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A Safety and Efficacy Study for Combinational Treatment of DaRT and Check Point Inhibitor for Recurrent Unresectable or mHNSCC

Head and Neck Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

This will be a prospective, open-label, one arm, single center two-stage adaptive trial designed to stop for either futility or efficacy after the first stage. This approach will combine Diffusing Alpha Radiation Emitters seeds implantation along with standard treatment of Pembrolizumab for patients with recurrent unresectable or metastatic Head and Neck Squamous Cell Carcinoma (mHNSCC). The DaRT seeds will be implanted in the target lesion and removed 15-22 days after implantation. Concurrently, patient will receive standard treatment of Pembrolizumab. Disease evaluation will be assessed by a radiological imaging every 6 weeks starting at day 42 after the DaRT insertion procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05047094
Study type Interventional
Source Alpha Tau Medical LTD.
Contact Tami Granot
Phone +972-2-3737-212
Email TamiG@alphatau.com
Status Recruiting
Phase N/A
Start date November 2, 2021
Completion date June 2027
View Details
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