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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha Tau Medical LTD.

About this trial

A unique combinational treatment for cancer employing intratumoral diffusing alpha radiation emitter device with check point inhibitor for recurrent unresectable or metastatic Head and Neck Squamous Cell Carcinoma

Eligibility criteria

Qualifiers

Pathologically confirmed, metastatic, or recurrent unresectable squamous cell carcinoma of the head and neck.

Ability to provide tissue sample, either from an archive or undergo another biopsy to provide a fresh sample

Targetable lesion must be technically amenable for the DaRT seeds implantation

Brachytherapy indication validated by a multidisciplinary team

Disqualifiers

Previous treatment for metastatic disease (for recurrent unresectable disease, previous treatment is allowed given that 6 months had elapsed from completion of treatment for primary disease)

Patients with brain metastases

Combined Positive Scores (CPS) <1

Patients with known contraindications to radiotherapy

Trial design

Treatments tested in this trial

  • Diffusing Alpha Radiation Emitters Therapy (DaRT)
  • Pembrolizumab

Treatment groups

48 Participants
are divided into 1 treatment group

Sponsors and collaborators