drugset / Trial / 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

NCT06064877

Phase 3 Recruiting 410 enrolled AVEO Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-01-11
Primary completion
2027-08
Completion
2027-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ficlatuzumab Monoclonal antibody Intravenous
Background Cetuximab Monoclonal antibody Intravenous