drugset / Trial / NCT03878719
Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a multicenter Phase 1b, open-label study to evaluate the pharmacokinetic, safety and efficacy of binimetinib and encorafenib co-administered to adolescent patients with BRAF V600-mutant advanced/metastatic melanoma. The study consists of a Safety Run-in Phase to determine the RDE (recommended dose in expansion), followed by an Expansion Phase.
Timeline
- Start
- 2020-08-03
- Primary completion
- 2022-08-19
- Completion
- 2022-08-19
Outcome
Outcome not reported
Stopped (Enrollment): “The trial was terminated early on 05 October 2022 due to non-feasibility and poor recruitment and not based on safety concerns.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Binimetinib | Small molecule | — | Oral |
| Subject | Encorafenib | Small molecule | — | Oral |