Status:
ACTIVE_NOT_RECRUITING
Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
IsoRay Medical, Inc.
Conditions:
HNSCC
Eligibility:
All Genders
19-90 years
Phase:
PHASE1
PHASE2
Brief Summary
To Study Perioperative PD-1 Inhibitor and Cesium-131 Interstitial Brachytherapy in patients with locally recurrent HNSCC eligible for salvage surgery.
Detailed Description
This study is a non-randomized, single-arm, multi-institutional phase 1b/II study including patients with locally recurrent head and neck cancer eligible for resection. Patients who are identified to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 4 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04340258
Start Date
February 4 2021
End Date
September 4 2025
Last Update
June 8 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
2
Thomas Jefferson
Philadelphia, Pennsylvania, United States, 19144