Clinical trial • Phase III • Oncology

AMIVANTAMAB for Left-sided colorectal cancer (KRAS/NRAS and BRAF wild-type)

Phase III trial of AMIVANTAMAB for Left-sided colorectal cancer (KRAS/NRAS and BRAF wild-type).

Overview

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

Key dates

Initial CTIS Submission Date
29-08-2024
First CTIS Authorization Date
11-12-2024

Trial design

Randomised, open-label, cetuximab (erbitux 5 mg/ml solution for infusion) combined with mfolfox6 or folfiri (dosing/schedule not specified in ctis entry)-controlled Phase III trial in Hungary, Belgium, Poland and others.

Randomised
Yes
Open Label
Yes
Comparator
Cetuximab (Erbitux 5 mg/mL solution for infusion) combined with mFOLFOX6 or FOLFIRI (dosing/schedule not specified in CTIS entry)
Biomarker Stratified
True, KRAS/NRAS and BRAF wild-type status
Target Sample Size
734

Eligibility

Recruits 734 Vulnerable populations are addressed via dedicated documents (SIS and ICF addenda). Country-specific ICFs include 'Pregnant Partner' and 'PRIVACY CHILD EXPOSED TO IP' documents indicating considerations for pregnant partners and children exposed to investigational product; consent and privacy handling are provided via specific ICFs and privacy appendices for parents/guardians. Assent procedures are not specified in the available CTIS documents..

Vulnerable Population
Vulnerable populations are addressed via dedicated documents (SIS and ICF addenda). Country-specific ICFs include 'Pregnant Partner' and 'PRIVACY CHILD EXPOSED TO IP' documents indicating considerations for pregnant partners and children exposed to investigational product; consent and privacy handling are provided via specific ICFs and privacy appendices for parents/guardians. Assent procedures are not specified in the available CTIS documents.

Inclusion criteria

  • {"criterion_text":"- 1. Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease."}
  • {"criterion_text":"- 2.Determined to have KRAS, NRAS, and BRAF WTtumor by local and/or central testing (if available). Both tissue - and blood-based testing is an acceptable method for the eligibility determination. The use of tissue (preferred) or plasma NGS is strongly recommended for eligibility determination. Sanger sequencing or pyrosequencing are not accepted for eligibility determination."}
  • {"criterion_text":"- 3. Must agree to the submission of fresh tumor tissue."}
  • {"criterion_text":"- 4. Have measurable disease according to RECIST v1.1. If only 1 measurable lesion exists, it may be used for the screening biopsy as long as baseline tumor assessment scans are performed ≥7 days after the biopsy."}
  • {"criterion_text":"- 5. Have an ECOG PS of 0 or 1"}
  • {"criterion_text":"- 6. Has not received any prior systemic therapy for unresectable or metastatic CRC."}

Exclusion criteria

  • {"criterion_text":"- 1. Has medical history of (noninfectious) ILD/pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening."}
  • {"criterion_text":"- 2. Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: a. amivantamab (refer to the IB) or cetuximab (refer to the product label) (all participants) b. any component of mFOLFOX6 (refer to the product labels) (participants receiving mFOLFOX6) c. any component of FOLFIRI (refer to the product labels) (participants receiving FOLFIRI)"}
  • {"criterion_text":"- 3. Participant has a history of clinically significant cardiovascular disease including, but not limited to, the following: a. Diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization or any of the following within 6 months prior to randomization: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically nonsignificant thrombosis, such as nonobstructive catheter-associated clots, are not exclusionary. b. Prolonged QTcF interval >480 msec or clinically significant cardiac arrhythmia or electrophysiologic disease (eg, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate). Note: Participants with cardiac pacemakers who are clinically stable are eligible. c. Uncontrolled (persistent) hypertension: systolic BP >180 mm Hg; diastolic BP >100 mm Hg d. Congestive heart failure defined as NYHA class III or IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of randomization e. Pericarditis/clinically significant pericardial effusion f. Myocarditis"}
  • {"criterion_text":"- 4. Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s). Prior or concurrent second malignancies must be reviewed and agreed to with the medical monitor."}
  • {"criterion_text":"- 5. Participant with known dMMR/MSI-H status."}
  • {"criterion_text":"- 6. Participant with known HER2-positive/amplified tumor."}
  • {"criterion_text":"- 7. Has prior exposure to any agents that target EGFR or MET (including but not limited to protein products, monoclonal antibodies, tyrosine kinase inhibitors, or antisense oligonucleotide therapy)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS (using RECIST v1.1), as assessed by BICR","definition_or_measurement_approach":"Progression-free survival measured using RECIST v1.1 criteria and assessed by Blinded Independent Central Review (BICR)."}

Recruitment

Planned Sample Size
734
Recruitment Window Months
84
Consent Approach
Informed consent is obtained using country-specific SIS and ICF documents (Main ICF and addenda). Dedicated ICFs/addenda exist for pregnant partners, genetic testing, withdrawal, and child-exposed privacy. ICFs are provided in multiple languages corresponding to participating countries (examples in the CTIS documents include English, Dutch, French, Italian, Spanish, Polish, German, Hungarian, Swedish). Consent is provided by the participant; for minors/children exposed to IP or for partner privacy issues, specific parent/guardian privacy and consent appendices are provided. Assent specifics are not detailed in the CTIS materials.

Geography

Total Number Of Sites
64
Total Number Of Participants
266

Hungary

Earliest CTIS Part Ii Submission Date
18-11-2024
Latest Decision Or Authorization Date
18-12-2024
Processing Time Days
30
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
University Of Pecs
Department Name
Department of Oncotherapy
Contact Person Name
Oszkár Karádi
Contact Person Email
karadioszkar@gmail.com
Site Name
Semmelweis Egyetem
Department Name
Department of Oncology
Contact Person Name
Gyongyver Szentmartoni
Contact Person Email
gyszentmartoni@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
Site Name
University Of Szeged
Department Name
Department of Oncotherapy
Contact Person Name
Anikó Maráz
Contact Person Email
dr.aniko.maraz@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
05-12-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
6
Number Of Sites
7
Number Of Participants
28

Sites

Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Gastro-enterology
Contact Person Name
Alexander Vanden Bulcke
Site Name
CHU Helora
Department Name
Medical oncology
Contact Person Name
Alexandre Dermine
Contact Person Email
alexandre.dermine@helora.be
Site Name
UZ Leuven
Department Name
Gastro-enterology
Contact Person Name
Jeroen Dekervel
Contact Person Email
secretariaatmdl@uzleuven.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
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
Antwerp University Hospital
Department Name
Medical oncology
Contact Person Name
Hans Prenen
Contact Person Email
oncologie@uza.be

Poland

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
20-12-2024
Processing Time Days
28
Number Of Sites
9
Number Of Participants
38

Sites

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
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
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
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
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Onkologii
Contact Person Name
Ewa Kalinka
Contact Person Email
ewakalinka@wp.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
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
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
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Department Name
Oddzial Chemioterapii i Hematologii Onkologicznej
Contact Person Name
Dariusz Sawka

Sweden

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
13-12-2024
Processing Time Days
21
Number Of Sites
5
Number Of Participants
20

Sites

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
Karolinska University Hospital
Department Name
Tema Cancer, Department of Oncology
Contact Person Name
Mia Karlberg
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
Uppsala University Hospital
Department Name
Department of Hematology, Oncology and Endocrine tumors
Contact Person Name
Tanweera Khan
Contact Person Email
tanweera.khan@akademiska.se
Site Name
Soedersjukhuset AB
Department Name
Oncology Department
Contact Person Name
Anna Schedin

Netherlands

Earliest CTIS Part Ii Submission Date
29-11-2024
Latest Decision Or Authorization Date
18-12-2024
Processing Time Days
19
Number Of Sites
6
Number Of Participants
26

Sites

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
Stichting Radboud universitair medisch centrum
Department Name
Medical Oncology
Principal Investigator Name
Elske Gootjes
Principal Investigator Email
studies.onco@radboudumc.nl
Contact Person Name
Henk Verheul
Contact Person Email
nterne.oncologie@erasmusmc.nl
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
Meander Medisch Centrum
Department Name
Medical Oncology
Contact Person Name
Hans Martin Otten
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Medical Oncology
Contact Person Name
Robert Jan Kwakman
Contact Person Email
oncostudies@umcutrecht.nl

Italy

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
16-12-2024
Processing Time Days
52
Number Of Sites
5
Number Of Participants
22

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. di Oncologia Medica ed Ematologia
Contact Person Name
Armando Santoro
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
c/o Ospedale Santa Maria delle Croci Dipartimento Oncoematologico UOC Oncologia
Contact Person Name
Stefano Tamberi
Contact Person Email
stefano.tamberi@auslromagna.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UOC Oncologia 2
Contact Person Name
Chiara Cremolini
Contact Person Email
chiaracremolini@gmail.com
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 1
Contact Person Name
Francesca Bergamo
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Oncologia Medica 1
Contact Person Name
Filippo Pietrantonio

Germany

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
13-12-2024
Processing Time Days
21
Number Of Sites
10
Number Of Participants
40

Sites

Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Onkologie, Hämatologie, Palliativmedizin und Rheumatologie
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
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
National Center For Tumor Diseases (NCT) Heidelberg
Contact Person Name
Sebastian Dieter
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik III
Contact Person Name
Sabrina Opatz
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Medizinische Klinik für Onkologie
Contact Person Name
Gunnar Folprecht
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
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
Contact Person Name
Patrick Marschner
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Innere Medizin I
Contact Person Name
Thomas Seufferlein
Site Name
Universitaetsklinikum Essen AöR
Department Name
Westdeutsches Tumorzentrum - Innere Klinik (Tumorforschung)
Contact Person Name
Stefan Kasper-Virchow
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I. Medizinische Klinik und Poliklinik
Contact Person Name
Markus Moehler

Spain

Earliest CTIS Part Ii Submission Date
28-11-2024
Latest Decision Or Authorization Date
11-12-2024
Processing Time Days
13
Number Of Sites
9
Number Of Participants
36

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncologia Medica
Contact Person Name
David Paez
Contact Person Email
dpaez@santpau.cat
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
Hospital General Universitario Gregorio Maranon
Department Name
Oncologia Medica
Contact Person Name
Pilar Garcia
Contact Person Email
pgarcaalfonso@gmail.com
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
Hospital Universitario Ramon Y Cajal
Department Name
Oncología Médica
Contact Person Name
Iñigo Martinez
Contact Person Email
imdelfrade@salud.madrid.org
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 Universitario 12 De Octubre
Department Name
Oncologia Medica
Contact Person Name
Cristina Gravalos
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncologia Medica
Contact Person Name
Susana Rosello
Contact Person Email
srosello@incliva.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Oncologia Medica
Contact Person Name
Javier Rodriguez
Contact Person Email
jrodriguez@unav.es

France

Earliest CTIS Part Ii Submission Date
18-10-2024
Latest Decision Or Authorization Date
12-12-2024
Processing Time Days
55
Number Of Sites
9
Number Of Participants
40

Sites

Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Contact Person Name
Thibault Mazard
Site Name
Institut Gustave Roussy
Department Name
Département de Médecine - Comité 040
Contact Person Name
Michel Ducreux
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Medical Oncology Department
Contact Person Name
Anthonny Turpin
Contact Person Email
anthony.turpin@chu-lille.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
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 Nantes
Department Name
Medical Oncology
Contact Person Name
Yann Touchefeu
Contact Person Email
yann.touchefeu@chu-nantes.fr
Site Name
Hopital Prive Jean Mermoz
Department Name
Medical Oncology
Contact Person Name
Pascal Artru
Contact Person Email
dr.artru@wanadoo.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Medical Oncology
Contact Person Name
Thierry Andre
Contact Person Email
thierry.andre@aphp.fr

Sponsor

Primary sponsor

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

Contract research organisations

Name
Iqvia Rds Inc.
Responsibilities
Clinical Programming services
Name
Icon (Lr) Limited
Responsibilities
Translation of PRO AE Text
Name
4g Clinical LLC

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Lab Services","organisation_type":"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":"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":"Cytel Inc.","duties_or_roles":"Statistical support group for the IDMC","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"IP storage and distribution","organisation_type":"Pharmaceutical company"}
  • {"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":"Smithers PDS LLC","duties_or_roles":"PK and immunogenicity (ADA) sample analysis for amivantamab serum ROW","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Clinical Programming services","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":"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":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Continuum Clinical LLC","duties_or_roles":"Design development, content development, prodution, shipping","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"PK Office","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Translation of PRO AE Text","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Ignite Data Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-61186372
Active Substance
AMIVANTAMAB
Modality
Bispecific antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Investigational (no marketing authorisation listed in CTIS product entry)
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
Marketing authorisation (EU) - EU/1/04/281/003 and EU/1/04/281/005
Combination Treatment
Yes

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