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

Phase 3

Completed

Brief Summary: 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Nivolumab + BMS-986205	Nivolumab	Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion
Nivolumab + Placebo	Placebo	Specified dose on specified day Participants will no longer receive BMS-986205 Placebo
Nivolumab + Placebo	Nivolumab	Specified dose on specified day Participants will no longer receive BMS-986205 Placebo
Nivolumab + BMS-986205	BMS-986205	Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Adverse Events	From first dose to 30 days following last dose (up to approximately 25 months)	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

Secondary Outcome Measures

Name	Time	Method

Locations (19): Angeles Clinic and Research Institute
🇺🇸
Los Angeles, California, United States
University Of Chicago
🇺🇸
Chicago, Illinois, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸
Miami Beach, Florida, United States
Local Institution
🇬🇧
Tauton, United Kingdom
Dermatovenerologicka klinika 3. LF UK a FNKV
🇨🇿
Praha 10, Czechia
Klinika onkologie a radioterapie
🇨🇿
Hradec Kralove, Czechia
Dermatovenerologicka klinika VFN a 1. LF UK
🇨🇿
Praha 2, Czechia
Melanoma Institute Australia
🇦🇺
North Sydney, New South Wales, Australia
Elbe Klinikum Buxtehude
🇩🇪
Buxtehude, Germany
Universitaetsklinikum Carl Gustav Carus
🇩🇪
Dresden, Germany
SRH Wald-Kliniken Gera GmbH
🇩🇪
Gera, Germany
Georg August Universitaet Goettingen
🇩🇪
Goettingen, Germany
Interbalkan European Medical Center
🇬🇷
Thessaloniki, Greece
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
🇵🇱
Warszawa, Poland
Azienda Ospedaliera Universitaria Senese
🇮🇹
Siena, Italy
Istituto Nazionale Tumori Fondazione Pascale
🇮🇹
Napoli, Italy
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
University Of Colorado
🇺🇸
Aurora, Colorado, United States
Universitaetsspital Zuerich
🇨🇭
Zürich, Switzerland