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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04340258
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : March 4, 2021
IsoRay Medical, Inc.
Information provided by (Responsible Party):
Shuchi Gulati, University of Cincinnati

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

Condition or disease Intervention/treatment Phase
HNSCC Device: Cesium-131 Drug: Pembrolizumab Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Non-randomized, single-arm
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 4, 2021
Estimated Primary Completion Date : February 4, 2023
Estimated Study Completion Date : February 4, 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pembrolizumab & Cesium-131
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
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.
Other Name: Cs-131

Drug: Pembrolizumab
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.

Primary Outcome Measures :
  1. Overall Safety measured by dose limiting toxicities (DLTs). [ Time Frame: 2 years ]
    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. Disease-free survival [ Time Frame: 2 years ]
    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

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 4 years ]
    To estimate the Overall Survival (OS) Rate

  2. Loco-regional control rate [ Time Frame: 4 years ]
    To estimate the Loco-regional control rate (LCR)

  3. Adverse events [ Time Frame: 4 years ]
    To estimate the frequency and severity of adverse events (AE)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04340258

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Contact: UCCC Clinical Trials Office 513-584-7698

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United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: UCCC CTO    513-584-7698   
Principal Investigator: Shuchi Gulati, MD         
Case Western Reserve Not yet recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Thomas Jefferson Not yet recruiting
Philadelphia, Pennsylvania, United States, 19144
Sponsors and Collaborators
University of Cincinnati
IsoRay Medical, Inc.
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Principal Investigator: Shuchi Gulati, MD University of Cincinnati
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Responsible Party: Shuchi Gulati, Principal Investigator, University of Cincinnati Identifier: NCT04340258    
Other Study ID Numbers: UCCC-HN-20-01
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Immunological
Antineoplastic Agents