Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer
Public ClinicalTrials.gov record NCT04576091. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I Trial of BAY 1895344 ATR Inhibitor Combined With Stereotactic Body Radiation Therapy and Pembrolizumab for Recurrent Head and Neck Squamous Cell Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04576091
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 7 participants
Conditions and interventions
Conditions
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Recurrent Head and Neck Cutaneous Squamous Cell Carcinoma
- Recurrent Head and Neck Squamous Cell Carcinoma
- Recurrent Hypopharyngeal Squamous Cell Carcinoma
- Recurrent Laryngeal Squamous Cell Carcinoma
- Recurrent Oral Cavity Squamous Cell Carcinoma
- Recurrent Oropharyngeal Squamous Cell Carcinoma
- Recurrent Paranasal Sinus Squamous Cell Carcinoma
- Recurrent Salivary Gland Carcinoma
- Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Stage III Hypopharyngeal Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage III Lip and Oral Cavity Cancer AJCC v8
- Stage III Major Salivary Gland Cancer AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage III Sinonasal Cancer AJCC v8
- Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Stage IV Hypopharyngeal Carcinoma AJCC v8
- Stage IV Laryngeal Cancer AJCC v8
- Stage IV Lip and Oral Cavity Cancer AJCC v8
- Stage IV Major Salivary Gland Cancer AJCC v8
- Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IV Sinonasal Cancer AJCC v8
- Unresectable Head and Neck Cutaneous Squamous Cell Carcinoma
- Unresectable Head and Neck Squamous Cell Carcinoma
- Unresectable Hypopharyngeal Squamous Cell Carcinoma
- Unresectable Laryngeal Squamous Cell Carcinoma
- Unresectable Oral Cavity Squamous Cell Carcinoma
- Unresectable Oropharyngeal Squamous Cell Carcinoma
- Unresectable Paranasal Sinus Squamous Cell Carcinoma
- Unresectable Salivary Gland Squamous Cell Carcinoma
Interventions
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Elimusertib Drug
- Pembrolizumab Biological
- Positron Emission Tomography Procedure
- Quality-of-Life Assessment Other
- Stereotactic Body Radiation Therapy Radiation
Procedure · Drug · Biological + 2 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 6, 2022 (Actual)
- Primary completion
- Jul 22, 2025 (Actual)
- Completion
- Jan 14, 2027 (Estimated)
- Last update posted
- Aug 21, 2026
2022 – 2027
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Angeles General Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | — |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04576091, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 21, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04576091 live on ClinicalTrials.gov.