Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06064877

PHASE3

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

Sponsor: AVEO Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

410

Start Date

2024-01-11

Completion Date

2027-11

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Metastatic Head-and-neck Squamous-cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

BIOLOGICAL

Ficlatuzumab

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

BIOLOGICAL

Cetuximab

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

OTHER

Placebo

Placebo for this study will be normal saline

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.

Locations (112)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

University of California Los Angeles

Los Angeles, California, United States

Yale School of Medicine - Smilow Cancer Hospital

New Haven, Connecticut, United States

The George Washington University

Washington D.C., District of Columbia, United States

AdventHealth Medical Group Oncology & Hematology at Orlando

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

MaineHealth Institute for Research

South Portland, Maine, United States

University of Maryland

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Siteman Cancer Center - Washington University

St Louis, Missouri, United States

Northwell Health Cancer Institute

Lake Success, New York, United States

Manhattan Eye, Ear & Throat Hospital

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of Cincinnati - UC Health Barrett Cancer Center

Cincinnati, Ohio, United States

Ohio State University, James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center - Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

Oncology Consultants

Houston, Texas, United States

VCU Massey Cancer Center

Richmond, Virginia, United States

Medical College of Wisconsin - Froedtert Hospital Cancer Center

Milwaukee, Wisconsin, United States

St George Hospital

Kogarah, New South Wales, Australia

St. Vincent's Hospital

Sydney, New South Wales, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

St. John of God Murdoch Hospital

Murdoch, Western Australia, Australia

CHU Liège

Liège, Belgium

CHU Universite Catholique de Louvain

Namur, Belgium

Vitaz-Sint-Niklaas Moerland

Sint-Niklaas, Belgium

University Hospital

Panagyurishte, Bulgaria

Tom Baker Cancer Centre (Alberta Health Services)

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Cancer Center - University Health Network

Toronto, Ontario, Canada

McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

Fakultni nemocnice Brno

Brno, Czechia

Masaryk Memorial Cancer Institute

Brno, Czechia

Fakultni Nemocnice Olomouc

Olomouc, Czechia

Fakultni Nemocnice Kralovske Vinohrady

Prague, Czechia

Fakultni nemocnice Bulovka

Prague, Czechia

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

Brest, France

Pôle Santé Léonard de Vinci

Chambray-lès-Tours, France

Centre Léon Bérard

Lyon, France

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

Marseille, France

Institut Curie

Paris, France

Hôpital Privé des Côtes d'Armor

Plérin, France

Institut Gustave Roussy

Villejuif, France

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

Berlin, Germany

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

Freiburg im Breisgau, Germany

Ludwig-Maximilians University

Munich, Germany

Orszagos Onkologiai Intezet

Budapest, Hungary

Petz Aladar Country Teaching Hospital

Győr, Hungary

Josa Andras Oktatokorhaz

Nyíregyháza, Hungary

University of Pecs - Oncology

Pécs, Hungary

Szent Lázár Megyei Kórház

Salgótarján, Hungary

IRCCS Istituto Scienze Neurologiche

Bologna, Italy

AOU Careggi

Florence, Italy

IRCCS Istituto Clinico Humanitas - Cancer center

Milan, Italy

IRCCS Ospedale San Raffaele Milano

Milan, Italy

Fondazione IRCCS - Istituto Nazionale Tumori - Oncologia

Milan, Italy

Azienda Ospedaliera Universitaria Maggiore Della Carita Novara

Novara, Italy

Istituto Oncologico Veneto

Padua, Italy

IRCCS - ICS Maugeri

Pavia, Italy

Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy

Bydgoszcz, Poland

National Research Institute of Oncology

Gliwice, Poland

Medisprof Cancer Center

Cluj-Napoca, Romania

Centrul radioterapie Amethyst Cluj-Napoca

Floreşti, Romania

Institute of Oncology and Radiology of Serbia

Belgrade, Serbia

Institute for Oncology Vojvodina

Kamenitz, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Keimyung University Dongsan Hospital

Daegu, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

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

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

Hospital Universitario Vinalopo

Alicante, Spain

Institut Catala d'Oncologia - Hospital Duran i Reynals

Badalona, Spain

UOMI Cancer Center-Clinica Tres Torres

Barcelona, Spain

Institut Catala d'Oncologia (ICO) - Hospitalet

Barcelona, Spain

Vall d'Hebron Institut d'Oncologia (VHIO)

Barcelona, Spain

Hospital universitario Jerez

Cadiz, Spain

Hospital Universitario La Paz

Madrid, Spain

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

Madrid, Spain

Hospital Universitario de Torrejón

Madrid, Spain

Hospital Quironsalud Malaga

Málaga, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Hospital Clinico Universitario de Valencia (CHUV)

Valencia, Spain

Changhua Christian Hospital

Changhua, Taiwan

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung City, Taiwan

China Medical University Hospital (CMUH)

Taichung, Taiwan

National Cheng-Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan District, Taiwan

NHS Grampian - Aberdeen Royal Infirmary

Aberdeen, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Sarah Cannon Research Institute

London, United Kingdom

City Hospital Nottingham

Nottingham, United Kingdom

The Royal Marden Hospital, Surrey

Sutton, United Kingdom

Torbay Hospital

Torquay, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (112)