Clinical trial • Phase III • Oncology

RILVEGOSTOMIG for Biliary tract adenocarcinoma|Intrahepatic cholangiocarcinoma|Extrahepatic cholangiocarcinoma|Gallbladder cancer

Phase III trial of RILVEGOSTOMIG for Biliary tract adenocarcinoma|Intrahepatic cholangiocarcinoma|Extrahepatic cholangiocarcinoma|Gallbladder cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Biliary tract adenocarcinoma|Intrahepatic cholangiocarcinoma|Extrahepatic cholangiocarcinoma|Gallbladder cancer
Trial Stage
Phase III
Drug Modality
Bispecific antibody

Key dates

Initial CTIS Submission Date
19-01-2024
First CTIS Authorization Date
03-05-2024

Trial design

Randomised, placebo (sodium chloride or dextrose) in combination with investigator’s choice of chemotherapy (investigator’s choice chemotherapy agents listed in trial documents include gemcitabine, cisplatin, capecitabine, tegafur and others); experimental arm: rilvegostomig (azd2936) plus investigator’s choice chemotherapy-controlled Phase III trial across 58 sites in Italy, Spain, Norway and others.

Randomised
Yes
Comparator
Placebo (Sodium chloride or Dextrose) in combination with investigator’s choice of chemotherapy (investigator’s choice chemotherapy agents listed in trial documents include GEMCITABINE, CISPLATIN, CAPECITABINE, TEGAFUR and others); experimental arm: Rilvegostomig (AZD2936) plus investigator’s choice chemotherapy
Target Sample Size
568
Trial Duration For Participant
365

Eligibility

Recruits 568 Vulnerable population selected. Subject information sheets and informed consent forms are provided (multiple L1_SIS and ICF documents including 'Pregnant partner' versions and optional genetic ICF). Consent is obtained via these ICF documents..

Vulnerable Population
Vulnerable population selected. Subject information sheets and informed consent forms are provided (multiple L1_SIS and ICF documents including 'Pregnant partner' versions and optional genetic ICF). Consent is obtained via these ICF documents.

Inclusion criteria

  • {"criterion_text":"- Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) after macroscopically complete resection (R0 or R1)\n- Provision of a tumor sample collected at surgical resection\n- Randomization within 12 weeks after resection with adequate healing and removal of drains\n- Confirmed to be disease-free by imaging within 28 days prior to randomization\n- Eastern Cooperative Oncology Group performance status of 0 or 1"}

Exclusion criteria

  • {"criterion_text":"- Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis\n- Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors\n- Any anti-cancer therapy for BTC prior to surgery\n- Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease\n- Current or prior use of immunosuppressive medication within 14 days before the first dose\n- Thromboembolic event within 3 months\n- Active HBV or HCV infection unless treated"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Recurrence free survival (RFS) for Arm A vs. Arm B","definition_or_measurement_approach":"Assessment of RFS (recurrence-free survival) comparing rilvegostomig + chemotherapy versus placebo + chemotherapy; RFS assessed by scheduled tumour imaging and survival follow-up as per protocol"}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival (OS) for Arm A vs. Arm B","definition_or_measurement_approach":"Assessment of OS (overall survival) comparing Arm A vs Arm B"}
  • {"endpoint_text":"- Patient-reported tolerability Arm A vs. Arm B","definition_or_measurement_approach":"Patient-reported outcomes (PRO) instruments (e.g., PROMIS, PRO-CTCAE) as listed in trial documents"}
  • {"endpoint_text":"- Progression Free Survival (PFS) following recurrence Arm A vs. Arm B","definition_or_measurement_approach":"Assessment of PFS after recurrence comparing Arm A vs Arm B"}

Recruitment

Planned Sample Size
568
Recruitment Window Months
77
Consent Approach
Informed consent obtained using Subject Information Sheets and Informed Consent Forms (L1_SIS and ICF). Specific ICF versions include adult ICFs, pregnant partner ICFs, and optional genetic ICFs. ICF and subject information materials are provided in multiple country-specific languages as per documents (examples: English, Polish, Italian, Spanish, Norwegian, Danish, French, Dutch, German).

Geography

Total Number Of Sites
58
Total Number Of Participants
182

Italy

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
07-05-2024
Processing Time Days
50
Number Of Sites
9
Number Of Participants
30

Sites

Site Name
Humanitas Research Hospital
Department Name
medical oncology and hematology
Contact Person Name
Lorenza Rimessa
Contact Person Email
lorenza.rimessa@hunimed.eu
Site Name
Istituto Oncologico Veneto
Department Name
Oncology
Contact Person Name
Sara Lonardi
Contact Person Email
sara.lonardi@iov.veneto.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
medical oncology
Contact Person Name
Federica Morano
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Oncology
Contact Person Name
Gianluca Masi
Contact Person Email
gianluca.masi@unipi.it
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
Oncology
Contact Person Name
Emiliano Tamburini
Site Name
Careggi University Hospital
Department Name
Clinical Oncology
Contact Person Name
Lorenzo Antonuzzo
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncology
Contact Person Name
Katia Bruna Bencardino
Site Name
Ospedale San Raffaele S.r.l.
Department Name
medical oncology
Contact Person Name
Andrea Casadei Gardini
Contact Person Email
casadeigardini.andrea@hsr.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori (additional site entry)
Department Name
medical oncology
Contact Person Name
Federica Morano

Spain

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
09-05-2024
Processing Time Days
27
Number Of Sites
9
Number Of Participants
37

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Oncología Hepatica
Contact Person Name
Alejandro Forner
Contact Person Email
aforner@clinic.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Servicio de Oncologia Medica
Contact Person Name
Eva Martínez de Castro
Contact Person Email
evamdecastro@hotmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncologia Medica
Contact Person Name
Ángela Lamarca
Contact Person Email
angela.lamarca@quironsalud.es
Site Name
Clinica Universidad De Navarra
Department Name
Oncologia Medica
Contact Person Name
Mariano Ponz
Contact Person Email
mponz@unav.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
UGCI de Oncología/Oncologia Médica
Contact Person Name
Inmaculada Alés
Contact Person Email
inales@hotmail.com
Site Name
Institut Catala D'oncologia
Department Name
Servicio de Oncologia Medica
Contact Person Name
Berta Laquente
Contact Person Email
blaquente@iconcologia.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Unidad de cáncer gastrointestinal. Oncología médica
Contact Person Name
Alejandro Garcia Alvarez
Contact Person Email
agalvarez@vhio.net
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Unidad de Investigación Oncológica HGUG Marañón
Contact Person Name
Andrés Jesús Muñoz
Contact Person Email
andresmunmar@hotmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Unidad de Tumores Digestivos. Unidad Cancer familiar.
Contact Person Name
Jorge Adeva
Contact Person Email
jorge.adeva@salud.madrid.org

Norway

Earliest CTIS Part Ii Submission Date
12-04-2024
Latest Decision Or Authorization Date
03-05-2024
Processing Time Days
21
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Oslo University Hospital HF
Department Name
Department of Oncology
Contact Person Name
Olav Dajani
Contact Person Email
uxolaj@ous-hf.no

Poland

Earliest CTIS Part Ii Submission Date
08-04-2024
Latest Decision Or Authorization Date
07-05-2024
Processing Time Days
29
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lwyrwicz@coi.waw.pl
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddzial Onkologiczny z Pododzialem Dziennej Chemioterapii
Contact Person Name
Kamil Kuc
Contact Person Email
kkuc@wszp.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Zurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Oddzial Onkologii Klinicznej i Chemioterapii
Contact Person Name
Tomasz Ciszewski
Contact Person Email
tciszewski@spsk1.lublin.pl
Site Name
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
Department Name
Oddzial Onkologii
Contact Person Name
Ewa Chmielowska
Contact Person Email
ewa.chmielowska@nu-med.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Onkologii
Contact Person Name
Piotr Wysocki
Contact Person Email
piotr.wysocki@uj.edu.pl

Belgium

Earliest CTIS Part Ii Submission Date
22-07-2024
Latest Decision Or Authorization Date
06-08-2024
Processing Time Days
15
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Antwerp University Hospital
Department Name
Digestive Oncology
Contact Person Name
Timon Vandamme
Contact Person Email
Timon.Vandamme@uza.be
Site Name
UZ Leuven
Department Name
Digestive Oncology
Contact Person Name
Jeroen Dekervel
Contact Person Email
jeroen.dekervel@uzleuven.br
Site Name
Hopital Erasme
Department Name
Digestive Oncology
Contact Person Name
Anne Demols
Contact Person Email
anne.demols@hubruxelles.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Digestive Oncology
Contact Person Name
Marc Van Den Eynde

Denmark

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
03-08-2024
Processing Time Days
4
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Region Hovedstaden
Department Name
Department of Oncology
Contact Person Name
Alice Markussen
Contact Person Email
alice.markussen.01@regionh.dk
Site Name
Region Midtjylland
Department Name
Departement of Oncology
Contact Person Name
Lise Bech Jellesmark Thorsen

France

Earliest CTIS Part Ii Submission Date
09-08-2024
Latest Decision Or Authorization Date
13-08-2024
Processing Time Days
4
Number Of Sites
8
Number Of Participants
26

Sites

Site Name
Centre Regional Lutte Contre Le Cancer
Department Name
Medical Oncology
Contact Person Name
Meher Ben Abdelghani
Contact Person Email
m.ben-abdelghani@icans.eu
Site Name
Institut Paoli Calmettes
Department Name
Oncologie digestive
Contact Person Name
Brice Chanez
Contact Person Email
CHANEZB@ipc.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Oncologie digestive
Contact Person Name
Nadim Fares
Contact Person Email
fares.n@chu-toulouse.fr
Site Name
Hopital Paul Brousse
Department Name
Gastro entérologie et Hépatologie
Contact Person Name
Olivier Rosmorduc
Contact Person Email
olivier.rosmorduc@aphp.fr
Site Name
Institut Curie
Department Name
Département d’Oncologie Médicale
Contact Person Name
Cindy Neuzillet
Contact Person Email
cindy.neuzillet@curie.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncologie médicale
Contact Person Name
Julien Edeline
Contact Person Email
j.edeline@rennes.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d'hépato-gastro-entérologie et oncologie digestive
Contact Person Name
Jean-Frederic Blanc
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Oncologie médicale
Contact Person Name
Eric Assenat
Contact Person Email
e-assenat@chu-montpellier.fr

Germany

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
02-08-2024
Processing Time Days
28
Number Of Sites
19
Number Of Participants
47

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
WTZ - Innere Klinik (Tumorfoschung)
Contact Person Name
Isabel Virchow
Contact Person Email
isabel.virchow@uk-essen.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik I
Contact Person Name
Maria Gonzalez-Carmona
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik I
Contact Person Name
Jens Marquardt
Contact Person Email
Jens.Marquardt@uksh.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Medizinische Klinik II – Hepatologie
Contact Person Name
Florian van Boemmel
Site Name
Klinikum Dortmund gGmbH
Department Name
Klinik fuer Gastroenterologie, Haematologie und internistische Onkologie und Endokrinologie
Contact Person Name
Marcus-Alexander Woerns
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut fuer Klinisch-Onkologische Forschung (IKF)
Contact Person Name
Thorsten Goetze
Contact Person Email
goetze.thorsten@ikf-khnw.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Universitätsklinikum Tübingen
Contact Person Name
Michael Bitzer
Contact Person Email
M.Bitzer@med.uni-tuebingen.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik fuer Gastroenterologie, Hepatologie und Infektiologie
Contact Person Name
Dirk-Thomas Waldschmidt
Contact Person Email
dirk.waldschmidt@uk-koeln.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Medizinische Klinik 1 - Gastroenterologie, Pneumologie und Endokrinologie
Contact Person Name
Juergen Siebler
Contact Person Email
Juergen.Siebler@uk-erlangen.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie
Contact Person Name
Dominik Modest
Contact Person Email
dominik.modest@charite.de
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Klinik fuer Gastroenterologie, gastrointestinale Onkologie,Hepatologie,Infektiologie und Pneumologie
Contact Person Name
Jan Peveling-Oberhag
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Medizinische Onkologie
Contact Person Name
Christoph Springfeld
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik
Contact Person Name
Alexander Philipp
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Zentrum für Innere Medizin Klinik für Innere Medizin I
Contact Person Name
Lukas Perkhofer
Site Name
Universitaet Muenster
Department Name
Med. Klinik A|Hämatologie/ Onkologie
Contact Person Name
Klaus Wethmar
Contact Person Email
klaus.wethmar@ukmuenster.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Abteilung Onkologie, Haematologie
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Muenchen Klinik gGmbH
Department Name
Klinik fuer Haematologie und Onkologie
Contact Person Name
Stefan Boeck
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik I, Studienzentrale internistische Onkologie
Contact Person Name
Gunnar Folprecht
Contact Person Email
Gunnar.Folprecht@ukdd.de
Site Name
Klinikum Esslingen GmbH
Department Name
Allgemeine Innere Medizin, Onkologie / Haematologie, Gastroenterologie und Infektiologie
Contact Person Name
Henning Wege
Contact Person Email
H.Wege@klinikum-esslingen.de

Sponsor

Primary sponsor

Full Name
Astrazeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Rilvegostomig
Active Substance
RILVEGOSTOMIG
Modality
Bispecific antibody
Routes Of Administration
Intravenous
Route
Intravenous
Maximum Dose
13500 mg
Combination Treatment
Yes

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