Study on Adding Tazemetostat to Usual Treatment for Metastatic Melanoma That Has Progressed
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04557956
This clinical trial is testing whether adding the drug tazemetostat to the usual treatment of dabrafenib and trametinib can help control melanoma that has spread and has a specific BRAF mutation. The study aims to find the best dose and understand the benefits and side effects of this combination.
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Program Overview
This study is exploring if adding tazemetostat to the standard treatment of dabrafenib and trametinib can help manage melanoma that has a BRAF V600 mutation and has spread to other parts of the body. Tazemetostat, dabrafenib, and trametinib may work together to stop tumor growth by blocking certain enzymes needed for cell growth. The trial will determine the best dose and evaluate the potential benefits and side effects of this combination treatment.
Description
The study is divided into two phases. In Phase I, researchers will find the safest dose of tazemetostat when combined with dabrafenib and trametinib for patients whose melanoma has resisted previous treatments. In Phase II, the study will assess if adding tazemetostat improves the time patients live without the disease getting worse compared to using tazemetostat alone.
Participants in Phase I will receive tazemetostat, dabrafenib, and trametinib. In Phase II, participants will be randomly assigned to receive either tazemetostat alone or the combination of tazemetostat, dabrafenib, and trametinib. Treatment cycles last 28 days and continue as long as the disease does not progress and side effects are manageable. Throughout the study, participants will undergo various tests, including tumor biopsies and imaging scans, to monitor their response to the treatment.
After completing the study treatment, participants will have follow-up visits 30 days later and then annually to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Must have metastatic melanoma with a BRAF V600E/K mutation.
- Must have shown disease progression while on BRAF/MEK inhibitor therapy.
- For Phase 2, must have an EZH2 alteration confirmed by specific tests.
- Must have measurable disease and a tumor lesion that can be biopsied.
- Must be 18 years or older.
- Must have a performance status score of 2 or less, indicating they are able to carry out light work.
- Must have stable central nervous system metastases if previously treated.
- Must meet specific blood count and organ function criteria.
- Must be able to swallow oral medication.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test.
- Men must use contraception and refrain from donating sperm during and after treatment.
- Must understand and agree to the study requirements and sign informed consent.
Exclusion Criteria
- Previous treatment with a demethylating agent or EZH2 inhibitor.
- History of severe reactions to BRAF or MEK inhibitors.
- Active infection requiring IV therapy.
- Untreated or progressing CNS metastases.
- Recent radiation therapy or systemic anti-cancer therapy.
- Use of certain medications that interact with study drugs.
- HIV-positive patients on antiretroviral therapy.
- History of hepatitis B or C infection.
- History of lung disease or significant bleeding disorders.
- History of certain blood cancers or genetic abnormalities.
- History of cardiovascular issues or uncontrolled hypertension.
- Pregnant or breastfeeding women.
- Uncontrolled diabetes or eye conditions like retinal vein occlusion.
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