Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
NCT04533750 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2026-04-13
Summary
This phase I trial investigates the side effects and best dose of peposertib when given together with radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced) who cannot take cisplatin. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This trial aims to see whether adding peposertib to radiation therapy is safe and works well in treating patients with head and neck cancer.
Conditions
- Advanced Head and Neck Squamous Cell Carcinoma
- Advanced Hypopharyngeal Squamous Cell Carcinoma
- Advanced Laryngeal Squamous Cell Carcinoma
- Advanced Oral Cavity Squamous Cell Carcinoma
- Advanced Oropharyngeal Squamous Cell Carcinoma
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal 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 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 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
Interventions
- PROCEDURE
-
Computed Tomography
Undergo CT or PET/CT
- OTHER
-
Fludeoxyglucose F-18
Given IV
- RADIATION
-
Intensity-Modulated Radiation Therapy
Undergo IMRT
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- DRUG
-
Peposertib
Given PO
- PROCEDURE
-
Positron Emission Tomography
Undergo PET/CT
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH - collaborator OTHER
Principal Investigators
-
Maura L Gillison · NRG Oncology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-20
- Primary Completion
- 2025-12-07
- Completion
- 2026-12-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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