Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC

NCT04340258 | Active Not Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: UCCC-HN-20-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

To Study Perioperative PD-1 Inhibitor and Cesium-131 Interstitial Brachytherapy in patients with locally recurrent HNSCC eligible for salvage surgery.

Conditions

HNSCC

Outcome Measures

Primary Outcomes (2)

• Overall Safety measured by dose limiting toxicities (DLTs).

  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.

  2 years

• Disease-free survival

  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

  2 years

Secondary Outcomes (3)

• Overall Survival

  4 years

• Loco-regional control rate

  4 years

• Adverse events

  4 years

Study Arms (1)

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)

Device: Cesium-131; Drug: Pembrolizumab

Interventions

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.

Also known as: Cs-131

Pembrolizumab & Cesium-131

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.

Pembrolizumab & Cesium-131

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• IsoRay Medical, Inc.: collaborator

Study Sites (2)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Thomas Jefferson

Philadelphia, Pennsylvania, 19144, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Chad Zender, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-randomized, single-arm

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 9, 2020
• Study Start: February 4, 2021
• Primary Completion: June 3, 2025
• Study Completion: September 4, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)