Clinical trial · Observational
A Study of Adult Participants With BRAF V600 Mutation-Positive Advanced Melanoma Treated With Cobimetinib (Cotellic®) During the French Early Access Program (Temporary Authorization for Use [TAU])
Survival in Adult Patients With BRAF V600 Mutation-Positive Advanced Melanoma: A Non-Interventional Ambispective Study of a Cohort of Patients Treated With Cobimetinib During the French Early Access Program (TAU)
NCT03139513CI-TRIAL-00036657MELANIScompletedClinicalTrials.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 a multicentre, ambispective (both retrospective and prospective), and non-interventional study conducted in France in adult participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib (Zelboraf®).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cobimetinib | Drug | Cobimetinib | ALIAS |
| Vemurafenib | Drug | Vemurafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Metastatic Melanoma
- description
- Participants with BRAF V600 mutation-positive unresectable or metastatic melanoma, having started treatment with cobimetinib in combination with vemurafenib as per local guidelines and/or routine clinical practice in context of TAU program, will be observed.
- interventionNames
- Drug: Cobimetinib
- Drug: Vemurafenib
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)
Secondary outcomes (6)
- measure
- Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST)
- timeFrame
- From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants included in the TAU from 26 February 2015 * Participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib * For alive participants: participants who have been informed verbally and in writing about this study who do not object to their data being electronically processed or subjected to data quality control * For participants who died before the inclusion period: participants who did not express their opposition when they were alive Exclusion Criteria: \- Alive participants unable to give informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.