Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy (NICO)
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About
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.
Enrollment
Sex
Ages
Volunteers
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
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
Trial design
1,087 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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