RecruitingNot ApplicableNCT05047094

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

A Safety and Efficacy Study of Intratumoral Diffusing Alpha Radiation Emitters in Recurrent Unresectable or Metastatic Head and Neck Squamous Cell Carcinoma


Sponsor

Alpha Tau Medical LTD.

Enrollment

48 participants

Start Date

Nov 2, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two treatments — radioactive seed implants (called DaRT, which emit low-level radiation directly into a tumor) and immune checkpoint inhibitor drugs — for head and neck cancers that have come back or spread and cannot be surgically removed. **You may be eligible if...** - You are 18 or older with confirmed squamous cell carcinoma of the head and neck that has returned or spread - Your tumor can be targeted with the DaRT seed implant - You are in reasonably good health (ECOG performance status 0–2) - Your blood counts and kidney/liver function are within acceptable ranges - Your expected survival is more than 6 months **You may NOT be eligible if...** - You have poor organ function (kidney, liver, heart, or bone marrow) - You have certain serious infections like HIV or hepatitis - You have uncontrolled autoimmune diseases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDiffusing 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.

DRUGPembrolizumab

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


Locations(3)

Sharett institute, Hadassah University Hospital - Ein-Kerem

Jerusalem, Israel

Sheba Medical Center

Ramat Gan, Israel

Tel-Aviv Medical Center

Tel Aviv, Israel

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NCT05047094


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