NCT05047094 Alpha Radiation Emitters Device (DaRT) in Combination With Check Point Inhibitor for the Treatment of Recurrent Unresectable or mHNSCC
| NCT ID | NCT05047094 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alpha Tau Medical LTD. |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2021-11-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2021-11-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Pathologically confirmed, metastatic, or recurrent unresectable squamous cell carcinoma of the head and neck. 2. Ability to provide tissue sample, either from an archive or undergo another biopsy to provide a fresh sample 3. Targetable lesion must be technically amenable for the DaRT seeds implantation 4. Brachytherapy indication validated by a multidisciplinary team 5. Targetable lesion according to RECIST v1.1 6. Age ≥ 18 years old 7. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale ≤ 2 8. Subjects' life expectancy is more than 6 months 9. White Blood Count (WBC) ≥ 3500/µl, granulocyte ≥ 1500/µl 10. Platelet count ≥ 100,000/µl 11. Hemoglobin ≥ 9 g/dl 12. Calculated or measured creatinine clearance ≥ 60 cc/min 13. Aspartate Aminotransferase (AST) and Alanine Transaminase (ALT) ≤ 2.5 X Upper Limit of Normal (ULN) or ≤ 5 X ULN for subjects with liver metastases 14. International normalized ratio (INR) \<1.4 for patients not on Warfarin 15. Subjects are willing and able to sign an informed consent form 16. 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. Exclusion Criteria: 1. 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) 2. Patients with brain metastases 3. Combined Positive Scores (CPS) \<1 4. Patients with known contraindications to radiotherapy 5. Any prior therapy with anti-PD-L1 (Programmed death-ligand), anti-PD-L2, anti-CTLA-4 (Cytotoxic T lymphocyte antigen) antibody, etc. 6. Any history of a sever hypersensitivity reaction to any monoclonal antibody. 7. Known hypersensitivity to any of the components of the DaRT. 8. Has a known history of active TB (Tuberculosis Bacillus ) 9. 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. 10. Any diagnosis of immunodeficiency or current immunosuppressive therapy including \>10mg/day of prednisone within 14 days of enrollment is not permitted 11. 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. 12. 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. 13. Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT. 14. Has a known history of Human immunodeficiency virus (HIV) (HIV 1/2 antibodies). 15. Has known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA \[qualitative\] is detected) 16. Pregnancy or lactation. 17. 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.
Contact & Investigator
Aron Popovtzer, MD
PRINCIPAL INVESTIGATOR
Sharett institute, Hadassah Medical Center - Ein-Kerem
Frequently Asked Questions
Who can join the NCT05047094 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05047094 currently recruiting?
Yes, NCT05047094 is actively recruiting participants. Contact the research team at TamiG@alphatau.com for enrollment information.
Where is the NCT05047094 trial being conducted?
This trial is being conducted at Jerusalem, Israel, Ramat Gan, Israel, Tel Aviv, Israel.
Who is sponsoring the NCT05047094 clinical trial?
NCT05047094 is sponsored by Alpha Tau Medical LTD.. The principal investigator is Aron Popovtzer, MD at Sharett institute, Hadassah Medical Center - Ein-Kerem. The trial plans to enroll 48 participants.