A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France
Active, not recruiting
- Conditions
- Melanoma
- Registration Number
- NCT04550247
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This is an observational prospective study to estimate in real world conditions the effectiveness, the safety profile and the pattern of use of adjuvant nivolumab in adults participants with stage III/IV resected melanoma, and subsequent treatments administered in case of relapse.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 362
Inclusion Criteria
- Participants with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease
- Decision to treat with adjuvant nivolumab therapy has already been taken
- Participants who provide oral informed consent to participate in the study
Exclusion Criteria
- Any participant with a current diagnosis of persisting advanced melanoma
- Participants with a current primary diagnosis of a cancer other than advanced melanoma, ie, a cancer other than melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
- Any participants currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for OS/RFS can be enrolled. In case of a blinded study, the treatment arm needs to be known).
- Pregnant women
- Person under guardianship
Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-Free Survival (RFS) up to 60 months
- Secondary Outcome Measures
Name Time Method Frequency of nivolumab therapy: number of infusions Up to 60 months Assessment of sociodemographic characteristics Up to 60 months Frequency of nivolumab therapy: number of dosing Up to 60 months Overall Survival (OS) Up to 60 months Relapse-Free Survival 2 (RFS2) Up to 60 months Assessment of clinical characteristics Up to 60 months Frequency of Nivolumab: pattern of use Up to 60 months Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Incidence Up to 60 months Assessment of health related quality of life Up to 60 Months Distant Metastatasis-Free Survival (DMFS) Up to 60 months Progression Free Survival (PFS) Up to 60 months Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of time and duration of response Up to 60 months Estimate the effectiveness of subsequents treatments administered after relapse in terms of PFS Up to 60 months Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Outcome Up to 60 months Characteristics of nivolumab adjuvant safety profile: time to onset of other immune- related AEs Up to 60 months Characteristics of nivolumab adjuvant safety profile: time to resolution of other immune-related AEs Up to 60 months Characteristics of nivolumab adjuvant safety profile: management Up to 60 months Characteristics of nivolumab adjuvant safety profile: incidence Up to 60 months Characteristics of nivolumab adjuvant safety profile: type Up to 60 months Characteristics of nivolumab adjuvant safety profile: time to onset of select AEs Up to 60 months Characteristics of nivolumab adjuvant safety profile: time to resolution of select AEs Up to 60 months Describe the use of subsequent therapies after relapse following adjuvant nivolumab Up to 60 months Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of overall response rate Up to 60 months Safety profile of systemic therapies administered after relapse in terms of severe adverse events incidence, type, management and outcome Up to 60 months Characteristics of nivolumab adjuvant safety profile: grade Up to 60 months Estimate the effectiveness of subsequents treatments administered after relapse in terms of RFS2 Up to 60 months Estimate the effectiveness of subsequents treatments administered after relapse in terms of OS Up to 60 months Characteristics of nivolumab adjuvant safety profile: outcome Up to 60 months Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Type Up to 60 months Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Management Up to 60 months
Trial Locations
- Locations (1)
Local Institution
🇫🇷Lille, France