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

PHASE3RecruitingINTERVENTIONAL
Enrollment

410

Participants

Timeline

Start Date

January 11, 2024

Primary Completion Date

August 31, 2027

Study Completion Date

November 30, 2027

Conditions
Metastatic Head-and-neck Squamous-cell CarcinomaRecurrent 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

Trial Locations (110)

100

RECRUITING

National Taiwan University Hospital, Taipei

500

RECRUITING

Changhua Christian Hospital, Changhua

1066

RECRUITING

Antoni van Leeuwenhoek, Amsterdam

1122

NOT_YET_RECRUITING

Orszagos Onkologiai Intezet, Budapest

2010

RECRUITING

St. Vincent's Hospital, Sydney

2217

RECRUITING

St George Hospital, Kogarah

3100

NOT_YET_RECRUITING

Szent Lázár Megyei Kórház, Salgótarján

4000

RECRUITING

CHU Liège, Liège

4102

RECRUITING

Princess Alexandra Hospital, Brisbane

4400

RECRUITING

Josa Andras Oktatokorhaz, Nyíregyháza

4500

RECRUITING

University Hospital, Panagyurishte

6150

RECRUITING

St. John of God Murdoch Hospital, Murdoch

6525

RECRUITING

Radboud University Medical Center, Nijmegen

7624

RECRUITING

University of Pecs - Oncology, Pécs

9024

WITHDRAWN

Petz Aladar Country Teaching Hospital, Győr

9100

RECRUITING

Vitaz-Sint-Niklaas Moerland, Sint-Niklaas

10042

RECRUITING

Northwell Health Cancer Institute, Lake Success

10065

RECRUITING

Manhattan Eye, Ear & Throat Hospital, New York

10461

RECRUITING

Montefiore Medical Center, The Bronx

11407

RECRUITING

Hospital universitario Jerez, Cadiz

12200

RECRUITING

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

13005

RECRUITING

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

13400

RECRUITING

Fakultni Nemocnice Kralovske Vinohrady, Prague

15232

RECRUITING

University of Pittsburgh Medical Center - Hillman Cancer Center, Pittsburgh

16499

RECRUITING

Ajou University Hospital, Suwon

19111

RECRUITING

Fox Chase Cancer Center, Philadelphia

20089

RECRUITING

IRCCS Istituto Clinico Humanitas - Cancer center, Milan

20132

RECRUITING

IRCCS Ospedale San Raffaele Milano, Milan

20133

RECRUITING

Fondazione IRCCS - Istituto Nazionale Tumori - Oncologia, Milan

21201

RECRUITING

University of Maryland, Baltimore

22190

RECRUITING

Hôpital Privé des Côtes d'Armor, Plérin

23298

RECRUITING

VCU Massey Cancer Center, Richmond

27100

RECRUITING

IRCCS - ICS Maugeri, Pavia

RECRUITING

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

28046

RECRUITING

Hospital Universitario La Paz, Madrid

28051

RECRUITING

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

28100

RECRUITING

Azienda Ospedaliera Universitaria Maggiore Della Carita Novara, Novara

29004

RECRUITING

Hospital Quironsalud Malaga, Málaga

29200

RECRUITING

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

29425

RECRUITING

Medical University of South Carolina (MUSC), Charleston

30308

RECRUITING

Emory University, Atlanta

32804

RECRUITING

AdventHealth Medical Group Oncology & Hematology at Orlando, Orlando

33305

RECRUITING

Chang Gung Memorial Hospital - Linkou, Taoyuan District

35128

RECRUITING

Istituto Oncologico Veneto, Padua

37170

RECRUITING

Pôle Santé Léonard de Vinci, Chambray-lès-Tours

40139

RECRUITING

IRCCS Istituto Scienze Neurologiche, Bologna

40447

RECRUITING

China Medical University Hospital (CMUH), Taichung

42601

RECRUITING

Keimyung University Dongsan Hospital, Daegu

43210

RECRUITING

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

45219

RECRUITING

University of Cincinnati - UC Health Barrett Cancer Center, Cincinnati

51134

RECRUITING

AOU Careggi, Florence

53202

RECRUITING

Medical College of Wisconsin - Froedtert Hospital Cancer Center, Milwaukee

60200

RECRUITING

Fakultni nemocnice Brno, Brno

60612

RECRUITING

University of Illinois Cancer Center, Chicago

63110

RECRUITING

Siteman Cancer Center - Washington University, St Louis

65653

RECRUITING

Masaryk Memorial Cancer Institute, Brno

66205

RECRUITING

University of Kansas Cancer Center, Westwood

69008

RECRUITING

Centre Léon Bérard, Lyon

70809

RECRUITING

Mary Bird Perkins Cancer Center, Baton Rouge

75248

RECRUITING

Institut Curie, Paris

77030

RECRUITING

MD Anderson Cancer Center, Houston

RECRUITING

Oncology Consultants, Houston

77900

RECRUITING

Fakultni Nemocnice Olomouc, Olomouc

79106

RECRUITING

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

81377

RECRUITING

Ludwig-Maximilians University, Munich

85212

RECRUITING

Banner MD Anderson Cancer Center, Gilbert

85719

RECRUITING

The University of Arizona Cancer Center, Tucson

90024

RECRUITING

University of California Los Angeles, Westwood, Los Angeles

94805

RECRUITING

Institut Gustave Roussy, Villejuif

112201

RECRUITING

Taipei Veterans General Hospital, Taipei

400641

RECRUITING

Medisprof Cancer Center, Cluj-Napoca

407280

RECRUITING

Centrul radioterapie Amethyst Cluj-Napoca, Floreşti

704017

RECRUITING

National Cheng-Kung University Hospital, Tainan City

833401

RECRUITING

Chang Gung Memorial Hospital - Kaohsiung, Kaohsiung City

06511

RECRUITING

Yale School of Medicine - Smilow Cancer Hospital, New Haven

20052-0042

RECRUITING

The George Washington University, Washington D.C.

04106

RECRUITING

MaineHealth Institute for Research, South Portland

02215

RECRUITING

Dana Farber Cancer Institute, Boston

B5000

RECRUITING

CHU Universite Catholique de Louvain, Namur

T3N 4N1

RECRUITING

Tom Baker Cancer Centre (Alberta Health Services), Calgary

T6G 1Z2

RECRUITING

Cross Cancer Institute, Edmonton

K1H 8L6

RECRUITING

The Ottawa Hospital Cancer Centre, Ottawa

M5G 2M9

RECRUITING

Princess Margaret Cancer Center - University Health Network, Toronto

H4A3J1

RECRUITING

McGill University Health Centre (MUHC), Montreal

Unknown

RECRUITING

Fakultni nemocnice Bulovka, Prague

NOT_YET_RECRUITING

Institute of Oncology and Radiology of Serbia, Belgrade

RECRUITING

Institute for Oncology Vojvodina, Kamenitz

NOT_YET_RECRUITING

University Clinical Center Kragujevac, Kragujevac

RECRUITING

Vall d'Hebron Institut d'Oncologia (VHIO), Barcelona

RECRUITING

Hospital Universitario de Torrejón, Madrid

NOT_YET_RECRUITING

Hospital Universitario Marques de Valdecilla, Santander

RECRUITING

Hospital Clinico Universitario de Valencia (CHUV), Valencia

00168

WITHDRAWN

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

85-796

RECRUITING

Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy, Bydgoszcz

44-100

RECRUITING

National Research Institute of Oncology, Gliwice

02841

RECRUITING

Korea University Anam Hospital, Seoul

03080

RECRUITING

Seoul National University Hospital, Seoul

03312

RECRUITING

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

03722

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

03293

RECRUITING

Hospital Universitario Vinalopo, Alicante

08907

RECRUITING

Institut Catala d'Oncologia - Hospital Duran i Reynals, Badalona

08017

RECRUITING

UOMI Cancer Center-Clinica Tres Torres, Barcelona

08908

RECRUITING

Institut Catala d'Oncologia (ICO) - Hospitalet, Barcelona

AB25 2ZN

RECRUITING

NHS Grampian - Aberdeen Royal Infirmary, Aberdeen

SW3 6JJ

RECRUITING

The Royal Marsden NHS Foundation Trust, London

W1G 6AD

RECRUITING

Sarah Cannon Research Institute, London

NG5 1PB

RECRUITING

City Hospital Nottingham, Nottingham

SM2 5PT

RECRUITING

The Royal Marden Hospital, Surrey, Sutton

TQ2 7AA

RECRUITING

Torbay Hospital, Torquay

Sponsors
All Listed Sponsors
lead

AVEO Pharmaceuticals, Inc.

INDUSTRY