FIERCE-HN study design

Not actual patient

Not actual patient

FIERCE-HN study design

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 (FIERCE-HN)

The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with R/M human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (R/M HNSCC).

Multicenter, randomized, double-blind, placebo-controlled Phase 3 study
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)
- Ficlatuzumab is a humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G1 (IgG1) monoclonal antibody (mAb)
- Cetuximab is an epidermal growth factor receptor (EGFR) antagonist
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
Anticipated enrollment: 410 participants

Randomization

HPV-negative
R/M HNSCC
N≈410

Arm 1

IV ficlatuzumab dose A on Day 1 (D1) and D15 of each 28-day cycle IV cetuximab on D1 and D15 of each 28-day cycle

Outcome measures

Primary

Overall survival (OS), defined as the time from the date of randomization

Secondary

Progression-free survival (PFS), defined as the time from randomization to the first documented progressive disease (PD) per RECIST v1.1, or death from any cause
Objective response rate (ORR), defined as the percentage of participants who have a complete response (CR) or a partial response (PR) per RECIST v1.1
Duration of response (DOR), defined as the time from first documented evidence of a confirmed CR or PR per RECIST v1.1
Safety and tolerability: Number of times participants experience adverse events (AE) or abnormal laboratory values
Pharmacokinetics: Serum samples will be assessed for concentrations of ficlatuzumab and cetuximab
Immunogenicity: Serum samples will be assessed for the presence of anti-drug antibodies (ADA) to ficlatuzumab
- Serum samples that test positive for the presence of ADA to ficlatuzumab will be further tested for the presence of neutralizing antibodies

Arm 2

IV ficlatuzumab dose B on D1 and D15 of each 28-day cycle IV cetuximab on D1 and D15 of each 28-day cycle

Arm 3

IV placebo (saline) on D1 and D15 of each 28-day cycle IV cetuximab on D1 and D15 of each 28-day cycle