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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab treatment | Administered according to the market authorization in France |
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| Measure | Description | Time Frame |
|---|---|---|
| Relapse-Free Survival (RFS) | up to 60 months |
| 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) |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation,please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply
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The study will collect data primarily from hospital based dermatology and oncology care facilities
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Lille | 59000 | France |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| 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 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |