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OncoMatch/Clinical Trials/NCT06912087

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

Is NCT06912087 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Zanzalintinib and Cetuximab for head and neck neoplasms.

Phase 1RecruitingUniversity of ChicagoNCT06912087Data as of May 2026

Treatment: Zanzalintinib · Cetuximab · PembrolizumabThis Phase I clinical trial evaluates the safety, tolerability, and optimal dosing of Zanzalintinib in combination with Pembrolizumab and Cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The study aims to establish the maximally tolerated dose (MTD) and recommended Phase II dose (RP2D) while also exploring efficacy outcomes, including progression-free survival (PFS) and overall survival (OS).

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: CDKN2A p16 overexpression

For oropharyngeal cancer: HPV (p16) testing is required. p16 Immunohistochemistry (IHC) is sufficient for Human Papillomavirus (HPV) testing.

Required: PD-L1 (CD274) CPS ≥ 1 (CPS ≥ 1)

Programmed cell death ligand 1 (PD-L1) combined positive score (CPS) : For patients with previously untreated R/M disease, a combined positive score (CPS) of 1 or greater is required. There is no PD-L1 restriction for patients who have previously received anti-PD(L)1 therapy.

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines

Cannot have received: vegfr inhibitor (zanzalintinib)

Cannot have received: egfr inhibitor (cetuximab)

Lab requirements

Blood counts

anc ≥ 1500/mm3; platelets ≥ 100,000/mm3; hemoglobin ≥ 9 g/dl

Kidney function

normal kidney function

Liver function

normal liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Chicago Medicine Comprehensive Cancer Center · Chicago, Illinois

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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