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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-07-06 |
| Est. Completion | 2025-12-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04576091
The ClinicalTrials.gov registry entry for NCT04576091 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 120-participant average among 24 other Recurrent Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (94% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 reports 11 study locations spanning 9 distinct geographic areas - top geographies include 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.
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Recurrent Head and Neck Squamous Cell Carcinoma
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Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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