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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title Alpha Radiation Emitters Device (DaRT) in Combination With Check Point Inhibitor for the Treatment of Recurrent Unresectable or mHNSCC
ClinicalTrials.gov ID: NCT05047094
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head and neck squamous cell carcinoma.
Also referred to as KEYTRUDA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Previous treatment for metastatic disease (for recurrent unresectable disease, previous treatment is allowed given that 6 months had elapsed from...
- 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.
See the full eligibility criteria
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status Scale ≤ 2
- people' 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 people with liver metastases
- International normalized ratio (INR) \<1.4 for patients not on Warfarin
- people 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...
- 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.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel; Ramat Gan, Israel; Tel Aviv, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.