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.
Treatment: Zanzalintinib · Cetuximab · Pembrolizumab — This 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).
Check if I qualifyExtracted 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
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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