Actively Recruiting
A Safety and Efficacy Study of Intratumoral Diffusing Alpha Radiation Emitters in Combination with Pembrolizumab for Recurrent Unresectable or Metastatic Head and Neck Squamous Cell Carcinoma
Led by Alpha Tau Medical LTD. · Updated on 2026-04-06
48
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a unique combination treatment for patients with recurrent unresectable or metastatic Head and Neck Squamous Cell Carcinoma (mHNSCC). This trial evaluates the use of an intratumoral diffusing alpha radiation emitter device together with the checkpoint inhibitor drug Pembrolizumab. The goal is to assess the safety and effectiveness of this combined approach for treating this type of cancer. The treatment involves implanting Diffusing Alpha Radiation Emitter (DaRT) seeds directly into the tumor, which release alpha radiation inside the lesion. These seeds are removed 15 to 22 days after implantation. At the same time, patients receive standard Pembrolizumab infusions of 200 mg intravenously every 3 weeks. The study is open-label, with one treatment arm combining DaRT seeds and Pembrolizumab. Participants will have disease evaluations using radiological imaging every 6 weeks starting from 42 days after the seed implantation. Researchers will monitor the treatment's effectiveness up to 24 months by measuring the best response to therapy. Safety assessments will continue for about 2 years, including tracking adverse events, progression-free survival, overall survival, and duration of response. The total study duration depends on individual patient response and follow-up.
CONDITIONS
Brief 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 biopsy
- Lesion suitable for DaRT seed implantation as confirmed by a multidisciplinary team
- Targetable lesion according to RECIST v1.1
- Age 18 years or older
- ECOG Performance Status 0 to 2
- Life expectancy greater 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 less than or equal to 2.5 times ULN (or 5 times ULN if liver metastases)
- INR less than 1.4 if not on Warfarin
- Willing and able to sign informed consent
- Women of childbearing potential must have a negative pregnancy test before Ra-224 implantation and use contraception for 3 months after brachytherapy
You will not qualify if you...
- Previous treatment for metastatic disease (recurrent unresectable disease allowed if 6 months since last treatment)
- Brain metastases
- Combined Positive Scores (CPS) less than 1
- Contraindications to radiotherapy
- Prior therapy with anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies
- History of severe hypersensitivity to monoclonal antibodies
- Known hypersensitivity to components of DaRT
- Active tuberculosis
- Additional progressing malignancy requiring treatment (except certain skin or cervical cancers)
- Immunodeficiency or immunosuppressive therapy >10mg prednisone within 14 days
- Significant cardiovascular disease or recent myocardial infarction
- Uncontrolled infection or psychiatric/substance abuse disorders
- Concurrent treatments conflicting with study endpoints
- Known HIV infection
- Active hepatitis B or C
- Pregnancy or lactation
- Must agree to use contraception during study and for 6 months after last Pembrolizumab dose
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 to 22 days
Participants undergo intratumoral implantation of Diffusing Alpha Radiation Emitters (DaRT) seeds in the target lesion, which are removed 15 to 22 days after implantation.
1 procedure visit and 1 removal visit
Duration - Up to 24 months
Participants receive standard treatment with Pembrolizumab administered as an intravenous infusion every 3 weeks concurrently with DaRT therapy.
Infusion visits every 3 weeks
Duration - Up to 24 months
Disease evaluations are conducted by radiological imaging every 6 weeks starting at day 42 after DaRT implantation to assess treatment efficacy.
Imaging visits every 6 weeks
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
L
Liron Dimnik
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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