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Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma

NCT04624113 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-02-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Tazemetostat

Epizyme will supply the study agent, which will be provided free of charge to the patient.

DRUG

Pembrolizumab

Pembrolizumab is commercially available

Sponsors & Collaborators

  • Epizyme, Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Douglas Adkins, M.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2022-08-09
Completion
2024-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04624113 on ClinicalTrials.gov