Description:
To Study Perioperative PD-1 Inhibitor and Cesium-131 Interstitial Brachytherapy in patients
with locally recurrent HNSCC eligible for salvage surgery.
Title
- Brief Title: Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
UCCC-HN-20-01
- NCT ID:
NCT04340258
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Pembrolizumab | | Pembrolizumab & Cesium-131 |
Purpose
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 be eligible for surgical resection will be screened and consented to receive
one 200mg IV dose of pembrolizumab followed by salvage surgery. At the time of surgery, they
will have Cesium131 seeds implanted. Two to six weeks after surgery, subjects will be started
on 200 mg IV of pembrolizumab to be continued every 3 weeks for 6 months. The phase 1b part
will enroll 3 patients for a safety run-in, followed by the phase 2 part if no DLTs are seen
in these 3 patients. Phase 2 will be used to estimate the 2-year DFS in comparison to a
benchmark selected based on a historical control. For correlative studies, archived tissue
and surgical specimen will be evaluated by H&E and IHC for immune phenotype. Blood samples
will also be collected as shown in schema above for correlative studies (blood will be
collected for correlatives and biomarkers before and after the first of pembrolizumab, before
starting adjuvant pembrolizumab and at completion of 6 month course of adjuvant
pembrolizumab). Patients will be followed approximately every 3 weeks during treatment for
the first 6 months, then monthly for 3 months following treatment and then every 3 months
thereafter for 24 months for disease free survival (DFS) and overall survival (OS).
Trial Arms
Name | Type | Description | Interventions |
---|
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) | |
Eligibility Criteria
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
Maximum Eligible Age: | 90 Years |
Minimum Eligible Age: | 19 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Safety measured by dose limiting toxicities (DLTs). |
Time Frame: | 2 years |
Safety Issue: | |
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. |
Secondary Outcome Measures
Measure: | Overall Survival |
Time Frame: | 4 years |
Safety Issue: | |
Description: | To estimate the Overall Survival (OS) Rate |
Measure: | Loco-regional control rate |
Time Frame: | 4 years |
Safety Issue: | |
Description: | To estimate the Loco-regional control rate (LCR) |
Measure: | Adverse events |
Time Frame: | 4 years |
Safety Issue: | |
Description: | To estimate the frequency and severity of adverse events (AE) |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Cincinnati |
Last Updated
March 4, 2021