Head and Neck Squamous Cell CarcinomaNCT05047094
Alpha Radiation Emitters Device (DaRT) in Combination With Check Point Inhibitor for the Treatment of Recurrent Unresectable or mHNSCC
A study testing Diffusing Alpha Radiation Emitters Therapy (DaRT) and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma and Skin Cancer, run by Alpha Tau Medical LTD. at 3 sites in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Skin Cancer, Metastatic Head-and-neck Squamous-cell Carcinoma
- What is being tested?
- Diffusing Alpha Radiation Emitters Therapy (DaRT) and Pembrolizumab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesIsrael
- Study dates
- 2 Nov 2021to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed, metastatic, or recurrent unresectable squamous cell carcinoma of the head and neck.
- Ability to provide tissue sample, either from an archive or undergo another biopsy to provide a fresh sample
- Targetable lesion must be technically amenable for the DaRT seeds implantation
- Brachytherapy indication validated by a multidisciplinary team
- Targetable lesion according to RECIST v1.1
- Age ≥ 18 years old
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- Eastern Cooperative Oncology Group (ECOG) Performance Status Scale ≤ 2
- Subjects' life expectancy is more than 6 months
- White Blood Count (WBC) ≥ 3500/µl, granulocyte ≥ 1500/µl
- Platelet count ≥ 100,000/µl
- Hemoglobin ≥ 9 g/dl
- Calculated or measured creatinine clearance ≥ 60 cc/min
- Aspartate Aminotransferase (AST) and Alanine Transaminase (ALT) ≤ 2.5 X Upper Limit of Normal (ULN) or ≤ 5 X ULN for subjects with liver metastases
- International normalized ratio (INR) <1.4 for patients not on Warfarin
- Subjects are willing and able to sign an informed consent form
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.
Who cannot join
- Previous treatment for metastatic disease (for recurrent unresectable disease, previous treatment is allowed given that 6 months had elapsed from completion of treatment for primary disease)
- Patients with brain metastases
- Combined Positive Scores (CPS) <1
- Patients with known contraindications to radiotherapy
- Any prior therapy with anti-PD-L1 (Programmed death-ligand), anti-PD-L2, anti-CTLA-4 (Cytotoxic T lymphocyte antigen) antibody, etc.
- Any history of a sever hypersensitivity reaction to any monoclonal antibody.
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- Known hypersensitivity to any of the components of the DaRT.
- Has a known history of active TB (Tuberculosis Bacillus )
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Any diagnosis of immunodeficiency or current immunosuppressive therapy including >10mg/day of prednisone within 14 days of enrollment is not permitted
- Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
- Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
- Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
- Has a known history of Human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
- Has known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA [qualitative] is detected)
- Pregnancy or lactation.
- Patients must agree to use adequate contraception (abstinence, barrier method of birth control, or any other medically acceptable form of contraception) prior to study entry, for the duration of study participation and for 6 months after last dose of Pembrolizumab.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel3 sites, 3 recruiting
- Recruiting
Sharett institute, Hadassah University Hospital - Ein-Kerem
Jerusalem, 91120
Aron Popovtzer, MD
- Recruiting
Sheba Medical Center
Ramat Gan
Iris Gluck, MD, 052-6669142, Iris.gluck@sheba.health.gov.il
- Not yet recruiting
Tel-Aviv Medical Center
Tel Aviv
Inbar Finkel, MD, 03-6973494, Inbarfi@tlvmc.gov.il
About this study
Official title: A Safety and Efficacy Study of Intratumoral Diffusing Alpha Radiation Emitters in Recurrent Unresectable or Metastatic Head and Neck Squamous Cell Carcinoma
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
Read the detailed 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma, Skin Cancer, Metastatic Head-and-neck Squamous-cell Carcinoma
- Being tested
- Diffusing Alpha Radiation Emitters Therapy (DaRT), Pembrolizumab
- Keywords
- Squamous Cell Carcinoma, SCC, Skin Cancer, Skin metastasis, HNSCC, Carcinoma, Squamous, Recurrent disease, Alpha radiation, Brachytherapy, Pembrolizumab, Check Point Inhibitor, KEYTRUDA, Immunomodulators
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Skin Neoplasms, Carcinoma, Squamous Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusing Alpha Radiation Emitters Therapy (DaRT)Device
Also called 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.
PembrolizumabDrug
Also called KEYTRUDA
200 mg administered as an intravenous infusion over 30 minutes every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| DaRT seeds | Experimental | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds in Combination with Standard Treatment of Pembrolizumab Receives: Device: Diffusing Alpha Radiation Emitters Therapy (DaRT); Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Efficacy of DaRT Treatment in Combination with Pembrolizumab
Assessed via the Confirmed Best Overall Response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Measured: From Day 26 to date of documented best response, assessed up to 24 months
Secondary outcomes (4)
Adverse Events
Assessment of the frequency, severity and causality of acute adverse events related to the DaRT treatment in combination with immune checkpoint inhibitors. This will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. (graded 1-5, 1 is mild and 5 is death)
Measured: Until completion of the last study-related procedure, approximately 2 years
Progression Free Survival (PFS)
PFS will be defined as time from Pembrolizumab treatment start date to progressive disease according to RECIST v1.1 or death due to any cause, whichever occurs first
Measured: From first dose of Pembrolizumab until progressive disease is recorded (up to 24 months)
Overall Survival (OS)
Defined as the time from Pembrolizumab treatment start date to death due to any cause or lost to follow up.
Measured: From Pembrolizumab treatment start date to death or lost to follow-up (up to 24 months)
Duration of Response (DOR)
Duration of response is defined as the interval from the time measurement criteria are first met for Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (whichever is first recorded) until the first date recurrent or progressive disease is objectively documented.
Measured: From first record of response until the first date recurrent or progressive disease is documented (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start2 Nov 2021
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aron Popovtzer, MD, Principal investigator, Sharett institute, Hadassah Medical Center - Ein-Kerem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047094
- Sponsor's protocol ID
- CTP-HNCPI-00
- Status last verified
- Nov 2025
- First submitted
- 29 Aug 2021
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Intratumoral Diffusing Alpha Radiation Emitters in Recurrent Unresectable or Metastatic Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05047094
- Acronym / sponsor ID
- CTP-HNCPI-00
- Conditions
- Head and Neck Squamous Cell Carcinoma, Skin Cancer, Metastatic Head-and-neck Squamous-cell Carcinoma
- Keywords
- Squamous Cell Carcinoma, SCC, Skin Cancer, Skin metastasis, HNSCC, Carcinoma, Squamous, Recurrent disease, Alpha radiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DaRT seeds | Experimental | Device: Diffusing Alpha Radiation Emitters Therapy (DaRT), Drug: PembrolizumabIntratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds in Combination with Standard Treatment of Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Pathologically confirmed, metastatic, or recurrent unresectable squamous cell carcinoma of the head and neck.
- Ability to provide tissue sample, either from an archive or undergo another biopsy to provide a fresh sample
- Targetable lesion must be technically amenable for the DaRT seeds implantation
- Brachytherapy indication validated by a multidisciplinary team
- Targetable lesion according to RECIST v1.1
Key exclusion criteria (17 listed)
- Previous treatment for metastatic disease (for recurrent unresectable disease, previous treatment is allowed given that 6 months had elapsed from completion of treatment for primary disease)
- Patients with brain metastases
- Combined Positive Scores (CPS) <1
- Patients with known contraindications to radiotherapy
- Any prior therapy with anti-PD-L1 (Programmed death-ligand), anti-PD-L2, anti-CTLA-4 (Cytotoxic T lymphocyte antigen) antibody, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusing Alpha Radiation Emitters Therapy (DaRT)Also: DaRTAn 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. | Device | DaRT seeds |
| PembrolizumabAlso: KEYTRUDA200 mg administered as an intravenous infusion over 30 minutes every 3 weeks | Drug | DaRT seeds |
Primary outcome
Evaluation of Efficacy of DaRT Treatment in Combination with Pembrolizumab
Time frame: From Day 26 to date of documented best response, assessed up to 24 months
Assessed via the Confirmed Best Overall Response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
4 secondary outcomes
Adverse Events
Time frame: Until completion of the last study-related procedure, approximately 2 years
Progression Free Survival (PFS)
Time frame: From first dose of Pembrolizumab until progressive disease is recorded (up to 24 months)
Overall Survival (OS)
Time frame: From Pembrolizumab treatment start date to death or lost to follow-up (up to 24 months)
Duration of Response (DOR)
Time frame: From first record of response until the first date recurrent or progressive disease is documented (up to 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aron Popovtzer, MD principal investigator
Sharett institute, Hadassah Medical Center - Ein-Kerem
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusing Alpha Radiation Emitters Therapy (DaRT) and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma and Skin Cancer, run by Alpha Tau Medical LTD. at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tami Granot (+972-2-3737-212, TamiG@alphatau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Efficacy of DaRT Treatment in Combination with Pembrolizumab (time frame: From Day 26 to date of documented best response, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.