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New drug cocktail aims to shrink oral tumors before surgery

NCT ID NCT07484139

Disease control Sponsor: UNC Lineberger Comprehensive Cancer Center 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This phase 2 trial tests a combination of two drugs, XL-092 and pembrolizumab (Keytruda), given before surgery to people with a type of oral cancer that is HPV-negative and can be removed. The goal is to see if the drugs can shrink or eliminate the tumor before the operation. About 26 participants will be enrolled, and the study will check how many have a major or complete response in their tumor tissue after treatment.

What this could mean

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

Active substance
XL-092 (Zanzalintinib) and pembrolizumab (Keytruda)
What this could lead to
If this works, it could lead to a new treatment option that shrinks oral cavity tumors before surgery, potentially improving survival and reducing recurrence.
What could go wrong
This is a small, early-phase trial with only 26 participants. The combination may cause side effects, and it's not yet known if it works better than current treatments.

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 26 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

May 2028

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: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee. * Age ≥ 18 years at the time of consent. * Tumors must have PD-L1 Combined Positive Score (CPS) ≥ 1. * ECOG or Karnofsky Performance Status of 0-1 * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) within 30 days prior to treatment . Exclusion Criteria: * Known HPV-positive cancer * Active infection requiring systemic therapy. * Prior treatment with XL-092 * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms 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.

Head and neck cancer 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 places running it

    3 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

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