An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
Phase 3
Completed
- Conditions
- Melanoma
- Registration Number
- JPRN-jRCT2080223779
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 700
Inclusion Criteria
Males and Females, ages 18 years or 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-naive 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method