Actively Recruiting
Alpha Radiation Emitters Device (DaRT) in Combination With Check Point Inhibitor for the Treatment of Recurrent Unresectable or mHNSCC
Led by Alpha Tau Medical LTD. · Updated on 2026-04-06
48
Participants Needed
3
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Alpha Radiation Emitters Device (DaRT) in Combination With Check Point Inhibitor for the Treatment of Recurrent Unresectable or mHNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed metastatic or recurrent unresectable squamous cell carcinoma of the head and neck
- Ability to provide a tissue sample from archive or fresh biopsy
- Target lesion suitable for DaRT seed implantation
- Brachytherapy indication approved by multidisciplinary team
- Target lesion meets criteria according to RECIST v1.1
- Age 18 years or older
- ECOG Performance Status of 2 or less
- Life expectancy longer than 6 months
- White Blood Count at least 3500/µl and granulocytes at least 1500/µl
- Platelet count at least 100,000/µl
- Hemoglobin level at least 9 g/dl
- Creatinine clearance at least 60 cc/min
- AST and ALT levels less than or equal to 2.5 times upper limit normal or up to 5 times for liver metastases
- INR less than 1.4 for patients not on Warfarin
- Willingness and ability to sign informed consent
- Women of childbearing potential must have negative pregnancy test before Ra-224 implantation and use acceptable contraception for 3 months after brachytherapy
You will not qualify if you...
- Previous treatment for metastatic disease (allowed for recurrent unresectable disease if at least 6 months have passed since prior treatment)
- Presence of brain metastases
- Combined Positive Scores (CPS) less than 1
- Known contraindications to radiotherapy
- Prior therapy with anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or similar
- History of severe hypersensitivity to monoclonal antibodies
- Known hypersensitivity to any components of DaRT
- Active tuberculosis infection
- Additional progressing malignancy requiring active treatment, except certain skin or cervical cancers
- Immunodeficiency or current immunosuppressive therapy including prednisone over 10 mg/day within 14 days prior
- Significant cardiovascular disease or recent myocardial infarction within 12 months
- Uncontrolled illnesses or psychiatric/substance abuse disorders interfering with trial participation
- Treatment requirement conflicting with study endpoints
- Known HIV infection
- Active hepatitis B or C infection
- Pregnancy or breastfeeding
- Failure to agree to use adequate contraception before and during study and for 6 months after last Pembrolizumab dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Sharett institute, Hadassah University Hospital - Ein-Kerem
Jerusalem, Israel, 91120
Actively Recruiting
2
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
3
Tel-Aviv Medical Center
Tel Aviv, Israel
Not Yet Recruiting
Research Team
T
Tami Granot
CONTACT
L
Liron Dimnik
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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