Phase I/ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma
Trial Parameters
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Brief Summary
The purpose of the Phase I study is to see if it is safe to use X-ray photon radiation (XRT) and proton radiation (PT) before surgery in patients with recurrent head and neck squamous cell carcinoma (rHNSCC). The purpose of the Phase II study is to see if using XRT or PT before immunotherapy (pembrolizumab) prior to surgery benefits patients with recurrent head and neck squamous cell carcinoma (rHNSCC).
Eligibility Criteria
Inclusion Criteria (Both Phase I and Phase II) 1. Patients must have histologically or cytologically confirmed recurrent head and neck squamous cell carcinoma including oral cavity, laryngeal, hypopharyngeal, or oropharyngeal (HPV-) SCC. 2. Patients must be a candidate for salvage surgical resection. 3. Patients must have failed prior RT \>6 months prior to recurrence with at least 30 Gy delivered to the current target volume. 4. 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 cm. 5. Patients must have a CPS PD-L1 of ≥1%. This may be tested on a new biopsy or archival tissue. 6. Age ≥18 years. 7. ECOG performance status ≤1 (or Karnofsky ≥70%, see Appendix A). 8. Patients must have adequate organ and marrow function as defined below: Platelets ≥100,000/mcL Total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN C