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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Nivolumab/Ipilimumab combination therapy | Participants who start a new systemic therapy with nivolumab/ipilimumab combination therapy for the first time | ||
| Cohort 2: Nivolumab monotherapy | Participants who start a new systemic therapy with nivolumab monotherapy for the first time | ||
| Cohort 3: Nivolumab adjuvant therapy | Participants who start adjuvant treatment with nivolumab after complete surgical tumor resection and no evidence of disease |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) of nivolumab/ipilimumab combination therapy | 5 years | |
| Relapse free survival (RFS) of adjuvant nivolumab therapy | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) of nivolumab monotherapy | 5 years | |
| Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest | 5 years |
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Inclusion Criteria:
For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
For Cohort 3: (Recruitment ended by 08/31/2020)
Exclusion Criteria:
For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
For Cohort 3: (Recruitment ended by 08/31/2020)
Other protocol-defined inclusion/exclusion criteria apply
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Adult participants who are at least 18 years of age of the time of treatment decision with a primary diagnosis of advanced melanoma (histologically confirmed Stage III [unresectable] or Stage IV skin, ocular, or mucosal melanoma) and whose physician has already decided to initiate a treatment with nivolumab or nivolumab/ipilimumab for the first time for the treatment of melanoma, according to the label approved in Germany. Participants with a current primary diagnosis of a cancer other than advanced melanoma, participants currently included in an interventional clinical trial, or participants who have already received nivolumab in a prior line of therapy (for monotherapy arm) will all be excluded from this study. Adult participants in the adjuvant nivolumab treatment cohort will be enrolled after complete surgical resection and no evidence of disease after the treating physician has decided to initiate an adjuvant therapy with nivolumab according to the label approved in Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Essen | 45147 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41833546 | Derived | Gutzmer 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. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| Progression-free survival (PFS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy | 5 years |
| Overall response rate (ORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy | 5 years |
| Best overall response (BOR) of nivolumab monotherapy and of nivolumab/ipilimumab combination therapy | 5 years |
| Best overall response rate (BORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy | 5 years |
| Duration of response of monotherapy and combination therapy | Up to 5 years |
| Distribution of sociodemographic characteristics: Age | 5 years |
| Distribution of sociodemographic characteristics: Gender | 5 years |
| Distribution of sociodemographic characteristics: BMI | 5 years |
| Distribution of clinical characteristics: Initial diagnosis of melanoma | 5 years |
| Distribution of clinical characteristics: Diagnosis of advanced melanoma | 5 years |
| Distribution of clinical characteristics: Duration of disease from date of initial melanoma diagnosis to initial treatment in study, or date of study entry (if untreated) | 5 years |
| Distribution of clinical characteristics: Surgery of complete tumor resection and no evidence of disease | 5 years |
| Distribution of clinical characteristics: Clinical code and staging melanoma subtypes | 5 years |
| Distribution of clinical characteristics: Comorbidities | 5 years |
| Distribution of clinical characteristics: Diagnostic procedures | 5 years |
| Distribution of clinical characteristics: Mutation status | 5 years |
| Distribution of clinical characteristics: Performance status as measured by Eastern Cancer Oncology Group (ECOG) scale | 5 years |
| Distribution of clinical characteristics: Medical history | 5 years |
| Distribution of clinical characteristics: Concomitant medication | 5 years |
| Distribution of clinical characteristics: History of cancer | 5 years |
| Distribution of clinical characteristics: Previous enrollment in an interventional study randomized controlled trials (RCTS) | 5 years |
| Distribution of treatment patterns: Type of treatment previously received | 5 years |
| Distribution of treatment patterns: Stage of melanoma | 5 years |
| Distribution of treatment patterns: Current treatment details | 5 years |
| European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C-30) | 5 years |
| Incidence of adverse events (AEs) | 5 years |
| Severity of adverse events (AEs) | 5 years |
| Distribution of management of adverse events (AEs) | 5 years |
| Overall survival (OS) of adjuvant therapy | 5 years |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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