Clinical Trials /

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

NCT04340258

Description:

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

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04340258

Trial Eligibility

Document

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

  • HNSCC

Interventions

DrugSynonymsArms
PembrolizumabPembrolizumab & 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

NameTypeDescriptionInterventions
Pembrolizumab & Cesium-131Experimental200 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)
  • Pembrolizumab

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