drugset / Trial / NCT04557956
Testing the Addition of the Anti-cancer Drug, Tazemetostat, to (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment
RandomizedSequentialOpen-labelTreatment
Summary
This phase I/II trial investigates the best dose, possible benefits and/or side effects of tazemetostat in combination with dabrafenib and trametinib in treating patients with melanoma that has a specific mutation in the BRAF gene (BRAFV600) and that has spread from where it first started (primary site) to other places in the body (metastatic). Tazemetostat, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving tazemetostat in combination with dabrafenib and trametinib may stabilize BRAFV600 mutated melanoma.
Timeline
- Start
- 2021-08-19
- Primary completion
- 2025-10-15
- Completion
- 2027-03-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabrafenib | Small molecule | 150 mg | Oral |
| Subject | Tazemetostat | Small molecule | 400 mg | Oral |
| Subject | Tazemetostat | Small molecule | 600 mg | Oral |
| Subject | Tazemetostat | Small molecule | 800 mg | Oral |
| Subject | Trametinib | Small molecule | 2 mg | Oral |