Clinical trial · Observational
Post-ATU Study of Nivolumab
Two-years Follow-up of Melanoma Patients Treated by Nivolumab During the French ATU Program
- 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)
Nivolumab obtained European Marketing authorization in June 2015. Before this date, a Temporary Authorization for Use (ATU) Program in France for nivolumab was set up between September 2014 and August 2015. This program enrolled approximately 600 melanoma patients (unresectable or metastatic). It appears relevant to conduct a study on patients treated during the ATU to assess thoroughly patient characteristics, efficacy, safety, and patterns of use of nivolumab in real-life conditions.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Routine care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Survival of patients included in the study thanks to subgroups of interest
- timeFrame
- 2 years
- description
- Overall survival is defined as the time from index date (initiation of Nivolumab) until date of death due to any cause. Overall survival will be censored on the last date a subject was known to be alive. Estimates of survival rates will be realized for 1-year and 2-year survival. Median time will also be calculated. Subgroups of interest are described in the description of the first Secondary Outcome Measure. Safety Issue: No
Secondary outcomes (7)
- measure
- Distribution of melanoma patients included in the study in all subgroups of interest thanks to their clinical features at the time of treatment initiation
- timeFrame
- Day 1
- description
- Subgroups of interest, based on information collected in medical records, were : * ECOG performance status (PF). ECOG PF is attempted to quantify cancer patients' general well-being and activities of daily life. The classifications were 0, 1 or ≥2. * LDH level. This level is considered as a prognostic factor: higher the LDH level, the worst the prognosis. The classifications were ≤Upper Limit of Normal (ULN), \>ULN, \>2 ULN or N/R (Unknown). * History of brain metastasis. These metastases are considered as one of the most difficult-to-treat complications of melanoma. The classifications were No or Yes. * Line of therapy. The classifications were 0, 1, 2 or \>2. * BRAF status. BRAF is a proto-oncogene. Melanoma patients with BRAF mutation are eligible to targeted therapy.The classifications were Yes (mutated), No (wild-type) and Unknown (no research). * Number of metastatic sites. Safety Issue: No
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with unresectable or metastatic melanoma cared in participating sites, * Patients included in French nivolumab ATU program, * Patients treated by at least one perfusion of nivolumab, * Patients agreed to participate to the study. Exclusion Criteria: * Patients with unresectable or metastatic melanoma not included in French nivolumab ATU program, * Patients having initiated Nivolumab after the 31th December 2015, * Patients disagreed to participate.
References
Publications (0)
Data not yet available