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
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
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
Single group
Diffusing Alpha Radiation Emitters Therapy (DaRT)
DeviceAn 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.
Pembrolizumab
Drug200 mg administered as an intravenous infusion over 30 minutes every 3 weeks
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)
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)
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
Overall Survival (OS)
Defined as the time from Pembrolizumab treatment start date to death due to any cause or lost to follow up.
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.
Change in Expression of Immune-Related Biomarkers
This study will assess the change in immune related biomarkers in peripheral blood using Fluorescence-activated cell sorting (FACS) analysis. These biomarkers include: CD3, CD4, CD8, CD69, CD137
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