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
Recruiting
National Cancer Institute (NCI)
Phase 1/Phase 2
2021-02-01
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 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.
Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma
Recruiting
Epizyme, Inc.
Phase 1/Phase 2
2021-04-14
The primary aim of the phase 1 portion of the trial is to establish the recommended phase 2
dose (RP2D) of tazemetostat in combination with a fixed dose of pembrolizumab in patients
with recurrent or metastatic (RM) head and neck cancer.
The primary aim of the phase 2 portion of the trial is to establish the proportion of
patients with pembrolizumab- or nivolumab-resistant, PD-L1 positive, RM head and neck
squamous-cell carcinoma (HNSCC) who achieve an objective tumor response to tazemetostat and
pembrolizumab.
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