Study of Intratumoral Alpha Radiation Emitters with Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are studying a unique combination treatment for patients with recurrent unresectable or metastatic Head and Neck Squamous Cell Carcinoma mHNSCC. This trial evaluates the use of an intratumoral diffusing alpha radiation emitter device together with the checkpoint inhibitor drug Pembrolizumab. The goal is to assess the safety and effectiveness of this combined approach for treating this type of cancer. The treatment involves implanting Diffusing Alpha Radiation Emitter DaRT seeds directly into the tumor, which release alpha radiation inside the lesion. These seeds are removed 15 to 22 days after implantation. At the same time, patients receive standard Pembrolizumab infusions of 200 mg intravenously every 3 weeks. The study is open-label, with one treatment arm combining DaRT seeds and Pembrolizumab. Participants will have disease evaluations using radiological imaging every 6 weeks starting from 42 days after the seed implantation. Researchers will monitor the treatments effectiveness up to 24 months by measuring the best response to therapy. Safety assessments will continue for about 2 years, including tracking adverse events, progression-free survival, overall survival, and duration of response. The total study duration depends on individual patient response and follow-up.

Alpha Radiation Emitters Device (DaRT) in Combination With Check Point Inhibitor for the Treatment of Recurrent Unresectable or mHNSCC