Trials / Recruiting
RecruitingNCT05047094
Alpha Radiation Emitters Device (DaRT) in Combination With Check Point Inhibitor for the Treatment of Recurrent Unresectable or mHNSCC
A Safety and Efficacy Study of Intratumoral Diffusing Alpha Radiation Emitters in Recurrent Unresectable or Metastatic Head and Neck Squamous Cell Carcinoma
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Alpha Tau Medical LTD. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Diffusing Alpha Radiation Emitters Therapy (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. |
| DRUG | Pembrolizumab | 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks |
Timeline
- Start date
- 2021-11-02
- Primary completion
- 2026-12-01
- Completion
- 2027-06-01
- First posted
- 2021-09-16
- Last updated
- 2026-04-06
Locations
3 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT05047094. Inclusion in this directory is not an endorsement.