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

Conditions

• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Metastatic Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo tumor biopsy
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Dabrafenib Mesylate — DRUG
  Given PO
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Tazemetostat Hydrobromide — DRUG
  Given PO
• Trametinib Dimethyl Sulfoxide — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Aug 19, 2021

Status verified

Mar 2026

Primary completion

Oct 15, 2025

Completion

Mar 11, 2027

Study Design

Enrollment

16 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase I; Phase II Arm 2 (tazemetostat, dabrafenib, trametinib)
  Patients receive tazemetostat PO BID, dabrafenib PO BID, and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, and MUGA or ECHO throughout the study.
• Active Comparator: Phase II, Arm 1 (tazemetostat)
  Patients receive tazemetostat PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. At the time of progression, patients may crossover to Arm 2 after completion of radiation therapy.

Primary Outcome Measure

Recommended phase 2 dose (Phase I) [ Time Frame: Up to 30 days ]

Locations (17)

Find similar trials in Aventura, FL

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