Phase I/ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma

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).

Trial Details

NCT ID
NCT07213934
Phase
PHASE1 / PHASE2
Sponsor
University of Cincinnati
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Proton therapy
  • Pembrolizumab
Locations (sample)
  • Cincinnati, Ohio, United States|39.12711,-84.51439

Key Eligibility Criteria

  • Patients must have histologically or cytologically confirmed recurrent head and neck squamous cell carcinoma including oral cavity, laryngeal, hypo…
  • Patients must be a candidate for salvage surgical resection.
  • Patients must have failed prior RT \>6 months prior to recurrence with at least 30 Gy delivered to the current target volume.
  • 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 tum…

For full eligibility, visit ClinicalTrials.gov.

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