NCT04576091View on ClinicalTrials.gov

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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

July 6, 2022

Primary Completion Date

November 27, 2024

Study Completion Date

December 11, 2025

Conditions
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Recurrent Cutaneous Squamous Cell Carcinoma of the Head and NeckRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRecurrent Paranasal Sinus Squamous Cell CarcinomaRecurrent Salivary Gland CarcinomaStage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage III Major Salivary Gland Cancer AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage III Sinonasal Cancer AJCC v8Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Stage IV Major Salivary Gland Cancer AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Sinonasal Cancer AJCC v8Unresectable Cutaneous Squamous Cell Carcinoma of the Head and NeckUnresectable Head and Neck Squamous Cell CarcinomaUnresectable Hypopharyngeal Squamous Cell CarcinomaUnresectable Laryngeal Squamous Cell CarcinomaUnresectable Oral Cavity Squamous Cell CarcinomaUnresectable Oropharyngeal Squamous Cell CarcinomaUnresectable Paranasal Sinus Squamous Cell CarcinomaUnresectable Salivary Gland Squamous Cell Carcinoma
Interventions
PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT and/or PET-CT scan

DRUG

Elimusertib

Given PO

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET-CT scan

OTHER

Quality-of-Life Assessment

Ancillary studies

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

Trial Locations (11)

10461

Montefiore Medical Center-Einstein Campus, The Bronx

10467

Montefiore Medical Center - Moses Campus, The Bronx

15232

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

27710

Duke University Medical Center, Durham

37232

Vanderbilt University/Ingram Cancer Center, Nashville

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

60611

Northwestern University, Chicago

73104

University of Oklahoma Health Sciences Center, Oklahoma City

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

90033

Los Angeles General Medical Center, Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH