NICO: Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1: Nivolumab/Ipilimumab combination therapy Participants who start a new systemic therapy with nivolumab/ipilimumab combination therapy for the first time |
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| Cohort 2: Nivolumab monotherapy Participants who start a new systemic therapy with nivolumab monotherapy for the first time |
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| Cohort 3: Nivolumab adjuvant therapy Participants who start adjuvant treatment with nivolumab after complete surgical tumor resection and no evidence of disease |
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) of nivolumab/ipilimumab combination therapy [5 years]
- Relapse free survival (RFS) of adjuvant nivolumab therapy [5 years]
Secondary Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
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Advanced melanoma (Stage III/Stage IV)
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Histologically confirmed diagnosis
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Treatment decision for nivolumab monotherapy or nivolumab/ipilimumab combination therapy has already been taken
For Cohort 3: (Recruitment ended by 08/31/2020)
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Primary diagnosis of advanced melanoma after complete surgical tumor resection and no evidence of disease
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Treatment decision for adjuvant nivolumab therapy has already been taken
Exclusion Criteria:
For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
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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)
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Previous treatment with nivolumab, for nivolumab monotherapy cohort only
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Current active participation in an interventional clinical trial
For Cohort 3: (Recruitment ended by 08/31/2020)
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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)
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Current active participation in an interventional clinical trial
Other protocol-defined inclusion/exclusion criteria apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Essen | Germany | 45147 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CA209-654