Clinical trial • Phase III • Oncology

RILVEGOSTOMIG for HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma

Phase III trial of RILVEGOSTOMIG for HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
Trial Stage
Phase III
Drug Modality
Bispecific antibody|ADC|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
31-01-2025
First CTIS Authorization Date
27-05-2025

Trial design

Randomised, open-label, intervention arm b: pembrolizumab (keytruda) and trastuzumab and chemotherapy (comparator/standard treatment); intervention arm c: rilvegostomig and trastuzumab and chemotherapy (active comparator). doses and schedules not specified in ctis record.-controlled Phase III trial in Austria, Belgium, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Intervention Arm B: Pembrolizumab (KEYTRUDA) and Trastuzumab and chemotherapy (comparator/standard treatment); Intervention Arm C: Rilvegostomig and Trastuzumab and chemotherapy (active comparator). Doses and schedules not specified in CTIS record.
Target Sample Size
636

Eligibility

Recruits 636 Vulnerable population selection is indicated. Subject information and informed consent forms are provided for adults and for pregnant partners (documents titled e.g. 'L1_SIS and ICF Adults', 'L1_SIS and ICF Pregnant Partner'); additional consent/addenda for pre-screening, optional genetic research and treatment beyond progression are available. No description of child assent or minor consent procedures is provided..

Vulnerable Population
Vulnerable population selection is indicated. Subject information and informed consent forms are provided for adults and for pregnant partners (documents titled e.g. 'L1_SIS and ICF Adults', 'L1_SIS and ICF Pregnant Partner'); additional consent/addenda for pre-screening, optional genetic research and treatment beyond progression are available. No description of child assent or minor consent procedures is provided.

Inclusion criteria

  • {"criterion_text":"- HER2 positive for gastric cancer on a tumor biopsy.\n- PD-L1 combined positive score (CPS) ≥ 1.\n- Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.\n- Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.\n- WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.\n- Have measurable target disease assessed by the Investigator based on RECISTv1.1.\n- Have adequate organ and bone marrow function within 14 days before randomization.\n- LVEF ≥ 55% within 28 days before randomization.\n- Adequate treatment washout period before randomization."}

Exclusion criteria

  • {"criterion_text":"- Lack of physiological integrity of the upper gastrointestinal tract.\n- Any concurrent anti-cancer treatment with the exception of receptor activator ofnuclear factor kappa-B ligand inhibitors.\n- Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.\n- Known dihydropyrimidine dehydrogenase enzyme deficiency.\n- Current or prior use of immunosuppressive medication within 14 days before study intervention.\n- Contraindication to pembrolizumab or trastuzumab, contraindications tofluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.\n- History of another primary malignancy except for malignancy treated with curativeintent with no known active disease within 3 years before the first dose of studyintervention and of low potential risk for recurrence.\n- Persistent toxicities caused by previous anti-cancer therapy.\n- Has spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.\n- Uncontrolled infection including tuberculosis and active hepatitis A infection.\n- Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.\n- Chronic/active HBV or HCV infection unless controlled.\n- Recent receipt of live, attenuated vaccine.\n- Clinically significant cardiac or psychological conditions.\n- Active or prior documented autoimmune or inflammatory disorders requiringchronic treatment with steroids or other immunosuppressive treatment.\n- History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or wheresuspected ILD/pneumonitis cannot be ruled out by imaging at screening.\n- Lung-specific intercurrent clinically significant illnesses.\n- Any active non-infectious skin disease requiring systemic treatment.\n- A pleural effusion, ascites or pericardial effusion that requires drainage, peritonealshunt, or cell-free and concentrated ascites reinfusion therapy (CART).\n- History of any of the following: drug-induced severecutaneous adverse reaction."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free Survival (PFS) per RECIST v1.1","definition_or_measurement_approach":"PFS assessed per RECIST v1.1 (as measured by Blinded Independent Central Review (BICR) as stated in the main objective)"}
  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Overall Survival (OS) as stated in the main objective; no further definition provided in the CTIS record"}

Secondary endpoints

  • {"endpoint_text":"- PFS based on RECIST v1.1.","definition_or_measurement_approach":"Progression-free survival assessed using RECIST v1.1"}
  • {"endpoint_text":"- Objective Response Rate (ORR) according to RECIST v1.1.","definition_or_measurement_approach":"ORR assessed according to RECIST v1.1"}
  • {"endpoint_text":"- Duration of Response (DoR) according to RECIST v1.1.","definition_or_measurement_approach":"DoR measured per RECIST v1.1"}
  • {"endpoint_text":"- Time to second progression or death.","definition_or_measurement_approach":"Time elapsed to second progression or death (definition not further specified)"}
  • {"endpoint_text":"- Progression-free Survival (PFS) at 6 and 12 months (PFS6 and PFS12).","definition_or_measurement_approach":"PFS assessed at fixed timepoints of 6 and 12 months"}
  • {"endpoint_text":"- Overall Survival (OS) at 12 and 24 months (OS12 and OS24).","definition_or_measurement_approach":"OS assessed at 12 and 24 months"}
  • {"endpoint_text":"- Occurrence of AEs, SAEs, AESIs.","definition_or_measurement_approach":"Adverse events, serious adverse events and adverse events of special interest occurrence (standard safety reporting; no additional definition provided)"}
  • {"endpoint_text":"- Changes from baseline in laboratory parameters, vitalsigns, electrocardiogram data, and results of echocardiogram/multiple gated acquisition.","definition_or_measurement_approach":"Changes from baseline in labs, vital signs, ECG and echocardiogram/MUGA results"}
  • {"endpoint_text":"- Serum concentration of rilvegostomig, T-DXd, total anti-HER2 antibody, T-DXd, plasma concentration of 5-FU and capecitabine.","definition_or_measurement_approach":"Pharmacokinetic measurements of serum/plasma concentrations for listed agents"}
  • {"endpoint_text":"- Presence of anti-drug antibodies for rilvegostomig and T-DXd.","definition_or_measurement_approach":"Immunogenicity assessment: presence of anti-drug antibodies to rilvegostomig and T-DXd"}
  • {"endpoint_text":"- Time to increase in enteral feeding assistance and/or eating difficulties.","definition_or_measurement_approach":"Time to event measuring need for increased enteral feeding assistance and/or onset of eating difficulties"}
  • {"endpoint_text":"- The proportion of time on study intervention with high side-effect bother.","definition_or_measurement_approach":"Proportion of time on study intervention during which participants report high bother from side-effects (definition/details not further specified)"}
  • {"endpoint_text":"- The proportion of participants with stable or improved physical function while on treatment.","definition_or_measurement_approach":"Proportion of participants maintaining or improving physical function during treatment (specific measurement instrument not specified)"}

Recruitment

Planned Sample Size
636
Recruitment Window Months
68
Consent Approach
Informed consent is obtained from adult study participants. Subject information and consent forms are provided for adults, pre-screening, pregnant partners, and include addenda for treatment beyond progression, optional genetic research and future research. Language-specific ICFs are provided (examples in the CTIS documents include English, Dutch, French, German, Hungarian, Polish, Spanish, Italian). No assent or minor-consent procedures are described in the CTIS record.

Geography

Total Number Of Sites
67
Total Number Of Participants
204

Austria

Earliest CTIS Part Ii Submission Date
13-05-2025
Latest Decision Or Authorization Date
14-08-2025
Processing Time Days
93
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Medical University Of Vienna
Department Name
Clinical department of Oncology
Principal Investigator Name
Ayseguel Ilhan-Mutlu
Principal Investigator Email
aysegul.ilhan@meduniwien.ac.at
Contact Person Name
Ayseguel Ilhan-Mutlu
Contact Person Email
aysegul.ilhan@meduniwien.ac.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Internal I Medical Oncology and Hematology
Principal Investigator Name
Bernhard Doleschal
Principal Investigator Email
bernhard.doleschal@ordentsklinikum.at
Contact Person Name
Bernhard Doleschal
Site Name
Noe LGA Gesundheit Thermenregion GmbH
Department Name
Department of internal medicine hematologie and internal oncology
Principal Investigator Name
Birgit Gruenberger
Principal Investigator Email
birgit.gruenberger@wienerneustadt.lknoe.at
Contact Person Name
Birgit Gruenberger
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
3rd Medical Department
Principal Investigator Name
Florian Huemer
Principal Investigator Email
f.huemer@salk.at
Contact Person Name
Florian Huemer
Contact Person Email
f.huemer@salk.at

Belgium

Earliest CTIS Part Ii Submission Date
25-04-2025
Latest Decision Or Authorization Date
10-09-2025
Processing Time Days
138
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
-
Principal Investigator Name
Eduard Callebout
Principal Investigator Email
eduard.callebout@uzgent.be
Contact Person Name
Eduard Callebout
Contact Person Email
eduard.callebout@uzgent.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
-
Principal Investigator Name
Joëlle Collignon
Principal Investigator Email
joelle.collignon@chuliege.be
Contact Person Name
Joëlle Collignon
Contact Person Email
joelle.collignon@chuliege.be
Site Name
UZ Leuven
Department Name
-
Principal Investigator Name
Filip van Herpe
Principal Investigator Email
Filip.vanherpe@uzleuven.be
Contact Person Name
Filip van Herpe
Contact Person Email
Filip.vanherpe@uzleuven.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
-
Principal Investigator Name
Timon Vandamme
Principal Investigator Email
timon.vandamme@uza.be
Contact Person Name
Timon Vandamme
Contact Person Email
timon.vandamme@uza.be

France

Earliest CTIS Part Ii Submission Date
30-04-2025
Latest Decision Or Authorization Date
03-09-2025
Processing Time Days
126
Number Of Sites
11
Number Of Participants
26

Sites

Site Name
Institut Bergonie
Department Name
Medical Oncology
Principal Investigator Name
Lola-Jade Palmieri
Principal Investigator Email
l.palmieri@bordeaux.unicancer.fr
Contact Person Name
Lola-Jade Palmieri
Site Name
Institut Gustave Roussy
Department Name
Département de Médecine / Comité 040
Principal Investigator Name
Michel Ducreux
Principal Investigator Email
michel.ducreux@gustaveroussy.fr
Contact Person Name
Michel Ducreux
Site Name
Centre Leon Berard
Department Name
Department of Medical Oncology
Principal Investigator Name
Clélia Coutzac
Principal Investigator Email
clelia.coutzac@lyon.unicancer.fr
Contact Person Name
Clélia Coutzac
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Digestive Surgery and Oncology Department
Principal Investigator Name
Marine Jary
Principal Investigator Email
mjary@chu-clermontferrand.fr
Contact Person Name
Marine Jary
Contact Person Email
mjary@chu-clermontferrand.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Medical oncology
Principal Investigator Name
François Ghiringhelli
Principal Investigator Email
fghiringhelli@cgfl.fr
Contact Person Name
François Ghiringhelli
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Institut Paoli Calmettes
Department Name
Medical Oncology Department
Principal Investigator Name
Christelle De La Fouchardière
Principal Investigator Email
delafouchardierec@ipc.unicancer.fr
Contact Person Name
Christelle De La Fouchardière
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Gastro-enterology and medical oncology
Principal Investigator Name
David Tougeron
Principal Investigator Email
david.tougeron@chu-poitiers.fr
Contact Person Name
David Tougeron
Contact Person Email
david.tougeron@chu-poitiers.fr
Site Name
Centre Francois Baclesse
Department Name
-
Principal Investigator Name
Mélanie Dos Santos
Principal Investigator Email
m.dossantos@baclesse.unicancer.fr
Contact Person Name
Mélanie Dos Santos
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service d'oncologie médicale
Principal Investigator Name
Rosine Guimbaud
Principal Investigator Email
guimbaud.r@chu-toulouse.fr
Contact Person Name
Rosine Guimbaud
Contact Person Email
guimbaud.r@chu-toulouse.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Medical oncology
Principal Investigator Name
Samuel Le Sourd
Principal Investigator Email
s.lesourd@rennes.unicancer.fr
Contact Person Name
Samuel Le Sourd
Contact Person Email
s.lesourd@rennes.unicancer.fr
Site Name
Institut Paoli Calmettes (duplicate listing?)
Department Name
Medical Oncology Department
Principal Investigator Name
Christelle De La Fouchardière
Principal Investigator Email
delafouchardierec@ipc.unicancer.fr
Contact Person Name
Christelle De La Fouchardière

Germany

Earliest CTIS Part Ii Submission Date
28-04-2025
Latest Decision Or Authorization Date
31-07-2025
Processing Time Days
94
Number Of Sites
15
Number Of Participants
42

Sites

Site Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Department Name
Medizinische Klinik C
Principal Investigator Name
Ralf Jakobs
Principal Investigator Email
jakobsr@klilu.de
Contact Person Name
Ralf Jakobs
Contact Person Email
jakobsr@klilu.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Westdeutsches Tumorzentrum Essen
Principal Investigator Name
Isabel Virchow
Principal Investigator Email
isabel.virchow@uk-essen.de
Contact Person Name
Isabel Virchow
Contact Person Email
isabel.virchow@uk-essen.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Gastroenterologie, gastrointestinale Onkologie und Endokrinologie
Principal Investigator Name
Alexander König
Principal Investigator Email
alexander.koenig@med.uni-goettingen.de
Contact Person Name
Alexander König
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Gastroenterologie, Hepatologie und Infektiologie
Principal Investigator Name
Christoph Roderburg
Principal Investigator Email
Christoph.Roderburg@med.uni-duesseldorf.de
Contact Person Name
Christoph Roderburg
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Medizinische Klinik III
Principal Investigator Name
Miriam Ahlborn
Principal Investigator Email
m.ahlborn@skbs.de
Contact Person Name
Miriam Ahlborn
Contact Person Email
m.ahlborn@skbs.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Innere Medizin I
Principal Investigator Name
Thomas Ettrich
Principal Investigator Email
thomas.ettrich@uniklinik-ulm.de
Contact Person Name
Thomas Ettrich
Site Name
HELIOS Klinikum Bad Saarow GmbH
Department Name
Klinik für Onkologie und Palliativmedizin Klinik für Hämatologie
Principal Investigator Name
Daniel Pink
Principal Investigator Email
daniel.pink@helios-gesundheit.de
Contact Person Name
Daniel Pink
Site Name
Heidelberg University
Department Name
Interdisziplinäres Tumorzentrum
Principal Investigator Name
Ralf Dieter Hofheinz
Contact Person Name
Ralf Dieter Hofheinz
Site Name
Klinikum Chemnitz gGmbH
Department Name
Innere Medizin III
Principal Investigator Name
Jack Chater
Principal Investigator Email
J.Chater@skc.de
Contact Person Name
Jack Chater
Contact Person Email
J.Chater@skc.de
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung (IKF)
Principal Investigator Name
Thorsten Goetze
Principal Investigator Email
goetze.thorsten@ikf-khnw.de
Contact Person Name
Thorsten Goetze
Contact Person Email
goetze.thorsten@ikf-khnw.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum Onkologie; II. Medizinische Klinik und Poliklinik
Principal Investigator Name
Joseph Tintelnot
Principal Investigator Email
j.tintelnot@uke.de
Contact Person Name
Joseph Tintelnot
Contact Person Email
j.tintelnot@uke.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie
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
Onkologische Schwerpunktpraxis Kurfürstendamm
Principal Investigator Name
Ingo Schwaner
Principal Investigator Email
ingo.schwaner@onkologie-kurfuerstendamm.de
Contact Person Name
Ingo Schwaner
Site Name
Universitaet Leipzig
Department Name
Universitäres Krebszentrum Leipzig
Principal Investigator Name
Florian Lordick
Contact Person Name
Florian Lordick
Site Name
Universitaetsklinikum Augsburg
Department Name
III. Medizinische Klinik
Principal Investigator Name
Alexander Reichart
Principal Investigator Email
alexander.reichart@uk-augsburg.de
Contact Person Name
Alexander Reichart

Hungary

Earliest CTIS Part Ii Submission Date
31-03-2025
Latest Decision Or Authorization Date
23-09-2025
Processing Time Days
176
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Onkoradiológiai Osztály
Principal Investigator Name
András Szigeti
Principal Investigator Email
drszigetia2@gmail.com
Contact Person Name
András Szigeti
Contact Person Email
drszigetia2@gmail.com
Site Name
Semmelweis University
Department Name
Pankreász Betegségek Intézete
Principal Investigator Name
Tibor Csőszi
Principal Investigator Email
dr.cstibor@freemail.hu
Contact Person Name
Tibor Csőszi
Contact Person Email
dr.cstibor@freemail.hu
Site Name
Orszagos Onkologiai Intezet
Department Name
Mellkasi és Hasüregi Daganatok és Klinikai Farmakológiai Osztály "Kemoterápia B"
Principal Investigator Name
Erika Hitre
Principal Investigator Email
hitre.erika@onco.hu
Contact Person Name
Erika Hitre
Contact Person Email
hitre.erika@onco.hu
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Onkológiai Osztály
Principal Investigator Name
László Torday
Principal Investigator Email
laszlo.torday@gmail.com
Contact Person Name
László Torday
Contact Person Email
laszlo.torday@gmail.com
Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Onkoradiológiai Osztály
Principal Investigator Name
Zsuzsa Póti
Principal Investigator Email
drpoti.zs@uzsoki.hu
Contact Person Name
Zsuzsa Póti
Contact Person Email
drpoti.zs@uzsoki.hu
Site Name
Zala Varmegyei Szent Rafael Korhaz
Department Name
Onkológiai Osztály
Principal Investigator Name
Károly Máhr
Principal Investigator Email
mahrkaroly1967@gmail.com
Contact Person Name
Károly Máhr
Contact Person Email
mahrkaroly1967@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
23-04-2025
Latest Decision Or Authorization Date
12-09-2025
Processing Time Days
142
Number Of Sites
7
Number Of Participants
24

Sites

Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Oddzial Onkologii Klinicznej i Radioterapii
Principal Investigator Name
Joanna Wojcik-Tomaszewska
Principal Investigator Email
jwojcik@wco.gda.pl
Contact Person Name
Joanna Wojcik-Tomaszewska
Contact Person Email
jwojcik@wco.gda.pl
Site Name
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
KLINIKA ONKOLOGII I IMMUNOONKOLOGII Z ODDZIAŁEM DZIENNYM TERAPII ONKOLOGICZNEJ
Principal Investigator Name
Tomasz Lewandowski
Principal Investigator Email
tomasz.lewandowski@poliklinika.net
Contact Person Name
Tomasz Lewandowski
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Oddzial Onkologii Klinicznej
Principal Investigator Name
Izabella Debicka
Principal Investigator Email
izabella.debicka@usk.wroc.pl
Contact Person Name
Izabella Debicka
Contact Person Email
izabella.debicka@usk.wroc.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddzial Dzienny Chemioterapii
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
mariusz.kwiatkowski@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med.pl
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
Principal Investigator Name
Kamil Kuc
Principal Investigator Email
kkuc@wszp.pl
Contact Person Name
Kamil Kuc
Contact Person Email
kkuc@wszp.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
lucjanwyrwicz@gmail.com
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
lucjanwyrwicz@gmail.com
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@onkologia.bialystok.pl
Contact Person Name
Piotr Tokajuk

Spain

Earliest CTIS Part Ii Submission Date
31-03-2025
Latest Decision Or Authorization Date
19-09-2025
Processing Time Days
172
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Tania Fleitas
Principal Investigator Email
tfleitask@gmail.com
Contact Person Name
Tania Fleitas
Contact Person Email
tfleitask@gmail.com
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 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 Acosta Eyzaguirre
Principal Investigator Email
dacosta@vhio.net
Contact Person Name
Daniel Acosta Eyzaguirre
Contact Person Email
dacosta@vhio.net
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
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Maria Luisa Limon Miron
Principal Investigator Email
mllimon02@hotmail.com
Contact Person Name
Maria Luisa Limon Miron
Contact Person Email
mllimon02@hotmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Oncology
Principal Investigator Name
Cinta Hierro Carbo
Principal Investigator Email
chierro@iconcologia.net
Contact Person Name
Cinta Hierro Carbo
Contact Person Email
chierro@iconcologia.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Maria Carmen Riesco Martinez
Principal Investigator Email
m.carmen.riesco@gmail.com
Contact Person Name
Maria Carmen Riesco Martinez
Contact Person Email
m.carmen.riesco@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
17-04-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
222
Number Of Sites
9
Number Of Participants
27

Sites

Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Dipartimento di Oncologia
Principal Investigator Name
Massimo Di Maio
Principal Investigator Email
massimo.dimaio@unito.it
Contact Person Name
Massimo Di Maio
Contact Person Email
massimo.dimaio@unito.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Abdominal Medical Oncology Unit
Principal Investigator Name
Antonio Avallone
Principal Investigator Email
a.avallone@istitutotumori.na.it
Contact Person Name
Antonio Avallone
Site Name
Istituto Oncologico Veneto
Department Name
Oncology Unit
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
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Medical Oncology
Principal Investigator Name
Katia Bruna Bencardino
Principal Investigator Email
katia.bencardino@ospedaleniguarda.it
Contact Person Name
Katia Bruna Bencardino
Site Name
Humanitas Mirasole S.p.A.
Department Name
Unit of Oncology and Hematology
Principal Investigator Name
Giuseppe Mondello
Contact Person Name
Giuseppe Mondello
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
S.C. Oncologia Medica
Principal Investigator Name
Mario Scartozzi
Principal Investigator Email
mario.scartozzi@unica.it
Contact Person Name
Mario Scartozzi
Contact Person Email
mario.scartozzi@unica.it
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
Oncology and Palliative Care Department
Principal Investigator Name
Emiliano Tamburini
Principal Investigator Email
e.tamburini@piafondazionepanico.it
Contact Person Name
Emiliano Tamburini
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SODc Clinical Oncology
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
antonuzzol@aou-careggi.toscana.it
Contact Person Name
Lorenzo Antonuzzo
Site Name
Istituto Oncologico Veneto (duplicate listing?)
Department Name
Oncology Unit
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

Netherlands

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
203
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Amsterdam UMC Stichting
Department Name
-
Principal Investigator Name
Hanneke van Laarhoven
Principal Investigator Email
h.vanlaarhoven@amsterdamumc.nl
Contact Person Name
Hanneke van Laarhoven
Contact Person Email
h.vanlaarhoven@amsterdamumc.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Medical Oncology
Principal Investigator Name
Marije Slingerland
Principal Investigator Email
m.slingerland@lumc.nl
Contact Person Name
Marije Slingerland
Contact Person Email
m.slingerland@lumc.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
-
Principal Investigator Name
Inge Werter
Principal Investigator Email
iwerter@rijnstate.nl
Contact Person Name
Inge Werter
Contact Person Email
iwerter@rijnstate.nl

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
Investigational Product Name
DS-8201a
Active Substance
TRASTUZUMAB DERUXTECAN
Modality
ADC
Routes Of Administration
Intravenous
Route
Intravenous
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
EU/1/15/1024/002
Investigational Product Name
TRASTUZUMAB
Active Substance
TRASTUZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Investigational Product Name
CAPECITABINE
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Investigational Product Name
FLUOROURACIL
Active Substance
FLUOROURACIL (5-FU)
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Investigational Product Name
OXALIPLATIN
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Investigational Product Name
INFLIXIMAB
Active Substance
INFLIXIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Maximum Dose
5 mg/kg (maxTotalDoseAmount given as 5 in record)
Investigational Product Name
MYCOPHENOLATE MOFETIL
Active Substance
MYCOPHENOLATE MOFETIL
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Combination Treatment
Yes

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