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

Bristol-Myers Squibb1,087 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,087

Conditions

Melanoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution - 0001

Essen, Germany

Outcomes

Primary Outcomes

Overall survival (OS) of nivolumab/ipilimumab combination therapy

Time frame: 5 years

Relapse free survival (RFS) of adjuvant nivolumab therapy

Time frame: 5 years

Secondary Outcomes

Overall survival (OS) of nivolumab monotherapy

Time frame: 5 years

Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest

Time frame: 5 years

Progression-free survival (PFS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy

Time frame: 5 years

Overall response rate (ORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy

Time frame: 5 years

Best overall response (BOR) of nivolumab monotherapy and of nivolumab/ipilimumab combination therapy

Time frame: 5 years

Best overall response rate (BORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy

Time frame: 5 years

Duration of response of monotherapy and combination therapy

Time frame: Up to 5 years

Distribution of sociodemographic characteristics: Age

Time frame: 5 years

Distribution of sociodemographic characteristics: Gender

Data from ClinicalTrials.gov

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