OncoMatch/Clinical Trials/NCT06912087
Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC
Is NCT06912087 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
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 →Frequently asked questions
Is NCT06912087 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior vegfr inhibitor, egfr inhibitor disqualifies patients from enrollment.
Does this trial require CDKN2A?
Yes, CDKN2A p16 overexpression is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 CPS ≥ 1 is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify