Status:
COMPLETED
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Melanoma
Skin Cancer
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03329846
Start Date
November 30 2017
End Date
July 2 2020
Last Update
July 9 2021
Active Locations (63)
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1
Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
2
University Of Colorado
Aurora, Colorado, United States, 80045
3
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
4
University Of Chicago
Chicago, Illinois, United States, 60637