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)

April 6, 2026 updated by: AVEO Pharmaceuticals, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

410

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • St George Hospital
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • St. Vincent's Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • St. John of God Murdoch Hospital
  • Belgium
      • Liège, Belgium, 4000
        • Recruiting
        • Chu Liege
      • Namur, Belgium, B5000
        • Recruiting
        • CHU Universite Catholique de Louvain
      • Sint-Niklaas, Belgium, 9100
        • Recruiting
        • Vitaz-Sint-Niklaas Moerland
  • Bulgaria
      • Panagyurishte, Bulgaria, 4500
        • Withdrawn
        • University Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3N 4N1
        • Recruiting
        • Tom Baker Cancer Centre (Alberta Health Services)
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Withdrawn
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Center - University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H4A3J1
        • Recruiting
        • McGill University Health Centre (MUHC)
  • Czechia
      • Brno, Czechia, 65653
        • Recruiting
        • Masaryk Memorial Cancer Institute
      • Brno, Czechia, 60200
        • Recruiting
        • Fakultni nemocnice Brno
      • Olomouc, Czechia, 77900
        • Withdrawn
        • Fakultni nemocnice Olomouc
      • Prague, Czechia, 13400
        • Recruiting
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Czechia
        • Recruiting
        • Fakultni nemocnice Bulovka
  • France
      • Brest, France, 29200
        • Withdrawn
        • Clinique Pasteur - Lanroze- Centre Finistérien de Radiothérapie et d'Oncologie
      • Chambray-lès-Tours, France, 37170
        • Recruiting
        • Pole Sante Leonard de Vinci
      • Lyon, France, 69008
        • Recruiting
        • Centre Léon Bérard
      • Marseille, France, 13005
        • Recruiting
        • Assistance Publique Hopitaux de Marseille (APHM)-Hôpital La Timone
      • Paris, France, 75248
        • Recruiting
        • Institut Curie
      • Plérin, France, 22190
        • Recruiting
        • Hôpital Privé Des Côtes d'Armor
      • Villejuif, France, 94805
        • Recruiting
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, 12200
        • Recruiting
        • Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie
      • Freiburg im Breisgau, Germany, 79106
        • Recruiting
        • UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Innere Medizin I, Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
      • Munich, Germany, 81377
        • Recruiting
        • Ludwig-Maximilians University
  • Hungary
      • Budapest, Hungary, 1122
        • Not yet recruiting
        • Orszagos Onkologiai Intezet
      • Győr, Hungary, 9024
        • Withdrawn
        • Petz Aladar Country Teaching Hospital
      • Nyíregyháza, Hungary, 4400
        • Recruiting
        • Jósa András Oktatókórház
      • Pécs, Hungary, 7624
        • Recruiting
        • University of Pecs - Oncology
      • Salgótarján, Hungary, 3100
        • Withdrawn
        • Szent Lazar Megyei Korhaz
  • Italy
      • Bologna, Italy, 40139
        • Recruiting
        • IRCCS Istituto Scienze Neurologiche
      • Florence, Italy, 51134
        • Recruiting
        • AOU Careggi
      • Milan, Italy, 20089
        • Recruiting
        • IRCCS Istituto Clinico Humanitas - Cancer Center
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele Milano
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS - Istituto Nazionale Tumori - Oncologia
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliera Universitaria Maggiore Della Carita Novara
      • Padua, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto
      • Pavia, Italy, 27100
        • Recruiting
        • Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo
      • Pavia, Italy, 27100
        • Recruiting
        • IRCCS - ICS Maugeri
      • Roma, Italy, 00168
        • Withdrawn
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Netherlands
      • Amsterdam, Netherlands, 1066
        • Withdrawn
        • Antoni van Leeuwenhoek
      • Nijmegen, Netherlands, 6525
        • Recruiting
        • Radboud University Medical Center
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Recruiting
        • Centrum Onkologii Im. Prof. F. Lukaszczyka W Bydgoszczy
      • Gliwice, Poland, 44-100
        • Recruiting
        • National Research Institute of Oncology
  • Romania
      • Cluj-Napoca, Romania, 400641
        • Recruiting
        • Medisprof Cancer Center
      • Floreşti, Romania, 407280
        • Recruiting
        • Centrul radioterapie Amethyst Cluj-Napoca
  • Serbia
      • Belgrade, Serbia
        • Recruiting
        • Institute of Oncology and Radiology of Serbia
      • Kamenitz, Serbia
        • Recruiting
        • Institute for Oncology Vojvodina
      • Kragujevac, Serbia
        • Recruiting
        • University Clinical Center Kragujevac
  • South Korea
      • Daegu, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 02841
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, South Korea, 03312
        • Recruiting
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Suwon, South Korea, 16499
        • Recruiting
        • Ajou University Hospital
  • Spain
      • Alicante, Spain, 03293
        • Recruiting
        • Hospital Universitario Vinalopo
      • Badalona, Spain, 08907
        • Recruiting
        • Institut Català d'Oncologia - Hospital Duran i Reynals
      • Barcelona, Spain, 08017
        • Recruiting
        • Uomi Cancer Center-Clinica Tres Torres
      • Barcelona, Spain, 08908
        • Recruiting
        • Institut Catala d'Oncologia (ICO) - Hospitalet
      • Barcelona, Spain
        • Recruiting
        • Vall d'Hebron Institut d'Oncologia (VHIO)
      • Cadiz, Spain, 11407
        • Recruiting
        • Hospital universitario Jerez
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario de Torrejón
      • Madrid, Spain, 28051
        • Recruiting
        • Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
      • Málaga, Spain, 29004
        • Recruiting
        • Hospital Quironsalud Malaga
      • Santander, Spain
        • Withdrawn
        • Hospital Universitario Marqués de Valdecilla
      • Valencia, Spain
        • Recruiting
        • Hospital Clinico Universitario de Valencia (CHUV)
  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • Changhua Christian Hospital
      • Kaohsiung City, Taiwan, 833401
        • Recruiting
        • Chang Gung Memorial Hospital - Kaohsiung
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital (CMUH)
      • Tainan, Taiwan, 704017
        • Withdrawn
        • National Cheng-Kung University Hospital
      • Taipei, Taiwan, 100
        • Withdrawn
        • National Taiwan University Hospital
      • Taipei, Taiwan, 112201
        • Recruiting
        • Taipei Veterans General Hospital
      • Taoyuan District, Taiwan, 33305
        • Recruiting
        • Chang Gung Memorial Hospital - Linkou
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Recruiting
        • NHS Grampian - Aberdeen Royal Infirmary
      • London, United Kingdom, W1G 6AD
        • Recruiting
        • Sarah Cannon Research Institute
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • The Royal Marsden NHS Foundation Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • City Hospital Nottingham
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marden Hospital, Surrey
      • Torquay, United Kingdom, TQ2 7AA
        • Withdrawn
        • Torbay Hospital
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85212
        • Recruiting
        • Banner MD Anderson Cancer Center
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • The University of Arizona Cancer Center
    • California
      • Los Angeles, California, United States, 90024
        • Recruiting
        • University of California Los Angeles
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale School of Medicine - Smilow Cancer Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20052-0042
        • Recruiting
        • The George Washington University
    • Florida
      • Orlando, Florida, United States, 32804
        • Recruiting
        • AdventHealth Medical Group Oncology & Hematology at Orlando
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Cancer Center
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Mary Bird Perkins Cancer Center
    • Maine
      • South Portland, Maine, United States, 04106
        • Recruiting
        • MaineHealth Institute for Research
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Siteman Cancer Center - Washington University
    • New York
      • Lake Success, New York, United States, 10042
        • Recruiting
        • Northwell Health Cancer Institute
      • New York, New York, United States, 10065
        • Recruiting
        • Manhattan Eye, Ear & Throat Hospital
      • The Bronx, New York, United States, 10461
        • Withdrawn
        • Montefiore Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Withdrawn
        • University of Cincinnati - UC Health Barrett Cancer Center
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University, James Cancer Hospital and Solove Research Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Medical Center - Hillman Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina (MUSC)
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Recruiting
        • Oncology Consultants
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Vcu Massey Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53202
        • Terminated
        • Medical College of Wisconsin - Froedtert Hospital Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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)

Exclusion Criteria:

  • 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):

    1. 2 weeks (14 days) or 5 half-lives, whichever is shorter, for chemotherapeutic agents, small molecules, and checkpoint inhibitors
    2. 3 weeks (21 days) or 5 half-lives, whichever is shorter, for antibody-drug conjugates
    3. 4 weeks (28 days) for cell therapies
    4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (Investigational Arm: ficlatuzumab plus cetuximab)
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
Biological: Ficlatuzumab
Ficlatuzumab (AV-299) is a humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G1 (IgG1) monoclonal antibody (mAb).
Other Names:
  • AV-299
Biological: Cetuximab
Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.
Other Names:
  • Erbitux
Experimental: Arm 2 (Investigational Arm: ficlatuzumab plus cetuximab)
IV ficlatuzumab dose B on D1 and D15 of each 28-day cycle IV cetuximab on D1 and D15 of each 28-day cycle
Biological: Ficlatuzumab
Ficlatuzumab (AV-299) is a humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G1 (IgG1) monoclonal antibody (mAb).
Other Names:
  • AV-299
Biological: Cetuximab
Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.
Other Names:
  • Erbitux
Placebo Comparator: Arm 3 (Comparator Arm: placebo plus cetuximab)
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
Biological: Cetuximab
Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.
Other Names:
  • Erbitux
Other: Placebo
Placebo for this study will be normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Overall survival (OS), defined as the time from the date of randomization to the date of death for any cause
From Randomization until death from any cause (Approximately 44 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the safety and tolerability of ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC
Time Frame: From Screening until 30 days after last dose
Number of times participants experience Adverse Events (AE) or abnormal laboratory values.
From Screening until 30 days after last dose
To assess the immunogenicity of ficlatuzumab via antidrug antibodies (ADAs)
Time Frame: From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)
Serum samples will be assessed for the presence of ADA to ficlatuzumab.
From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)
To assess the immunogenicity of ficlatuzumab via neutralizing antibodies (nAB)
Time Frame: From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)
Serum samples that test positive for the presence of ADA to ficlatuzumab will be further tested for the presence of nAB.
From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)
To evaluate progression-free survival (PFS) for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC
Time Frame: From Randomization until disease progression or death (Approximately 44 months)
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
From Randomization until disease progression or death (Approximately 44 months)
To evaluate additional objective response rate for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC
Time Frame: 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)
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
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)
To evaluate disease control rate (DCR) for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC
Time Frame: 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)
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
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)
To evaluate duration of response (DOR) for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC
Time Frame: 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)
Duration of response (DOR), defined as the time from first documented evidence of a confirmed CR or PR per RECIST v1.1
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)
To evaluate the pharmacokinetics (PK) of ficlatuzumab
Time Frame: From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)
Serum samples will be assessed for concentrations of ficlatuzumab
From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)
To evaluate the quality of life (QOL) of ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC
Time Frame: From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)
Change from baseline in overall health status and time to clinically meaningful deterioration based on scoring of standardized participant questionnaires
From Baseline (Cycle 1 Day 1 pre-dose) until End of Treatment (Approximately 44 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AVEO Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV-299-23-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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