Clinical trial • Phase III • Oncology

RILVEGOSTOMIG for Endometrial cancer | HER2-expressing endometrial cancer | Advanced or recurrent endometrial cancer

Phase III trial of RILVEGOSTOMIG for Endometrial cancer | HER2-expressing endometrial cancer | Advanced or recurrent endometrial cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Endometrial cancer | HER2-expressing endometrial cancer | Advanced or recurrent endometrial cancer
Trial Stage
Phase III
Drug Modality
Bispecific antibody | ADC | Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
31-03-2025
First CTIS Authorization Date
21-07-2025

Trial design

Randomised, open-label, chemotherapy (carboplatin + paclitaxel) plus pembrolizumab (comparator soc arm). doses and schedules not specified in the available records.-controlled Phase III trial in Norway, Netherlands, Poland and others.

Randomised
Yes
Open Label
Yes
Comparator
Chemotherapy (carboplatin + paclitaxel) plus pembrolizumab (comparator SOC arm). Doses and schedules not specified in the available records.
Biomarker Stratified
True, HER2, MMR and PD-L1 (prospective central testing for randomization/stratification)
Target Sample Size
381

Eligibility

Recruits 381 Vulnerable population selected (isVulnerablePopulationSelected = true). No specific details on consent or assent handling are provided in the available records..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). No specific details on consent or assent handling are provided in the available records.

Inclusion criteria

  • {"criterion_text":"- Participants must be ≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations."}
  • {"criterion_text":"- Adequate organ and bone marrow function within 14 days before randomization."}
  • {"criterion_text":"- Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies are allowed except for sarcomas (carcinosarcomas are allowed)."}
  • {"criterion_text":"- Following surgery or diagnostic biopsy, participant must have primary advanced disease (Stage III/IV) or first recurrent endometrial cancer and meet at least one of the following criteria: - Primary Stage III (per FIGO 2023) disease with measurable disease at baseline per RECIST 1.1 based on the investigator’s assessment. - Primary Stage IV disease (per FIGO 2023) regardless of presence of measurable disease at baseline. - First recurrent disease regardless of presence of measurable disease at baseline."}
  • {"criterion_text":"- Endometrial cancer with HER2 IHC expression of 3+ or 2+ as assessed by prospective central testing."}
  • {"criterion_text":"- Endometrial cancer that is determined pMMR by prospective central IHC testing."}
  • {"criterion_text":"- Provision of adequate FFPE tumor tissue sample of a tumor lesion that was not previously irradiated for central HER2, MMR, and PD-L1 IHC testing and valid central test results for randomization/ stratification."}
  • {"criterion_text":"- Prior therapy: - Naïve to first-line systemic anticancer therapy. Participants may have received one prior line of adjuvant/neoadjuvant chemotherapy with curative intent (chemotherapy or chemoradiation) if disease recurrence or progression occurred ≥ 6 months after last dose of chemotherapy. Prior trastuzumab in the adjuvant/neoadjuvant setting is allowed. - No prior exposure to ADCs or immune checkpoint inhibitors including (but not limited to) anti-PD-1/PD-L1/PD-L2 and anti-CTLA-4 antibodies and therapeutic anticancer vaccines. - Participants may have received prior radiation therapy for the treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy. Adequate treatment washout period is required."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1."}
  • {"criterion_text":"- Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days before randomization."}

Exclusion criteria

  • {"criterion_text":"- History of organ transplant."}
  • {"criterion_text":"- Uncontrolled intercurrent illness, including, but not limited to ongoing or active known infection, serious chronic gastrointestinal conditions associated with diarrhea and active non-infectious skin disease requiring systemic treatment."}
  • {"criterion_text":"- Spinal cord compression or clinically active central nervous system metastases."}
  • {"criterion_text":"- Participants with a medical history of myocardial infarction (MI) within 6 months before randomization, or symptomatic congestive heart failure (CHF) (NYHA Class II to IV), clinically significant arrhythmia, or cardiomyopathy of any etiology. Participants with troponin levels above ULN at screening (as defined by the manufacturer), should have a cardiologic consultation before enrollment to rule out MI"}
  • {"criterion_text":"- History of (non-infectious) ILD/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening."}
  • {"criterion_text":"- Lung criteria: - Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion etc.). - Any autoimmune, connective tissue or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of screening. - Prior pneumonectomy (complete)."}
  • {"criterion_text":"- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment."}
  • {"criterion_text":"- Active primary immunodeficiency/ active infectious disease(s) including: - Tuberculosis (TB) - HIV infection that is not well controlled. - Chronic or active hepatitis B, chronic or active hepatitis C; however, participants who have chronic hepatitis B and are receiving suppressive antiviral therapy are allowed to be enrolled if alanine aminotransferase (ALT) is normal and viral load is controlled."}
  • {"criterion_text":"- Any concurrent anticancer treatment without an adequate washout period prior to the first dose of study intervention. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., HRT) is allowed."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression free survival (PFS) as assessed by BICR defined as time from randomization until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.","definition_or_measurement_approach":"Defined as time from randomization until progression per RECIST 1.1 as assessed by BICR, or death due to any cause."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS) defined as the time from randomization until the date of death due to any cause.","definition_or_measurement_approach":"Defined as the time from randomization until the date of death due to any cause."}
  • {"endpoint_text":"- PFS as assessed by investigator (has the same attributes as estimand of PFS by BICR, except tumor assessment is by the investigator).","definition_or_measurement_approach":"Same attributes as PFS by BICR except tumor assessment performed by the investigator."}
  • {"endpoint_text":"- PFS2 defined as the time from randomization to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.","definition_or_measurement_approach":"Defined as time from randomization to the earliest of progression after initial investigator-assessed progression following first subsequent therapy, or death."}
  • {"endpoint_text":"- ORR as assessed by BICR is defined as the proportion of participants who have a complete response (CR) or partial response (PR), as determined and confirmed by BICR per RECIST 1.1. ORR as assessed and confirmed by the investigator has the same attributes as estimand of ORR by BICR except tumor assessment per the investigator.","definition_or_measurement_approach":"Proportion of participants with CR or PR per RECIST 1.1 as determined/confirmed by BICR (and analogous investigator-assessed ORR)."}
  • {"endpoint_text":"- DoR as assessed by BICR will be defined as the time from the date of first documented response of confirmed responders until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause. DoR as assessed by the investigator has the same attributes as estimand of DoR by BICR except tumor assessment per the investigator.","definition_or_measurement_approach":"Time from first documented response in confirmed responders to documented progression per RECIST 1.1 by BICR or death."}
  • {"endpoint_text":"- Safety and tolerability (evaluated in terms of AEs/serious AEs (SAEs), AESI, vital signs, clinical safety laboratory assessments, ECG and ECHO/MUGA scan results).","definition_or_measurement_approach":"Evaluated by adverse events/serious adverse events, AESI, vital signs, lab safety assessments, ECG and ECHO/MUGA."}
  • {"endpoint_text":"- Serum concentration of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig.","definition_or_measurement_approach":"Measurement of serum concentrations of listed analytes (PK assessments)."}
  • {"endpoint_text":"- Presence of ADAs for T-DXd and rilvegostomig.","definition_or_measurement_approach":"Assessment of anti-drug antibodies (immunogenicity assays)."}
  • {"endpoint_text":"- Patient-reported tolerability.","definition_or_measurement_approach":"Patient-reported outcomes describing tolerability."}
  • {"endpoint_text":"- Assessment of MMR and HER2 expression in tissue samples and their impact to clinical endpoints, addressing clinical utility of the tests.","definition_or_measurement_approach":"Evaluation of biomarker (MMR, HER2) expression in tissue and association with clinical endpoints; informs clinical utility of tests."}

Recruitment

Planned Sample Size
381
Recruitment Window Months
64
Consent Approach
Informed consent is obtained from participants (participants must be ≥18 years). Subject information sheets and informed consent forms (L1 SIS and ICF) are provided; redacted ICF/SIS documents are available for multiple countries/languages (examples in the dossier: Norwegian, Dutch, Polish, Hungarian, French, Spanish, German, Italian, Finnish). No assent process for minors is described (paediatric participation excluded).

Geography

Total Number Of Sites
82
Total Number Of Participants
381

Norway

Earliest CTIS Part Ii Submission Date
10-07-2025
Latest Decision Or Authorization Date
25-07-2025
Processing Time Days
15
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Helse Stavanger HF
Department Name
Department of Oncology/Gynecology
Contact Person Name
Elisabeth Nilsen
Contact Person Email
elisabeth.berge.nilsen@sus.no
Site Name
Oslo University Hospital HF
Department Name
Section for gynecological oncology, Department of surgical oncology
Contact Person Name
Kristina Lindemann
Contact Person Email
klinde@ous-hf.no

Netherlands

Earliest CTIS Part Ii Submission Date
24-06-2025
Latest Decision Or Authorization Date
28-07-2025
Processing Time Days
34
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Gynaecology/Oncology
Contact Person Name
Martin Rijlaarsdam
Contact Person Email
m.rijlaarsdam@nki.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Medical Oncology
Contact Person Name
Judith Kroep
Contact Person Email
J.R.Kroep@lumc.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Medical Oncology
Contact Person Name
Petronella Ottevanger
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Internal Oncology
Contact Person Name
Ingrid Boere
Contact Person Email
i.boere@erasmusmc.nl

Poland

Earliest CTIS Part Ii Submission Date
01-07-2025
Latest Decision Or Authorization Date
28-07-2025
Processing Time Days
27
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Instytut Centrum Zdrowia Matki Polki
Department Name
Klinika Onkologii
Contact Person Name
Ewa Kalinka
Contact Person Email
sek.onkol.kl@iczmp.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
Department Name
Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Doroslych i Dziewczat
Contact Person Name
Anita Chudecka-Glaz
Contact Person Email
szpital@usk2.szczecin.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Położnictwa i Ginekologii, Ginekologii Onkologicznej i Endokrynologii Ginekologicznej
Contact Person Name
Dagmara Klasa-Mazurkiewicz
Contact Person Email
ginekologia@uck.gda.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddzial Ginekologii Onkologicznej
Contact Person Name
Radoslaw Madry
Contact Person Email
katedraonkologii@ump.edu.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddzial Ginekologii Onkologicznej
Contact Person Name
Beata Mackowiak-Matejczyk
Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawla II W Siedlcach Sp. z o.o.
Department Name
Siedleckie Centrum Onkologii
Contact Person Name
Lubomir Bodnar
Contact Person Email
lbodnar@szpital.siedlce.pl

Hungary

Earliest CTIS Part Ii Submission Date
01-07-2025
Latest Decision Or Authorization Date
22-07-2025
Processing Time Days
21
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
University Of Debrecen
Department Name
Szülészeti és Nőgyógyászati Klinika
Contact Person Name
Róbert Póka
Contact Person Email
pokar@med.unideb.hu
Site Name
Semmelweis University
Department Name
Szülészeti és Nőgyógyászati Klinika, Nőgyógyászati Onkológiai és Daganatsebészeti Osztály
Contact Person Name
Szabolcs Máté
Contact Person Email
mate.szabolcs@semmelweis.hu
Site Name
Orszagos Onkologiai Intezet
Department Name
Nőgyógyászati Multidiszciplináris Központ, Nőgyógyászati Onkológiai Részleg
Contact Person Name
Zoltán Novák
Contact Person Email
novak.zoltan@oncol.hu

Italy

Earliest CTIS Part Ii Submission Date
25-06-2025
Latest Decision Or Authorization Date
24-07-2025
Processing Time Days
29
Number Of Sites
12
Number Of Participants
27

Sites

Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Provincial Medical Oncology
Contact Person Name
Alessandra Bologna
Contact Person Email
alessandra.bologna@ausl.re.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Oncology
Contact Person Name
Giorgio Valabrega
Contact Person Email
giorgio.valabrega@unito.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Medical Oncology Gynecology
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Gynecology and Ostetrics
Contact Person Name
Vanda Salutari
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Falck Oncology
Contact Person Name
Giulia Carlo Stella
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Uro-Gynecological Experimental Oncology
Contact Person Name
Carmela Pisano
Contact Person Email
c.pisano@istitutotumori.na.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Medical Oncology Gynecology
Contact Person Name
Maria Cristina Petrella
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Ginecology
Contact Person Name
Annamaria Ferrero
Contact Person Email
annamaria.ferrero@unito.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Medical Oncology Gynecology
Contact Person Name
Nicoletta Colombo
Contact Person Email
nicoletta.colombo@ieo.it
Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Department Name
medical Oncology
Contact Person Name
Giuseppa Scandurra
Contact Person Email
giuseppa.scandurra@aoec.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Medical Oncology 1
Contact Person Name
Antonella Savarese
Contact Person Email
antonella.savarese@ifo.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
medical Oncology
Contact Person Name
Stefania Canova

Spain

Earliest CTIS Part Ii Submission Date
14-07-2025
Latest Decision Or Authorization Date
24-07-2025
Processing Time Days
10
Number Of Sites
10
Number Of Participants
32

Sites

Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncology
Contact Person Name
Ana Puertes Boix
Contact Person Email
ana.puertes@carm.es
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Contact Person Name
Maria Quindos Varela
Contact Person Email
mariaquindosvarela@hotmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Alfonso Cortes Salgado
Contact Person Email
acsalgado86@gmail.com
Site Name
Hospital Universitario Miguel Servet
Department Name
Oncology
Contact Person Name
Maria Eugenia Ortega Izquierdo
Contact Person Email
eortegai@hotmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Beatriz Pardo Burdalo
Contact Person Email
bpardo@iconcologia.net
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Contact Person Name
Maria Jesus Rubio Perez
Contact Person Email
mjesusrubio63@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Jose Alejandro Perez Fidalgo
Contact Person Email
japfidalgo@msn.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Luis Manso Sanchez
Contact Person Email
luismansosanchez@gmail.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Contact Person Name
Ignacio Romero Noguera
Contact Person Email
iromero@fivo.org
Site Name
Hospital Universitario Donostia
Department Name
Oncology
Contact Person Name
Maria Churruca Galaz

Austria

Earliest CTIS Part Ii Submission Date
24-06-2025
Latest Decision Or Authorization Date
24-07-2025
Processing Time Days
30
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Medical University Of Vienna
Department Name
University clinic for Gynaecology
Contact Person Name
Nicole Concin
Contact Person Email
nicole.concin@meduniwien.ac.at
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Department of Gynaecology, Obstetrics and Gyn. Endocrinology
Contact Person Name
Caroline Preuss
Site Name
Medizinische Universitaet Innsbruck
Department Name
University clinic for Gynaecology
Contact Person Name
Christian Marth
Site Name
Klinik Hietzing
Department Name
Karl Landsteiner Institute for Gynecology and Senology, Department of Gynecology and Obstetrics
Contact Person Name
Christian Peters-Engl

France

Earliest CTIS Part Ii Submission Date
16-06-2025
Latest Decision Or Authorization Date
25-07-2025
Processing Time Days
39
Number Of Sites
12
Number Of Participants
30

Sites

Site Name
CHU Besancon
Department Name
Medical Oncology
Contact Person Name
Laura Mansi
Contact Person Email
lmansi@chu-besancon.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Isabelle Ray-Coquard
Site Name
Oncopole Claudius Regaud
Department Name
Medical Oncology
Contact Person Name
Laurence Gladieff
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Contact Person Name
Stanislas Quesada
Site Name
Hopital Prive Des Cotes D'armor
Department Name
Oncology
Contact Person Name
Anne-Claire Hardy-Bessard
Contact Person Email
ac.hardy@cario-sante.fr
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Medical Oncology - Avron Site
Contact Person Name
Frédéric Selle
Contact Person Email
fselle@hopital-dcss.org
Site Name
Centre Jean Perrin
Department Name
Oncology Department
Contact Person Name
Elsa Kalbacher
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Oncologie Medicale
Contact Person Name
Patrick Bouchaert
Contact Person Email
l.eberst@icans.eu
Site Name
Centre Antoine Lacassagne
Department Name
Oncology Department
Contact Person Name
Phillippe Follana
Site Name
Centre Francois Baclesse
Department Name
Oncology Department
Contact Person Name
Florence Joly
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Institut Bergonie
Department Name
Medical Oncology
Contact Person Name
Corolian Lebreton
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncology Department
Contact Person Name
Jean-Sébastien Frenel

Sweden

Earliest CTIS Part Ii Submission Date
24-06-2025
Latest Decision Or Authorization Date
22-07-2025
Processing Time Days
28
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Region Oestergoetland
Department Name
Oncology Department
Contact Person Name
Gabriel Lindahl
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO Hematologi, Onkologi & Strålningsfysik
Contact Person Name
Susanne Malander
Contact Person Email
susanne.malander@med.lu.se
Site Name
Karolinska University Hospital
Department Name
Tema Cancer, ME Bäckencancer
Contact Person Name
Emelie Wallin
Site Name
Uppsala University Hospital
Department Name
Blod och tumörsjukdomar, Onkologiska kliniken
Contact Person Name
Camilla Sköld
Contact Person Email
camilla.skold@akademiska.se

Finland

Earliest CTIS Part Ii Submission Date
24-06-2025
Latest Decision Or Authorization Date
22-07-2025
Processing Time Days
28
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
HUS-Yhtymae
Department Name
Clinical Pharmaceutical Research, 3.floor
Contact Person Name
Heini Lassus
Contact Person Email
heini.lassus@hus.fi
Site Name
Oulu University Hospital
Department Name
Naisten poliklinikka
Contact Person Name
Marja Simojoki
Contact Person Email
marja.simojoki@pohde.fi
Site Name
Turku University Hospital
Department Name
Department of Oncology
Contact Person Name
Sakari Hietanen
Contact Person Email
sakari.hietanen@tyks.fi
Site Name
Tampere University Hospital
Department Name
Onkologinen lääketutkimusyksikkö, FONK, Oncology
Contact Person Name
Synnöve Staff
Contact Person Email
synnove.staff@pirha.fi

Belgium

Earliest CTIS Part Ii Submission Date
23-06-2025
Latest Decision Or Authorization Date
23-07-2025
Processing Time Days
30
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
UZ Leuven
Department Name
Gynaecology/Oncology
Contact Person Name
Toon Van Gorp
Contact Person Email
toon.vangorp@uzleuven.be
Site Name
Institut Jules Bordet
Department Name
Medical Oncology
Contact Person Name
Laura Polastro
Contact Person Email
laura.polastro@hubruxelles.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical Oncology
Contact Person Name
Jean-François Baurain
Site Name
Centre hospitalier universitaire de Liege
Department Name
Medical Oncology
Contact Person Name
Christine Gennigens
Site Name
Az Maria Middelares Gent
Department Name
Clinical Trial Unit Medical Oncology
Contact Person Name
Christof Vulsteke
Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology
Contact Person Name
Hannelore Denys
Contact Person Email
hannelore.denys@uzgent.be

Denmark

Earliest CTIS Part Ii Submission Date
11-07-2025
Latest Decision Or Authorization Date
21-07-2025
Processing Time Days
10
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Aalborg University Hospital
Department Name
Afdelingen for kræftbehandling
Contact Person Name
Adam Luczak
Contact Person Email
adal@rn.dk
Site Name
Rigshospitalet
Department Name
Department of Oncology
Contact Person Name
Trine Jakobi Noettrup
Site Name
Odense University Hospital
Department Name
Onkologisk Afdeling R
Contact Person Name
Trine Jørgensen
Contact Person Email
trine.joergensen@rsyd.dk

Germany

Earliest CTIS Part Ii Submission Date
28-05-2025
Latest Decision Or Authorization Date
24-07-2025
Processing Time Days
57
Number Of Sites
12
Number Of Participants
35

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik für Gynäkologie
Contact Person Name
Barbara Schmalfeldt
Contact Person Email
b.schmalfeldt@uke.de
Site Name
Staedtisches Klinikum Dessau
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Hermann Voss
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Gynäkologie mit Zentrum für onkologische Chirurgie (CVK) und Klinik für Gynäkologie (CBF)
Contact Person Name
Elena Braicu
Contact Person Email
elena.braicu@charite.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Onkologisches Centrum Chemnitz Frauenklinik/Brustzentrum
Contact Person Name
Paul Gass
Contact Person Email
paul.gass@skc.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Frauenheilkunde
Contact Person Name
Bahriye Aktas
Site Name
Universitaet Muenster
Department Name
Gynäkologie
Contact Person Name
Ralf Witteler
Contact Person Email
Ralf.Witteler@ukmuenster.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Paul Buderath
Contact Person Email
paul.buderath@uk-essen.de
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Abteilung für gynäkologische Onkologie
Contact Person Name
Frederik Marmé
Contact Person Email
frederik.marme@umm.de
Site Name
Caritas Traegergesellschaft Saarbruecken mbH (CTS)
Department Name
Klinik für Frauenheilkunde Gynäkologisches Krebszentrum
Contact Person Name
Mustafa Deryal
Contact Person Email
m.deryal@caritasklinikum.de
Site Name
Technische Universitaet Dresden
Department Name
Nationales Centrum für Tumorerkrankungen Dresden (NCT)
Contact Person Name
Pauline Wimberger
Site Name
Philipps-Universitaet Marburg
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Niklas Gremke
Contact Person Email
Gremken@staff.uni-marburg.de
Site Name
Klinikum Kassel GmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Yvonne Norpoth
Contact Person Email
yvonne.norpoth@gnh.net

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
Active Substance
TRASTUZUMAB DERUXTECAN
Modality
ADC
Routes Of Administration
Intravenous use
Route
Intravenous
Combination Treatment
Yes

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