Eligibility
Caution: ClinicalTrials.gov appears to have newer eligibility criteria than the version saved here. Review the current criteria in ClinicalTrials.gov.
Show Criteria
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 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 HBV or 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.
Sites (112)
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St George Hospital
Kogarah, New South Wales, 2217, Australia
No email / No phone
Status: Recruiting
St. Vincent's Hospital
Sydney, New South Wales, 2010, Australia
No email / No phone
Status: Recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
No email / No phone
Status: Recruiting
St. John of God Murdoch Hospital
Murdoch, Western Australia, 6150, Australia
No email / No phone
Status: Recruiting
CHU Liège
Liège, 4000, Belgium
No email / No phone
Status: Recruiting
CHU Universite Catholique de Louvain
Namur, B5000, Belgium
No email / No phone
Status: Recruiting
Vitaz-Sint-Niklaas Moerland
Sint-Niklaas, 9100, Belgium
No email / No phone
Status: Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
No email / No phone
Status: Recruiting
Tom Baker Cancer Centre (Alberta Health Services)
Calgary, Alberta, T3N 4N1, Canada
No email / No phone
Status: Recruiting
Princess Margaret Cancer Center - University Health Network
Toronto, Ontario, M5G 2M9, Canada
No email / No phone
Status: Recruiting
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A3J1, Canada
No email / No phone
Status: Recruiting
Fakultni Nemocnice Kralovske Vinohrady
Prague, 13400, Czechia
No email / No phone
Status: Recruiting
Fakultni nemocnice Brno
Brno, 60200, Czechia
No email / No phone
Status: Recruiting
Fakultni nemocnice Bulovka
Prague, Czechia
No email / No phone
Status: Recruiting
Masaryk Memorial Cancer Institute
Brno, 65653, Czechia
No email / No phone
Status: Recruiting
Assistance Publique Hopitaux de Marseille (APHM)-Hôpital La Timone
Marseille, 13005, France
No email / No phone
Status: Recruiting
Centre Léon Bérard
Lyon, 69008, France
No email / No phone
Status: Recruiting
Hôpital Privé des Côtes d'Armor
Plérin, 22190, France
No email / No phone
Status: Recruiting
Institut Curie
Paris, 75248, France
No email / No phone
Status: Recruiting
Institut Gustave Roussy
Villejuif, 94805, France
No email / No phone
Status: Recruiting
Pôle Santé Léonard de Vinci
Chambray-lès-Tours, 37170, France
No email / No phone
Status: Recruiting
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie
Berlin, 12200, Germany
No email / No phone
Status: Recruiting
Ludwig-Maximilians University
Munich, 81377, Germany
No email / No phone
Status: Recruiting
UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Innere Medizin I, Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
Freiburg im Breisgau, 79106, Germany
No email / No phone
Status: Recruiting
Josa Andras Oktatokorhaz
Nyíregyháza, 4400, Hungary
No email / No phone
Status: Recruiting
University of Pecs - Oncology
Pécs, 7624, Hungary
No email / No phone
Status: Recruiting
AOU Careggi
Florence, 51134, Italy
No email / No phone
Status: Recruiting
Azienda Ospedaliera Universitaria Maggiore Della Carita Novara
Novara, 28100, Italy
No email / No phone
Status: Recruiting
Fondazione IRCCS - Istituto Nazionale Tumori - Oncologia
Milan, 20133, Italy
No email / No phone
Status: Recruiting
IRCCS - ICS Maugeri
Pavia, 27100, Italy
No email / No phone
Status: Recruiting
IRCCS Istituto Clinico Humanitas - Cancer center
Milan, 20089, Italy
No email / No phone
Status: Recruiting
IRCCS Istituto Scienze Neurologiche
Bologna, 40139, Italy
No email / No phone
Status: Recruiting
IRCCS Ospedale San Raffaele Milano
Milan, 20132, Italy
No email / No phone
Status: Recruiting
Istituto Oncologico Veneto
Padua, 35128, Italy
No email / No phone
Status: Recruiting
Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
No email / No phone
Status: Recruiting
Radboud University Medical Center
Nijmegen, 6525, Netherlands
No email / No phone
Status: Recruiting
Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, 85-796, Poland
No email / No phone
Status: Recruiting
National Research Institute of Oncology
Gliwice, 44-100, Poland
No email / No phone
Status: Recruiting
Centrul radioterapie Amethyst Cluj-Napoca
Floreşti, 407280, Romania
No email / No phone
Status: Recruiting
Medisprof Cancer Center
Cluj-Napoca, 400641, Romania
No email / No phone
Status: Recruiting
Institute for Oncology Vojvodina
Kamenitz, Serbia
No email / No phone
Status: Recruiting
Institute of Oncology and Radiology of Serbia
Belgrade, Serbia
No email / No phone
Status: Recruiting
University Clinical Center Kragujevac
Kragujevac, Serbia
No email / No phone
Status: Recruiting
Ajou University Hospital
Suwon, 16499, South Korea
No email / No phone
Status: Recruiting
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
No email / No phone
Status: Recruiting
Korea University Anam Hospital
Seoul, 02841, South Korea
No email / No phone
Status: Recruiting
Samsung Medical Center
Seoul, 06351, South Korea
No email / No phone
Status: Recruiting
Seoul National University Hospital
Seoul, 03080, South Korea
No email / No phone
Status: Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
No email / No phone
Status: Recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312, South Korea
No email / No phone
Status: Recruiting
Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, 28051, Spain
No email / No phone
Status: Recruiting
Hospital Clinico Universitario de Valencia (CHUV)
Valencia, Spain
No email / No phone
Status: Recruiting
Hospital Quironsalud Malaga
Málaga, 29004, Spain
No email / No phone
Status: Recruiting
Hospital Universitario La Paz
Madrid, 28046, Spain
No email / No phone
Status: Recruiting
Hospital Universitario Vinalopo
Alicante, 03293, Spain
No email / No phone
Status: Recruiting
Hospital Universitario de Torrejón
Madrid, Spain
No email / No phone
Status: Recruiting
Hospital universitario Jerez
Cadiz, 11407, Spain
No email / No phone
Status: Recruiting
Institut Catala d'Oncologia (ICO) - Hospitalet
Barcelona, 08908, Spain
No email / No phone
Status: Recruiting
Institut Catala d'Oncologia - Hospital Duran i Reynals
Badalona, 08907, Spain
No email / No phone
Status: Recruiting
UOMI Cancer Center-Clinica Tres Torres
Barcelona, 08017, Spain
No email / No phone
Status: Recruiting
Vall d'Hebron Institut d'Oncologia (VHIO)
Barcelona, Spain
No email / No phone
Status: Recruiting
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, 833401, Taiwan
No email / No phone
Status: Recruiting
Chang Gung Memorial Hospital - Linkou
Taoyuan District, 33305, Taiwan
No email / No phone
Status: Recruiting
Changhua Christian Hospital
Changhua, 500, Taiwan
No email / No phone
Status: Recruiting
China Medical University Hospital (CMUH)
Taichung, 40447, Taiwan
No email / No phone
Status: Recruiting
Taipei Veterans General Hospital
Taipei, 112201, Taiwan
No email / No phone
Status: Recruiting
City Hospital Nottingham
Nottingham, NG5 1PB, United Kingdom
No email / No phone
Status: Recruiting
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
No email / No phone
Status: Recruiting
Sarah Cannon Research Institute
London, W1G 6AD, United Kingdom
No email / No phone
Status: Recruiting
The Royal Marden Hospital, Surrey
Sutton, SM2 5PT, United Kingdom
No email / No phone
Status: Recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
No email / No phone
Status: Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85212, United States
No email / No phone
Status: Recruiting
The University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
No email / No phone
Status: Recruiting
University of California Los Angeles
Los Angeles, California, 90024, United States
No email / No phone
Status: Recruiting
Yale School of Medicine - Smilow Cancer Hospital
New Haven, Connecticut, 06511, United States
No email / No phone
Status: Recruiting
The George Washington University
Washington D.C., District of Columbia, 20052-0042, United States
No email / No phone
Status: Recruiting
AdventHealth Medical Group Oncology & Hematology at Orlando
Orlando, Florida, 32804, United States
No email / No phone
Status: Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612, United States
No email / No phone
Status: Recruiting
Emory University
Atlanta, Georgia, 30308, United States
No email / No phone
Status: Recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
No email / No phone
Status: Recruiting
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
No email / No phone
Status: Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
No email / No phone
Status: Recruiting
MaineHealth Institute for Research
South Portland, Maine, 04106, United States
No email / No phone
Status: Recruiting
University of Maryland
Baltimore, Maryland, 21201, United States
No email / No phone
Status: Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
No email / No phone
Status: Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
No email / No phone
Status: Recruiting
Siteman Cancer Center - Washington University
St Louis, Missouri, 63110, United States
No email / No phone
Status: Recruiting
Manhattan Eye, Ear & Throat Hospital
New York, New York, 10065, United States
No email / No phone
Status: Recruiting
Northwell Health Cancer Institute
Lake Success, New York, 10042, United States
No email / No phone
Status: Recruiting
Ohio State University, James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210, United States
No email / No phone
Status: Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
No email / No phone
Status: Recruiting
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
No email / No phone
Status: Recruiting
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
No email / No phone
Status: Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030, United States
No email / No phone
Status: Recruiting
Oncology Consultants
Houston, Texas, 77030, United States
No email / No phone
Status: Recruiting
VCU Massey Cancer Center
Richmond, Virginia, 23298, United States
No email / No phone
Status: Recruiting
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
No email / No phone
Status: Not yet recruiting
University Hospital
Panagyurishte, 4500, Bulgaria
No email / No phone
Status: Withdrawn
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
No email / No phone
Status: Withdrawn
Fakultni Nemocnice Olomouc
Olomouc, 77900, Czechia
No email / No phone
Status: Withdrawn
Clinique Pasteur - Lanroze- Centre Finistérien de Radiothérapie et d'Oncologie
Brest, 29200, France
No email / No phone
Status: Withdrawn
Petz Aladar Country Teaching Hospital
Győr, 9024, Hungary
No email / No phone
Status: Withdrawn
Szent Lázár Megyei Kórház
Salgótarján, 3100, Hungary
No email / No phone
Status: Withdrawn
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
No email / No phone
Status: Withdrawn
Antoni van Leeuwenhoek
Amsterdam, 1066, Netherlands
No email / No phone
Status: Withdrawn
Hospital Universitario Marques de Valdecilla
Santander, Spain
No email / No phone
Status: Withdrawn
National Cheng-Kung University Hospital
Tainan, 704017, Taiwan
No email / No phone
Status: Withdrawn
National Taiwan University Hospital
Taipei, 100, Taiwan
No email / No phone
Status: Withdrawn
Torbay Hospital
Torquay, TQ2 7AA, United Kingdom
No email / No phone
Status: Withdrawn
Montefiore Medical Center
The Bronx, New York, 10461, United States
No email / No phone
Status: Withdrawn
University of Cincinnati - UC Health Barrett Cancer Center
Cincinnati, Ohio, 45219, United States
No email / No phone
Status: Withdrawn
Medical College of Wisconsin - Froedtert Hospital Cancer Center
Milwaukee, Wisconsin, 53202, United States
No email / No phone
Status: TERMINATED
