Tazemetostat + Dabrafenib + Trametinib for Melanoma
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude those using certain medications that strongly affect specific enzymes. It's best to discuss your current medications with the trial team to see if they might interfere with the study.
What data supports the effectiveness of the drug combination of Tazemetostat, Dabrafenib, and Trametinib for melanoma?
Research shows that the combination of Dabrafenib and Trametinib is effective for treating melanoma with a specific BRAF mutation, improving survival rates and response compared to using Dabrafenib alone. This combination also has fewer skin-related side effects than using a BRAF inhibitor alone.12345
What makes the drug combination of Tazemetostat, Dabrafenib, and Trametinib unique for treating melanoma?
This drug combination is unique because it combines Tazemetostat, which targets a specific protein involved in cancer cell growth, with Dabrafenib and Trametinib, which are known to inhibit pathways that help melanoma cells survive and multiply. This multi-targeted approach may offer a more comprehensive treatment strategy compared to using each drug alone.678910
Research Team
Tanner M Johanns
Principal Investigator
Yale University Cancer Center LAO
Eligibility Criteria
Adults with BRAFV600 mutated metastatic melanoma that has worsened despite treatment can join this trial. They must have had prior anti-PD-1 therapy, be able to perform daily activities (ECOG <=2), and have organs functioning well. Pregnant women, those with certain psychiatric or medical conditions, or a history of specific cancers are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase I
Dose-escalation trial of tazemetostat in combination with dabrafenib and trametinib for BRAF/MEK inhibitor-resistant metastatic melanoma
Treatment Phase II
Randomized trial of tazemetostat alone or in combination with dabrafenib and trametinib, with crossover option after progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dabrafenib Mesylate
- Tazemetostat Hydrobromide
- Trametinib Dimethyl Sulfoxide
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor