Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Cohort 1: Nivolumab/Ipilimumab combination therapy
- description
- Participants who start a new systemic therapy with nivolumab/ipilimumab combination therapy for the first time
- label
- Cohort 2: Nivolumab monotherapy
- description
- Participants who start a new systemic therapy with nivolumab monotherapy for the first time
- label
- Cohort 3: Nivolumab adjuvant therapy
- description
- Participants who start adjuvant treatment with nivolumab after complete surgical tumor resection and no evidence of disease
Primary outcomes (2)
- measure
- Overall survival (OS) of nivolumab/ipilimumab combination therapy
- timeFrame
- 5 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGutzmer R, Weichenthal M, Eigentler T, Mohr P, Sickmann T, Ducker P, Gebhardt C, Haferkamp S, Kahler KC, Meier F, Pfohler C, Sindrilaru A, Terheyden P, von Wasielewski I, Ugurel S, Ulrich J, Utikal J, Weishaupt C, Schadendorf D. Real-world effectiveness and safety with nivolumab plus ipilimumab or nivolumab alone in patients with or without melanoma brain metastasis: Results from the German noninterventional NICO study. Int J Cancer. 2026 Aug 1;159(3):683-698. doi: 10.1002/ijc.70440. Epub 2026 Mar 15. PMID 41833546