Clinical trial • Phase III • Oncology

RILVEGOSTOMIG for Advanced HER2-expressing biliary tract cancer

Phase III trial of RILVEGOSTOMIG for Advanced HER2-expressing biliary tract cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced HER2-expressing biliary tract cancer
Trial Stage
Phase III
Drug Modality
Bispecific antibody|ADC|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
06-02-2025
First CTIS Authorization Date
23-05-2025

Trial design

Randomised, standard of care: gemcitabine + cisplatin + durvalumab (no doses or schedule specified in the available data)-controlled Phase III trial in Netherlands, Italy, Poland and others.

Randomised
Yes
Comparator
Standard of Care: Gemcitabine + Cisplatin + Durvalumab (no doses or schedule specified in the available data)
Biomarker Stratified
True, HER2 IHC status (HER2 IHC 3+ and HER2 IHC 2+)
Target Sample Size
194

Eligibility

Recruits 194 Vulnerable population flag selected. All participants must be adults (≥18 years) and provide informed consent. Specific subject information sheets and informed consent forms are provided for adult participants and for pregnant participants/partners (country-specific ICFs listed), and optional genomic-consent materials are provided. No paediatric assent procedures or enrolment of minors are included..

Pregnancy Exclusion
Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential.
Vulnerable Population
Vulnerable population flag selected. All participants must be adults (≥18 years) and provide informed consent. Specific subject information sheets and informed consent forms are provided for adult participants and for pregnant participants/partners (country-specific ICFs listed), and optional genomic-consent materials are provided. No paediatric assent procedures or enrolment of minors are included.

Inclusion criteria

  • {"criterion_text":"- Male and female patients must be at least 18 years of age at the time of signing the informed consent. Other age restrictions may apply as per local regulations.\n- Unresectable, previously untreated, locally advanced or metastatic Biliary tract adenocarcinoma. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is > 3 months (90 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.\n- Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC.\n- Patients must provide an FFPE tumor sample that is no older than 3 years for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 status, and other correlatives.\n- Has at least one target lesion assessed by the Investigator based on RECIST v1.1. (randomized portion only)\n- WHO/ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n- Adequate organ and bone marrow function within 14 days before randomization.\n- Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential.\n- Minimum life expectancy of 12 weeks"}

Exclusion criteria

  • {"criterion_text":"- Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines.\n- Serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment\n- Active autoimmune, connective tissue or inflammatory disorders that has required systemic treatment in the past 2 years, or where there is documented, or a suspicion of pulmonary involvement at the time of screening\n- Corrected QT interval (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG\n- History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening\n- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected nonmelanoma skin cancer and curatively treated in situ disease. For certain participant populations, exceptions could also include carcinomas in-situ or Ta tumors treated with curative intent.\n- Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (Drainage and Cell free and Concentrated Ascites Reinfusion Therapy are not allowed within 2 weeks prior to screening assessment).\n- Any concurrent anticancer treatment without an adequate washout period prior to randomization. Concurrent use of hormonal therapy for non-cancer related conditions (eg, hormone replacement therapy) is allowed.\n- History of organ transplants or allogenic stem cell transplant.\n- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder(eg, pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion etc).\n- Prior pneumonectomy (complete)\n- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. Patients with prior cholangitis/biliary tract infections/biliary intervention (eg, stent, external drain) should have completed a full course of antibiotics prior to randomization.\n- Active primary immunodeficiency, known uncontrolled active HIV infection or HCV\n- Histologically confirmed ampullary carcinoma\n- Any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the Investigator, interfere with the patient’s participation in the clinical study or evaluation of the clinical study results.\n- Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms\n- Medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+) population","definition_or_measurement_approach":"Overall Survival (OS) in the Full Analysis Set (FAS) HER2 IHC 3+ population as stated in the primary objective (efficacy comparison of arms in terms of OS)."}

Secondary endpoints

  • {"endpoint_text":"- To evaluate the efficacy of T-DXd with rilvegostomig vs SoC in terms of OS in the FAS population (HER2 IHC 3+/2+).\n- To evaluate the efficacy of T-DXd monotherapy vs SoC in terms of OS in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.\n- To further evaluate efficacy of T‑DXd with rilvegostomig or in monotherapy vs SoC in terms of PFS in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.\n- To further evaluate the efficacy of T-DXd with rilvegostomig or in monotherapy vs SoC in terms of ORR in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.\n- To further evaluate efficacy of T‑DXd with rilvegostomig or in monotherapy vs SoC in terms of DoR in patients with HER2‑expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.\n- To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of OS, PFS, DoR and ORR in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations.\n- To assess the safety and tolerability of T‑DXd with rilvegostomig or in monotherapy vs SoC.\n- To assess the safety and tolerability of TDXd with rilvegostomig vs T-DXd monotherapy.\n- To describe patient-reported tolerability of TDXd with rilvegostomig or in monotherapy in comparison to SoC based on a summary of symptomatic AEs and overall side-effect bother.\n- To describe patient-reported tolerability of TDXd with rilvegostomig in comparison to T-DXd monotherapy based on a summary of symptomatic AEs and overall side-effect bother.\n- To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig or in monotherapy vs SoC.\n- To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs T-DXd monotherapy.\n- To assess the PK of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig in serum.\n- To investigate the immunogenicity of T-DXd and of rilvegostomig.","definition_or_measurement_approach":"Endpoints as stated: OS (overall survival), PFS (progression-free survival), ORR (objective response rate), DoR (duration of response), safety/tolerability (adverse events), patient-reported tolerability and time-to-deterioration in physical functioning, PK measured in serum for listed analytes, and immunogenicity assessment for T-DXd and rilvegostomig (as specified in endpoint descriptions)."}

Recruitment

Planned Sample Size
194
Recruitment Window Months
47
Consent Approach
Informed consent must be provided by the adult participant (participants must be ≥18 years). Country-specific subject information sheets and informed consent forms are provided (documents available in multiple languages and country variants). There are ICFs for adult participants and specific ICFs/addenda for pregnant participants/partners and optional genomic research; consent is therefore participant-provided with additional materials for pregnant participants/partners and optional genomic consent.

Geography

Total Number Of Sites
67
Total Number Of Participants
194

Netherlands

Earliest CTIS Part Ii Submission Date
05-05-2025
Latest Decision Or Authorization Date
02-06-2025
Processing Time Days
28
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Department of medical Oncology
Principal Investigator Name
Fredericus Eskens
Principal Investigator Email
f.eskens@erasmusmc.nl
Contact Person Name
Fredericus Eskens
Contact Person Email
f.eskens@erasmusmc.nl

Italy

Earliest CTIS Part Ii Submission Date
29-04-2025
Latest Decision Or Authorization Date
30-05-2025
Processing Time Days
31
Number Of Sites
9
Number Of Participants
19

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncology
Principal Investigator Name
Katia Bruna Bencardino
Principal Investigator Email
katia.bencardino@ospedaleniguarda.it
Contact Person Name
Katia Bruna Bencardino
Site Name
Ospedale San Raffaele S.r.l.
Department Name
medical oncology
Principal Investigator Name
Andrea Casadei Gardini
Principal Investigator Email
casadeigardini.andrea@hsr.it
Contact Person Name
Andrea Casadei Gardini
Contact Person Email
casadeigardini.andrea@hsr.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
PRECISION MEDICINE
Principal Investigator Name
Erika Martinelli
Principal Investigator Email
erika.martinelli@unicampania.it
Contact Person Name
Erika Martinelli
Site Name
Careggi University Hospital
Department Name
Clinical Oncology
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
antonuzzol@aou-careggi.toscana.it
Contact Person Name
Lorenzo Antonuzzo
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
Oncology
Principal Investigator Name
Emiliano Tamburini
Principal Investigator Email
e.tamburini@piafondazionepanico.it
Contact Person Name
Emiliano Tamburini
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Dept. of Clinical Medicine and Surgery
Principal Investigator Name
Roberto Bianco
Principal Investigator Email
robianco@unina.it
Contact Person Name
Roberto Bianco
Contact Person Email
robianco@unina.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncology
Principal Investigator Name
Sara Lonardi
Principal Investigator Email
sara.lonardi@iov.veneto.it
Contact Person Name
Sara Lonardi
Contact Person Email
sara.lonardi@iov.veneto.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
medical oncology and hematology
Principal Investigator Name
Lorenza Rimassa
Principal Investigator Email
lorenza.rimassa@hunimed.eu
Contact Person Name
Lorenza Rimassa
Contact Person Email
lorenza.rimassa@hunimed.eu
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
medical oncology
Principal Investigator Name
Vincenzo Formica
Principal Investigator Email
Vincenzo.formica@ptvonline.it
Contact Person Name
Vincenzo Formica
Contact Person Email
Vincenzo.formica@ptvonline.it

Poland

Earliest CTIS Part Ii Submission Date
06-05-2025
Latest Decision Or Authorization Date
01-06-2025
Processing Time Days
26
Number Of Sites
5
Number Of Participants
10

Sites

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
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Poradnia Onkologiczna oraz 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
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Oddzial Onkologii Klinicznej i Chemioterapii
Principal Investigator Name
Tomasz Ciszewski
Principal Investigator Email
tciszewski@usk1.pl
Contact Person Name
Tomasz Ciszewski
Contact Person Email
tciszewski@usk1.pl
Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddzial Onkologii II
Principal Investigator Name
Jacek Kabut
Principal Investigator Email
jacekkabut@gmail.com
Contact Person Name
Jacek Kabut
Contact Person Email
jacekkabut@gmail.com
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
lucjanwyrwicz@gmail.com
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjanwyrwicz@gmail.com

France

Earliest CTIS Part Ii Submission Date
21-07-2025
Latest Decision Or Authorization Date
20-08-2025
Processing Time Days
30
Number Of Sites
11
Number Of Participants
11

Sites

Site Name
Centr Georges Francois Leclerc
Department Name
Oncologie médicale
Principal Investigator Name
Francois Ghiringhelli
Principal Investigator Email
FGhiringhelli@cgfl.fr
Contact Person Name
Francois Ghiringhelli
Contact Person Email
FGhiringhelli@cgfl.fr
Site Name
Hopital Prive Jean Mermoz
Department Name
Gastro entérologie et cancérologie digestive
Principal Investigator Name
Pascal Artru
Principal Investigator Email
dr.artru@wanadoo.fr
Contact Person Name
Pascal Artru
Contact Person Email
dr.artru@wanadoo.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Principal Investigator Name
Philippe Cassier
Principal Investigator Email
philippe.cassier@lyon.unicancer.fr
Contact Person Name
Philippe Cassier
Site Name
Hopital Beaujon
Department Name
Oncologie Digestive
Principal Investigator Name
Mohamed Bouattour
Principal Investigator Email
mohamed.bouattour@aphp.fr
Contact Person Name
Mohamed Bouattour
Contact Person Email
mohamed.bouattour@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Oncologie médicale
Principal Investigator Name
Eric Assenat
Principal Investigator Email
e-assenat@chu-montpellier.fr
Contact Person Name
Eric Assenat
Contact Person Email
e-assenat@chu-montpellier.fr
Site Name
Hopital Huriez
Department Name
Maladie de l’Appareil Digestif et Oncologie Médicale
Principal Investigator Name
Stéphane Cattan
Principal Investigator Email
Stephane.CATTAN@chu-lille.fr
Contact Person Name
Stéphane Cattan
Contact Person Email
Stephane.CATTAN@chu-lille.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hépato-gastro-entérologie et oncologie digestive
Principal Investigator Name
Jean-Frederic Blanc
Principal Investigator Email
jean-frederic.blanc@chu-bordeaux.fr
Contact Person Name
Jean-Frederic Blanc
Site Name
Hopital Saint Joseph
Department Name
Hépato-gastro-entérologie et d'oncologie digestive
Principal Investigator Name
Xavier Adhoute
Principal Investigator Email
xadhoute@hopital-saint-joseph.fr
Contact Person Name
Xavier Adhoute
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncologie Digestive
Principal Investigator Name
Jean-Philippe Metges
Principal Investigator Email
jean-philippe.metges@chu-brest.fr
Contact Person Name
Jean-Philippe Metges
Site Name
Hopital Paul Brousse
Department Name
Gastro entérologie et Hépatologie
Principal Investigator Name
Olivier Rosmorduc
Principal Investigator Email
olivier.rosmorduc@aphp.fr
Contact Person Name
Olivier Rosmorduc
Contact Person Email
olivier.rosmorduc@aphp.fr
Site Name
Hopital Beaujon (duplicate/contact variant included above)
Department Name
Oncologie Digestive

Germany

Earliest CTIS Part Ii Submission Date
05-05-2025
Latest Decision Or Authorization Date
27-05-2025
Processing Time Days
22
Number Of Sites
13
Number Of Participants
37

Sites

Site Name
Universitaetsklinikum Ulm AöR
Department Name
Zentrum fuer Innere Medizin; Klinik fuer Innere Medizin I
Principal Investigator Name
Lukas Perkhofer
Principal Investigator Email
lukas.perkhofer@uniklinik-ulm.de
Contact Person Name
Lukas Perkhofer
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik 1; Studienzentrale Internistische Onkologie
Principal Investigator Name
Ulrike Ubbelohde
Principal Investigator Email
ulrike.ubbelohde@uniklinikum-dresden.de
Contact Person Name
Ulrike Ubbelohde
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Abteilung Onkologie; Hämatologie
Principal Investigator Name
Dirk Arnold
Principal Investigator Email
d.arnold@asklepios.com
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik und Poliklinik fuer Onkologie, Gastroenterologie, Hepatologie und Pneumologie
Principal Investigator Name
Florian van Boemmel
Principal Investigator Email
florian.vanboemmel@medizin.uni-leipzig.de
Contact Person Name
Florian van Boemmel
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik und Poliklinik II; Interdisziplinäres Studienzentrum mit ECTU
Principal Investigator Name
Volker Kunzmann
Principal Investigator Email
kunzmann_v@ukw.de
Contact Person Name
Volker Kunzmann
Contact Person Email
kunzmann_v@ukw.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik fuer Gastroenterologie und Gastrointestinale Onkologie
Principal Investigator Name
Alexander Koenig
Principal Investigator Email
alexander.koenig@med.uni-goettingen.de
Contact Person Name
Alexander Koenig
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik 1
Principal Investigator Name
Jens Marquardt
Principal Investigator Email
jens.marquardt@uksh.de
Contact Person Name
Jens Marquardt
Contact Person Email
jens.marquardt@uksh.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie
Principal Investigator Name
Annabel Alig
Principal Investigator Email
annabel.alig@charite.de
Contact Person Name
Annabel Alig
Contact Person Email
annabel.alig@charite.de
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung (IKF)
Principal Investigator Name
Thorsten O. Goetze
Principal Investigator Email
goetze.thorsten@khnw.de
Contact Person Name
Thorsten O. Goetze
Contact Person Email
goetze.thorsten@khnw.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medinzinische Klinik und Poliklinik III
Principal Investigator Name
Sabrina Opatz
Principal Investigator Email
sabrina.opatz@med.uni-muenchen.de
Contact Person Name
Sabrina Opatz
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Maria Gonzalez-Carmona
Principal Investigator Email
maria.gonzalez-carmona@ukbonn.de
Contact Person Name
Maria Gonzalez-Carmona
Site Name
University Hospital Cologne AöR
Department Name
Klinik fuer Gastroenterologie und Hepatologie
Principal Investigator Name
Dirk-Thomas Waldschmidt
Principal Investigator Email
dirk.waldschmidt@uk-koeln.de
Contact Person Name
Dirk-Thomas Waldschmidt
Contact Person Email
dirk.waldschmidt@uk-koeln.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik fuer Innere Medizin II; Gastrointestinale Onkologie
Principal Investigator Name
Michael Quante
Principal Investigator Email
michael.quante@uniklinik-freiburg.de
Contact Person Name
Michael Quante

Spain

Earliest CTIS Part Ii Submission Date
08-04-2025
Latest Decision Or Authorization Date
23-05-2025
Processing Time Days
45
Number Of Sites
6
Number Of Participants
21

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Servicio de Oncologia Medica
Principal Investigator Name
Eva Martínez de Castro
Principal Investigator Email
evamdecastro@hotmail.com
Contact Person Name
Eva Martínez de Castro
Contact Person Email
evamdecastro@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Unidad de cáncer gastrointestinal. Oncología médica
Principal Investigator Name
Jaume Capdevilla Castillo
Principal Investigator Email
jcapdevila@vhio.net
Contact Person Name
Jaume Capdevilla Castillo
Contact Person Email
jcapdevila@vhio.net
Site Name
Hospital Universitario Regional De Malaga
Department Name
UGCI de Oncología/Oncologia Médica
Principal Investigator Name
Inmaculada Alés Díaz
Principal Investigator Email
inales@hotmail.com
Contact Person Name
Inmaculada Alés Díaz
Contact Person Email
inales@hotmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncologia Médica
Principal Investigator Name
Ángela Lamarca Lete
Principal Investigator Email
angela.lamarca@quironsalud.es
Contact Person Name
Ángela Lamarca Lete
Contact Person Email
angela.lamarca@quironsalud.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Unidad de Tumores Digestivos. Unidad Cancer familiar.
Principal Investigator Name
Jorge Adeva Alfonso
Principal Investigator Email
jorge.adeva@salud.madrid.org
Contact Person Name
Jorge Adeva Alfonso
Contact Person Email
jorge.adeva@salud.madrid.org
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Unidad de Investigación Oncológica
Principal Investigator Name
Andrés Muñoz Martín
Principal Investigator Email
andresmunmar@hotmail.com
Contact Person Name
Andrés Muñoz Martín
Contact Person Email
andresmunmar@hotmail.com

Slovakia

Earliest CTIS Part Ii Submission Date
05-05-2025
Latest Decision Or Authorization Date
27-05-2025
Processing Time Days
22
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Narodny Onkologicky Ustav
Department Name
Outpatient clinical oncology care in hospital
Principal Investigator Name
Štefan Pörsök
Principal Investigator Email
stefan.porsok@nou.sk
Contact Person Name
Štefan Pörsök
Contact Person Email
stefan.porsok@nou.sk
Site Name
Vychodoslovensky Onkologicky Ustav a.s.
Department Name
Outpatient clinical oncology care in hospital
Principal Investigator Name
Dominik Šafčák
Principal Investigator Email
safcak@vou.sk
Contact Person Name
Dominik Šafčák
Contact Person Email
safcak@vou.sk
Site Name
Fakultna Nemocnica Trnava
Department Name
Outpatient clinical oncology care in hospital
Principal Investigator Name
Marian Streško
Principal Investigator Email
marian.stresko@fntt.sk
Contact Person Name
Marian Streško
Contact Person Email
marian.stresko@fntt.sk
Site Name
F D Roosevelt University General Hospital Of Banska Bystrica
Department Name
Outpatient clinical oncology care in hospital
Principal Investigator Name
Matej Hrnčár
Principal Investigator Email
mhrncar@nspbb.sk
Contact Person Name
Matej Hrnčár
Contact Person Email
mhrncar@nspbb.sk
Site Name
Univerzitna Nemocnica Martin
Department Name
Outpatient clinical radiotherapy care in hospital
Principal Investigator Name
Ivan Kecskés
Principal Investigator Email
ivan.kecskes@unm.sk
Contact Person Name
Ivan Kecskés
Contact Person Email
ivan.kecskes@unm.sk

Czechia

Earliest CTIS Part Ii Submission Date
05-05-2025
Latest Decision Or Authorization Date
27-05-2025
Processing Time Days
22
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologicka klinika 2. LF UK a FN Motol
Principal Investigator Name
Stanislav Batko
Principal Investigator Email
stanislav.batko@fnmotol.cz
Contact Person Name
Stanislav Batko
Contact Person Email
stanislav.batko@fnmotol.cz
Site Name
University Hospital Olomouc
Department Name
Onkologicka klinika
Principal Investigator Name
Bohuslav Melichar
Principal Investigator Email
bohuslav.melichar@fnol.cz
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexni onkologicke pece
Principal Investigator Name
Igor Kiss
Principal Investigator Email
kiss@mou.cz
Contact Person Name
Igor Kiss
Contact Person Email
kiss@mou.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika Onkologie a Radioterapie
Principal Investigator Name
Stanislav John
Principal Investigator Email
stanislav.john@fnhk.cz
Contact Person Name
Stanislav John
Contact Person Email
stanislav.john@fnhk.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Onkologicka klinika 3. LF UK a FNKV
Principal Investigator Name
Marian Liberko
Principal Investigator Email
marian.liberko@fnkv.cz
Contact Person Name
Marian Liberko
Contact Person Email
marian.liberko@fnkv.cz

Austria

Earliest CTIS Part Ii Submission Date
21-05-2025
Latest Decision Or Authorization Date
02-06-2025
Processing Time Days
12
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Medicine I - Division of Oncology
Principal Investigator Name
Gerald Prager
Principal Investigator Email
gerald.prager@meduniwien.ac.at
Contact Person Name
Gerald Prager
Contact Person Email
gerald.prager@meduniwien.ac.at
Site Name
Medical University Of Graz
Department Name
Clinical Division for Oncology
Principal Investigator Name
Renate Schaberl-Moser
Principal Investigator Email
renate.schaberl-moser@medunigraz.at
Contact Person Name
Renate Schaberl-Moser
Site Name
Noe LGA Gesundheit Thermenregion GmbH
Department Name
Department for Internal Medicine, Hematology and Internal Oncology
Principal Investigator Name
Birgit Gruenberger
Principal Investigator Email
birgit.gruenberger@wienerneustadt.lknoe.at
Contact Person Name
Birgit Gruenberger
Site Name
Ordensklinikum Linz GmbH
Department Name
Internal I: Medical Oncology and Hematology
Principal Investigator Name
Bernhard Doleschal
Principal Investigator Email
bernhard.doleschal@ordensklinikum.at
Contact Person Name
Bernhard Doleschal
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
University Clinic for Internal Medicine III
Principal Investigator Name
Lukas Weiss
Principal Investigator Email
lu.Weiss@salk.at
Contact Person Name
Lukas Weiss
Contact Person Email
lu.Weiss@salk.at

Belgium

Earliest CTIS Part Ii Submission Date
30-04-2025
Latest Decision Or Authorization Date
26-05-2025
Processing Time Days
26
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Antwerp University Hospital
Department Name
Oncology
Principal Investigator Name
Timon Vandamme
Principal Investigator Email
Timon.Vandamme@uza.be
Contact Person Name
Timon Vandamme
Contact Person Email
Timon.Vandamme@uza.be
Site Name
Centre Hospitalier Universitaire De Liege
Department Name
Oncology
Principal Investigator Name
Florence Troisfontaine
Principal Investigator Email
ftroisfontaine@chuliege.be
Contact Person Name
Florence Troisfontaine
Contact Person Email
ftroisfontaine@chuliege.be
Site Name
UZ Leuven
Department Name
Oncology
Principal Investigator Name
Jeroen Dekervel
Principal Investigator Email
jeroen.dekervel@uzleuven.be
Contact Person Name
Jeroen Dekervel
Contact Person Email
jeroen.dekervel@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Oncology
Principal Investigator Name
Suzane Moura Ribeiro
Principal Investigator Email
Suzane.RibeiroMoura@uzgent.be
Contact Person Name
Suzane Moura Ribeiro
Contact Person Email
Suzane.RibeiroMoura@uzgent.be
Site Name
Hopital Erasme
Department Name
Oncology
Principal Investigator Name
Anne Demols
Principal Investigator Email
anne.demols@hubruxelles.be
Contact Person Name
Anne Demols
Contact Person Email
anne.demols@hubruxelles.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Oncology
Principal Investigator Name
Sofie De Meulder
Principal Investigator Email
Sofie.DeMeulder@azdelta.be
Contact Person Name
Sofie De Meulder
Contact Person Email
Sofie.DeMeulder@azdelta.be
Site Name
Antwerp University Hospital (additional contact variant)
Department Name
Oncology

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 USE
Route
Intravenous
Investigational Product Name
DS-8201a (trastuzumab deruxtecan, T-DXd)
Active Substance
TRASTUZUMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Investigational Product Name
IMFINZI (Durvalumab)
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Marketing authorisation exists (EU/1/18/1322/001 noted in product data)
Investigational Product Name
GEMCITABINE
Active Substance
GEMCITABINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Investigational Product Name
INFLIXIMAB
Active Substance
INFLIXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Investigational Product Name
MYCOPHENOLATE MOFETIL
Active Substance
MYCOPHENOLATE MOFETIL
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Combination Treatment
Yes

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