Clinical trial · Observational
Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US
Comparative Effectiveness of Different Targeted Therapies for BRAF-mutated Unresectable/Metastatic Melanoma in the United States
NCT05260684CI-TRIAL-00086867OCEANMISTcompletedResults postedClinicalTrials.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 study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy. The Flatiron Health electronic health record (EHR) data from US cancer clinics will be used for this retrospective database analysis.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Binimetinib | Drug | Binimetinib | ALIAS |
| Cobimetinib | Drug | Cobimetinib | ALIAS |
| Dabrafenib | Drug | Dabrafenib | ALIAS |
| Encorafenib | Drug | Encorafenib | ALIAS |
| Trametinib | Drug | Trametinib | ALIAS |
| Vemurafenib | Drug | Vemurafenib | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- Encorafenib + binimetinib
- description
- Encorafenib 450 mg once a day (QD) Binimetinib 45 mg twice a day (BID)
- interventionNames
- Drug: Encorafenib
- Drug: Binimetinib
- label
- Vemurafenib + Cobimetinib
- description
- Vemurafenib 960 mg twice a day (BID) for 28 days of 28 day cycle Cobimetinib 60 mg once a day (QD) for 21 days of 28 day cycle
- interventionNames
- Drug: Vemurafenib
- Drug: Cobimetinib
- label
- Dabrafenib + trametinib
- description
- Dabrafenib 150 mg twice a day (BID) Trametinib 2 mg once a day (QD)
- interventionNames
- Drug: Dabrafenib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with melanoma based on International Classification of Disease 9th and 10th Revisions (ICD-9: 172.x; ICD-10: C43x, D03x) and ≥2 visits on different days in the Flatiron database on or after January 1, 2011. * Clinically confirmed diagnosis of melanoma with pathologic stages III or IV at initial diagnosis or earlier stage disease with a first locoregional or distant recurrence on or after January 1, 2011. * Age ≥18 years at the time of advanced melanoma diagnosis. * Evidence of ≥1 BRAF positive test result at any time based on laboratory or genetic analysis results. Exclusion Criteria: -• Patients with prior BRAF- or MEK-inhibitor therapy • Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron EHR)
References
Publications (0)
Data not yet available
No reference posted for this study.