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PD-1 Inhibitor

Pembrolizumab + Cesium-131 for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

Led By Chad Zender, MD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have locally recurrent HNSCC and be eligible for salvage surgery

Tumor needs to be deemed resectable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial will study the safety and efficacy of combining PD-1 inhibitor and Cesium-131 interstitial brachytherapy in patients with head and neck squamous cell carcinoma.

Who is the study for?

This trial is for individuals with a type of throat cancer called HNSCC that has come back and can be removed by surgery. They should have recovered from any serious side effects if they've had radiation before. People with exposed arteries in the neck, ongoing skin-throat connections, or more than one area of cancer spread far away can't join.Check my eligibility

What is being tested?

The study tests combining Pembrolizumab (a drug that helps the immune system fight cancer) and Cesium-131 Brachytherapy (a type of targeted internal radiation therapy) along with salvage surgery to remove recurrent throat cancer.See study design

What are the potential side effects?

Pembrolizumab may cause immune-related reactions affecting various organs, fatigue, skin rash, and infusion reactions. Cesium-131 might lead to localized pain, swelling at the treatment site, and typical risks associated with radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My head or neck cancer has returned and I can undergo another surgery.

Select...

My tumor can be surgically removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease-free survival

Overall Safety measured by dose limiting toxicities (DLTs).

Secondary outcome measures

Adverse events

Loco-regional control rate

Overall Survival

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab & Cesium-131Experimental Treatment2 Interventions

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cesium-131

2015

Completed Early Phase 1

~30

Pembrolizumab

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor

427 Previous Clinical Trials

634,312 Total Patients Enrolled

IsoRay Medical, Inc.Industry Sponsor

3 Previous Clinical Trials

Chad Zender, MDPrincipal InvestigatorUniversity of Cincinnati

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04340258 — Phase 1 & 2

Head and Neck Squamous Cell Carcinoma Research Study Groups: Pembrolizumab & Cesium-131

Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04340258 — Phase 1 & 2

Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04340258 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study include participants aged 40 and above?

"According to the enrollment criteria, participants must be a minimum of 19 years old and no greater than 90."

Answered by AI

Has Pembrolizumab been subject to any prior research initiatives?

"The initial study of pembrolizumab at City of Hope began in 2010, and there have been 251 completed trials as a result. At present, 961 active clinical studies are underway with many occuring around Philadelphia, Pennsylvania."

Answered by AI

What criteria must a person meet to be eligible for participation in this research?

"This cancer trial is targeting 50 individuals between the ages 19 and 90, diagnosed with oral squamous cell carcinoma. Furthermore, these patients must have endured a relapse of head and neck squamous cell carcinoma (HNSCC) that can feasibly be salvaged through surgery, recovered from any past radiation toxicity under grade 1 severity, and possess a tumor amenable to resection."

Answered by AI

Is this clinical research still accepting volunteers?

"Affirmative. The information posted on clinicaltrials.gov stipulates that this research is currently recruiting for volunteers. It was first published on February 4th 2021 and has been recently updated as of October 4th 2022, with a goal to enrol 50 participants from 3 sites."

Answered by AI

For what medical purposes is Pembrolizumab typically utilized?

"Pembrolizumab is traditionally utilized to treat malignant neoplasms but can also be taken for a variety of other ailments, such as advanced melanoma and microsatellite instability high disease progression after chemotherapy."

Answered by AI

How many participants have signed up to partake in this trial thus far?

"Affirmative. Per the information on clinicaltrials.gov, this medical trial is actively recruiting individuals and was initially posted in February 2021 before its last update happened in October 2022. The study requires 50 participants to be sourced from 3 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Chad Zender 2021. "Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04340258.

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