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H&N NEO-COMBAT XL: Zanzalintinib and Pembrolizumab for Oral Cavity Cancer

This study is testing a combination of two drugs, XL092 (Zanzalintinib) and Pembrolizumab (Keytruda), before surgery for oral cavity squamous cell carcinoma (OCSCC), a type of head and neck cancer. Researchers want to see if this combination is safe and if it can shrink tumors more effectively than standard treatment. To join, you must be at least 18 years old, have surgically removable OCSCC, and your tumor must show a certain level of a biomarker called PD-L1. The main goal is to measure how much the tumor shrinks or disappears after treatment and surgery. This study is currently enrolling 26 participants.

Study design
This is a single-arm Phase 2B study, meaning all participants will receive the same treatment. It plans to enroll 26 participants in total, starting with 11 in the first stage.
What's involved
You would take XL092 orally once a day and receive Pembrolizumab intravenously every 21 days. The primary response will be measured up to 66 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured up to 66 days after treatment, but the full duration of follow-up is not specified.

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NCT07484139

H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC)

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~26 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:XL092Pembrolizumab

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of pathologic response
Measured over Up to 66 days

Conditions

Oral Cavity Squamous Cell Carcinoma
Head and Neck Cancer

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Where it's being run

3 sites across 3 states
Georgia1
North Carolina1
Pennsylvania1

Study leadership

  • Siddharth Sheth, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Rose Hall
[email protected]
919-984-0000
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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Rate of pathologic responseUp to 66 days

    Rate of pathologic response, assessed following surgery, will be defined as either pathological complete response (pCR), which is the absence of residual viable tumor or major pathological response (MPR), which is \<10% residual tumor.