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NCT07484139PHASE2NOT_YET_RECRUITING

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

Sponsor: UNC Lineberger Comprehensive Cancer Center + Exelixis

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Oral Cavity Squamous Cell Carcinoma, Head and Neck Cancer
Interventions
XL092, Pembrolizumab
Enrollment
26 participants
Primary completion
May 2028
Study completion
May 2028
First posted
Mar 2026
Last updated
May 2026

Primary Endpoints (CT.gov)

Rate of pathologic response

Time frame: Up to 66 days

Secondary Endpoints

Neoadjuvant Adverse Events

Events Free Survival (EFS)

Objective response rate (ORR)

Eligibility Criteria

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).

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov