Phase I/II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma
Phase 1/2
40
about 6 years
18+
1 site in OH
What this study is about
Researchers are testing whether combining proton radiation therapy (PT) or photon radiation therapy (XRT) with pembrolizumab, a drug that blocks the PD-1 protein, before surgery can benefit patients with recurrent head and neck squamous cell carcinoma. The trial will also assess if this combination is safe for adults.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Proton therapy
- 2.Take Pembrolizumab
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)
infusion
Primary: 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.
Secondary: Disease Free Survival as measured from time of surgery until either disease recurrence or death from any cause., Safety using CTCAE v6.0 and toxicity evaluation.
radiation
Oncology