A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France

Study Overview
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Brief Summary
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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.

Official Title
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A National, Prospective, Non- Interventional Study (NIS) in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma and Subsequent Treatments in Case of Relapse

Conditions
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Melanoma

Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation,please visit www.BMSStudyConnect.com. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nivolumab treatment<br>Administered according to the market authorization in France | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-Free Survival (RFS) |  | up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant Metastatasis-Free Survival (DMFS) |  | Up to 60 months | 
| Overall Survival (OS) |  | Up to 60 months | 
| Relapse-Free Survival 2 (RFS2) |  | Up to 60 months | 
| Progression Free Survival (PFS) |  | Up to 60 months | 
| Assessment of health related quality of life |  | Up to 60 Months | 
| Assessment of sociodemographic characteristics |  | Up to 60 months | 
| Assessment of clinical characteristics |  | Up to 60 months | 
| Frequency of nivolumab therapy: number of infusions |  | Up to 60 months | 
| Frequency of nivolumab therapy: number of dosing |  | Up to 60 months | 
| Frequency of Nivolumab: pattern of use |  | Up to 60 months | 
| Characteristics of nivolumab adjuvant safety profile: incidence |  | Up to 60 months | 
| Characteristics of nivolumab adjuvant safety profile: grade |  | 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 onset of other immune- related AEs |  | Up to 60 months | 
| Characteristics of nivolumab adjuvant safety profile: time to resolution of select AEs |  | Up to 60 months | 
| Characteristics of nivolumab adjuvant safety profile: time to resolution of other immune-related 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 time and duration of response |  | 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 | 
| Estimate the effectiveness of subsequents treatments administered after relapse in terms of PFS |  | 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: management |  | 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: Incidence |  | 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 | 
| Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Outcome |  | Up to 60 months |