A Multicenter, Randomized, Double Blind, Placebo - Controlled, Phase 3 Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV -Negative Head and Neck Squamous Cell Carcinoma. (FIERCE-HN)
AVEO Pharmaceuticals, Inc.
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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-bas…
Interventions
- BiologicalFiclatuzumab
Ficlatuzumab (AV-299) is a humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G1 (IgG1) monoclonal antibody (mAb).
- BiologicalCetuximab
Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.
- OtherPlacebo
Placebo for this study will be normal saline
Locations (112)
- Banner MD Anderson Cancer CenterGilbert, Arizona
- The University of Arizona Cancer CenterTucson, Arizona
- University of California Los AngelesLos Angeles, California
- Yale School of Medicine - Smilow Cancer HospitalNew Haven, Connecticut
- The George Washington UniversityWashington D.C., District of Columbia
- AdventHealth Medical Group Oncology & Hematology at OrlandoOrlando, Florida