Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04340258 | Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC | PHASE1 | ACTIVE NOT_RECRUITING | 50 | — | — | Feb 4, 2021 | Sep 4, 2025 | Jun 8, 2025 | 2 | United States |
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 ...