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)

Status: Recruiting
Location: See all (105) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Arizona
Banner MD Anderson Cancer Center
RECRUITING
Gilbert
The University of Arizona Cancer Center
RECRUITING
Tucson
California
University of California Los Angeles
RECRUITING
Westwood, Los Angeles
Connecticut
Yale School of Medicine - Smilow Cancer Hospital
RECRUITING
New Haven
Washington, D.c.
The George Washington University
RECRUITING
Washington D.c.
Florida
AdventHealth Medical Group Oncology & Hematology at Orlando
RECRUITING
Orlando
Georgia
Emory University
RECRUITING
Atlanta
Illinois
University of Illinois Cancer Center
RECRUITING
Chicago
Kansas
University of Kansas Cancer Center
RECRUITING
Westwood
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Maryland
University of Maryland
RECRUITING
Baltimore
Maine
MaineHealth Institute for Research
RECRUITING
South Portland
Missouri
Siteman Cancer Center - Washington University
RECRUITING
St Louis
New York
Northwell Health Cancer Institute
RECRUITING
Lake Success
Manhattan Eye, Ear & Throat Hospital
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
University of Cincinnati - UC Health Barrett Cancer Center
RECRUITING
Cincinnati
Ohio State University, James Cancer Hospital and Solove Research Institute
RECRUITING
Columbus
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
University of Pittsburgh Medical Center - Hillman Cancer Center
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina (MUSC)
RECRUITING
Charleston
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Oncology Consultants
RECRUITING
Houston
Virginia
VCU Massey Cancer Center
RECRUITING
Richmond
Wisconsin
Medical College of Wisconsin - Froedtert Hospital Cancer Center
RECRUITING
Milwaukee
Other Locations
Australia
Princess Alexandra Hospital
RECRUITING
Brisbane
St George Hospital
RECRUITING
Kogarah
St. John of God Murdoch Hospital
RECRUITING
Murdoch
St. Vincent's Hospital
RECRUITING
Sydney
Belgium
CHU Liège
RECRUITING
Liège
CHU Universite Catholique de Louvain
RECRUITING
Namur
Vitaz-Sint-Niklaas Moerland
RECRUITING
Sint-niklaas
Bulgaria
University Hospital
RECRUITING
Panagyurishte
Canada
Tom Baker Cancer Centre (Alberta Health Services)
RECRUITING
Calgary
Cross Cancer Institute
RECRUITING
Edmonton
McGill University Health Centre (MUHC)
RECRUITING
Montreal
The Ottawa Hospital Cancer Centre
RECRUITING
Ottawa
Princess Margaret Cancer Center - University Health Network
RECRUITING
Toronto
France
Clinique Pasteur - Lanroze- Centre Finistérien de Radiothérapie et d'Oncologie
RECRUITING
Brest
Pôle Santé Léonard de Vinci
RECRUITING
Chambray-lès-tours
Centre Léon Bérard
RECRUITING
Lyon
Assistance Publique Hopitaux de Marseille (APHM)-Hôpital La Timone
RECRUITING
Marseille
Institut Curie
RECRUITING
Paris
Hôpital Privé des Côtes d'Armor
RECRUITING
Plérin
Institut Gustave Roussy
RECRUITING
Villejuif
Germany
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie
RECRUITING
Berlin
UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Innere Medizin I, Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
RECRUITING
Freiburg Im Breisgau
Ludwig-Maximilians University
RECRUITING
Munich
Hungary
Orszagos Onkologiai Intezet
NOT_YET_RECRUITING
Budapest
Petz Aladar Country Teaching Hospital
WITHDRAWN
Győr
Josa Andras Oktatokorhaz
RECRUITING
Nyíregyháza
University of Pecs - Oncology
RECRUITING
Pécs
Szent Lázár Megyei Kórház
NOT_YET_RECRUITING
Salgótarján
Italy
IRCCS Istituto Scienze Neurologiche
RECRUITING
Bologna
AOU Careggi
RECRUITING
Florence
Fondazione IRCCS - Istituto Nazionale Tumori - Oncologia
RECRUITING
Milan
IRCCS Istituto Clinico Humanitas - Cancer center
RECRUITING
Milan
IRCCS Ospedale San Raffaele Milano
RECRUITING
Milan
Azienda Ospedaliera Universitaria Maggiore Della Carita Novara
RECRUITING
Novara
Istituto Oncologico Veneto
RECRUITING
Padua
IRCCS - ICS Maugeri
RECRUITING
Pavia
Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
WITHDRAWN
Roma
Netherlands
Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Radboud University Medical Center
RECRUITING
Nijmegen
Poland
Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
RECRUITING
Bydgoszcz
National Research Institute of Oncology
RECRUITING
Gliwice
Republic of Korea
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Korea University Anam Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Romania
Medisprof Cancer Center
RECRUITING
Cluj-napoca
Centrul radioterapie Amethyst Cluj-Napoca
RECRUITING
Floreşti
Serbia
Institute of Oncology and Radiology of Serbia
NOT_YET_RECRUITING
Belgrade
Institute for Oncology Vojvodina
RECRUITING
Kamenitz
University Clinical Center Kragujevac
NOT_YET_RECRUITING
Kragujevac
Spain
Hospital Universitario Vinalopo
RECRUITING
Alicante
Institut Catala d'Oncologia - Hospital Duran i Reynals
RECRUITING
Badalona
Institut Catala d'Oncologia (ICO) - Hospitalet
RECRUITING
Barcelona
UOMI Cancer Center-Clinica Tres Torres
RECRUITING
Barcelona
Vall d'Hebron Institut d'Oncologia (VHIO)
RECRUITING
Barcelona
Hospital universitario Jerez
RECRUITING
Cadiz
Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
RECRUITING
Madrid
Hospital Universitario de Torrejón
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Quironsalud Malaga
RECRUITING
Málaga
Hospital Universitario Marques de Valdecilla
NOT_YET_RECRUITING
Santander
Hospital Clinico Universitario de Valencia (CHUV)
RECRUITING
Valencia
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Chang Gung Memorial Hospital - Kaohsiung
RECRUITING
Kaohsiung City
China Medical University Hospital (CMUH)
RECRUITING
Taichung
National Cheng-Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital - Linkou
RECRUITING
Taoyuan District
United Kingdom
NHS Grampian - Aberdeen Royal Infirmary
RECRUITING
Aberdeen
Sarah Cannon Research Institute
RECRUITING
London
The Royal Marsden NHS Foundation Trust
RECRUITING
London
City Hospital Nottingham
RECRUITING
Nottingham
The Royal Marden Hospital, Surrey
RECRUITING
Sutton
Torbay Hospital
RECRUITING
Torquay
Contact Information
Primary
Clinical Trials Office
clinical@aveooncology.com
+1.857.400.0101
Time Frame
Start Date: 2024-01-11
Estimated Completion Date: 2027-11
Participants
Target number of participants: 410
Treatments
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
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
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
Sponsors
Leads: AVEO Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials