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

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

• 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

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Yvonne M Mowery · University of Pittsburgh Cancer Institute LAO

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-06

Primary Completion

2024-11-27

Completion

2025-12-11

FDA Drug

Yes

Countries

• United States

Study Locations