Clinical trial · Observational
A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France
A National, Prospective, Non- Interventional Study (NIS) in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma and Subsequent Treatments in Case of Relapse
NCT04550247CI-TRIAL-00057238AdjuMelactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Nivolumab treatment
- description
- Administered according to the market authorization in France
Primary outcomes (1)
- measure
- Relapse-Free Survival (RFS)
- timeFrame
- up to 60 months
Secondary outcomes (30)
- measure
- Distant Metastatasis-Free Survival (DMFS)
- timeFrame
- Up to 60 months
- measure
- Overall Survival (OS)
- timeFrame
- Up to 60 months
- measure
- Relapse-Free Survival 2 (RFS2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDalle S, Saiag P, Lebbe C, Grob JJ, Dreno B, Dalac S, Asselain B, Skowron F, Darras S, Jovenin N, Quereux G, Khammari A, Rieuf C, Brellier F, Mortier L. Real-World Use of Adjuvant Nivolumab for Resected Stage III-IV Melanoma: 2-Year Analysis of AdjuMel. Dermatol Ther (Heidelb). 2026 Aug 29. doi: 10.1007/s13555-026-01853-4. Online ahead of print. PMID 42667537