Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma

Summary

This phase I trial tests the safety, side effects, and best dose of camonsertib in combination with stereotactic body radiation therapy in controlling disease in patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that cannot be removed by surgery (unresectable). Camonsertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving camonsertib in combination with stereotactic body radiation therapy may help control disease in patients with recurrent or unresectable head and neck squamous cell cancers.

Conditions

• Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• 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
• 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 Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage III Sinonasal Cancer AJCC v8
• Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
• Stage IVA Hypopharyngeal Carcinoma AJCC v8
• Stage IVA Laryngeal Cancer AJCC v8
• Stage IVA Lip and Oral Cavity Cancer AJCC v8
• Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage IVA Sinonasal Cancer AJCC v8
• Stage IVB Hypopharyngeal Carcinoma AJCC v8
• Stage IVB Laryngeal Cancer AJCC v8
• Stage IVB Lip and Oral Cavity Cancer AJCC v8
• Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
• Stage IVB Sinonasal Cancer AJCC v8
• 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

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

DRUG

Camonsertib

Given PO

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Yvonne M Mowery · UPMC Hillman Cancer Center 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

2026-06-22

Primary Completion

2029-05-31

Completion

2029-05-31

FDA Drug

Yes