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

> **NCT04576091** · PHASE1 · ACTIVE_NOT_RECRUITING · sponsor: **National Cancer Institute (NCI)** · enrollment: 7 (actual)

## Conditions studied

- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck
- 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 Cutaneous Squamous Cell Carcinoma of the Head and Neck 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 Cutaneous Squamous Cell Carcinoma of the Head and Neck 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 Cutaneous Squamous Cell Carcinoma of the Head and Neck
- 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

- **PROCEDURE:** Biospecimen Collection
- **PROCEDURE:** Computed Tomography
- **DRUG:** Elimusertib
- **BIOLOGICAL:** Pembrolizumab
- **PROCEDURE:** Positron Emission Tomography
- **OTHER:** Quality-of-Life Assessment
- **RADIATION:** Stereotactic Body Radiation Therapy

## Key facts

- **NCT ID:** NCT04576091
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2022-07-06
- **Primary completion:** 2024-11-27
- **Final completion:** 2025-12-11
- **Target enrollment:** 7 (ACTUAL)
- **Last updated:** 2024-12-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04576091

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04576091, "Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer". Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/clinical/NCT04576091. Licensed CC0.

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