concentration (Tmax) |  | Over the dosing interval at Week 1 and Week 17 | 
| Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) |  | Through Week 51 Day 1 | 
| Number of Participants With Serious Adverse Events (SAEs) |  | Up to 65 weeks | 
| Number of Participants With Adverse Events leading to Discontinuation |  | Up to 65 weeks | 
| Number of Participants With Adverse Events (AEs) |  | Up to 65 weeks | 
| Number of Participants With Clinically Significant Laboratory Abnormalities |  | Up to 65 weeks | 
| Number of Participants with AEs leading to death |  | Up to 65 weeks |