Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin (NCT04533750)

🧪 Interventions in This Study

• Peposertib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Pathologically (histologically) proven diagnosis of HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx prior to registration;
2. Patients with oropharynx cancer need p16 determination by immunohistochemistry (where positive is defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells), Note: Institutions must screen patients using a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process similar to the United States (U.S.) CLIA certification, such as the provincial accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in Canada, the College of American Pathologists (CAP), or an equivalent accreditation in other countries, is acceptable. The p16 results must be reported on the pathology report being submitted;
3. Oral cavity, larynx, hypopharynx, or p16-negative oropharynx cancer must be stages T1-2N2-3 or T3N1-3 or T4N0-3 (American Joint Committee on Cancer \[AJCC\] version 8);
4. p16-positive oropharynx cancer patients, stages T4N0-3 or T1-3N2-3 (AJCC version 8);
5. The patient has measurable disease as defined by the presence of at least one measurable lesion per RECIST 1.1;
6. Please note: A histological or pathological specimen from cervical lymph nodes with well-defined primary site documented clinically or radiologically is acceptable
7. Clinical stage noted above should be based upon following diagnostic workup:
8. History/physical examination within 30 days prior to registration;
9. Examination by radiation oncologist or medical oncologist or otolaryngology (ENT) or head \& neck surgeon 30 days prior to registration, including fiber optic exam with laryngopharyngoscopy;
10. Diagnostic quality computed tomography (CT) or magnetic resonance imaging (MRI) of neck, with contrast, within 30 days prior to registration. Fludeoxyglucose F-18 (18F-FDG) whole body positron emission tomography (PET)-CT scan within 42 days of registration is strongly recommended but does not replace the CT or MRI study. Note: If CT component of the PET/CT is of diagnostic quality then PET/CT can be used for eligibility, however the PET/CT scan must be done within 30 days prior to registration
11. Diagnostic quality, cross sectional imaging of the thorax within 42 days prior to registration; 18-F-FDG-PET/CT or conventional CT are acceptable
12. Age \>= 18 years

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (27 Sites)

Showing the first 25 of 27 sites.

• Banner MD Anderson Cancer Center — Gilbert, Arizona
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona
• Banner University Medical Center - Tucson — Tucson, Arizona
• University of Arizona Cancer Center-North Campus — Tucson, Arizona
• UC San Diego Moores Cancer Center — La Jolla, California
• Stanford Cancer Institute Palo Alto — Palo Alto, California
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
• Moffitt Cancer Center — Tampa, Florida
• Emory University Hospital Midtown — Atlanta, Georgia
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
• Carle at The Riverfront — Danville, Illinois
• Carle Physician Group-Effingham — Effingham, Illinois
• Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois
• Carle Cancer Center — Urbana, Illinois
• The James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky
• NYU Langone Hospital - Long Island — Mineola, New York
• Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York
• Highland Hospital — Rochester, New York
• University of Rochester — Rochester, New York
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
• Providence Portland Medical Center — Portland, Oregon
• Medical University of South Carolina — Charleston, South Carolina
• Sanford Cancer Center Oncology Clinic — Sioux Falls, South Dakota
• Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota

📞 Contact the Study Coordinator

Phone: (877) 632-6789

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Advanced Head and Neck Squamous Cell Carcinoma

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• Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer — Ann Arbor, Michigan

Explore by condition: All Advanced Head and Neck Squamous Cell Carcinoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.