Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Melanoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: Nivolumab/Ipilimumab combination therapy<br>Participants who start a new systemic therapy with nivolumab/ipilimumab combination therapy for the first time | |
| Cohort 2: Nivolumab monotherapy<br>Participants who start a new systemic therapy with nivolumab monotherapy for the first time | |
| Cohort 3: Nivolumab adjuvant therapy<br>Participants who start adjuvant treatment with nivolumab after complete surgical tumor resection and no evidence of disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) of nivolumab/ipilimumab combination therapy |  | 5 years | 
| Relapse free survival (RFS) of adjuvant nivolumab therapy |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |