Study of Ficlatuzumab and Cetuximab for Head and Neck Cancer
This study is testing a new combination of medicines, ficlatuzumab and cetuximab, for people with recurrent or metastatic (cancer that has come back or spread) HPV-negative head and neck squamous cell carcinoma. Ficlatuzumab is a type of antibody that blocks a protein called HGF, and cetuximab blocks another protein called EGFR. Researchers want to see if this combination works better than cetuximab alone (with a placebo, which is like a sugar pill) to help people live longer. You might be able to join if you are 18 or older, have this type of head and neck cancer, and your cancer has progressed after previous treatments, including certain immunotherapy and chemotherapy. The study aims to enroll about 410 participants.
- Study design
- This is a randomized, double-blind, placebo-controlled study with approximately 410 participants. It compares two doses of ficlatuzumab plus cetuximab to placebo plus cetuximab.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from randomization until death from any cause, which is estimated to be approximately 44 months.
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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
Recruiting
PHASE3Ages 18+InterventionalTreatmentAVEO Pharmaceuticals, Inc.
~410 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:FiclatuzumabCetuximabPlacebo
At a glance
Recruiting sites
96 of 112 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To compare the efficacy by overall survival of ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)
Measured over From Randomization until death from any cause (Approximately 44 months)
Conditions
Where it's being run
112 sites across 41 statesSpain12
Italy10
France7
South Korea7
Taiwan7
United Kingdom6
Czechia5
Hungary5
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Male or female and ≥ 18 years of age
Histologically and/or cytologically confirmed primary diagnosis of R/M HNSCC
Participants with oropharyngeal cancer will be required to have proof of p16 negative status submitted on the basis of a pathology report
At least 1 measurable lesion by contrast CT or MRI scan according to RECIST v.1.1. Such lesions must not have been previously irradiated; if the measurable lesion(s) has been irradiated, clear progression must be documented
Participants must have failed prior therapy with an anti-PD-1/PD-L1 ICI and with platinum-based chemotherapy administered in combination or sequentially, in either the locally advanced or R/M setting. Failure of prior treatment may be due to progression of disease or intolerance to treatment
Patient's tumor must be considered inoperable and incurable
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with a life expectancy of at least 12 weeks
For women of childbearing potential (WOCBP), documentation of negative serum pregnancy test within 30 days of randomization
For WOCBP and male participants whose sexual partners are of childbearing potential, agreement to use an effective method of contraception during the study and for at least 5 months after the last dose of study treatment. Birth control methods which may be considered highly effective include methods that achieve a failure rate of less than 1% per year when used consistently and correctly.
Ability to give written informed consent and comply with protocol requirements
Patients with feeding tubes are eligible for the study.
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)
Exclusion
Participants who have received \> 2 prior lines of anticancer therapy or prior treatment with cetuximab/alternative EGFR inhibitors for the treatment of R/M HNSCC
History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or cetuximab
Known or suspected untreated and uncontrolled brain metastases or leptomeningeal carcinomatosis Note: Participants with locally treated brain metastases are eligible provided 2 weeks have elapsed since local therapy. Participants are allowed to continue steroid taper during the start of study treatment.
Prior treatment with any other investigational drug or biologic agent or radiation therapy before a washout has been completed (must be completed prior to randomization):
Any unresolved and significant toxicity (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 5.0) Grade 2 or greater from previous anticancer therapy (including radiation therapy), other than alopecia
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)
Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the participant's involvement in the study or interfere with the interpretation of study results
History of prior malignancy within 2 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early-stage prostate cancer, without evidence of recurrence; participants may or may not be on maintenance therapy)
Participants who are positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) with indication of acute or chronic hepatitis (as defined in protocol)
Radiographic evidence (historical or at screening) of interstitial lung disease or idiopathic pulmonary fibrosis
Female participants who are pregnant or breastfeeding
What this trial measures
- To compare the efficacy by overall survival of ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)From Randomization until death from any cause (Approximately 44 months)
Overall survival (OS), defined as the time from the date of randomization to the date of death for any cause