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

NCT05047094 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-06

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

Diffusing Alpha Radiation Emitters Therapy (DaRT)

An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.

DRUG

Pembrolizumab

200 mg administered as an intravenous infusion over 30 minutes every 3 weeks

Sponsors & Collaborators

  • Alpha Tau Medical LTD.

    lead INDUSTRY

Principal Investigators

  • Aron Popovtzer, MD · Sharett institute, Hadassah Medical Center - Ein-Kerem

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05047094 on ClinicalTrials.gov