Actively Recruiting
A Multicenter, Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Ficlatuzumab with Cetuximab in Recurrent or Metastatic HPV-Negative Head and Neck Squamous Cell Carcinoma
Led by AVEO Pharmaceuticals, Inc. · Updated on 2026-04-09
410
Participants Needed
112
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of combining ficlatuzumab with cetuximab compared to cetuximab alone in people with recurrent or metastatic (R/M) HPV-negative head and neck squamous cell carcinoma (HNSCC). This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants who have not responded to prior anti-PD-1/PD-L1 immune checkpoint inhibitors and platinum-based chemotherapy. The goal is to see if adding ficlatuzumab improves survival outcomes in this patient group. Participants are assigned to one of three groups: two groups receive different doses of intravenous ficlatuzumab plus cetuximab on days 1 and 15 of each 28-day cycle, while the third group receives a placebo plus cetuximab on the same schedule. The study will enroll about 410 participants and compare progression-free survival and overall survival among these groups. Treatment cycles continue until disease progression or other study endpoints. During the study, participants will undergo regular imaging scans (CT or MRI) to assess tumor response every 8 weeks during the first year, then every 12 weeks in years 2 and 3, and every 6 months thereafter. Researchers will monitor safety, quality of life, and immune responses, including antidrug antibodies. The study period spans approximately 44 months with ongoing evaluations from randomization until death or last response assessment.
CONDITIONS
Brief Title
A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Confirmed diagnosis of recurrent or metastatic HPV-negative head and neck squamous cell carcinoma
- At least one measurable tumor lesion by CT or MRI scan not previously irradiated or with documented progression after radiation
- Prior failure of anti-PD-1/PD-L1 immune checkpoint inhibitor and platinum-based chemotherapy treatment
- Tumor considered inoperable and incurable
- ECOG performance status of 0 or 1 and life expectancy of at least 12 weeks
- Negative pregnancy test for women of childbearing potential within 30 days before randomization
- Agreement to use effective contraception during the study and for at least 5 months after last dose if applicable
- Ability to provide written informed consent and comply with study requirements
- Patients with feeding tubes are eligible
- Submission of archived tissue sample or fresh biopsy for c-Met analysis within 60 days of randomization
You will not qualify if you...
- More than 2 prior lines of anticancer therapy or prior treatment with cetuximab or other EGFR inhibitors for R/M HNSCC
- History of severe allergic or anaphylactic reactions to proteins in the study drugs
- Untreated or uncontrolled brain metastases or leptomeningeal carcinomatosis
- Recent treatment with investigational drugs or radiation therapy without required washout periods
- Unresolved significant toxicity (Grade 2 or higher) from prior cancer treatments except hair loss
- Significant cardiovascular disease including recent severe heart conditions
- Other medical or psychiatric conditions that could interfere with study participation
- History of other cancers within 2 years except certain treated early-stage cancers without recurrence
- Positive for hepatitis B or C with active hepatitis
- Evidence of interstitial lung disease or idiopathic pulmonary fibrosis
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Repeated 28-day cycles until disease progression or discontinuation (up to approximately 44 months)
Participants receive intravenous ficlatuzumab or placebo combined with cetuximab on Day 1 and Day 15 of each 28-day cycle as part of their treatment for recurrent or metastatic HPV-negative head and neck squamous cell carcinoma.
Visits on Day 1 and Day 15 of each 28-day cycle
Duration - 30 days after last dose
Participants are monitored for safety, pharmacokinetics, immunogenicity, and quality of life after treatment ends.
Approximately 1 follow-up visit
Trial Site Locations
Total: 112 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85212
Actively Recruiting
2
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Actively Recruiting
3
University of California Los Angeles
Los Angeles, California, United States, 90024
Actively Recruiting
4
Yale School of Medicine - Smilow Cancer Hospital
New Haven, Connecticut, United States, 06511
Actively Recruiting
5
The George Washington University
Washington D.C., District of Columbia, United States, 20052-0042
Actively Recruiting
6
AdventHealth Medical Group Oncology & Hematology at Orlando
Orlando, Florida, United States, 32804
Actively Recruiting
7
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
8
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
9
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
10
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
11
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
12
MaineHealth Institute for Research
South Portland, Maine, United States, 04106
Actively Recruiting
13
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
14
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
15
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
16
Siteman Cancer Center - Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
17
Northwell Health Cancer Institute
Lake Success, New York, United States, 10042
Actively Recruiting
18
Manhattan Eye, Ear & Throat Hospital
New York, New York, United States, 10065
Actively Recruiting
19
Montefiore Medical Center
The Bronx, New York, United States, 10461
Withdrawn
20
University of Cincinnati - UC Health Barrett Cancer Center
Cincinnati, Ohio, United States, 45219
Withdrawn
21
Ohio State University, James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
22
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
23
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
24
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
25
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
26
Oncology Consultants
Houston, Texas, United States, 77030
Actively Recruiting
27
VCU Massey Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
28
Medical College of Wisconsin - Froedtert Hospital Cancer Center
Milwaukee, Wisconsin, United States, 53202
Terminated
29
St George Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
30
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Actively Recruiting
31
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Actively Recruiting
32
St. John of God Murdoch Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
33
CHU Liège
Liège, Belgium, 4000
Actively Recruiting
34
CHU Universite Catholique de Louvain
Namur, Belgium, B5000
Actively Recruiting
35
Vitaz-Sint-Niklaas Moerland
Sint-Niklaas, Belgium, 9100
Actively Recruiting
36
University Hospital
Panagyurishte, Bulgaria, 4500
Withdrawn
37
Tom Baker Cancer Centre (Alberta Health Services)
Calgary, Alberta, Canada, T3N 4N1
Actively Recruiting
38
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
39
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Withdrawn
40
Princess Margaret Cancer Center - University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
41
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada, H4A3J1
Actively Recruiting
42
Fakultni nemocnice Brno
Brno, Czechia, 60200
Actively Recruiting
43
Masaryk Memorial Cancer Institute
Brno, Czechia, 65653
Actively Recruiting
44
Fakultni Nemocnice Olomouc
Olomouc, Czechia, 77900
Withdrawn
45
Fakultni Nemocnice Kralovske Vinohrady
Prague, Czechia, 13400
Actively Recruiting
46
Fakultni nemocnice Bulovka
Prague, Czechia
Actively Recruiting
47
Clinique Pasteur - Lanroze- Centre Finistérien de Radiothérapie et d'Oncologie
Brest, France, 29200
Withdrawn
48
Pôle Santé Léonard de Vinci
Chambray-lès-Tours, France, 37170
Actively Recruiting
49
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
50
Assistance Publique Hopitaux de Marseille (APHM)-Hôpital La Timone
Marseille, France, 13005
Actively Recruiting
51
Institut Curie
Paris, France, 75248
Actively Recruiting
52
Hôpital Privé des Côtes d'Armor
Plérin, France, 22190
Actively Recruiting
53
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
54
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie
Berlin, Germany, 12200
Actively Recruiting
55
UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Innere Medizin I, Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
56
Ludwig-Maximilians University
Munich, Germany, 81377
Actively Recruiting
57
Orszagos Onkologiai Intezet
Budapest, Hungary, 1122
Not Yet Recruiting
58
Petz Aladar Country Teaching Hospital
Győr, Hungary, 9024
Withdrawn
59
Josa Andras Oktatokorhaz
Nyíregyháza, Hungary, 4400
Actively Recruiting
60
University of Pecs - Oncology
Pécs, Hungary, 7624
Actively Recruiting
61
Szent Lázár Megyei Kórház
Salgótarján, Hungary, 3100
Withdrawn
62
IRCCS Istituto Scienze Neurologiche
Bologna, Italy, 40139
Actively Recruiting
63
AOU Careggi
Florence, Italy, 51134
Actively Recruiting
64
IRCCS Istituto Clinico Humanitas - Cancer center
Milan, Italy, 20089
Actively Recruiting
65
IRCCS Ospedale San Raffaele Milano
Milan, Italy, 20132
Actively Recruiting
66
Fondazione IRCCS - Istituto Nazionale Tumori - Oncologia
Milan, Italy, 20133
Actively Recruiting
67
Azienda Ospedaliera Universitaria Maggiore Della Carita Novara
Novara, Italy, 28100
Actively Recruiting
68
Istituto Oncologico Veneto
Padua, Italy, 35128
Actively Recruiting
69
IRCCS - ICS Maugeri
Pavia, Italy, 27100
Actively Recruiting
70
Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
71
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Withdrawn
72
Antoni van Leeuwenhoek
Amsterdam, Netherlands, 1066
Withdrawn
73
Radboud University Medical Center
Nijmegen, Netherlands, 6525
Actively Recruiting
74
Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, Poland, 85-796
Actively Recruiting
75
National Research Institute of Oncology
Gliwice, Poland, 44-100
Actively Recruiting
76
Medisprof Cancer Center
Cluj-Napoca, Romania, 400641
Actively Recruiting
77
Centrul radioterapie Amethyst Cluj-Napoca
Floreşti, Romania, 407280
Actively Recruiting
78
Institute of Oncology and Radiology of Serbia
Belgrade, Serbia
Actively Recruiting
79
Institute for Oncology Vojvodina
Kamenitz, Serbia
Actively Recruiting
80
University Clinical Center Kragujevac
Kragujevac, Serbia
Actively Recruiting
81
Keimyung University Dongsan Hospital
Daegu, South Korea, 42601
Actively Recruiting
82
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
83
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
84
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, South Korea, 03312
Actively Recruiting
85
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
86
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
87
Ajou University Hospital
Suwon, South Korea, 16499
Actively Recruiting
88
Hospital Universitario Vinalopo
Alicante, Spain, 03293
Actively Recruiting
89
Institut Catala d'Oncologia - Hospital Duran i Reynals
Badalona, Spain, 08907
Actively Recruiting
90
UOMI Cancer Center-Clinica Tres Torres
Barcelona, Spain, 08017
Actively Recruiting
91
Institut Catala d'Oncologia (ICO) - Hospitalet
Barcelona, Spain, 08908
Actively Recruiting
92
Vall d'Hebron Institut d'Oncologia (VHIO)
Barcelona, Spain
Actively Recruiting
93
Hospital universitario Jerez
Cadiz, Spain, 11407
Actively Recruiting
94
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
95
Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, Spain, 28051
Actively Recruiting
96
Hospital Universitario de Torrejón
Madrid, Spain
Actively Recruiting
97
Hospital Quironsalud Malaga
Málaga, Spain, 29004
Actively Recruiting
98
Hospital Universitario Marques de Valdecilla
Santander, Spain
Withdrawn
99
Hospital Clinico Universitario de Valencia (CHUV)
Valencia, Spain
Actively Recruiting
100
Changhua Christian Hospital
Changhua, Taiwan, 500
Actively Recruiting
101
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, Taiwan, 833401
Actively Recruiting
102
China Medical University Hospital (CMUH)
Taichung, Taiwan, 40447
Actively Recruiting
103
National Cheng-Kung University Hospital
Tainan, Taiwan, 704017
Withdrawn
104
National Taiwan University Hospital
Taipei, Taiwan, 100
Withdrawn
105
Taipei Veterans General Hospital
Taipei, Taiwan, 112201
Actively Recruiting
106
Chang Gung Memorial Hospital - Linkou
Taoyuan, Taiwan, 33305
Actively Recruiting
107
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Actively Recruiting
108
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
109
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Actively Recruiting
110
City Hospital Nottingham
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
111
The Royal Marden Hospital, Surrey
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
112
Torbay Hospital
Torquay, United Kingdom, TQ2 7AA
Withdrawn
Research Team
C
Clinical Trials Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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