Clinical Trials in France / NCT04550247
Active, not recruiting
Observational
A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France
NCT04550247 · tracked via the Priya Life Science France tracker
Condition(s) studied
Melanoma
Study 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.
Eligibility
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
Primary outcome measure(s)
- Relapse-Free Survival (RFS) — up to 60 months
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution | Lille | France |
More Bristol-Myers Squibb trials in France
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04550247 on ClinicalTrials.gov ↗ ← All trials in France