Clinical trial • Phase III • Oncology

RILVEGOSTOMIG for Biliary tract cancer | Cholangiocarcinoma | Gallbladder carcinoma

Phase III trial of RILVEGOSTOMIG for Biliary tract cancer | Cholangiocarcinoma | Gallbladder carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Biliary tract cancer | Cholangiocarcinoma | Gallbladder carcinoma
Trial Stage
Phase III
Drug Modality
Bispecific antibody | Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
17-11-2025
First CTIS Authorization Date
23-03-2026

Trial design

Randomised, open-label, active comparator: durvalumab 1500 mg iv q3w for up to 8 cycles (21 days). then q4w. gemcitabine/cisplatin iv: gemcitabine 1000 mg/m2 plus cisplatin 25 mg/m2 on day 1 and day 8 of each 21-day cycle.-controlled Phase III trial in Belgium, France, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Active Comparator: Durvalumab 1500 mg IV Q3W for up to 8 cycles (21 days). Then Q4W. Gemcitabine/Cisplatin IV: Gemcitabine 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle.
Target Sample Size
868

Eligibility

Recruits 868 adults.

Inclusion criteria

  • {"criterion_text":"- Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC)."}
  • {"criterion_text":"- Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting."}
  • {"criterion_text":"- Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample."}
  • {"criterion_text":"- Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements."}
  • {"criterion_text":"- ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS > 1) over the previous 2 weeks prior to baseline at screening and prior to randomization."}
  • {"criterion_text":"- Adequate bone marrow and organ function."}

Exclusion criteria

  • {"criterion_text":"- Ampullary carcinoma."}
  • {"criterion_text":"- Any prior systemic therapy received for unresectable locally advanced or metastatic BTC."}
  • {"criterion_text":"- Any prior exposure to any therapy targeting immune-regulatory receptors or mechanisms."}
  • {"criterion_text":"- Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study."}
  • {"criterion_text":"- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment."}
  • {"criterion_text":"- Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival of Rilvegostomig+Chemotherapy vs Durvalumab+Chemotherapy","definition_or_measurement_approach":"Assessment of Overall Survival (OS) in the PD-L1 ≥ 1% population."}

Secondary endpoints

  • {"endpoint_text":"- Progression Free Survival of Rilvegostomig+Chemotherapy vs Durvalumab+Chemotherapy","definition_or_measurement_approach":"Assessment of Progression-Free Survival (PFS) in the PD-L1 ≥ 1% population (and ITT population as specified in secondary objectives)."}

Recruitment

Planned Sample Size
868
Recruitment Window Months
43
Consent Approach
Informed consent is obtained from adult participants. Subject information and informed consent form (SIS and ICF) documents are provided in country-specific languages as per the submitted ICFs (examples include French, Dutch, German, Polish, English). No specific assent/parental consent procedures for minors are described in the available documentation.

Geography

Total Number Of Sites
47
Total Number Of Participants
232

Belgium

Earliest CTIS Part Ii Submission Date
25-02-2026
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
26
Number Of Sites
5
Number Of Participants
27

Sites

Site Name
UZ Leuven
Department Name
Oncology
Contact Person Name
Jeroen Dekervel
Contact Person Email
jeroen.dekervel@uzleuven.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Oncology
Contact Person Name
Timon Vandamme
Contact Person Email
timon.vandamme@uza.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Oncology
Contact Person Name
Florence Troisfontaine
Contact Person Email
ftroisfontaine@chuliege.be
Site Name
Hopital Erasme
Department Name
Oncology
Contact Person Name
Anne Demols
Contact Person Email
anne.demols@hubruxelles.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Oncology
Contact Person Name
Sofie De Meulder
Contact Person Email
sofie.demeulder@azdelta.be

France

Earliest CTIS Part Ii Submission Date
16-02-2026
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
42
Number Of Sites
4
Number Of Participants
22

Sites

Site Name
Hopital Beaujon
Department Name
Service d'Oncologie Hépatique et Innovation Thérapeutique
Contact Person Name
Mohamed Bouattour
Contact Person Email
mohamed.bouattour@aphp.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service d'Hepato-Gastroentérologie
Contact Person Name
Gaël Roth
Contact Person Email
GRoth@chu-grenoble.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
Oncologie Médicale
Contact Person Name
Aurélien Lambert
Contact Person Email
a.lambert@nancy.unicancer.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Unité d'Oncologie digestive
Contact Person Name
Laetitia Dahan
Contact Person Email
laetitia.dahan@ap-hm.fr

Italy

Earliest CTIS Part Ii Submission Date
12-02-2026
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
41
Number Of Sites
5
Number Of Participants
34

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
uo medical oncology
Contact Person Name
Lisa Salvatore
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
Humanitas Mirasole S.p.A.
Department Name
Medical oncology and hematology
Contact Person Name
Lorenza Rimassa
Contact Person Email
lorenza.rimassa@hunimed.eu
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
uo medical oncology 2
Contact Person Name
Gianluca Masi
Contact Person Email
gianluca.masi@unipi.it
Site Name
National Institute Of Gastroenterology Saverio De Bellis Research Hospital
Department Name
uo oncology
Contact Person Name
Claudio Lotesoriere

Spain

Earliest CTIS Part Ii Submission Date
02-02-2026
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
51
Number Of Sites
6
Number Of Participants
28

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology Department
Contact Person Name
Eva Martinez de Castro
Contact Person Email
evamdecastro@hotmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology Department
Contact Person Name
Angela Lamarca Lete
Contact Person Email
angela.lamarca@quironsalud.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology Department
Contact Person Name
Andres Muñoz Martin
Contact Person Email
andresmunmar@hotmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology Department
Contact Person Name
Berta Laquente Saez
Contact Person Email
blaquente@iconcologia.net
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology Department
Contact Person Name
Teresa Macarulla Mercade
Contact Person Email
macarulla@clinic.cat
Site Name
Hospital Universitario Marques De Valdecilla (duplicate listing accounted above)
Department Name
Oncology Department

Netherlands

Earliest CTIS Part Ii Submission Date
20-02-2026
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
39
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Oncology
Contact Person Name
Daan Knapen
Contact Person Email
d.g.knapen@umcg.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Oncology
Contact Person Name
Nadia Haj Mohammad
Contact Person Email
n.hajmohammad@umcutrecht.nl
Site Name
Amsterdam UMC Stichting
Department Name
Oncology
Contact Person Name
Johanna Wilmink
Contact Person Email
j.w.wilmink@amc.uva.nl
Site Name
Universiteit Maastricht
Department Name
Oncology
Contact Person Name
Judith de Vos
Contact Person Email
judith.de.vos@mumc.nl

Poland

Earliest CTIS Part Ii Submission Date
24-02-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
31
Number Of Sites
5
Number Of Participants
31

Sites

Site Name
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
Klinika Onkologii i Immunoonkologii z Oddzialem Dziennym Terapii Onkologicznej
Contact Person Name
Tomasz Lewandowski
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
lucjanwyrwicz@gmail.com
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Poradnia Onkologiczna oraz Oddzial Kliniczny Onkologii
Contact Person Name
Piotr Wysocki
Contact Person Email
piotr.wysocki@uj.edu.pl
Site Name
Umed Clinical Trials Sp. z o.o.
Contact Person Name
Piotr Potemski
Contact Person Email
piotr.potemski@umed.lodz.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med.pl

Germany

Earliest CTIS Part Ii Submission Date
03-03-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
62
Number Of Sites
18
Number Of Participants
66

Sites

Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinik fuer Innere Medizin II
Contact Person Name
Patrick Wenzel
Contact Person Email
patrick.wenzel@mri.tum.de
Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Klinik fuer Gastroenterologie, Hepatologie und Infektiologie
Contact Person Name
Marino Venerito
Contact Person Email
m.venerito@med.ovgu.de
Site Name
Staedtisches Klinikum Karlsruhe gGmbH
Department Name
Medizinische Klinik III
Contact Person Name
Stefanie Lemnitz
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik fuer Innere Medizin I
Contact Person Name
Heiko Becker
Site Name
Universitaetsklinikum Essen AöR
Department Name
Innere Klinik (Tumorforschung)
Contact Person Name
Stefan Kasper-Virchow
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik 1
Contact Person Name
Maria A. Gonzalez-Carmona
Site Name
Haematologisch Onkologische Praxis Eppendorf
Department Name
Norddeutsches Studienzentrum für Innovative Onkologie
Contact Person Name
Alexander Stein
Contact Person Email
stein@hope-hamburg.de
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut fuer Klinisch-Onkologische Forschung (IKF)
Contact Person Name
Thorsten Oliver Goetze
Contact Person Email
goetze.thorsten@khnw.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Klinik fuer Innere Medizin III
Contact Person Name
Uwe Martens
Contact Person Email
uwe.martens@slk-kliniken.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Zentrum fuer Innere Medizin - Klinik fuer Innere Medizin I
Contact Person Name
Lukas Perkhofer
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Onkologie und Palliativmedizin mit Sektionen Hämatologie und Rheumatologie
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Medizinische Klinik III - Studienzentrum Viszeralonkologie
Contact Person Name
Marie-Luise Berres
Contact Person Email
mberres@ukaachen.de
Site Name
Muenchen Klinik gGmbH
Department Name
Klinik fuer Onkologie und Haematologie
Contact Person Name
Stefan Boeck
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Gastroenterologie, Hepatologie und Infektiologie
Contact Person Name
Christoph Roderburg
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik 1
Contact Person Name
Joerg Trojan
Contact Person Email
trojan@em.uni-frankfurt.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
Sana Kliniken Berlin-Brandenburg GmbH
Department Name
Klinik fuer Innere Medizin IV - Haematologie, Onkologie und Palliativmedizin
Contact Person Name
Uwe Pelzer
Contact Person Email
uwe.pelzer@sana.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Medizinische Onkologie
Contact Person Name
Christoph Springfeld

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
Authorisation Status
Investigational
Frequency
Q3W (per protocol description)
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
Authorised
Starting Dose
1500 mg
Frequency
1500 mg IV Q3W for up to 8 cycles then Q4W
Investigational Product Name
GEMCITABINE
Active Substance
GEMCITABINE
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised
Starting Dose
1000 mg/m2
Frequency
Day 1 and Day 8 of each 21-day cycle (per protocol description with cisplatin)
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised
Starting Dose
25 mg/m2
Frequency
Day 1 and Day 8 of each 21-day cycle (per protocol description with gemcitabine)
Investigational Product Name
INFLIXIMAB
Active Substance
INFLIXIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised
Investigational Product Name
MYCOPHENOLATE MOFETIL
Active Substance
MYCOPHENOLATE MOFETIL
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Combination Treatment
Yes

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