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Monoclonal Antibodies

Ficlatuzumab + Cetuximab for Head and Neck Cancer (FIERCE-HN Trial)

Phase 3

Recruiting

Research Sponsored by AVEO Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically and/or cytologically confirmed primary diagnosis of R/M HNSCC

Participants with oropharyngeal cancer will be required to have proof of HPV-negative status submitted on the basis of a pathology report

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until death from any cause (approximately 44 months)

Awards & highlights

FIERCE-HN Trial Summary

This trial will test if adding a drug to cetuximab helps people with head and neck cancer live longer.

Who is the study for?

This trial is for adults over 18 with recurrent or metastatic HPV-negative head and neck squamous cell carcinoma who've had prior unsuccessful treatment with anti-PD-1/PD-L1 therapy and platinum-based chemo. They should be reasonably healthy (ECOG status of 0 or 1) and not pregnant, willing to use contraception, and have a measurable lesion that hasn't been treated by radiation unless it's clearly growing.Check my eligibility

What is being tested?

The study tests if ficlatuzumab combined with cetuximab improves survival compared to placebo plus cetuximab in patients whose cancer has returned or spread. It aims to see which combination is better at stopping the cancer from progressing.See study design

What are the potential side effects?

Possible side effects include allergic reactions, skin rash, low magnesium levels, fatigue, nausea, diarrhea from cetuximab; ficlatuzumab may cause similar effects but also can affect blood pressure and kidney function.

FIERCE-HN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis of head and neck cancer is confirmed by lab tests.

Select...

My oropharyngeal cancer is HPV-negative, as confirmed by a pathology report.

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I have a tumor that can be measured and has not been treated with radiation, or if it was, it has grown since then.

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My cancer progressed or I couldn't tolerate previous treatments with anti-PD-1/PD-L1 and platinum-based chemotherapy.

Select...

I can care for myself and doctors expect me to live at least 12 more weeks.

FIERCE-HN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until death from any cause (approximately 44 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until death from any cause (approximately 44 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until death from any cause (approximately 44 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To compare the efficacy by overall survival of ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)

Secondary outcome measures

To assess the immunogenicity of ficlatuzumab via antidrug antibodies (ADAs)

To assess the immunogenicity of ficlatuzumab via neutralizing antibodies (nAB)

To compare the safety and tolerability of ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC

+2 more

FIERCE-HN Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 2 (Investigational Arm: ficlatuzumab plus cetuximab)Experimental Treatment2 Interventions

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

Group II: Arm 1 (Investigational Arm: ficlatuzumab plus cetuximab)Experimental Treatment2 Interventions

Intravenous (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

Group III: Arm 3 (Comparator Arm: placebo plus cetuximab)Placebo Group2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ficlatuzumab

2015

Completed Phase 2

~120

Cetuximab

2011

Completed Phase 3

~2480

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AVEO Pharmaceuticals, Inc.Lead Sponsor

45 Previous Clinical Trials

3,540 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently involved in this clinical trial?

"Affirmative. Per the information on clinicaltrials.gov, this medical experiment is currently looking for participants to join its ranks. The trial was first published on November 1st 2023 and has been revised as recently as 14th of that same month. A total of 410 individuals are required from a single location."

Answered by AI

Are participants currently being enrolled for this experiment?

"The clinical trial registry on clinicaltrials.gov reveals that this research is still recruiting participants, with the initial posting occurring November 1st 2023 and a recent update made on November 14th of the same year."

Answered by AI

Do the potential benefits of Arm 1 (Investigational Arm: ficlatuzumab plus cetuximab) outweigh its risks for patients?

"Our experts at Power assigned a score of 3 to Arm 1 (Investigational Arm: ficlatuzumab plus cetuximab) due to the existence of robust evidence regarding its efficacy and safety collected through Phase 3 trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06064877.

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