Clinical trial • Phase III • Oncology
DURVALUMAB for Gastric cancer | Gastroesophageal junction adenocarcinoma
Phase III trial of DURVALUMAB for Gastric cancer | Gastroesophageal junction adenocarcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Gastric cancer | Gastroesophageal junction adenocarcinoma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 08-12-2023
- First CTIS Authorization Date
- 29-01-2024
Trial design
Randomised, arm b: placebo on day 1 + flot on days 1 and 15 q4w for 4 cycles (2 cycles neoadjuvant + 2 cycles adjuvant) followed by placebo on day 1 q4w for 10 additional cycles-controlled Phase III trial in Belgium, Netherlands, Germany and others.
- Randomised
- Yes
- Comparator
- Arm B: placebo on Day 1 + FLOT on Days 1 and 15 Q4W for 4 cycles (2 cycles neoadjuvant + 2 cycles adjuvant) followed by placebo on Day 1 Q4W for 10 additional cycles
- Target Sample Size
- 564
Eligibility
Recruits 564 Vulnerable population flag selected in the record. Subject information and informed consent forms for adult subjects are available (document titles include adult ICFs, genetic ICFs, pregnant partner ICFs and eConsent versions). Country-specific ICF documents are present (e.g. PL, HU, DK indicated in document titles). No explicit wording about assent or parental consent for minors is provided in the available materials..
- Vulnerable Population
- Vulnerable population flag selected in the record. Subject information and informed consent forms for adult subjects are available (document titles include adult ICFs, genetic ICFs, pregnant partner ICFs and eConsent versions). Country-specific ICF documents are present (e.g. PL, HU, DK indicated in document titles). No explicit wording about assent or parental consent for minors is provided in the available materials.
Inclusion criteria
- {"criterion_text":"- Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition)\n- Patients must have undergo radical surgery\n- No prior anti-cancer therapy for the current malignancy\n- World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment\n- Adequate organ and marrow function\n- Availability of tumor sample prior to study entry\n- Must have a life expectancy of at least 24 weeks"}
Exclusion criteria
- {"criterion_text":"- Patients with peritoneal dissemination or distant metastasis\n- Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor\n- History of allogeneic organ transplantation\n- Contra-indication to any of the study drugs\n- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab\n- Patients with peritoneal dissemination or distant metastasis"}
Endpoints
Primary endpoints
- {"endpoint_text":"- EFS (event free survival)","definition_or_measurement_approach":"To compare Arm A relative to Arm B on event-free survival (EFS)"}
Secondary endpoints
- {"endpoint_text":"- OS (Overall Survival)","definition_or_measurement_approach":"To compare Arm A relative to Arm B on overall survival (OS)"}
- {"endpoint_text":"- pCR rate","definition_or_measurement_approach":"Pathological complete response (pCR) rate: proportion of patients whose resected specimens show no residual viable tumor"}
Other endpoints
- {"endpoint_text":"- To compare Arm A relative to Arm B on the proportion of patients who undergo gastrectomy or gastrophagectomy\n- To compare Arm A relative to Arm B on the rate of complete resection (R0)\n- To compare Arm A relative to Arm B on metastasis-free survival (MFS) and disease-specific survival (DSS)\n- To compare Arm A relative to Arm B on disease-free survival in patients who undergo R0 resection surgery\n- To compare Arm A relative to Arm B on EFS24, EFS36, OS24, OS36, DFS24, and DFS36\n- To compare Arm A relative to Arm B on efficacy endpoints by PD-L1 expression\n- To compare Arm A relative to Arm B on disease-related symptoms, impacts, and HRQoL\n- To evaluate PK of Arm A and Arm B\n- To assess the immunogenicity of Arm A and Arm B","definition_or_measurement_approach":"Definitions/approaches are as stated in the protocol objectives: includes surgical rates and pathological assessments (pCR, R0), time-to-event measures (MFS, DSS, DFS at multiple timepoints), subgroup analyses by PD-L1 expression, patient-reported outcomes (disease-related symptoms, HRQoL), pharmacokinetics (PK) evaluation and immunogenicity assessments."}
Recruitment
- Planned Sample Size
- 564
- Recruitment Window Months
- 45
- Consent Approach
- Informed consent is obtained from adult subjects. Subject information and informed consent forms (ICFs) are provided for adult subjects, optional genetic research, and pregnant partners; eConsent versions are available. Country-specific ICF documents are present (document titles indicate PL, HU, DK, FR and others). There is no explicit description of assent or parental consent for minors in the available documents.
Geography
- Total Number Of Sites
- 58
- Total Number Of Participants
- 341
Belgium
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 16-10-2024
- Processing Time Days
- 286
- Number Of Sites
- 5
- Number Of Participants
- 30
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Hans Prenen
- Principal Investigator Email
- hans.prenen@uza.be
- Contact Person Name
- Hans Prenen
- Contact Person Email
- hans.prenen@uza.be
- Site Name
- CHC MontLegia
- Department Name
- Hémato-oncologie
- Principal Investigator Name
- Ghislain Houbiers
- Principal Investigator Email
- Ghislain.houbiers@chc.be
- Contact Person Name
- Ghislain Houbiers
- Contact Person Email
- Ghislain.houbiers@chc.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Digestive oncologie
- Principal Investigator Name
- Pieter Vandecandelaere
- Principal Investigator Email
- pieter.vandecandelaere@azdelta.be
- Contact Person Name
- Pieter Vandecandelaere
- Contact Person Email
- pieter.vandecandelaere@azdelta.be
- Site Name
- Grand Hopital De Charleroi
- Department Name
- onco hemato
- Principal Investigator Name
- Javier Carrasco
- Principal Investigator Email
- Javier.CARRASCO@ghdc.be
- Contact Person Name
- Javier Carrasco
- Contact Person Email
- Javier.CARRASCO@ghdc.be
- Site Name
- UZ Leuven
- Department Name
- Digestieve Oncologie
- Principal Investigator Name
- Eric Van Cutsem
- Principal Investigator Email
- eric.vancutsem@uzleuven.be
- Contact Person Name
- Eric Van Cutsem
- Contact Person Email
- eric.vancutsem@uzleuven.be
Netherlands
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 14-10-2024
- Processing Time Days
- 284
- Number Of Sites
- 3
- Number Of Participants
- 24
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Interne Oncologie
- Principal Investigator Name
- Bianca Mostert
- Principal Investigator Email
- b.mostert@erasmusmc.nl
- Contact Person Name
- Bianca Mostert
- Contact Person Email
- b.mostert@erasmusmc.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Medical oncology
- Principal Investigator Name
- Myriam Chalabi
- Principal Investigator Email
- m.chalabi@nki.nl
- Contact Person Name
- Myriam Chalabi
- Contact Person Email
- m.chalabi@nki.nl
- Site Name
- Catharina Ziekenhuis Stichting
- Department Name
- Medical oncology
- Principal Investigator Name
- Annemarie (Anna Maria Johanna) Thijs
- Principal Investigator Email
- annemarie.thijs@catharinaziekenhuis.nl
- Contact Person Name
- Annemarie (Anna Maria Johanna) Thijs
- Contact Person Email
- annemarie.thijs@catharinaziekenhuis.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 16-10-2024
- Processing Time Days
- 286
- Number Of Sites
- 12
- Number Of Participants
- 55
Sites
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin III
- Principal Investigator Name
- Sylvie Lorenzen
- Principal Investigator Email
- sylvie.lorenzen@mri.tum.de
- Contact Person Name
- Sylvie Lorenzen
- Contact Person Email
- sylvie.lorenzen@mri.tum.de
- Site Name
- Hämatologisch-Onkologische Praxis Eppendorf
- Department Name
- Facharztzentrum Eppendorf
- Principal Investigator Name
- Alexander Stein
- Principal Investigator Email
- stein@hope-hamburg.de
- Contact Person Name
- Alexander Stein
- Contact Person Email
- stein@hope-hamburg.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Innere Med. I -Gastroenterologie,Gastrointestinale Onkologie,Hepatologie,Infektiologie und Geriatrie
- Principal Investigator Name
- Michael Bitzer
- Principal Investigator Email
- michael.bitzer@med.uni-tuebingen.de
- Contact Person Name
- Michael Bitzer
- Contact Person Email
- michael.bitzer@med.uni-tuebingen.de
- Site Name
- SLK-Kliniken Heilbronn GmbH
- Department Name
- Klinik für Innere Medizin III Hämatologie, Onkologie, Palliativmedizin Klinik am Gesundbrunnen
- Principal Investigator Name
- Uwe Martens
- Principal Investigator Email
- uwe.martens@slk-kliniken.de
- Contact Person Name
- Uwe Martens
- Contact Person Email
- uwe.martens@slk-kliniken.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- II. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Marianne Sinn
- Principal Investigator Email
- ma.sinn@uke.de
- Contact Person Name
- Marianne Sinn
- Contact Person Email
- ma.sinn@uke.de
- Site Name
- Krankenhaus Nordwest GmbH
- Department Name
- Institut für Klinisch-Onkologische Forschung Universitäres Centrum für Tumorerkrankungen
- Principal Investigator Name
- Salah-Edin Al-Batran
- Principal Investigator Email
- albatran.studien@khnw.de
- Contact Person Name
- Salah-Edin Al-Batran
- Contact Person Email
- albatran.studien@khnw.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CVK) Charité
- Principal Investigator Name
- Annika Kurreck
- Principal Investigator Email
- annika.kurreck@charite.de
- Contact Person Name
- Annika Kurreck
- Contact Person Email
- annika.kurreck@charite.de
- Site Name
- Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH
- Department Name
- Medizinische Klinik II
- Principal Investigator Name
- Stephan Kanzler
- Principal Investigator Email
- skanzler@leopoldina.de
- Contact Person Name
- Stephan Kanzler
- Contact Person Email
- skanzler@leopoldina.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- I. Medizinische Klinik und Poliklinik Gastroenterologisch-onkologische Ambulanz
- Principal Investigator Name
- Markus Möhler
- Principal Investigator Email
- markus.moehler@unimedizin-mainz.de
- Contact Person Name
- Markus Möhler
- Contact Person Email
- markus.moehler@unimedizin-mainz.de
- Site Name
- Friedrich-Schiller-Universitaet Jena
- Department Name
- Klinik für Innere Medizin II Abteilung Hämatologie und internistische Onkologie
- Principal Investigator Name
- Udo Lindig
- Principal Investigator Email
- udo.lindig@med.uni-jena.de
- Contact Person Name
- Udo Lindig
- Contact Person Email
- udo.lindig@med.uni-jena.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Medizinische Klinik + Poliklinik I Fachbereich Onkologie
- Principal Investigator Name
- Gunnar Folprecht
- Principal Investigator Email
- gunnar.folprecht@ukdd.de
- Contact Person Name
- Gunnar Folprecht
- Contact Person Email
- gunnar.folprecht@ukdd.de
- Site Name
- National Center For Tumor Diseases (NCT) Heidelberg
- Department Name
- Nationales Centrum für Tumorerkrankungen Medizinische Onkologie
- Principal Investigator Name
- Georg-Martin Haag
- Principal Investigator Email
- georgmartin.haag@med.uni-heidelberg.de
- Contact Person Name
- Georg-Martin Haag
- Contact Person Email
- georgmartin.haag@med.uni-heidelberg.de
Spain
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 15-10-2024
- Processing Time Days
- 285
- Number Of Sites
- 10
- Number Of Participants
- 55
Sites
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology
- Principal Investigator Name
- Tania Fleitas Kanonnikoff
- Principal Investigator Email
- tfleitask@gmail.com
- Contact Person Name
- Tania Fleitas Kanonnikoff
- Contact Person Email
- tfleitask@gmail.com
- Site Name
- Complejo Hospitalario Universitario De Ourense
- Department Name
- Oncology
- Principal Investigator Name
- Ana Fernandez Montes
- Principal Investigator Email
- afm1003@hotmail.com
- Contact Person Name
- Ana Fernandez Montes
- Contact Person Email
- afm1003@hotmail.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncology
- Principal Investigator Name
- Inmaculada Ales Diaz
- Principal Investigator Email
- inales@hotmail.com
- Contact Person Name
- Inmaculada Ales Diaz
- Contact Person Email
- inales@hotmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Principal Investigator Name
- Raul Teres Lleida
- Principal Investigator Email
- RTeres@santpau.cat
- Contact Person Name
- Raul Teres Lleida
- Contact Person Email
- RTeres@santpau.cat
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncology
- Principal Investigator Name
- Fernando Rivera Herrero
- Principal Investigator Email
- fernando.rivera@scsalud.es
- Contact Person Name
- Fernando Rivera Herrero
- Contact Person Email
- fernando.rivera@scsalud.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Principal Investigator Name
- Pilar Aitana Calvo Ferrandiz
- Principal Investigator Email
- aitanacalvo@hotmail.com
- Contact Person Name
- Pilar Aitana Calvo Ferrandiz
- Contact Person Email
- aitanacalvo@hotmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Mariona Calvo Campos
- Principal Investigator Email
- mcalvo@iconcologia.net
- Contact Person Name
- Mariona Calvo Campos
- Contact Person Email
- mcalvo@iconcologia.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Maria Luisa Limon Miron
- Principal Investigator Email
- mluisalimon@gmail.com
- Contact Person Name
- Maria Luisa Limon Miron
- Contact Person Email
- mluisalimon@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Federico Longo Munoz
- Principal Investigator Email
- fedelongomunoz@hotmail.com
- Contact Person Name
- Federico Longo Munoz
- Contact Person Email
- fedelongomunoz@hotmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Daniel Alejandro Acosta Eyzaguirre
- Principal Investigator Email
- dacosta@vhio.net
- Contact Person Name
- Daniel Alejandro Acosta Eyzaguirre
- Contact Person Email
- dacosta@vhio.net
Poland
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 23-04-2025
- Processing Time Days
- 475
- Number Of Sites
- 8
- Number Of Participants
- 64
Sites
- Site Name
- Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
- Department Name
- Oddział Chemioterapii
- Principal Investigator Name
- Ewa Prochowska-Mróz
- Principal Investigator Email
- ewa.prochowska@wco.pl
- Contact Person Name
- Ewa Prochowska-Mróz
- Contact Person Email
- ewa.prochowska@wco.pl
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddzial Chemioterapii Nowotworow z Pododdzialem Chemioterapii Jednego Dnia
- Principal Investigator Name
- Rafał Czyżykowski
- Principal Investigator Email
- rafal.czyzykowski@wp.pl
- Contact Person Name
- Rafał Czyżykowski
- Contact Person Email
- rafal.czyzykowski@wp.pl
- Site Name
- Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
- Department Name
- Oddzial Onkologii Klinicznej
- Principal Investigator Name
- Piotr Tokajuk
- Principal Investigator Email
- ptokajuk@gmail.com
- Contact Person Name
- Piotr Tokajuk
- Contact Person Email
- ptokajuk@gmail.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Onkologii i Radioterapii
- Principal Investigator Name
- Jacek Jassem
- Principal Investigator Email
- jjassem@gumed.edu.pl
- Contact Person Name
- Jacek Jassem
- Contact Person Email
- jjassem@gumed.edu.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Oddzial Kliniczny Onkologii
- Principal Investigator Name
- Piotr Wysocki
- Principal Investigator Email
- piotr.wysocki@uj.edu.pl
- Contact Person Name
- Piotr Wysocki
- Contact Person Email
- piotr.wysocki@uj.edu.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Onkologii i Radioterapii
- Principal Investigator Name
- Lucjan Wyrwicz
- Principal Investigator Email
- lwyrwicz@coi.waw.pl
- Contact Person Name
- Lucjan Wyrwicz
- Contact Person Email
- lwyrwicz@coi.waw.pl
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Department Name
- Klinika Onkologii
- Principal Investigator Name
- Renata Duchnowska
- Principal Investigator Email
- rduchnowska@wim.mil.pl
- Contact Person Name
- Renata Duchnowska
- Contact Person Email
- rduchnowska@wim.mil.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddzial Kliniczny Onkologii Klinicznej i Doswiadczalnej
- Principal Investigator Name
- Jacek Mackiewicz
- Principal Investigator Email
- jmackiewicz@ump.edu.pl
- Contact Person Name
- Jacek Mackiewicz
- Contact Person Email
- jmackiewicz@ump.edu.pl
Hungary
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 27-06-2025
- Processing Time Days
- 540
- Number Of Sites
- 5
- Number Of Participants
- 33
Sites
- Site Name
- Tolna Varmegyei Balassa Janos Korhaz
- Department Name
- Onkológiai Osztály
- Principal Investigator Name
- Yousuf Al-Farhat
- Principal Investigator Email
- yousuf@tmkorhaz.hu
- Contact Person Name
- Yousuf Al-Farhat
- Contact Person Email
- yousuf@tmkorhaz.hu
- Site Name
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
- Department Name
- Onkoradiológiai Osztály
- Principal Investigator Name
- András Szigeti
- Principal Investigator Email
- drszigetia.petz@gmail.com
- Contact Person Name
- András Szigeti
- Contact Person Email
- drszigetia.petz@gmail.com
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Mellkasi és Hasüregi Daganatok és Klinikai Farmakológiai Osztály
- Principal Investigator Name
- Erika Hitre
- Principal Investigator Email
- hitre@oncol.hu
- Contact Person Name
- Erika Hitre
- Contact Person Email
- hitre@oncol.hu
- Site Name
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
- Department Name
- Onkológiai Központ
- Principal Investigator Name
- Anna Lengyel
- Principal Investigator Email
- lengyelanna66@freemail.hu
- Contact Person Name
- Anna Lengyel
- Contact Person Email
- lengyelanna66@freemail.hu
- Site Name
- Bacs-Kiskun Varmegyei Oktatokorhaz
- Department Name
- Onkoradiológiai Központ
- Principal Investigator Name
- Zsolt Horváth
- Principal Investigator Email
- horvathzso@kmk.hu
- Contact Person Name
- Zsolt Horváth
- Contact Person Email
- horvathzso@kmk.hu
France
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 30-06-2025
- Processing Time Days
- 543
- Number Of Sites
- 12
- Number Of Participants
- 50
Sites
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Maladies de l'Appreil Digestif
- Principal Investigator Name
- Astrid Lievre
- Principal Investigator Email
- TEC_4@chu-rennes.fr
- Contact Person Name
- Astrid Lievre
- Contact Person Email
- TEC_4@chu-rennes.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Gastro-entérologie
- Principal Investigator Name
- Ludovic Evesque
- Principal Investigator Email
- Soraya.MOUMENE@nice.unicancer.fr
- Contact Person Name
- Ludovic Evesque
- Contact Person Email
- Soraya.MOUMENE@nice.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hépato-gastroentérologie et oncologie digestive
- Principal Investigator Name
- Aziz Zaanan
- Principal Investigator Email
- fabrice.lacan@aphp.fr
- Contact Person Name
- Aziz Zaanan
- Contact Person Email
- fabrice.lacan@aphp.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Hépato-gastroentérologie
- Principal Investigator Name
- Thomas Aparicio
- Principal Investigator Email
- ewa.bartnicka@aphp.fr
- Contact Person Name
- Thomas Aparicio
- Contact Person Email
- ewa.bartnicka@aphp.fr
- Site Name
- Sainte Catherine Institut Du Cancer Avignon-Provence
- Department Name
- Oncologie Digestive
- Principal Investigator Name
- Laurent Mineur
- Principal Investigator Email
- n.solotahiana@isc84.org
- Contact Person Name
- Laurent Mineur
- Contact Person Email
- n.solotahiana@isc84.org
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Hépato-gastroentérologie et oncologie digestive
- Principal Investigator Name
- Antoine Adenis
- Principal Investigator Email
- Christine.Gestin-Boyer@icm.unicancer.fr
- Contact Person Name
- Antoine Adenis
- Contact Person Email
- Christine.Gestin-Boyer@icm.unicancer.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Oncologie Digestive
- Principal Investigator Name
- Jean-Philippe Metges
- Principal Investigator Email
- jeanne.viala@chu-brest.fr
- Contact Person Name
- Jean-Philippe Metges
- Contact Person Email
- jeanne.viala@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Hépato-gastroentérologie et oncologie digestive
- Principal Investigator Name
- Alice Gagnaire
- Principal Investigator Email
- janice.miens@chu-dijon.fr
- Contact Person Name
- Alice Gagnaire
- Contact Person Email
- janice.miens@chu-dijon.fr
- Site Name
- Besancon University Hospital Center
- Department Name
- Oncologie
- Principal Investigator Name
- Christophe Borg
- Principal Investigator Email
- mjdiomande@chu-besancon.fr
- Contact Person Name
- Christophe Borg
- Contact Person Email
- mjdiomande@chu-besancon.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Clélia Coutzac
- Principal Investigator Email
- Estelle.FASSION@lyon.unicancer.fr
- Contact Person Name
- Clélia Coutzac
- Contact Person Email
- Estelle.FASSION@lyon.unicancer.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Romain Cohen
- Principal Investigator Email
- ghylles.tchatat-ext@aphp.fr
- Contact Person Name
- Romain Cohen
- Contact Person Email
- ghylles.tchatat-ext@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hépato-gastroentérologie
- Principal Investigator Name
- Yann TOUCHEFEU
- Principal Investigator Email
- marie.bossiere@chu-nantes.fr
- Contact Person Name
- Yann TOUCHEFEU
- Contact Person Email
- marie.bossiere@chu-nantes.fr
Denmark
- Earliest CTIS Part Ii Submission Date
- 04-01-2024
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 797
- Number Of Sites
- 3
- Number Of Participants
- 30
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Oncology
- Principal Investigator Name
- Lene Baeksgaard Jensen
- Principal Investigator Email
- Lene.Baeksgaard.Jensen@regionh.dk
- Contact Person Name
- Lene Baeksgaard Jensen
- Contact Person Email
- Lene.Baeksgaard.Jensen@regionh.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Oncology
- Principal Investigator Name
- Laurids Poulsen
- Principal Investigator Email
- laop@rn.dk
- Contact Person Name
- Laurids Poulsen
- Contact Person Email
- laop@rn.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Oncology
- Principal Investigator Name
- Per Pfeiffer
- Principal Investigator Email
- Per.Pfeiffer@rsyd.dk
- Contact Person Name
- Per Pfeiffer
- Contact Person Email
- Per.Pfeiffer@rsyd.dk
Sponsor
Primary sponsor
- Full Name
- Astrazeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- IMFINZI 50 mg/mL concentrate for solution for infusion.
- Active Substance
- DURVALUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- EU/1/18/1322/001
- Starting Dose
- 1500 mg
- Frequency
- 1500 mg on Day 1 Q4W (per protocol description)
- Maximum Dose
- 1500 mg
- Investigational Product Name
- PLACEBO
- Modality
- Other
- Starting Dose
- placebo on Day 1
- Frequency
- placebo on Day 1 Q4W (per protocol description)
- Investigational Product Name
- FOLINIC ACID
- Active Substance
- FOLINIC ACID
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- -
- Starting Dose
- 200 mg/m2
- Frequency
- Days 1 and 15 Q4W as part of FLOT
- Maximum Dose
- 200 mg/m2
- Investigational Product Name
- DOCETAXEL
- Active Substance
- DOCETAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- -
- Starting Dose
- 50 mg/m2
- Frequency
- Days 1 and 15 Q4W as part of FLOT
- Maximum Dose
- 50 mg/m2
- Investigational Product Name
- OXALIPLATIN
- Active Substance
- OXALIPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- -
- Starting Dose
- 85 mg/m2
- Frequency
- Days 1 and 15 Q4W as part of FLOT
- Maximum Dose
- 85 mg/m2
- Investigational Product Name
- FLUOROURACIL
- Active Substance
- FLUOROURACIL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- -
- Starting Dose
- 2600 mg/m2
- Frequency
- Days 1 and 15 Q4W as part of FLOT (continuous infusion schedule per FLOT regimen)
- Maximum Dose
- 2600 mg/m2
- Investigational Product Name
- INFLIXIMAB
- Active Substance
- INFLIXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- -
- Investigational Product Name
- MYCOPHENOLATE MOFETIL
- Active Substance
- MYCOPHENOLATE MOFETIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- -
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- Fluorouracil for Gastric cancer | Gastroesophageal junction adenocarcinoma
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer