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Active, Not Recruiting

An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma - CA017-055

Updated: 30 January, 2019   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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Use the Study Participants Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.
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Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 12+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Nivolumab + BMS-986205
Biological: Nivolumab Drug: BMS-986205
Active Comparator: Nivolumab + Placebo
Drug: Placebo Biological: Nivolumab

Key Eligibility Criteria

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

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