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

Active:	Yes
Cancer Type:	Head and Neck Cancer Skin Cancer (Non-Melanoma) Unknown Primary	NCT ID:	NCT06064877
Trial Phases:	Phase III	Protocol IDs:	AV-299-23-301 (primary) NCI-2024-00596
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Aveo Pharmaceuticals Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT06064877

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.