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

Completed · Phase 3 · Has a placebo group

Conditions studied: Melanoma, Skin Cancer

In brief

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

Key facts

Study ID

NCT03329846

Run by

Bristol-Myers Squibb

People needed

20

Starts

2017-11-30

Expected to finish

2020-07-02

Last updated by the study team

2021-07-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Of Colorado — Aurora, Colorado, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• University Of Chicago — Chicago, Illinois, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Local Institution — Seattle, Washington, United States
• Local Institution — Blacktown, New South Wales, Australia
• Melanoma Institute Australia — North Sydney, New South Wales, Australia
• Local Institution — Greenslopes, Queensland, Australia
• Local Institution — Woolloongabba, Queensland, Australia
• Local Institution — Box Hill, Victoria, Australia
• Local Institution — Melbourne, Victoria, Australia
• Local Institution — Melbourne, Victoria, Australia
• Local Institution — Montreal, Quebec, Canada
• Local Institution — Québec, Quebec, Canada
• Klinika onkologie a radioterapie — Hradec Králové, Czechia
• Dermatovenerologicka klinika 3. LF UK a FNKV — Prague, Czechia
• Dermatovenerologicka klinika VFN a 1. LF UK — Prague, Czechia
• Local Institution — Boulogne-Billancourt, France
• Local Institution — Saint-Etienne, France
• Local Institution — Villejuif, France
• Elbe Klinikum Buxtehude — Buxtehude, Germany
• Universitaetsklinikum Carl Gustav Carus — Dresden, Germany
• Local Institution — Essen, Germany
• SRH Wald-Kliniken Gera GmbH — Gera, Germany
• Angeles Clinic and Research Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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