NCT04624113 is a Phase 1 clinical trial of Tazemetostat in Head and Neck Squamous Cell Carcinoma, sponsored by Washington University School of Medicine.

Who is sponsoring NCT04624113?

NCT04624113 is sponsored by Washington University School of Medicine.

What drugs are being tested in NCT04624113?

Interventions in NCT04624113: Tazemetostat, Pembrolizumab.

What condition does NCT04624113 study?

NCT04624113 studies Head and Neck Squamous Cell Carcinoma.

Is NCT04624113 still recruiting?

NCT04624113 is currently terminated. Last updated 21 February 2024.

Last reviewed 2024-02-21 · How we verify

NCT04624113

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Last updated 21 February 2024

What this trial tests

Phase 1 trial testing Tazemetostat in Head and Neck Squamous Cell Carcinoma in 13 participants. Terminated before completion.

Timeline

14 April 2021

Primary endpoint
9 August 2022

17 February 2024

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	14 April 2021
Primary completion	9 August 2022
Estimated completion	17 February 2024
Sites	1 location across United States

Drugs / interventions tested

Tazemetostat (tazemetostat) — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Epigenetic regulation in the tumor microenvironment: molecular mechanisms and therapeutic targets.
Yang J, Xu J, Wang W, Zhang B, et al · · 2023 · cited 251× · PMID 37217462 · DOI 10.1038/s41392-023-01480-x
The roles of EZH2 in cancer and its inhibitors.
Liu Y, Yang Q. · · 2023 · cited 100× · PMID 37148376 · DOI 10.1007/s12032-023-02025-6
Tackling tumor microenvironment through epigenetic tools to improve cancer immunotherapy.
Lodewijk I, Nunes SP, Henrique R, Jerónimo C, et al · · 2021 · cited 58× · PMID 33761971 · DOI 10.1186/s13148-021-01046-0
The epigenetic hallmarks of immune cells in cancer.
Ji Y, Xiao C, Fan T, Deng Z, et al · · 2025 · cited 28× · PMID 40038722 · DOI 10.1186/s12943-025-02255-4
H3K4 trimethylation regulates cancer immunity: a promising therapeutic target in combination with immunotherapy.
Xiao C, Fan T, Zheng Y, Tian H, et al · · 2023 · cited 21× · PMID 37553181 · DOI 10.1136/jitc-2022-005693
Novel insights into histone lysine methyltransferases in cancer therapy: From epigenetic regulation to selective drugs.
Liao Q, Yang J, Ge S, Chai P, et al · · 2023 · cited 19× · PMID 36908859 · DOI 10.1016/j.jpha.2022.11.009
Checkpoint Inhibitors in Cancer Therapy: Clinical Benefits for Head and Neck Cancers.
Ettl T, Grube M, Schulz D, Bauer RJ. · · 2022 · cited 11× · PMID 36291769 · DOI 10.3390/cancers14204985
Rational Combinations of Targeted Therapy and Immune Checkpoint Inhibitors in Head and Neck Cancers.
Chai AWY, Yee PS, Cheong SC. · · 2022 · cited 6× · PMID 35372020 · DOI 10.3389/fonc.2022.837835

Verify or expand the search:

Other trials of Tazemetostat

Trials testing the same drug.

NCT06575686 — Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma · Phase 2 · suspended
NCT06692452 — Tazemetostat Plus CHOP in 1L T-cell Lymphoma · Phase 2 · withdrawn
NCT06242834 — Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggres · Phase 2 · active not recruiting
NCT05983965 — Study of Tazemetostat in Lymphoid Malignancies · Phase 1 · terminated
NCT05151588 — Induction Chemotherapy and Tazemetostat for Locally Advanced SMARCB1-deficient Sinonasal Carcinoma · Phase 2 · not yet recruiting

Other recruiting trials for Head and Neck Squamous Cell Carcinoma

Currently open trials in the same condition.

NCT06980038 — Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone i · Phase 2 · recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT06995508 — Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial · Phase 2 · recruiting
NCT07254585 — SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma · Phase 2 · recruiting
NCT07514754 — Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients · NA · recruiting

Other Washington University School of Medicine trials

Trials by the same sponsor.

NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer · Phase 2 · not yet recruiting
NCT07101666 — Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer · Phase 2 · not yet recruiting
NCT07392970 — Motixafortide for MRD Sensitization in AML · Phase 2 · not yet recruiting
NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · not yet recruiting
NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04624113 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 21 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04624113.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing