RecruitingPhase 3NCT06064877

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 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)

Sponsor

AVEO Pharmaceuticals, Inc.

Enrollment

410 participants

Start Date

Jan 11, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Head and Neck Squamous Cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two targeted drugs — ficlatuzumab and cetuximab — for people with head and neck cancer (specifically squamous cell carcinoma) that has come back or spread, and is HPV-negative. HPV-negative head and neck cancers tend to be harder to treat and have fewer options. **You may be eligible if...** - You are 18 or older - You have confirmed recurrent or metastatic squamous cell carcinoma of the head and neck - Your cancer is HPV-negative (p16-negative) - You have already received platinum-based chemotherapy and an immunotherapy drug (anti-PD-1/PD-L1) and your cancer progressed - You have at least one measurable tumor **You may NOT be eligible if...** - Your cancer is HPV-positive - You have not previously tried platinum chemotherapy and immunotherapy - You have no measurable disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALFiclatuzumab

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

BIOLOGICALCetuximab

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

OTHERPlacebo

Placebo for this study will be normal saline

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, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06064877

Related Trials

BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study

NCT05136196221 locations

Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

NCT04671667177 locations

Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment

NCT06589804176 locations

Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation

NCT066620581 location

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

NCT069800385 locations