Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma

Summary

This phase I/II trial studies the side effects and best dose of dabrafenib, trametinib, and navitoclax and to see how well they work in treating patients with BRAF mutant melanoma or solid tumors that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Navitoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of tumor cells by blocking Bcl-2, a protein needed for tumor cell survival. Giving navitoclax, dabrafenib, and trametinib may help shrink tumors in patients with melanoma.

Timeline

Start

2014-03-24

Primary completion

2027-12-31

Completion

2027-12-31

Publications

• Giannitti G, Paganoni AJJ, Marchesi S, Garavaglia R, Fontana F. Mitochondrial bioenergetics and networks in melanoma: an update. Apoptosis. 2025 Oct;30(9-10):2042-2056. doi: 10.1007/s10495-025-02155-4. Epub 2025 Jul 28.

Drugs

Indications