Clinical trial · Interventional
Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC
Phase 1b/II Trial Combining PD1 Inhibition (Pembrolizumab) and Cesium 131 Brachytherapy With Salvage Surgery to Enhance Immunogenicity and Improve Local Control in Head and Neck Cancer
NCT04340258CI-TRIAL-00114135active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To Study Perioperative PD-1 Inhibitor and Cesium-131 Interstitial Brachytherapy in patients with locally recurrent HNSCC eligible for salvage surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cesium-131 | Device | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pembrolizumab & Cesium-131
- description
- 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)
- interventionNames
- Device: Cesium-131
- Drug: Pembrolizumab
Primary outcomes (2)
- measure
- Overall Safety measured by dose limiting toxicities (DLTs).
- timeFrame
- 2 years
- description
- 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.
- measure
- Disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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 requiring sacrifice or bypass intra-operatively * Patients with active pharyngo-cutaneous * Patients with more than one site of distant metastatic disease * Prior immune-based anticancer therapy within last six months
References
Publications (0)
Data not yet available
No reference posted for this study.