Clinical trial • Phase III • Oncology

AMIVANTAMAB for Colorectal cancer | KRAS/NRAS and BRAF wild-type colorectal cancer

Phase III trial of AMIVANTAMAB for Colorectal cancer | KRAS/NRAS and BRAF wild-type colorectal cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Colorectal cancer | KRAS/NRAS and BRAF wild-type colorectal cancer
Trial Stage
Phase III
Drug Modality
Bispecific antibody | Monoclonal antibody

Key dates

Initial CTIS Submission Date
05-09-2024
First CTIS Authorization Date
15-01-2025

Trial design

Randomised, open-label, cetuximab + folfiri; bevacizumab + folfiri (comparator arms). doses and schedules not specified in the ctis record.-controlled Phase III trial in Poland, Germany, Belgium and others.

Randomised
Yes
Open Label
Yes
Comparator
Cetuximab + FOLFIRI; Bevacizumab + FOLFIRI (comparator arms). Doses and schedules not specified in the CTIS record.
Target Sample Size
538

Eligibility

Recruits 538 Vulnerable population not selected (isVulnerablePopulationSelected=false). Trial enrols adults (≥18 years). Country-specific subject information and informed consent forms are provided (multiple country ICF documents and language variants present) and there are partner/pregnancy and child-exposure privacy appendices in the documentation..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected=false). Trial enrols adults (≥18 years). Country-specific subject information and informed consent forms are provided (multiple country ICF documents and language variants present) and there are partner/pregnancy and child-exposure privacy appendices in the documentation.

Inclusion criteria

  • {"criterion_text":"- 1.Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease"}
  • {"criterion_text":"- 2. Determined to have KRAS/NRAS G12, G13, and BRAF V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central NGS testing (if available)."}
  • {"criterion_text":"- 3. Must have received 1 line of systemic therapy for mCRC, with documented radiographic disease progression on or after one line of either fluoropyrimidine-based and oxaliplatin-based therapy"}
  • {"criterion_text":"- 4. 18 years and older with ECOG 0-1 and at least one measurable lesion per RECIST v1.1"}
  • {"criterion_text":"- 5. Adequate organ and bone marrow function"}
  • {"criterion_text":"- 6. Must be eligible for treatment with FOLFIRI according to respective local regulatory approvals and SoC guidelines"}

Exclusion criteria

  • {"criterion_text":"- 1. Uncontrolled illness"}
  • {"criterion_text":"- 2. history of clinically significant cardiovascular disease"}
  • {"criterion_text":"- 3. Participant with known dMMR/MSI-H status who has not received immunotherapy treatments.or HER2 amplified tumor"}
  • {"criterion_text":"- 4. Participant with known complete absence of DPD activity."}
  • {"criterion_text":"- 5. Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS (using RECIST v1.1), as assessed by BICR","definition_or_measurement_approach":"Progression-free survival assessed using RECIST v1.1 criteria as evaluated by Blinded Independent Central Review (BICR)."}
  • {"endpoint_text":"- OS","definition_or_measurement_approach":"Overall survival (OS); definition as time to death from any cause (no additional measurement detail provided in the record)."}

Recruitment

Planned Sample Size
538
Recruitment Window Months
56
Consent Approach
Informed consent is obtained via country-specific Subject Information Sheets and Informed Consent Forms (many country/translations available as listed in the documents). Participants (adults ≥18) provide consent. Country-specific addenda (e.g., treatment beyond progression, withdrawal, pregnancy, pregnant partner, child-exposed privacy appendices) and subject wallet cards are included in documentation; ICFs are available in multiple languages for participating countries.

Geography

Total Number Of Sites
72
Total Number Of Participants
162

Poland

Earliest CTIS Part Ii Submission Date
24-12-2024
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
336
Number Of Sites
9
Number Of Participants
21

Sites

Site Name
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
Klinika Onkologii I Immunoonkologii
Contact Person Name
Tomasz Lewandowski
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
Department Name
Oddzial Chemioterapii Dziennej
Contact Person Name
Wieslaw Bal
Contact Person Email
wieslaw.bal@io.gliwice.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjanwyrwicz@gmail.com
Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Onkologii
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.pl
Site Name
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Department Name
Oddzial Chemioterapii i Hematologii Onkologicznej
Contact Person Name
Dariusz Sawka
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Ewa Szutowicz
Contact Person Email
eszut@gumed.edu.pl
Site Name
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Klinika Onkologii
Contact Person Name
Barbara Radecka
Contact Person Email
brad@onkologia.opole.pl
Site Name
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Department Name
Oddzial Chemioterapii Dziennej
Contact Person Name
Maria Pawlowicz
Contact Person Email
maria.pawlowicz@szpitalbp.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddzial Onkologii Klinicznej
Contact Person Name
Piotr Tokajuk
Contact Person Email
ptokajuk@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
04-11-2024
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
386
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Krankenhaus Nordwest GmbH
Department Name
Innere Medizin/Hämatologie/Onkologie
Contact Person Name
Thorsten Götze
Contact Person Email
goetze.thorsten@khnw.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Contact Person Name
Markus Moehler
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Med. Klinik m. Schwerpunkt Hämatologie, Onkologie u. Tumorimmunologie
Contact Person Name
Dominik Modest
Contact Person Email
dominik.modest@charite.de
Site Name
Klinikum der Universitaet Muenchen AöR
Contact Person Name
Sabrina Opatz
Site Name
National Center For Tumor Diseases (NCT) Heidelberg
Contact Person Name
Sebastian Dieter

Belgium

Earliest CTIS Part Ii Submission Date
20-12-2024
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
339
Number Of Sites
7
Number Of Participants
18

Sites

Site Name
Antwerp University Hospital
Department Name
Medical oncology
Contact Person Name
Hans Prenen
Contact Person Email
oncologie@uza.be
Site Name
Centre Hospitalier Universitaire De Liege
Department Name
Medical oncology
Contact Person Name
Nathalie Marchal
Contact Person Email
oncologiemedicale@chuliege.be
Site Name
Institut Jules Bordet
Department Name
Medical oncology
Contact Person Name
Francesco Sclafani
Contact Person Email
accueil.oncologie@bordet.be
Site Name
CHU Helora
Department Name
Medical oncology
Contact Person Name
Alexandre Dermine
Contact Person Email
alexandre.dermine@helora.be
Site Name
Az Maria Middelares Gent
Department Name
Gastro-enterology
Contact Person Name
Erik Vanderstraeten
Contact Person Email
gastro.gent@mijnziekenhuis.be
Site Name
UZ Leuven
Department Name
Gastro-enterology
Contact Person Name
Jeroen Dekervel
Contact Person Email
secretariaatmdl@uzleuven.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Gastro-enterology
Contact Person Name
Alexander Vanden Bulcke

Romania

Earliest CTIS Part Ii Submission Date
19-12-2024
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
354
Number Of Sites
10
Number Of Participants
27

Sites

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
Department Name
Oncologie
Contact Person Name
Bogdan Gafton
Contact Person Email
gaftonbogdan@yahoo.com
Site Name
Pelican Impex S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Ioana Adriana Ciurescu
Contact Person Email
ioana_covaciu@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie Medicala
Contact Person Name
Alina Simona Muntean
Contact Person Email
muntean.alina@yahoo.fr
Site Name
Memorial Healthcare International S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Ingrid Adriana Iordan
Contact Person Email
mireliordan@yahoo.com
Site Name
Mnt Healthcare Europe S.R.L.
Department Name
Hematologie si Oncologie Medicala
Contact Person Name
Dan Corneliu Jinga
Contact Person Email
dan.jinga@neolife.ro
Site Name
Institutul Regional De Oncologie Iasi (alternate address)
Department Name
Oncologie Medicala
Contact Person Name
Bogdan Gafton
Contact Person Email
gaftonbogdan@yahoo.com
Site Name
Oncomed S.R.L.
Department Name
Oncologie
Contact Person Name
Dorel Ionel Popovici
Contact Person Email
dorelpopovici@gmail.com
Site Name
Centrul Medical Unirea S.R.L.
Department Name
Oncologie
Contact Person Name
Karoly Adrian Hajdu
Contact Person Email
adrian_hajdu@yahoo.com
Site Name
Delta Health Care S.R.L.
Department Name
Oncologie
Contact Person Name
Amalia Mara Rosu
Contact Person Email
amalia.rosu@reginamaria.ro

Hungary

Earliest CTIS Part Ii Submission Date
19-12-2024
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
341
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
University Of Pecs
Department Name
Department of Oncotherapy
Contact Person Name
Oszkár Karádi
Contact Person Email
karadioszkar@gmail.com
Site Name
University Of Szeged
Department Name
Department of Oncotherapy
Contact Person Name
Anikó Maráz
Contact Person Email
dr.aniko.maraz@gmail.com
Site Name
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department Name
Department of Oncology
Contact Person Name
Dániel Deme
Contact Person Email
danieldeme_md@ymail.com

Sweden

Earliest CTIS Part Ii Submission Date
29-11-2024
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
357
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
Uppsala University Hospital
Department Name
Department of Hematology, Oncology and Endocrine tumors
Contact Person Name
Henning Karlsson
Contact Person Email
henning.karlsson@akademiska.se
Site Name
Soedersjukhuset AB
Department Name
Oncology Department
Contact Person Name
Anna Schedin
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of Oncology
Contact Person Name
Ulrika Palenius
Contact Person Email
ulrika.palenius@skane.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Oncology Department
Contact Person Name
Leif Klint
Contact Person Email
leif.klint@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Tema Cancer, Department of Oncology
Contact Person Name
Mia Karlberg

Netherlands

Earliest CTIS Part Ii Submission Date
23-12-2024
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
359
Number Of Sites
6
Number Of Participants
16

Sites

Site Name
Meander Medisch Centrum
Department Name
Medical Oncology
Contact Person Name
Hans Martin Otten
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medical Oncology
Contact Person Name
Karen Bolhuis
Contact Person Email
k.bolhuis@nki.nl
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
Medical Oncology
Contact Person Name
Laurens Beerepoot
Contact Person Email
trialbureau-onco@etz.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Medical Oncology
Contact Person Name
Henk Verheul
Contact Person Email
nterne.oncologie@erasmusmc.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Medical Oncology
Contact Person Name
Harm Westdorp
Contact Person Email
studies.onco@radboudumc.nl
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis (additional entry)
Department Name
Medical Oncology
Contact Person Name
Laurens Beerepoot
Contact Person Email
trialbureau-onco@etz.nl

France

Earliest CTIS Part Ii Submission Date
08-01-2025
Latest Decision Or Authorization Date
07-01-2026
Processing Time Days
364
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
Medical Oncology
Contact Person Name
May Mabro
Contact Person Email
m.mabro@isc84.org
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Medical Oncology
Contact Person Name
David Tougeron
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Medical Oncology
Contact Person Name
Denis Smith
Contact Person Email
denis.smith@chu-bordeaux.fr

Spain

Earliest CTIS Part Ii Submission Date
20-12-2024
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
453
Number Of Sites
15
Number Of Participants
20

Sites

Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncología Médica
Contact Person Name
Ekaterina Meshoulam
Contact Person Email
emesholam@oncorosell.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncología Médica
Contact Person Name
Silvia Gil
Contact Person Email
silviagilcalle@yahoo.es
Site Name
Instituto Multidisciplinar De Oncologia S.A.
Department Name
Oncología médica
Contact Person Name
Esther Holgado
Contact Person Email
esther.holgado@genesiscare.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncología Médica
Contact Person Name
Raquel Fuentes
Contact Person Email
raquel.fmateos@quironsalud.es
Site Name
Hospital Del Mar
Department Name
Oncología Médica
Contact Person Name
Joana Vidal
Contact Person Email
jvidal@hmar.cat
Site Name
Hospital Universitario De Badajoz
Department Name
Oncología Médica
Contact Person Name
Maria Fernanda Martinez
Site Name
Hospital Universitari Vall D Hebron
Department Name
Institute of Oncology
Contact Person Name
Elena Elez
Contact Person Email
meelez@vhio.net
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Oncologia Medica
Contact Person Name
Javier Rodriguez
Contact Person Email
jrodriguez@unav.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncologia Medica
Contact Person Name
Susana Rosello
Contact Person Email
srosello@incliva.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncologia Medica
Contact Person Name
Cristina Gravalos
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncología Médica
Contact Person Name
Reyes Ferreiro
Contact Person Email
reyes-ferreiro@hotmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncologia Medica
Contact Person Name
Pilar Garcia
Contact Person Email
pgarcaalfonso@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncologia Medica
Contact Person Name
Amelia Lopez
Contact Person Email
alopezladron@yahoo.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Oncologia Medica
Contact Person Name
Javier Rodriguez
Contact Person Email
jrodriguez@unav.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncologia Medica
Contact Person Name
Anna Virgili
Contact Person Email
avirgili@santpau.cat

Italy

Earliest CTIS Part Ii Submission Date
28-11-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
508
Number Of Sites
9
Number Of Participants
10

Sites

Site Name
ARNAS Garibaldi Di Catania
Department Name
Oncologia Medica
Contact Person Name
Roberto Bordonaro
Contact Person Email
rbordonaro@arnasgaribaldi.it
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 1
Contact Person Name
Francesca Bergamo
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UOC Oncologia 2
Contact Person Name
Chiara Cremolini
Contact Person Email
chiaracremolini@gmail.com
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Dipartimento di Oncologia
Contact Person Name
Silvio Ken Garattini
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Oncologia Medica 1
Contact Person Name
Filippo Pietrantonio
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SOD Oncologia
Contact Person Name
Lorenzo Antonuzzo
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. di Oncologia Medica ed Ematologia
Contact Person Name
Alberto Puccini
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Oncologia Medica
Contact Person Name
Elisabetta Fenocchio
Contact Person Email
elisabetta.fenocchio@ircc.it
Site Name
Azienda Ospedaliero Universitaria Careggi (additional entry)
Department Name
SOD Oncologia (additional)
Contact Person Name
Lorenzo Antonuzzo

Sponsor

Primary sponsor

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

Contract research organisations

Name
Icon (Lr) Limited
Responsibilities
Translation of PRO AE
Name
Iqvia Rds Inc.
Responsibilities
Clinical Programming services
Name
Bioclinica Inc.
Responsibilities
Central Imaging
Name
Cytel Inc.
Responsibilities
Statistical support group for the IDMC

Third parties

  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Tumor Biopsy Chlid Samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Lab Services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"Predose exploratory biomarkers","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"IP storage and distribution","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Clinical Programming services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Statistical support group for the IDMC","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Lab Services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"PK and immunogenicity (ADA) sample analysis for amivantamab serum ROW","organisation_type":"Pharmaceutical company"}
  • {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"Central Lab Services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Translation of PRO AE","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"Clinical ink eCOA solution is utilized to capture clinical outcome assessments from Participant, Clinicians, or Caregivers","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Continuum Clinical LLC","duties_or_roles":"Design development, content development, prodution, shipping","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"PK Office","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-61186372
Active Substance
AMIVANTAMAB
Modality
Bispecific antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Investigational Product Name
Erbitux 5 mg/mL solution for infusion
Active Substance
CETUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised
Investigational Product Name
Bevacizumab (Avastin/VEGZELMA and other presentations)
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised
Combination Treatment
Yes

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