Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pembrolizumab · 1 trial · 1 indication
Phase Ib: To determine the safety of the combination of pembrolizumab and Cesium-131 in recurrent HNSCC patients undergoing salvage surgical resection. A 3+3 safety run in will be conducted for the phase 1b part of the protocol. Safety monitoring will begin at the time of enrollment on the study and will continue for at least 4 weeks after completion of the last treatment dose on study.
Phase II: To estimate the disease-free survival (DFS) rate for the combination of pembrolizumab and Cesium 131 in recurrent HNSCC patients undergoing salvage surgical resection
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab & Cesium-131 | EXPERIMENTAL | 200 mg Pembrolizumab (Day -14 pre-surgery; Every 3 weeks after surgery) + Cesium-131 Seeds to deliver 60-70Gy of radiation (Single dose at the time of salvage surgery) |
| Name | Type | Description |
|---|---|---|
| Cesium-131 | DEVICE | Cs-131 brachytherapy seed is a low-energy-gamma isotope that is contained in a titanium capsule. Dosing will be determined by a radiation oncologist study team member based on CT scan and intraoperative findings. The number of seeds and spacing will be outlined preoperatively based on the proposed square area of exposure in the resection bed. The plan is to deliver a total of 60-70Gy of radiation to the site. |
| Pembrolizumab | DRUG | Pembrolizumab 200 mg will be administered as a 30-minute IV infusion every 3 weeks. The drug will be infused through a peripheral line or an indwelling catheter. The first dose will be given 2 weeks prior to surgery. Post-surgery, pembrolizumab will be started between 2 and 6 weeks and will continue every 3 weeks for a duration of 6 months. Study Drug may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons. The Investigator's Brochure contains specific instructions for the preparation of the standard of care pembrolizumab infusion fluid. |
Inclusion Criteria: * locally recurrent HNSCC and be eligible for salvage surgery * If patient received radiation therapy in the past, they should have recovered from the acute toxicity to \<grade 1 * tumor needs to be deemed resectable Exclusion Criteria: * Exposed carotid artery preoperatively ...
Pembrolizumab is an investigational antibody being studied for the treatment of head and neck squamous cell carcinoma (HNSCC). It is currently in a Phase 1 clinical trial that combines pembrolizumab with cesium 131 brachytherapy and salvage surgery for patients with HNSCC.
Pembrolizumab is a monoclonal antibody, indicated by its -mab suffix. It is being evaluated in HNSCC, where it is combined with cesium 131 brachytherapy and salvage surgery in a Phase 1 clinical trial.
Pembrolizumab is being developed by Perspective Therapeutics, Inc., a company traded under the ticker CATX. The drug is currently in Phase 1 clinical development for the treatment of head and neck squamous cell carcinoma (HNSCC).
Pembrolizumab is in Phase 1 clinical development. It is being studied in an active, not recruiting clinical trial for head and neck squamous cell carcinoma (HNSCC), with a planned enrollment of 50 participants in the United States.
Pembrolizumab is being studied in clinical trial NCT04340258, titled "Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC." This Phase 1 trial is active but not recruiting, with an enrollment of 50 participants in the United States.
Pembrolizumab is the generic name for the drug marketed as Keytruda. In the context of this development program, Perspective Therapeutics is studying pembrolizumab in combination with cesium 131 brachytherapy and salvage surgery for HNSCC in a Phase 1 trial.