Clinical trial • Phase III • Oncology

AMIVANTAMAB for Recurrent/metastatic head and neck squamous cell carcinoma

Phase III trial of AMIVANTAMAB for Recurrent/metastatic head and neck squamous cell carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Recurrent/metastatic head and neck squamous cell carcinoma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
04-09-2025
First CTIS Authorization Date
14-01-2026

Trial design

Randomised, open-label, arm a (investigational): amivantamab (jnj-61186372) in addition to carboplatin and pembrolizumab. comparator (standard of care): platinum-based chemotherapy (cisplatin or carboplatin) + pembrolizumab + 5-fu. doses and schedules not specified in the ctis metadata.-controlled Phase III trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm A (investigational): Amivantamab (JNJ-61186372) in addition to Carboplatin and Pembrolizumab. Comparator (standard of care): Platinum-based chemotherapy (cisplatin or carboplatin) + Pembrolizumab + 5-FU. Doses and schedules not specified in the CTIS metadata.
Target Sample Size
308

Eligibility

Recruits 308 No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are adults (≥18 years). No specific assent or parental consent procedures for vulnerable populations are described in the available CTIS data..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are adults (≥18 years). No specific assent or parental consent procedures for vulnerable populations are described in the available CTIS data.

Inclusion criteria

  • {"criterion_text":"- 1. Have histologically or cytologically confirmed R/M HNSCC that is considered incurable by local therapies.\n- 2. Be treatment-naïve for systemic therapy in the R/M setting.\n- 3. 18 years and older with ECOG 0-1\n- 4. Have measurable disease according to RECIST v1.1"}

Exclusion criteria

  • {"criterion_text":"- 1. Uncontrolled illness\n- 2. Has untreated brain metastases or history or known presence of leptomeningeal disease\n- 3. Has a history of clinically significant cardiovascular disease\n- 4. Inadequate organ or bone marrow function"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- 1. PFS (using RECIST v1.1), as assessed by BICR\n- 2. ORR as assessed by BICR\n- 3. DOR as assessed by BICR\n- 4. ORR as assessed by the investigator\n- 5. Incidence and severity of TEAEs and laboratory abnormalities\n- 6. Proportion of participants with improved or stable symptoms relative to baseline, as measured by the EORTC QLQ-HN43 and symptom scales of the EORTC QLQ-C30\n- 7. Change from baseline in functioning and overall HRQoL, as measured by functioning and global health scales of the EORTC QLQ-C30\n- 8. Differences between treatment groups in the EORTC IL46 tolerabilityscale scores\n- 9. Serum amivantamab concentrations and serum anti-amivantamab antibodies","definition_or_measurement_approach":"Where specified in the endpoint text: PFS measured using RECIST v1.1 and assessed by blinded independent central review (BICR); ORR and DOR assessed by BICR or investigator as stated; HRQoL and symptoms measured by EORTC QLQ-HN43, EORTC QLQ-C30 and EORTC IL46 as specified; serum concentrations and anti-drug antibodies measured for amivantamab."}

Recruitment

Planned Sample Size
308
Recruitment Window Months
40
Consent Approach
Informed consent is obtained using subject information sheets and informed consent forms (SIS/ICF). Country- and language-specific ICF/SIS documents are provided (examples present for English, German, French, Dutch, Spanish, Portuguese, Hungarian, Polish, Czech, Romanian, Italian). Consent is provided by the participant (adults ≥18). Specific assent/parental consent procedures are not described in the available CTIS metadata.

Geography

Total Number Of Sites
86
Total Number Of Participants
192

Austria

Earliest CTIS Part Ii Submission Date
12-12-2025
Latest Decision Or Authorization Date
18-01-2026
Processing Time Days
37
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Universitätsklinikum St. Pölten - Klinische Abteilung für Innere Medizin
Contact Person Name
Martin Wiesholzer
Site Name
Medical University Of Vienna
Department Name
Innere Medizin I - Hämatologie und Hämostaseologie
Contact Person Name
Thorsten Fuereder
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Uniklinikum Salzburg Landeskrankenhaus Klinik f. Innere Medizin III/ CRCS GmbH-M3 CTC
Contact Person Name
Teresa Magnes
Contact Person Email
t.magnes@salk.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Innere Medizin V - Hämatologie und Onkologie
Contact Person Name
Florian Kocher
Site Name
Burgenlaendische Krankenanstalten GmbH
Department Name
Krhs. Oberwart, Abteilung für Onkologie, Hämatologie und Palliativmedizin
Contact Person Name
Martin Pichler

Belgium

Earliest CTIS Part Ii Submission Date
09-12-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
38
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
CHU Helora
Department Name
Oncology
Contact Person Name
Gaetan Catala
Contact Person Email
gaetan.catala@jolimont.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Oncology
Contact Person Name
Jean-Pascal Machiels
Site Name
Vitaz
Department Name
Oncology
Contact Person Name
Willem Lybaert
Contact Person Email
willem.lybaert@vitaz.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Oncology
Contact Person Name
Marika Rasschaert
Contact Person Email
Marika.Rasschaert@uza.be
Site Name
UZ Leuven
Department Name
Oncology
Contact Person Name
Paul Clement
Contact Person Email
trialunit@uzleuven.be

Czechia

Earliest CTIS Part Ii Submission Date
11-12-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
36
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologicka klinika 2. LF a FN Motol
Contact Person Name
Michaela Jirkovska
Contact Person Email
michaela.jirkovska@fnmotol.cz
Site Name
University Hospital Olomouc
Department Name
Onkologicka klinika
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Onkologicke klinika
Contact Person Name
Katerina Lickova
Contact Person Email
katerina.lickova@fnkv.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika onkologicka
Contact Person Name
Jana Jackaninova
Contact Person Email
jana.jackaninova@fno.cz
Site Name
Krajska Nemocnice T Bati a.s.
Department Name
Onkologicke oddeleni
Contact Person Name
Marketa Pospiskova
Contact Person Email
pospiskova@bnzlin.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika onkologie a radioterapie
Contact Person Name
Milan Vosmik
Contact Person Email
milan.vosmik@fnhk.cz

France

Earliest CTIS Part Ii Submission Date
12-12-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
33
Number Of Sites
11
Number Of Participants
22

Sites

Site Name
Centre Oscar Lambret
Department Name
Medical oncology
Contact Person Name
Cyril Abdeddaim
Contact Person Email
c-abdeddaim@o-lambret.fr
Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
Medical oncology
Contact Person Name
Benoit CALDERON
Contact Person Email
b.calderon@isc84.org
Site Name
Clinique Victor Hugo
Department Name
Oncology radiotherapy
Contact Person Name
Cedrik LAFOND
Contact Person Email
c.lafond@ilcgroupe.fr
Site Name
Centre Henri Becquerel
Department Name
Medical oncology
Contact Person Name
Florian CLATOT
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Medical oncology
Contact Person Name
Xavier BARTHERE
Contact Person Email
xavier.barthere@aphp.fr
Site Name
Institut Gustave Roussy
Department Name
Head and Neck department
Contact Person Name
Caroline Even
Contact Person Email
Caroline.EVEN@gustaveroussy.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Medical oncology
Contact Person Name
Sebastien SALAS
Contact Person Email
sebastien.salas@ap-hm.fr
Site Name
Institut Curie
Department Name
Clinical investigation Unit
Contact Person Name
Edith BORCOMAN
Contact Person Email
edith.borcoman@curie.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical oncology
Contact Person Name
Frederic ROLLAND
Site Name
Centre Oscar Lambret (additional entry?)
Department Name
Medical oncology
Contact Person Name
Cyril Abdeddaim
Contact Person Email
c-abdeddaim@o-lambret.fr
Site Name
Institut Curie (additional entry?)
Department Name
Head and Neck department
Contact Person Name
Caroline Even
Contact Person Email
Caroline.EVEN@gustaveroussy.fr

Germany

Earliest CTIS Part Ii Submission Date
09-12-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
38
Number Of Sites
9
Number Of Participants
22

Sites

Site Name
Goethe University Frankfurt
Department Name
Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie
Contact Person Name
Christian Brandts
Contact Person Email
brandts@em.uni-frankfurt.de
Site Name
Universitaet Leipzig
Department Name
Universitätsmedizin Leipzig AöR, Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde
Contact Person Name
Andreas Dietz
Site Name
Universitaetsklinikum Essen AöR
Department Name
Westdeutsches Tumorzentrum - Innere Klinik (Tumorforschung)
Contact Person Name
Michael Pogorzelski
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie
Contact Person Name
Simon Laban
Contact Person Email
simon.laban@uniklinik-ulm.de
Site Name
Klinikum Region Hannover GmbH
Department Name
KRH Klinikum Siloah - Klinik für Hämatologie, Onkologie und Immunologie
Contact Person Name
Martin Müller
Contact Person Email
inv.129265.3@dd-proxy.com
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik III - Innere Medizin
Contact Person Name
Peter Brossart
Contact Person Email
peter.brossart@ukb.uni-bonn.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Innere Medizin II
Contact Person Name
Florian Lüke
Contact Person Email
florian.lueke@ukr.de
Site Name
Rostock University Medical Center
Department Name
Zentrum für Innere Mediziin, Abt. für Onkologie/Hämatologie/Palliativmedizin
Contact Person Name
Ulrich Langenkamp
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Universitaetsklinikum Giessen und Marburg GmbH, Hals-Nasen-Ohren Klinik
Contact Person Name
Christine Langer

Romania

Earliest CTIS Part Ii Submission Date
10-12-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
40
Number Of Sites
9
Number Of Participants
15

Sites

Site Name
Institutul Regional De Oncologie Iasi
Department Name
Oncologie
Contact Person Name
Vlad Adrian Afrasanie
Contact Person Email
vladafrasanie@gmail.com
Site Name
Oncocenter Oncologie Clinica S.R.L.
Department Name
Oncologie
Contact Person Name
Roxana Ioana Scheusan
Contact Person Email
roxana.scheusan@gmail.com
Site Name
Cardiomed S.R.L.
Department Name
Oncologie
Contact Person Name
Calin Ioan Cainap
Contact Person Email
calin.cainap@cardiomedcluj.ro
Site Name
Spitalul Clinic Coltea
Department Name
Oncologie
Contact Person Name
Ileana Raluca Patru
Contact Person Email
raluca.patru@gmail.com
Site Name
Institutul Regional De Oncologie Iasi (second entry)
Department Name
Oncologie
Contact Person Name
Vlad Adrian Afrasanie
Contact Person Email
vladafrasanie@gmail.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie
Contact Person Name
Tudor Eliade Ciuleanu
Contact Person Email
tudor_ciuleanu@hotmail.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Institutul Regional De Oncologie Iasi (third entry)
Department Name
Oncologie
Contact Person Name
Vlad Adrian Afrasanie
Contact Person Email
vladafrasanie@gmail.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca (duplicate entry)
Department Name
Oncologie
Contact Person Name
Tudor Eliade Ciuleanu
Contact Person Email
tudor_ciuleanu@hotmail.com

Spain

Earliest CTIS Part Ii Submission Date
11-12-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
36
Number Of Sites
10
Number Of Participants
22

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Lara Iglesias
Contact Person Email
laraiglesias@hotmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Zara Vidales
Contact Person Email
zaravidales@iconcologia.net
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Santiago Cabezas
Site Name
Hospital Universitario Miguel Servet
Department Name
Oncology
Contact Person Name
Javier Martinez
Contact Person Email
jmartinezt@salud.aragon.es
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Oncology
Contact Person Name
Alfonso Berrocal
Contact Person Email
berrocal_alf@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Yolanda Escobar
Contact Person Email
yolandaesco@yahoo.es
Site Name
Fundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela
Department Name
Oncology
Contact Person Name
Santiago Aguin
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Contact Person Name
Irene Hernández
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Irene Braña
Contact Person Email
ibrana@vhio.net
Site Name
Hospital Universitario 12 De Octubre (additional entry)
Department Name
Oncology
Contact Person Name
Lara Iglesias
Contact Person Email
laraiglesias@hotmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
05-12-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
42
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Oncology
Contact Person Name
Jens Voortman
Contact Person Email
j.voortman@amsterdamumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Oncology
Contact Person Name
Sjoukje Oosting
Contact Person Email
s.oosting@umcg.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Oncology
Contact Person Name
Lars Steggink

Poland

Earliest CTIS Part Ii Submission Date
11-12-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
39
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Department Name
Oddzial Onkologii Klinicznej i Immunoonkologii z Pododdzialem Dziennym i Izba Przyjec
Contact Person Name
Zuzanna Synowiec
Contact Person Email
zuzanna.synowiec@wco.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
Department Name
Kilinka Nowotworow Glowy I Szyi
Contact Person Name
Andrzej Kawecki
Contact Person Email
andrzej.kawecki@nio.gov.pl
Site Name
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Department Name
II Oddzial Onkologii i Immunologii Klinicznej z Chemioterapia Dzienna
Contact Person Name
Izabela Kordzinska-Cisek
Contact Person Email
badania.kliniczne@cozl.eu
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Ewa Pawlowska
Contact Person Email
ewa.pawlowska@gumed.edu.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddzial Chorob Rozrostowych
Contact Person Name
Maja Lisik-Habib
Contact Person Email
ms.habib@kopernik.lodz.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
Department Name
Centrum Wsparcia Badan Klinicznych
Contact Person Name
Tomasz Rutkowski

Italy

Earliest CTIS Part Ii Submission Date
21-11-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
56
Number Of Sites
8
Number Of Participants
17

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Muscle scheletrical and head and neck
Contact Person Name
Francesco Perri
Contact Person Email
f.perri@istitutotumori.na.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncologia Medica Urogenitale e Cervico facciale
Contact Person Name
Franco Nolè
Contact Person Email
Franco.nole@ieo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Head and neck and non-melanoma skin cancer Oncology
Contact Person Name
Paolo Bossi
Contact Person Email
paolo.bossi@hunimed.eu
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Oncologia A
Contact Person Name
Alessio Cirillo
Contact Person Email
alessio.cirillo@uniroma1.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC Oncologia
Contact Person Name
Ilaria Imarisio
Contact Person Email
i.imarisio@smatteo.pv.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
UO Oncologia Medica
Contact Person Name
Gaetana Rinaldi
Contact Person Email
taniarinaldi02@gmail.com
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Oncologia Medica 3 - Tumori testa-collo
Contact Person Name
Lisa Licitra
Site Name
Istituto Europeo Di Oncologia (additional entry)
Department Name
Divisione di Oncologia Medica Urogenitale e Cervico facciale
Contact Person Name
Franco Nolè
Contact Person Email
Franco.nole@ieo.it

Portugal

Earliest CTIS Part Ii Submission Date
16-12-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
31
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Medical Oncology
Contact Person Name
Ricardo Pinto
Site Name
Hospital Cuf Descobertas S.A.
Department Name
Oncology
Contact Person Name
Diogo Alpuim Costa
Contact Person Email
diogo.costa@cuf.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Medical Oncology
Contact Person Name
Leonor Ribeiro
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Claudia Vieira
Site Name
Unidade Local de Saude do Algarve E.P.E.
Department Name
Oncology
Contact Person Name
Ana Varges Gomes
Site Name
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Maria Margarida Teixeira
Contact Person Email
676@ipocoimbra.min-saude.pt
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E. (additional entry)
Department Name
Medical Oncology
Contact Person Name
Ricardo Pinto

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Bioclinica Inc.
Responsibilities
CT/MRI imaging collection and central reading services
Name
Smithers PDS LLC
Responsibilities
PK and immunogenicity (ADA) sample analysis
Name
Eresearchtechnology Inc.

Third parties

  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"CT/MRI imaging collection and central reading services","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"PK and immunogenicity (ADA) sample analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-61186372
Active Substance
AMIVANTAMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
prodAuthStatus=1
Investigational Product Name
PEMBROLIZUMAB
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
prodAuthStatus=2
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
prodAuthStatus=2
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
prodAuthStatus=2
Investigational Product Name
FLUOROURACIL
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
prodAuthStatus=2
Combination Treatment
Yes

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