Clinical Trial

A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma

Study acronym: FIERCE-HN
Recruiting Phase 3
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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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2023-09-26; most recent amendment 2026-04-06.
Status change: Not Yet Recruiting → Recruiting 2023-11-14
Trial Details
NCT Number NCT06064877
Lead Sponsor AVEO Pharmaceuticals, Inc.
Conditions Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
Enrollment 410 participants
Start Date 2024-01-11
Primary Completion 2027-08 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-04-09