Phase I/II Trial for Recurrent Head and Neck Squamous Cell Carcinoma
This study is for people with recurrent head and neck squamous cell carcinoma (a type of cancer that comes back after treatment). It's testing a combination of radiation therapy (either proton therapy or X-ray photon radiation) and an immunotherapy drug called pembrolizumab. The first part of the study (Phase I) will check the safety of using radiation before surgery. The second part (Phase II) will see if adding radiation before pembrolizumab and surgery helps patients. Researchers will measure how many patients have a major pathologic response (meaning less than 10% viable tumor found after surgery). You may be eligible if you are 18 or older, have this type of cancer, and are a candidate for surgery. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 40 participants. It has a Phase I part to determine safe dosing and a Phase II part to evaluate effectiveness, with two independent arms.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured from the start of treatment to 28 days after surgery, and at the time of surgery (Week 4).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase I/ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- 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.From the initiation of study treatment to 28 days post resection.
To determine DLTs during Phase I to determine the recommended Phase 2 dose. A DLT is defined as experiencing ≥ Gr 4 AEs prior to surgery, a delay in surgery past 5 wks from RT, or ≥ Gr 4 surgical complications or Grade 5 adverse events are defined as deaths occurring during the study period, regardless of attribution, as assessed using CTCAE v6.0 criteria.
- Major Pathologic Response (MPR) defined as less than 10% viable tumor on resected tumor specimen.Surgery - Week 4
To determine the major pathological response (MPR) in patients undergoing neoadjuvant X-ray photon radiation (XRT) or proton radiation (PT) with pembrolizumab followed by surgical salvage compared to a historical control group undergoing salvage surgery with PD-1 alone.