drugset / Trial / NCT04557956

Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment

NCT04557956

Phase 1/2 Active not recruiting 16 enrolled National Cancer Institute (NCI)
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

EvaluationDrugModalityDoseRoute
Subject Dabrafenib Small molecule Oral
Subject Tazemetostat Small molecule Oral
Subject Trametinib Small molecule Oral