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Can a grid of proton beams boost immunotherapy against oral cancer?

NCT ID NCT07783581

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This phase II trial is testing whether adding a special type of radiation therapy to the immunotherapy drug pembrolizumab before surgery can help shrink oral cavity tumors. The study compares two radiation techniques: proton spatially fractionated radiotherapy (SFRT), which delivers radiation in a grid pattern to spare healthy tissue, and photon stereotactic body radiotherapy (SBRT), which precisely targets the tumor. Participants have locally advanced or recurrent oral cavity squamous cell carcinoma that has not been previously treated with radiation. The goal is to see if this combination can reduce the tumor size enough to improve surgical outcomes and potentially reduce the need for more extensive treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab combined with proton spatially fractionated radiotherapy (SFRT) or photon stereotactic body radiotherapy (SBRT)
What this could lead to
If successful, this approach could shrink oral cavity tumors before surgery, potentially reducing the extent of surgery and improving long-term outcomes.
What could go wrong
This is a phase II trial with a small number of participants, so results may not be conclusive. Combining radiation and immunotherapy may increase side effects, and the benefit over standard treatment is not yet proven.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2030

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

18 years and older

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: * Patients with histologically confirmed human papillomavirus (HPV)/p16-unrelated squamous cell carcinoma of the oral cavity and: * Either locally advanced (T3-T4) non-metastatic disease, or * Radiation-naïve locoregionally recurrent disease (prior radiation to a site outside of the treatment fields is permitted) * Age ≥ 18 years old * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 * Eligible to receive immunotherapy on multidisciplinary evaluation * Ability to complete questionnaire(s) by themselves or with assistance * Provide signed written informed consent in accordance with ethical, regulatory, and institutional requirements * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Willing to consent to and provide tissue and blood samples for correlative research purposes (not the optional Riskguard and OncoExtra testing) * PD-L1 combined positive score ≥ 1 Exclusion Criteria: * Participation in another clinical study with an investigational product during the last 3 months (12 weeks) * Exception: Unless it is an observational (non-interventional) clinical study during the follow-up period of the study * Contraindications to pembrolizumab * Prior radiation therapy to the head and neck * Previous anticancer therapeutic received ≤ 30 days prior to registration, or adequate washout period on a per-agent basis, or concurrent anti-cancer therapeutic not specified by this protocol * Uncontrolled pre-existing condition(s), such as infection, congestive heart failure, hypertension, angina, arrhythmia, chronic diarrhea, psychiatric conditions, or others, that in the opinion of the treating investigator limits the ability to provide consent or longitudinal participation in this study * Inability to place 2 or more SFRT spheres within the tumor target * Prophylactic placement of feeding tubes is not allowed

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Conditions

The condition(s) this trial relates to.

oral cavity 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.

Locally advanced oral cavity squamous cell carcinoma Locally recurrent oral cavity squamous cell carcinoma Oral cavity squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

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