AzTrials
AzTrials

Metastatic Head-and-neck Squamous-cell CarcinomaPhase 3FIERCE-HNNCT06064877

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

A Phase 3 study testing Ficlatuzumab and Cetuximab in people with Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, run by AVEO Pharmaceuticals, Inc. at 112 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ficlatuzumab and Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
410 participants
Where
112 sitesin 18 countries
Study dates
11 Jan 2024to Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female and ≥ 18 years of age
  • Histologically and/or cytologically confirmed primary diagnosis of R/M HNSCC
  • Participants with oropharyngeal cancer will be required to have proof of p16 negative status submitted on the basis of a pathology report
  • At least 1 measurable lesion by contrast CT or MRI scan according to RECIST v.1.1. Such lesions must not have been previously irradiated; if the measurable lesion(s) has been irradiated, clear progression must be documented
  • Participants must have failed prior therapy with an anti-PD-1/PD-L1 ICI and with platinum-based chemotherapy administered in combination or sequentially, in either the locally advanced or R/M setting. Failure of prior treatment may be due to progression of disease or intolerance to treatment
  • Patient's tumor must be considered inoperable and incurable
Show all 12Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with a life expectancy of at least 12 weeks
  • For women of childbearing potential (WOCBP), documentation of negative serum pregnancy test within 30 days of randomization
  • For WOCBP and male participants whose sexual partners are of childbearing potential, agreement to use an effective method of contraception during the study and for at least 5 months after the last dose of study treatment. Birth control methods which may be considered highly effective include methods that achieve a failure rate of less than 1% per year when used consistently and correctly.
  • Ability to give written informed consent and comply with protocol requirements
  • Patients with feeding tubes are eligible for the study.
  • Archived tissue sample must be submitted to the Sponsor-designated laboratory within 60 days of randomization for c-Met analysis (if a tissue sample is not available, a fresh biopsy may be required prior to enrollment)

Who cannot join

  • Participants who have received > 2 prior lines of anticancer therapy or prior treatment with cetuximab/alternative EGFR inhibitors for the treatment of R/M HNSCC
  • History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or cetuximab
  • Known or suspected untreated and uncontrolled brain metastases or leptomeningeal carcinomatosis Note: Participants with locally treated brain metastases are eligible provided 2 weeks have elapsed since local therapy. Participants are allowed to continue steroid taper during the start of study treatment.
  • Prior treatment with any other investigational drug or biologic agent or radiation therapy before a washout has been completed (must be completed prior to randomization):
  • 2 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors
  • 3 weeks (21 days) or 5 half-lives, whichever is shorter, for antibody-drug conjugates
Show all 16Show fewer
  • 4 weeks (28 days) for cell therapies
  • 2 weeks (14 days) for radiation therapy
  • Any unresolved and significant toxicity (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) Grade 2 or greater from previous anticancer therapy (including radiation therapy), other than alopecia
  • Significant cardiovascular disease, including: Cardiac failure New York Heart Association class III or IV; Myocardial infarction, severe or unstable angina within 6 months prior to randomization; History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
  • Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the participant's involvement in the study or interfere with the interpretation of study results
  • History of prior malignancy within 2 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early-stage prostate cancer, without evidence of recurrence; participants may or may not be on maintenance therapy)
  • Participants who are positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) with indication of acute or chronic hepatitis (as defined in protocol)
  • Radiographic evidence (historical or at screening) of interstitial lung disease or idiopathic pulmonary fibrosis
  • Female participants who are pregnant or breastfeeding
  • A full list of inclusion and exclusion criteria can be found in the protocol.

Trial locations and contacts

112 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Office contact

+1.857.400.0101

clinical@aveooncology.com

112 sites in 18 countries

United States28 sites, 25 recruiting

  • Emory University

    Atlanta, Georgia, 30308

    Recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Recruiting

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

    Recruiting

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

    Recruiting

  • University of Cincinnati - UC Health Barrett Cancer Center

    Cincinnati, Ohio, 45219

    Withdrawn

  • Ohio State University, James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85212

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Oncology Consultants

    Houston, Texas, 77030

    Recruiting

  • Northwell Health Cancer Institute

    Lake Success, New York, 10042

    Recruiting

  • University of California Los Angeles

    Los Angeles, California, 90024

    Recruiting

  • Medical College of Wisconsin - Froedtert Hospital Cancer Center

    Milwaukee, Wisconsin, 53202

    Terminated

  • Yale School of Medicine - Smilow Cancer Hospital

    New Haven, Connecticut, 06511

    Recruiting

  • Manhattan Eye, Ear & Throat Hospital

    New York, New York, 10065

    Recruiting

  • AdventHealth Medical Group Oncology & Hematology at Orlando

    Orlando, Florida, 32804

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • University of Pittsburgh Medical Center - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • VCU Massey Cancer Center

    Richmond, Virginia, 23298

    Recruiting

  • MaineHealth Institute for Research

    South Portland, Maine, 04106

    Recruiting

  • Siteman Cancer Center - Washington University

    St Louis, Missouri, 63110

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10461

    Withdrawn

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719

    Recruiting

  • The George Washington University

    Washington D.C., District of Columbia, 20052-0042

    Recruiting

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

    Recruiting

Other trials in United States

Spain12 sites, 11 recruiting

  • Hospital Universitario Vinalopo

    Alicante, 03293

    Recruiting

  • Institut Catala d'Oncologia - Hospital Duran i Reynals

    Badalona, 08907

    Recruiting

  • UOMI Cancer Center-Clinica Tres Torres

    Barcelona, 08017

    Recruiting

  • Institut Catala d'Oncologia (ICO) - Hospitalet

    Barcelona, 08908

    Recruiting

  • Vall d'Hebron Institut d'Oncologia (VHIO)

    Barcelona

    Recruiting

  • Hospital universitario Jerez

    Cadiz, 11407

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)

    Madrid, 28051

    Recruiting

  • Hospital Universitario de Torrejón

    Madrid

    Recruiting

  • Hospital Quironsalud Malaga

    Málaga, 29004

    Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander

    Withdrawn

  • Hospital Clinico Universitario de Valencia (CHUV)

    Valencia

    Recruiting

Other trials in Spain

Italy10 sites, 9 recruiting

  • IRCCS Istituto Scienze Neurologiche

    Bologna, 40139

    Recruiting

  • AOU Careggi

    Florence, 51134

    Recruiting

  • IRCCS Istituto Clinico Humanitas - Cancer center

    Milan, 20089

    Recruiting

  • IRCCS Ospedale San Raffaele Milano

    Milan, 20132

    Recruiting

  • Fondazione IRCCS - Istituto Nazionale Tumori - Oncologia

    Milan, 20133

    Recruiting

  • Azienda Ospedaliera Universitaria Maggiore Della Carita Novara

    Novara, 28100

    Recruiting

  • Istituto Oncologico Veneto

    Padua, 35128

    Recruiting

  • IRCCS - ICS Maugeri

    Pavia, 27100

    Recruiting

  • Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

    Withdrawn

Other trials in Italy

France7 sites, 6 recruiting

  • Clinique Pasteur - Lanroze- Centre Finistérien de Radiothérapie et d'Oncologie

    Brest, 29200

    Withdrawn

  • Pôle Santé Léonard de Vinci

    Chambray-lès-Tours, 37170

    Recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Recruiting

  • Assistance Publique Hopitaux de Marseille (APHM)-Hôpital La Timone

    Marseille, 13005

    Recruiting

  • Institut Curie

    Paris, 75248

    Recruiting

  • Hôpital Privé des Côtes d'Armor

    Plérin, 22190

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

South Korea7 sites, 7 recruiting

  • Keimyung University Dongsan Hospital

    Daegu, 42601

    Recruiting

  • Korea University Anam Hospital

    Seoul, 02841

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, 03312

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Ajou University Hospital

    Suwon, 16499

    Recruiting

Other trials in South Korea

Taiwan7 sites, 5 recruiting

  • Changhua Christian Hospital

    Changhua, 500

    Recruiting

  • Chang Gung Memorial Hospital - Kaohsiung

    Kaohsiung City, 833401

    Recruiting

  • China Medical University Hospital (CMUH)

    Taichung, 40447

    Recruiting

  • National Cheng-Kung University Hospital

    Tainan, 704017

    Withdrawn

  • National Taiwan University Hospital

    Taipei, 100

    Withdrawn

  • Taipei Veterans General Hospital

    Taipei, 112201

    Recruiting

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan, 33305

    Recruiting

Other trials in Taiwan

United Kingdom6 sites, 5 recruiting

  • NHS Grampian - Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

    Recruiting

  • Sarah Cannon Research Institute

    London, W1G 6AD

    Recruiting

  • City Hospital Nottingham

    Nottingham, NG5 1PB

    Recruiting

  • The Royal Marden Hospital, Surrey

    Sutton, SM2 5PT

    Recruiting

  • Torbay Hospital

    Torquay, TQ2 7AA

    Withdrawn

Other trials in United Kingdom

Canada5 sites, 4 recruiting

  • Tom Baker Cancer Centre (Alberta Health Services)

    Calgary, Alberta, T3N 4N1

    Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Recruiting

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A3J1

    Recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

    Withdrawn

  • Princess Margaret Cancer Center - University Health Network

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

Czechia5 sites, 4 recruiting

  • Fakultni nemocnice Brno

    Brno, 60200

    Recruiting

  • Masaryk Memorial Cancer Institute

    Brno, 65653

    Recruiting

  • Fakultni Nemocnice Olomouc

    Olomouc, 77900

    Withdrawn

  • Fakultni Nemocnice Kralovske Vinohrady

    Prague, 13400

    Recruiting

  • Fakultni nemocnice Bulovka

    Prague

    Recruiting

Other trials in Czechia

Hungary5 sites, 3 recruiting

  • Orszagos Onkologiai Intezet

    Budapest, 1122

    Not yet recruiting

  • Petz Aladar Country Teaching Hospital

    Győr, 9024

    Withdrawn

  • Josa Andras Oktatokorhaz

    Nyíregyháza, 4400

    Recruiting

  • University of Pecs - Oncology

    Pécs, 7624

    Recruiting

  • Szent Lázár Megyei Kórház

    Salgótarján, 3100

    Withdrawn

Other trials in Hungary

Australia4 sites, 4 recruiting

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

    Recruiting

  • St George Hospital

    Kogarah, New South Wales, 2217

    Recruiting

  • St. John of God Murdoch Hospital

    Murdoch, Western Australia, 6150

    Recruiting

  • St. Vincent's Hospital

    Sydney, New South Wales, 2010

    Recruiting

Other trials in Australia

Belgium3 sites, 3 recruiting

  • CHU Liège

    Liège, 4000

    Recruiting

  • CHU Universite Catholique de Louvain

    Namur, B5000

    Recruiting

  • Vitaz-Sint-Niklaas Moerland

    Sint-Niklaas, 9100

    Recruiting

Other trials in Belgium

Germany3 sites, 3 recruiting

  • Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie

    Berlin, 12200

    Recruiting

  • UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Innere Medizin I, Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation

    Freiburg im Breisgau, 79106

    Recruiting

  • Ludwig-Maximilians University

    Munich, 81377

    Recruiting

Other trials in Germany

Serbia3 sites, 3 recruiting

  • Institute of Oncology and Radiology of Serbia

    Belgrade

    Recruiting

  • Institute for Oncology Vojvodina

    Kamenitz

    Recruiting

  • University Clinical Center Kragujevac

    Kragujevac

    Recruiting

Other trials in Serbia

Netherlands2 sites, 1 recruiting

  • Antoni van Leeuwenhoek

    Amsterdam, 1066

    Withdrawn

  • Radboud University Medical Center

    Nijmegen, 6525

    Recruiting

Other trials in Netherlands

Poland2 sites, 2 recruiting

  • Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85-796

    Recruiting

  • National Research Institute of Oncology

    Gliwice, 44-100

    Recruiting

Other trials in Poland

Romania2 sites, 2 recruiting

  • Medisprof Cancer Center

    Cluj-Napoca, 400641

    Recruiting

  • Centrul radioterapie Amethyst Cluj-Napoca

    Floreşti, 407280

    Recruiting

Other trials in Romania

Bulgaria1 site

  • University Hospital

    Panagyurishte, 4500

    Withdrawn

Other trials in Bulgaria

About this study

Official title: A Multicenter, Randomized, Double Blind, Placebo - Controlled, Phase 3 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 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.

Read the detailed description

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.

Being tested
Ficlatuzumab, Cetuximab, Placebo
Keywords
Recurrent, Metastatic, HPV-negative, Head and Neck, Squamous Cell Carcinoma
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasm Metastasis, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FiclatuzumabBiological

    Also called AV-299

    Ficlatuzumab (AV-299) is a humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G1 (IgG1) monoclonal antibody (mAb).

  • CetuximabBiological

    Also called Erbitux

    Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.

  • PlaceboOther

    Placebo for this study will be normal saline

Study groups in NCT06064877
Study groupRoleWhat they receive
Arm 1 (Investigational Arm: ficlatuzumab plus cetuximab)ExperimentalIntravenous (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
Receives: Biological: Ficlatuzumab; Biological: Cetuximab
Arm 2 (Investigational Arm: ficlatuzumab plus cetuximab)ExperimentalIV ficlatuzumab dose B on D1 and D15 of each 28-day cycle IV cetuximab on D1 and D15 of each 28-day cycle
Receives: Biological: Ficlatuzumab; Biological: Cetuximab
Arm 3 (Comparator Arm: placebo plus cetuximab)Placebo comparatorIV placebo (saline, ficlatuzumab-matched) on D1 and D15 of each 28-day cycle IV cetuximab on D1 and D15 of each 28-day cycle
Receives: Biological: Cetuximab; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Overall survival (OS), defined as the time from the date of randomization to the date of death for any cause

    Measured: From Randomization until death from any cause (Approximately 44 months)

Secondary outcomes (9)

  1. To evaluate progression-free survival (PFS) for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC

    Progression-free survival (PFS), defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause, whichever occurs first

    Measured: From Randomization until disease progression or death (Approximately 44 months)

  2. To evaluate additional objective response rate for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC

    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

    Measured: From Cycle 1 Day 1 until last response assessment (response assessments are every 8 weeks for the first year, every 12 weeks for years 2 and 3 and then every 6 months)

  3. To evaluate disease control rate (DCR) for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC

    Disease control rate (DCR), defined for participants who have achieved a CR, PR or stable disease for at least 8 weeks per RECIST v1.1

    Measured: From Cycle 1 Day 1 until last response assessment (response assessments are every 8 weeks for the first year, every 12 weeks for years 2 and 3 and then every 6 months)

  4. To evaluate duration of response (DOR) for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC

    Duration of response (DOR), defined as the time from first documented evidence of a confirmed CR or PR per RECIST v1.1

    Measured: From Cycle 1 Day 1 until last response assessment (response assessments are every 8 weeks for the first year, every 12 weeks for years 2 and 3 and then every 6 months)

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

    Number of times participants experience Adverse Events (AE) or abnormal laboratory values.

    Measured: From Screening until 30 days after last dose

  6. To evaluate the pharmacokinetics (PK) of ficlatuzumab

    Serum samples will be assessed for concentrations of ficlatuzumab

    Measured: From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)

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

    Serum samples will be assessed for the presence of ADA to ficlatuzumab.

    Measured: From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)

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

    Serum samples that test positive for the presence of ADA to ficlatuzumab will be further tested for the presence of nAB.

    Measured: From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)

  9. To evaluate the quality of life (QOL) of ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC

    Change from baseline in overall health status and time to clinically meaningful deterioration based on scoring of standardized participant questionnaires

    Measured: From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2023
  2. Study start11 Jan 2024
  3. Primary completionAug 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
410 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06064877
Sponsor's protocol ID
AV-299-23-301
Acronym
FIERCE-HN
Status last verified
Apr 2026
First submitted
14 Sep 2023
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ficlatuzumab and Cetuximab in people with Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, run by AVEO Pharmaceuticals, Inc. at 112 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Spain, Italy, France, South Korea and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Office (+1.857.400.0101, clinical@aveooncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: From Randomization until death from any cause (Approximately 44 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06064877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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