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NCT04576091 · ClinicalTrials.gov registry record · Phase 1

Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer

A Phase 1 study of Recurrent Head and Neck Squamous Cell Carcinoma and Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
7
Enrollment target
11
Study locations

NCT04576091: Active Phase 1 study of Recurrent Head and Neck Squamous Cell Carcinoma and Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, sponsored by National Cancer Institute (NCI).

NCT04576091 is a Phase 1 study of Recurrent Head and Neck Squamous Cell Carcinoma and Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 7 participants, below the 120-participant average among 24 other Recurrent Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (94% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04576091, a Phase 1 study of Recurrent Head and Neck Squamous Cell Carcinoma and Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
7 participants
Enrollment target
11
Study locations

Study Summary

This phase I trial evaluates the best dose, possible benefits and/or side effects of combination therapy with elimusertib (BAY 1895344), stereotactic body radiation, and pembrolizumab in treating patients with head and neck squamous cell cancer that has come back (recurrent) and cannot be removed by surgery (unresectable). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving BAY 1895344, stereotactic body radiation therapy in combination with pembrolizumab may shrink or stabilize head and neck squamous cell cancer for longer than treatment with radiation and immunotherapy without BAY 1895344.

Primary Outcome

Dose of elimusertib (BAY 1895344) and concurrent stereotactic (8 Gy x 3 RT) body radiation therapy. Two 3-week cycles of therapy.

Conditions Studied

Recurrent Head and Neck Squamous Cell Carcinoma Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Recurrent Hypopharyngeal Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Recurrent Oral Cavity Squamous Cell Carcinoma Recurrent Oropharyngeal Squamous Cell Carcinoma Recurrent Salivary Gland Carcinoma Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck Recurrent Paranasal Sinus Squamous Cell Carcinoma

Interventions

  • BIOLOGICAL Pembrolizumab
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Positron Emission Tomography
  • DRUG Elimusertib

Study Locations (11)

California

  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles

New York

  • Montefiore Medical Center-Einstein Campus - The Bronx
  • Montefiore Medical Center - Moses Campus - The Bronx

Illinois

  • Northwestern University - Chicago

Michigan

  • University of Michigan Comprehensive Cancer Center - Ann Arbor

North Carolina

  • Duke University Medical Center - Durham

Oklahoma

  • University of Oklahoma Health Sciences Center - Oklahoma City

Pennsylvania

  • University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh

Tennessee

  • Vanderbilt University/Ingram Cancer Center - Nashville

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2022-07-06
Est. Completion 2025-12-11
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT04576091 still lists

NCT04576091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 120-participant average among 24 other Recurrent Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (94% lower).

The record links to 10 conditions, with Recurrent Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT04576091 lists 11 locations in 9 states (California, New York, Illinois).

Frequently Asked Questions

What is clinical trial NCT04576091 about?

NCT04576091 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer". This phase I trial evaluates the best dose, possible benefits and/or side effects of combination therapy with elimusertib (BAY 1895344), stereotactic body radiation, and pembrolizumab in treating patients with head and neck squamous cell cancer that has come back (recurrent) and cannot be removed by...

What is the current status of trial NCT04576091?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2022-07-06. Estimated completion is 2025-12-11.

What conditions does trial NCT04576091 study?

This clinical trial studies the following conditions: Recurrent Head and Neck Squamous Cell Carcinoma, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8.

What interventions are being tested in trial NCT04576091?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Elimusertib (DRUG).

Who is sponsoring clinical trial NCT04576091?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04576091 being conducted?

This trial has 11 study locations across California, Illinois, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Recurrent Head and Neck Squamous Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04576091's enrollment target sits among peer trials

7 25th of 24 the lowest of 24 other Recurrent Head and Neck Squamous Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04576091, the US trial registry maintained by the National Library of Medicine. NCT04576091 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.