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