An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
- Interventional
- Active
- NCT03329846
Contact Information
A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated
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
Gender
All
Age Group
12 Years and up
Accepting Healthy Volunteers?
No
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
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