Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy
About the study
The purpose of this study is to describe the safety and effectiveness of nivolumab treatment, either in monotherapy or in combination with ipilimumab, overall and according to various subgroups of interest, in participants with advanced melanoma and in participants with adjuvant nivolumab therapy.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
- Advanced melanoma (Stage III/Stage IV)
- Histologically confirmed diagnosis
- Treatment decision for nivolumab monotherapy or nivolumab/ipilimumab combination therapy has already been taken
For Cohort 3: (Recruitment ended by 08/31/2020)
- Primary diagnosis of advanced melanoma after complete surgical tumor resection and no evidence of disease
- Treatment decision for adjuvant nivolumab therapy has already been taken
EXCLUSION CRITERIA
Exclusion Criteria:
For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
- Current primary diagnosis of a cancer other than advanced melanoma, that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
- Previous treatment with nivolumab, for nivolumab monotherapy cohort only
- Current active participation in an interventional clinical trial
For Cohort 3: (Recruitment ended by 08/31/2020)
- Current diagnosis of persisting advanced melanoma or a cancer other than advanced melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
- Current active participation in an interventional clinical trial
Other protocol-defined inclusion/exclusion criteria apply
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Melanoma
Age (in years)
18+
Participants needed
1087
Est. Completion Date
Aug 31, 2025
Treatment type
Observational
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT02990611
Study number
CA209654
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