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

Active, not recruiting

• Conditions: Melanoma

• Registration Number: NCT02990611
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-02
• Study Start: 2016-12-06
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-13
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-28
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1087

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse free survival (RFS) of adjuvant nivolumab therapy	5 years
Overall survival (OS) of nivolumab/ipilimumab combination therapy	5 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇩🇪 Essen, Germany