Melanoma
Conditions
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) of nivolumab/ipilimumab combination therapy | 5 years |
| Relapse free survival (RFS) of adjuvant nivolumab therapy | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Overall survival (OS) of nivolumab monotherapy | 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 |
| Distribution of clinical characteristics: Diagnostic procedures | 5 years |
| Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest | 5 years |
Countries
Germany
Outcome results
None listed