A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma
Head and Neck Cancer
Skin Cancer (Non-Melanoma)
Unknown Primary
18 Years and older, Male and Female
AV-299-23-301 (primary)
NCI-2024-00596
Summary
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.
Objectives
This multicenter, randomized, double-blind, placebo-controlled Phase 3 study is designed
to compare the efficacy and safety of two dose levels of ficlatuzumab combined with
cetuximab (Arm 1 or Arm 2) to a control arm of placebo plus cetuximab (Arm 3) in
participants with R/M human papilloma virus (HPV)-negative HNSCC. Eligible participants
must have failed prior therapy with an anti-PD-1 [programmed cell death protein 1] or
PD-L1 [programmed death ligand 1] immune checkpoint inhibitor (ICI) and with
platinum-based chemotherapy, administered in combination or sequentially. Failure of
prior treatment may be due to progression of disease or intolerance to treatment. It is
anticipated that the study will enroll approximately 410 participants across 3 arms.
Eligibility
- 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 HPV-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
- 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 60 days 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/HGF analysis
Treatment Sites in Georgia
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