An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma

Study Overview
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Brief Summary
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The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated

Official Title
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A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated

Conditions
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Melanoma, Skin Cancer

Intervention / Treatment
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* Drug: BMS-986205
* Biological: Nivolumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 12 years and older unless not permitted by local regulations; in that case 18 years old and older Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1 Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition) Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma) Measurable disease per RECIST v1.1 Exclusion Criteria: Active brain metastases or leptomeningeal metastases Uveal or ocular melanoma Participants with active, known, or suspected autoimmune disease Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured Other protocol defined inclusion/exclusion criteria could 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nivolumab + Placebo<br>Specified dose on specified day Participants will no longer receive BMS-986205 Placebo | Biological: Nivolumab<br>* Specified dose on specified day<br>* Other names: BMS-936558;Drug: Placebo<br>* Specified dose on specified day<br>* Other names: BMS-986205 matching placebo;|
| Experimental: Nivolumab + BMS-986205<br>Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion | Drug: BMS-986205<br>* specified dose on specified day<br>Biological: Nivolumab<br>* Specified dose on specified day<br>* Other names: BMS-936558;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Adverse Events | Number of participants experiencing different types of Adverse Events, including Death, Any cause Adverse Events (AEs), Drug-related AEs, Any cause Serious Adverse Events (SAEs), Drug-related SAEs, SAEs leading to discontinuation, and Drug-related Non-serious AEs leading to discontinuation | From first dose to 30 days following last dose (up to approximately 25 months) |