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New combo therapy aims to fight returning head and neck cancer

NCT ID NCT04340258

Disease control Sponsor: University of Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of an immunotherapy drug (pembrolizumab) and a type of internal radiation (cesium-131 brachytherapy) given during surgery for head and neck cancer that has come back. The goal is to see if this approach is safe and helps prevent the cancer from returning. About 50 people whose cancer can be surgically removed are taking part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HNSCC

Contacts and locations

Locations

  • Thomas Jefferson

    Philadelphia, Pennsylvania, 19144, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

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