OncoMatch/Clinical Trials/NCT06064877
A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma
Is NCT06064877 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Ficlatuzumab and Cetuximab for metastatic head-and-neck squamous-cell carcinoma.
Treatment: Ficlatuzumab · Cetuximab — The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of progression-free survival and/or overall survival.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A p16 negative (negative)
Participants with oropharyngeal cancer will be required to have proof of p16 negative status submitted on the basis of a pathology report
Required: MET analysis required
Archived tissue sample must be submitted to the Sponsor-designated laboratory within 60 days of randomization for c-Met analysis (if a tissue sample is not available, a fresh biopsy may be required prior to enrollment)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — locally advanced or recurrent/metastatic
Participants must have failed prior therapy with an anti-PD-1/PD-L1 ICI
Must have received: platinum-based chemotherapy — locally advanced or recurrent/metastatic
Participants must have failed prior therapy with...platinum-based chemotherapy administered in combination or sequentially, in either the locally advanced or R/M setting
Cannot have received: EGFR inhibitor (cetuximab)
prior treatment with cetuximab/alternative EGFR inhibitors for the treatment of R/M HNSCC
Cannot have received: anticancer therapy
Exception: > 2 prior lines
Participants who have received > 2 prior lines of anticancer therapy
Lab requirements
Cardiac function
Significant cardiovascular disease, including: Cardiac failure New York Heart Association class III or IV; Myocardial infarction, severe or unstable angina within 6 months prior to randomization; History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
Significant cardiovascular disease, including: Cardiac failure New York Heart Association class III or IV; Myocardial infarction, severe or unstable angina within 6 months prior to randomization; History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- The University of Arizona Cancer Center · Tucson, Arizona
- University of California Los Angeles · Westwood, Los Angeles, California
- Yale School of Medicine - Smilow Cancer Hospital · New Haven, Connecticut
- The George Washington University · Washington D.C., District of Columbia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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