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 (Jun 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
Treatments studied
Targeted therapy
Other
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 →Frequently asked questions
Is NCT06064877 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior EGFR inhibitor, anticancer therapy disqualifies patients from enrollment.
Does this trial require CDKN2A?
Yes, CDKN2A p16 negative is a required biomarker for enrollment.
Does this trial require MET?
Yes, MET analysis required 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 qualifyRelated pages