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

Bristol-Myers Squibb1 site in 1 country1,087 target enrollmentDecember 6, 2016

ConditionsMelanoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Enrollment: 1087
Locations: 1
Primary Endpoint: Relapse free survival (RFS) of adjuvant nivolumab therapy
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 6, 2016

End Date

June 20, 2025

Last Updated

9 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Relapse free survival (RFS) of adjuvant nivolumab therapy

Time Frame: 5 years

Overall survival (OS) of nivolumab/ipilimumab combination therapy

Time Frame: 5 years

Secondary Outcomes

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)
Overall survival (OS) of nivolumab monotherapy(5 years)
Distribution of sociodemographic characteristics: Age(5 years)
Distribution of sociodemographic characteristics: BMI(5 years)
Best overall response rate (BORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy(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: Mutation status(5 years)
Distribution of clinical characteristics: Concomitant medication(5 years)
Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest(5 years)
Duration of response of monotherapy and combination therapy(Up to 5 years)
Distribution of sociodemographic characteristics: Gender(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: 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: Performance status as measured by Eastern Cancer Oncology Group (ECOG) scale(5 years)
Distribution of treatment patterns: Current treatment details(5 years)
Incidence of adverse events (AEs)(5 years)
Distribution of management of adverse events (AEs)(5 years)
Distribution of clinical characteristics: Comorbidities(5 years)
Distribution of clinical characteristics: Diagnostic procedures(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)
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C-30)(5 years)
Severity of adverse events (AEs)(5 years)
Distribution of clinical characteristics: Medical history(5 years)
Overall survival (OS) of adjuvant therapy(5 years)