SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma (NCT03546582)

🧪 Interventions in This Study

• Pembrolizumab (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 or cytologically) confirmed diagnosis of locoregional recurrent or any new primary squamous cell carcinoma of the head and neck (including of the nasopharynx or paranasal sinus) that is not amenable to curative resection.
2. Patients for whom curative resection would be medically contraindicated and/or would impose excessive surgical risk are eligible.
3. Patients who are medically and surgically resectable but for whom surgery would be associated with undue surgical morbidity are eligible.
4. For purposes of this protocol, undue surgical morbidity would include total glossectomy; carotid artery resection; laryngectomy or pharyngolaryngectomy; and major ablative resection requiring free flap reconstruction. Patients with primary tumors that can be resected without the forgoing are ineligible.
5. The principal investigators are available to review these criteria on a case by case basis if helpful to the enrolling institution. A new primary HNSCC is defined where any one of the following criteria are met:
6. Metachronous invasive SCC developing ≥ 6 months after an index HNSCC, more than 3 cm from the index lesion;
7. SCC developing in the same region as the index SCC if ≥ 36 months after the index diagnosis and if within 3 cm of a site where disease was completely resected or complete response was documented;
8. New SCC that is cytologically or molecularly distinct from index SCC (e.g. new HPV negative SCC with prior index SCC that was HPV positive).
9. Tumor tissue testing for p16 status is required for base of tongue, soft palate, and tonsil cancer. If a p16 testing has been previously performed on an oropharynx cancer that has recurred, then repeat testing for p16 status is not required. Participants whose first cancer was an unknown primary must have p16 testing from either the new primary tumor or the recurrent cancer.
10. Prior radiotherapy (RT) to the head and neck (30 Gy minimum)
11. Disease must be limited to a single site or adjacent sites that can be treated in a single contiguous target volume for which the maximum total tumor dimension (GTV) must be \<7.5cm. Examples of eligible patients include:
12. A primary site recurrence in the oropharynx with a concurrent level 2 nodal mass, or a laryngeal recurrence with a level 3 nodal mass

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

📍 All Participating Trial Locations (18 Sites)

• University of Arizona Cancer Center - North Campus — Tucson, Arizona
• Moffitt Cancer Center — Tampa, Florida
• Cleveland Clinic - Weston — Weston, Florida
• University of Louisville, James Graham Brown Cancer Center — Louisville, Kentucky
• Boston Medical Center — Boston, Massachusetts
• Washington University St. Louis — St Louis, Missouri
• Northwell Health — Lake Success, New York
• University of Cincinnati Cancer Center - UC Medical Center — Cincinnati, Ohio
• Cleveland Clinic — Cleveland, Ohio
• Ohio State University — Columbus, Ohio
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania
• Fox Chase Cancer Center — Philadelphia, Pennsylvania
• University of Pittsburgh Medical Center Shadyside — Pittsburgh, Pennsylvania
• University of Texas Southwestern — Dallas, Texas
• Medical College of Wisconsin — Milwaukee, Wisconsin
• Cross Cancer Institute — Edmonton, Alberta
• Centre Hospitalier de l'université de Montréal — Montreal, Quebec
• McGill University — Montreal, Quebec

💰 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 Head and Neck Squamous Cell Carcinoma (HNSCC)

• [18F]-AraG PET Imaging in LA HNSCC — Indianapolis, Indiana
• A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma — Los Angeles, California
• Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors — Los Angeles, California
• INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC — Duarte, California
• Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer — Pittsburgh, Pennsylvania

Explore by condition: All Head and Neck Squamous Cell Carcinoma (HNSCC) clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
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.