Phase I/ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in… (NCT07213934) | Clinical Trial Compass
RecruitingPhase 1/2
Phase I/ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma
United States40 participantsStarted 2025-10-08
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have histologically or cytologically confirmed recurrent head and neck squamous cell carcinoma including oral cavity, laryngeal, hypopharyngeal, or oropharyngeal (HPV-) SCC.
✓. 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 tumor dimension (GTV) must be \<7 cm.
✓. Patients must have a CPS PD-L1 of ≥1%. This may be tested on a new biopsy or archival tissue.
✓. Age ≥18 years.
✓. ECOG performance status ≤1 (or Karnofsky ≥70%, see Appendix A).
✓. Patients must have adequate organ and marrow function as defined below:
Exclusion criteria
✕. Patients who have metastatic disease.
✕. Patients who have ongoing adverse events from prior anti-cancer therapy that would preclude completion of the proposed study treatment at the opinion of the treating investigators.
✕. Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI.
What they're measuring
1
Dose Limiting Toxicity (DLT) Evaluation defined as the number of subjects experiencing a major, non-grade 5 adverse event as defined by CTCAE v6 or a grade 5 adverse event as defined by CTCAE 6.
Timeframe: From the initiation of study treatment to 28 days post resection.
2
Major Pathologic Response (MPR) defined as less than 10% viable tumor on resected tumor specimen.
✕. Prior treatment with PD-1 inhibitors in the last 6 months or progression on a PD-1 inhibitor at any time.
✕. Autoimmune disease or other pro-inflammatory conditions other than treated stable asthma, minor allergies (such as seasonal allergies), vitiligo or hypothyroidism.
✕. Active and ongoing steroid use \>10 mg prednisone, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, COPD, allergic rhinitis).
✕. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous, in the opinion of the Investigator.
✕. Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with breastfeeding should be discontinued if the mother is treated with pembrolizumab.