Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pembrolizumab · 1 trial · 4 indications
The number of participants who completed trial procedures among at least 80 percent of patients, among patients with recurrent or metastatic head and neck squamous cell carcinoma.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Pembro + Ultrasound-Induced Microbubble Cavitation | EXPERIMENTAL | Treatment will be administered on an outpatient basis. 200 mg Pembrolizumab + 3 mL Definity infusions will be administered by nurses at Thomas Jefferson University every 3 weeks for up to 3 cycles. The first cycle will take 60 minutes, while the subsequent infusions should take half an hour to complete. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks for up to 3 cycles |
| Definity | DRUG | Definity will be administered intravenously during each treatment cycle to facilitate ultrasound-induced microbubble cavitation. |
| Ultrasound-Induced Microbubble Cavitation | DEVICE | Therapeutic Ultrasound will be applied to the tumor site during and following the Definity infusion to induce microbubble cavitation using modified ultrasound parameters. |
Inclusion Criteria: * Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: 1. Pathologically confirmed, HPV-negative, R/M HNSCC per American Joint Committee on Cancer (AJCC) 8th Edition Staging Criteria, with CPS score \> 1 2. The t...
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Pembrolizumab is being studied for use in Head and Neck Cancer, including head and neck small cell carcinoma, metastatic head and neck cancer, and recurrent head and neck cancer. It is currently in Phase 1 clinical development as an investigational therapy for these conditions.
Pembrolizumab is a monoclonal antibody, indicated by its -mab suffix, that targets the PD-1 receptor. By binding to PD-1, it is designed to modulate the immune system's response against cancer cells, though specific efficacy data is not yet available from ongoing trials.
Pembrolizumab is being developed by Lantheus Holdings, Inc., a company traded on the stock exchange under the ticker symbol LNTH. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in head and neck cancer.
Pembrolizumab is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is currently recruiting participants to assess the drug's safety and preliminary efficacy.
Pembrolizumab is being evaluated in a single Phase 1 clinical trial with the identifier NCT07501650. The trial, titled 'Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer,' is recruiting 6 participants in the United States and is not randomized or blinded.