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New drug cocktail aims to extend life in Tough-to-Treat head and neck cancer

NCT ID NCT06064877

Disease control Sponsor: AVEO Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 3 trial is testing whether adding ficlatuzumab to the standard drug cetuximab helps people with recurrent or metastatic HPV-negative head and neck cancer live longer. About 410 adults will be randomly assigned to receive either the combination or a placebo plus cetuximab. The study is currently recruiting participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ficlatuzumab and cetuximab
What this could lead to
If successful, this combination could offer a new treatment option that helps people with recurrent or metastatic head and neck cancer live longer or delay disease progression.
What could go wrong
This is an early Phase 3 trial, so results are not guaranteed. The added drug may not improve outcomes over cetuximab alone, and side effects from the combination could be more severe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 410 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 or greater 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 hepatitis B virus (HBV) or hepatitis C virus (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.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Neoplasm Metastasis Recurrence squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic head and neck squamous cell carcinoma Recurrent head and neck squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    97 sites in 17 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Careggi

    RECRUITING

    Florence, 51134, Italy

  • AdventHealth Medical Group Oncology & Hematology at Orlando

    RECRUITING

    Orlando, Florida, 32804, United States

  • Ajou University Hospital

    RECRUITING

    Suwon, 16499, South Korea

  • Antoni van Leeuwenhoek

    WITHDRAWN

    Amsterdam, 1066, Netherlands

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

    RECRUITING

    Marseille, 13005, France

  • Azienda Ospedaliera Universitaria Maggiore Della Carita Novara

    RECRUITING

    Novara, 28100, Italy

  • Banner MD Anderson Cancer Center

    RECRUITING

    Gilbert, Arizona, 85212, United States

  • CHU Liège

    RECRUITING

    Liège, 4000, Belgium

  • CHU Universite Catholique de Louvain

    RECRUITING

    Namur, B5000, Belgium

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69008, France

  • Centrul radioterapie Amethyst Cluj-Napoca

    RECRUITING

    Floreşti, 407280, Romania

  • Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy

    RECRUITING

    Bydgoszcz, 85-796, Poland

  • Chang Gung Memorial Hospital - Kaohsiung

    RECRUITING

    Kaohsiung City, 833401, Taiwan

  • Chang Gung Memorial Hospital - Linkou

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Changhua Christian Hospital

    RECRUITING

    Changhua, 500, Taiwan

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

    RECRUITING

    Berlin, 12200, Germany

  • China Medical University Hospital (CMUH)

    RECRUITING

    Taichung, 40447, Taiwan

  • City Hospital Nottingham

    RECRUITING

    Nottingham, NG5 1PB, United Kingdom

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

    WITHDRAWN

    Brest, 29200, France

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Fakultni Nemocnice Kralovske Vinohrady

    RECRUITING

    Prague, 13400, Czechia

  • Fakultni Nemocnice Olomouc

    WITHDRAWN

    Olomouc, 77900, Czechia

  • Fakultni nemocnice Brno

    RECRUITING

    Brno, 60200, Czechia

  • Fakultni nemocnice Bulovka

    RECRUITING

    Prague, Czechia

  • Fondazione IRCCS - Istituto Nazionale Tumori - Oncologia

    RECRUITING

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    WITHDRAWN

    Roma, 00168, Italy

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

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

    RECRUITING

    Madrid, 28051, Spain

  • Hospital Clinico Universitario de Valencia (CHUV)

    RECRUITING

    Valencia, Spain

  • Hospital Quironsalud Malaga

    RECRUITING

    Málaga, 29004, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Marques de Valdecilla

    WITHDRAWN

    Santander, Spain

  • Hospital Universitario Vinalopo

    RECRUITING

    Alicante, 03293, Spain

  • Hospital Universitario de Torrejón

    RECRUITING

    Madrid, Spain

  • Hospital universitario Jerez

    RECRUITING

    Cadiz, 11407, Spain

  • Hôpital Privé des Côtes d'Armor

    RECRUITING

    Plérin, 22190, France

  • IRCCS - ICS Maugeri

    RECRUITING

    Pavia, 27100, Italy

  • IRCCS Istituto Clinico Humanitas - Cancer center

    RECRUITING

    Milan, 20089, Italy

  • IRCCS Istituto Scienze Neurologiche

    RECRUITING

    Bologna, 40139, Italy

  • IRCCS Ospedale San Raffaele Milano

    RECRUITING

    Milan, 20132, Italy

  • Institut Catala d'Oncologia (ICO) - Hospitalet

    RECRUITING

    Barcelona, 08908, Spain

  • Institut Catala d'Oncologia - Hospital Duran i Reynals

    RECRUITING

    Badalona, 08907, Spain

  • Institut Curie

    RECRUITING

    Paris, 75248, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Institute for Oncology Vojvodina

    RECRUITING

    Kamenitz, Serbia

  • Institute of Oncology and Radiology of Serbia

    RECRUITING

    Belgrade, Serbia

  • Istituto Oncologico Veneto

    RECRUITING

    Padua, 35128, Italy

  • Josa Andras Oktatokorhaz

    RECRUITING

    Nyíregyháza, 4400, Hungary

  • Keimyung University Dongsan Hospital

    RECRUITING

    Daegu, 42601, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, 02841, South Korea

  • Ludwig-Maximilians University

    RECRUITING

    Munich, 81377, Germany

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • MaineHealth Institute for Research

    RECRUITING

    South Portland, Maine, 04106, United States

  • Manhattan Eye, Ear & Throat Hospital

    RECRUITING

    New York, New York, 10065, United States

  • Mary Bird Perkins Cancer Center

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Masaryk Memorial Cancer Institute

    RECRUITING

    Brno, 65653, Czechia

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • McGill University Health Centre (MUHC)

    RECRUITING

    Montreal, Quebec, H4A3J1, Canada

  • Medical College of Wisconsin - Froedtert Hospital Cancer Center

    TERMINATED

    Milwaukee, Wisconsin, 53202, United States

  • Medical University of South Carolina (MUSC)

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medisprof Cancer Center

    RECRUITING

    Cluj-Napoca, 400641, Romania

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    WITHDRAWN

    The Bronx, New York, 10461, United States

  • NHS Grampian - Aberdeen Royal Infirmary

    RECRUITING

    Aberdeen, AB25 2ZN, United Kingdom

  • National Cheng-Kung University Hospital

    WITHDRAWN

    Tainan, 704017, Taiwan

  • National Research Institute of Oncology

    RECRUITING

    Gliwice, 44-100, Poland

  • National Taiwan University Hospital

    WITHDRAWN

    Taipei, 100, Taiwan

  • Northwell Health Cancer Institute

    RECRUITING

    Lake Success, New York, 10042, United States

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

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oncology Consultants

    RECRUITING

    Houston, Texas, 77030, United States

  • Orszagos Onkologiai Intezet

    NOT_YET_RECRUITING

    Budapest, 1122, Hungary

  • Petz Aladar Country Teaching Hospital

    WITHDRAWN

    Győr, 9024, Hungary

  • Princess Alexandra Hospital

    RECRUITING

    Brisbane, Queensland, 4102, Australia

  • Princess Margaret Cancer Center - University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Pôle Santé Léonard de Vinci

    RECRUITING

    Chambray-lès-Tours, 37170, France

  • Radboud University Medical Center

    RECRUITING

    Nijmegen, 6525, Netherlands

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Siteman Cancer Center - Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • St George Hospital

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • St. John of God Murdoch Hospital

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • St. Vincent's Hospital

    RECRUITING

    Sydney, New South Wales, 2010, Australia

  • Szent Lázár Megyei Kórház

    WITHDRAWN

    Salgótarján, 3100, Hungary

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112201, Taiwan

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

    RECRUITING

    Seoul, 03312, South Korea

  • The George Washington University

    RECRUITING

    Washington D.C., District of Columbia, 20052-0042, United States

  • The Ottawa Hospital Cancer Centre

    WITHDRAWN

    Ottawa, Ontario, K1H 8L6, Canada

  • The Royal Marden Hospital, Surrey

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • The University of Arizona Cancer Center

    RECRUITING

    Tucson, Arizona, 85719, United States

  • Tom Baker Cancer Centre (Alberta Health Services)

    RECRUITING

    Calgary, Alberta, T3N 4N1, Canada

  • Torbay Hospital

    WITHDRAWN

    Torquay, TQ2 7AA, United Kingdom

  • UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Innere Medizin I, Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation

    RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • UOMI Cancer Center-Clinica Tres Torres

    RECRUITING

    Barcelona, 08017, Spain

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

    RECRUITING

    Pavia, 27100, Italy

  • University Clinical Center Kragujevac

    RECRUITING

    Kragujevac, Serbia

  • University Hospital

    WITHDRAWN

    Panagyurishte, 4500, Bulgaria

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90024, United States

  • University of Cincinnati - UC Health Barrett Cancer Center

    WITHDRAWN

    Cincinnati, Ohio, 45219, United States

  • University of Illinois Cancer Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Pecs - Oncology

    RECRUITING

    Pécs, 7624, Hungary

  • University of Pittsburgh Medical Center - Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • VCU Massey Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Vall d'Hebron Institut d'Oncologia (VHIO)

    RECRUITING

    Barcelona, Spain

  • Vitaz-Sint-Niklaas Moerland

    RECRUITING

    Sint-Niklaas, 9100, Belgium

  • Yale School of Medicine - Smilow Cancer Hospital

    RECRUITING

    New Haven, Connecticut, 06511, United States

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