NCT02990611Completed
Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy
A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) Monotherapy or in Combination With Ipilimumab in Patients With Advanced (Unresectable or Metastatic) Melanoma and in Patients With Adjuvant Nivolumab Therapy
Source: ClinicalTrials.gov · Last updated 11 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1087 (actual)
- First submitted
- 2 Dec 2016
- Start date
- 6 Dec 2016
- Primary completion date
- 20 Jun 2025
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Melanoma
- NCT number
- NCT02990611
What you commit to
- Study type: Observational
- Participants enrolled: 1087
- From 6 Dec 2016 to the primary completion date, 20 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with nivolumab, for nivolumab monotherapy cohort only
Other illness
- 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)
- 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)
Other
- For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
- Current active participation in an interventional clinical trial
- For Cohort 3: (Recruitment ended by 08/31/2020)
- Current active participation in an interventional clinical trial
- Other protocol-defined inclusion/exclusion criteria apply
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.