Clinical trial • Phase III • Oncology

SACITUZUMAB TIRUMOTECAN for Endometrial carcinoma (pMMR)

Phase III trial of SACITUZUMAB TIRUMOTECAN for Endometrial carcinoma (pMMR).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Endometrial carcinoma (pMMR)
Trial Stage
Phase III
Drug Modality
ADC|Monoclonal antibody

Key dates

Initial CTIS Submission Date
04-03-2025
First CTIS Authorization Date
24-06-2025

Trial design

Randomised, open-label, pembrolizumab alone (monotherapy) versus sacituzumab tirumotecan in combination with pembrolizumab; dose and schedule not specified in the provided documents-controlled Phase III trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Pembrolizumab alone (monotherapy) versus sacituzumab tirumotecan in combination with pembrolizumab; dose and schedule not specified in the provided documents
Target Sample Size
797

Eligibility

Recruits 797 The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). Informed consent is obtained using subject information and informed consent form documents provided for participating countries (see L1/L2 ICF documents in the application documents)..

Vulnerable Population
The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). Informed consent is obtained using subject information and informed consent form documents provided for participating countries (see L1/L2 ICF documents in the application documents).

Inclusion criteria

  • {"criterion_text":"- Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)\n- Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator.\n- Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment"}

Exclusion criteria

  • {"criterion_text":"- Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas\n- Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)\n- Is a candidate for curative-intent surgery or curative-intent radiotherapy at the time of enrollment\n- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing\n- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n- Human Immunodeficiency Virus-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease\n- Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Maintenance Treatment: Progression Free Survival (PFS)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by BICR"}
  • {"endpoint_text":"- Maintenance Treatment: Overall Survival (OS)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Maintenance Treatment: Progression-Free Survival 2 (PFS2) as Assessed by Investigator","definition_or_measurement_approach":"Assessed by investigator"}
  • {"endpoint_text":"- Maintenance Treatment: Number of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Maintenance Treatment: Number of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Maintenance Treatment: Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Item Mean Score","definition_or_measurement_approach":"EORTC QLQ-C30 items 29 and 30; change from baseline"}
  • {"endpoint_text":"- Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score","definition_or_measurement_approach":"EORTC QLQ-C30 Physical Functioning (items 1-5); change from baseline"}
  • {"endpoint_text":"- Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score","definition_or_measurement_approach":"EORTC QLQ-C30 Role Functioning (items 6-7); change from baseline"}
  • {"endpoint_text":"- Maintenance Treatment: Change from baseline in EORTC QLQ Endometrial Cancer Symptom Score (QLQ-EN24)","definition_or_measurement_approach":"EORTC QLQ-EN24; change from baseline"}

Recruitment

Planned Sample Size
797
Recruitment Window Months
48
Consent Approach
Informed consent is obtained from adult participants (adult females) using country-specific subject information and informed consent forms. Multiple country-specific ICF documents are provided in the submission (L1/L2 ICF documents), in languages appropriate to each participating country.

Geography

Total Number Of Sites
91
Total Number Of Participants
355

Austria

Earliest CTIS Part Ii Submission Date
06-06-2025
Latest Decision Or Authorization Date
30-06-2025
Processing Time Days
24
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Medical University Of Graz
Department Name
Universitätsklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Vassiliki Kolovetsiou-Kreiner
Site Name
Medical University Of Vienna
Department Name
Universitätsklinik für Frauenheilkunde
Contact Person Name
Nicole Concin
Contact Person Email
nicole.concin@meduniwien.ac.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitätsklinik für Gynäkologie und Geburtshilfe
Contact Person Name
Christian Marth
Contact Person Email
christian.marth@i-med.ac.at

Belgium

Earliest CTIS Part Ii Submission Date
10-06-2025
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
27
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Grand Hopital De Charleroi
Department Name
Oncology
Contact Person Name
Alix Devaux
Contact Person Email
alix.devaux@ghdc.be
Site Name
CHU Saint Pierre
Department Name
La clinique du sein
Contact Person Name
Jesus Poveda Ferriols
Contact Person Email
jesus.poveda@stpierre-bru.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Medical Oncology
Contact Person Name
Christine Gennigens
Site Name
UZ Leuven
Department Name
Gynaecologische oncologie
Contact Person Name
Toon Van Groop
Contact Person Email
toon.vangorp@uzleuven.be
Site Name
Az Maria Middelares Gent
Department Name
Medical Oncology
Contact Person Name
Christof Vulsteke
Contact Person Email
christof.vulsteke@azmmsj.be

Czechia

Earliest CTIS Part Ii Submission Date
12-06-2025
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
25
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Oddělení radioterapie a onkologie
Contact Person Name
Vojtěch Tlustý
Contact Person Email
vojtech.tlusty@nnj.agel.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Gynekologicko-porodnická klinika
Contact Person Name
Jan Kümmel
Contact Person Email
jan.kummel@fno.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Gynekologicko-porodnická klinika
Contact Person Name
David Cibula
Contact Person Email
david.cibula@vfn.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologická klinika
Contact Person Name
Anna Nohejlová Medková
Contact Person Email
anna.nohejlova@fnmotol.cz

Germany

Earliest CTIS Part Ii Submission Date
11-06-2025
Latest Decision Or Authorization Date
01-07-2025
Processing Time Days
20
Number Of Sites
12
Number Of Participants
40

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Frauen- Poliklinik
Contact Person Name
Elena Braicu
Contact Person Email
Gyn-studien@charite.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik für Gynäkologie und Gynäkologische Onkologie
Contact Person Name
Alexander Mustea
Contact Person Email
studienzentrale-szb@ukbonn.de
Site Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Department Name
Klinik für Gynäkologie
Contact Person Name
Sebastian Jud
Contact Person Email
waladkhani@mutterhaus.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Frauenheilkunde
Contact Person Name
Bahriye Aktas
Site Name
Klinikum Kassel GmbH
Department Name
Gynäkologie des MVZ Gesundheit Nordhessen
Contact Person Name
Gabriele Feisel-Schwickardi
Site Name
Universitaet Muenster
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Stephanie Eltrop
Contact Person Email
stephanie.eltrop@ukmuenster.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Pauline Wimberger
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Gynäkologie und Gynäkologische Onkologie
Contact Person Name
Gerhard Gebauer
Contact Person Email
g.gebauer@asklepios.com
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Gynäkologie und Geburtshilfe
Contact Person Name
Marion Tina van Mackelenbergh
Contact Person Email
sgo@uksh.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Gynäkologie und Geburtsmedizin
Contact Person Name
Philipp Meyer-Wilmes
Contact Person Email
gynaekologie@ukaachen.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Frauenklinik
Contact Person Name
Dirk Bauerschlag
Site Name
Caritas Traegergesellschaft Saarbruecken mbH (CTS)
Department Name
Klinik für Frauenheilkunde
Contact Person Name
Mustafa Deryal

Hungary

Earliest CTIS Part Ii Submission Date
10-06-2025
Latest Decision Or Authorization Date
02-07-2025
Processing Time Days
22
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Nőgyógyászati Osztály
Contact Person Name
Andrea Bagaméri
Contact Person Email
bagameristudy@gmail.com
Site Name
Semmelweis University
Department Name
Szülészeti és Nőgyógyászati Klinika
Contact Person Name
Szabolcs Máté
Contact Person Email
dr.mate.szabolcs@gmail.com
Site Name
University Of Debrecen
Department Name
Szülészeti és Nőgyógyászati Klinika
Contact Person Name
Róbert Póka
Contact Person Email
pokar@med.unideb.hu

Ireland

Earliest CTIS Part Ii Submission Date
06-06-2025
Latest Decision Or Authorization Date
27-06-2025
Processing Time Days
21
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
St Vincent's University Hospital
Department Name
Oncology
Contact Person Name
Linda McSorley
Contact Person Email
Lynda.mcsorley@ccrt.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Oncology
Contact Person Name
Claire Thompson
Contact Person Email
ClaireThompson@mater.ie
Site Name
St James's Hospital
Department Name
Oncology
Contact Person Name
Karen Cadoo
Contact Person Email
Kcadoo@stjames.ie
Site Name
Cork University Hospital
Department Name
Oncology
Contact Person Name
Dearbhaile Collins
Contact Person Email
Dearbhaile.collins@hse.ie

Italy

Earliest CTIS Part Ii Submission Date
06-06-2025
Latest Decision Or Authorization Date
30-06-2025
Processing Time Days
24
Number Of Sites
13
Number Of Participants
50

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Oncologia Clinica Sperimentale Uro-Ginecologica
Contact Person Name
Carmela Pisano
Contact Person Email
carmen_pisano@libero.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Oncologia Medica 1
Contact Person Name
Carmelo Bengala
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
U.O. Oncologia
Contact Person Name
Alberto Farolfi
Contact Person Email
alberto.farolfi@irst.emr.it
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
Dipartimento di Medicina - Unità Oncologia
Contact Person Name
Grazia Artioli
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Ginecologia oncologica
Contact Person Name
Francesco Raspagliesi
Site Name
Humanitas Mirasole S.p.A.
Department Name
Ginecologia Oncologica
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu
Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Department Name
Oncologia Medica
Contact Person Name
Giuseppa Scandurra
Contact Person Email
giusy.scandurra@gmail.com
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Ginecologia Oncologica Medica
Contact Person Name
Giuseppe Caruso
Contact Person Email
giuseppe.caruso@ieo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Ginecologia Oncologica
Contact Person Name
Vanda Salutari
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
S.C.D.U. Oncologia
Contact Person Name
Giorgio Valabrega
Contact Person Email
giorgio.valabrega@unito.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SOD Oncologia medica ginecologica
Contact Person Name
Maria Cristina Petrella
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOC Oncologia Medica 1
Contact Person Name
Antonella Savarese
Contact Person Email
antonella.savarese@ifo.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Ostetricia e Ginecologia 2U
Contact Person Name
Elisa Piovano
Contact Person Email
piovano.elisa@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
12-06-2025
Latest Decision Or Authorization Date
01-07-2025
Processing Time Days
19
Number Of Sites
8
Number Of Participants
35

Sites

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 La Paz
Department Name
Oncology
Contact Person Name
Andres Redondo Sanchez
Contact Person Email
aredondo12@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Contact Person Name
Christine Gennigens
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Lorena Farinas Madrid
Contact Person Email
lfarinas@vhio.net
Site Name
Institut Catala D'oncologia (L'Hospitalet de Llobregat)
Department Name
Oncology
Contact Person Name
Beatriz Pardo Burdalo
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Oncology
Contact Person Name
Pilar Barretina Ginesta
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Eva Maria Guerra Alia
Contact Person Email
mjesusrubio63@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Luis Manuel Manso Sanchez
Contact Person Email
luismansosanchez@gmail.com

Norway

Earliest CTIS Part Ii Submission Date
11-06-2025
Latest Decision Or Authorization Date
30-06-2025
Processing Time Days
19
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Helse Stavanger HF
Department Name
Stavanger University Hospital, The cancer department
Contact Person Name
Elisabeth Berge Nilsen
Contact Person Email
elisabeth.berge.nilsen@sus.no
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
The cancer department
Contact Person Name
Vibeke Anett Ingebrigtsen
Site Name
Oslo University Hospital HF
Department Name
Radiumhospitalet, Department of Gynecological Oncology
Contact Person Name
Kristina Lindemann
Contact Person Email
klinde@ous-hf.no

Poland

Earliest CTIS Part Ii Submission Date
12-06-2025
Latest Decision Or Authorization Date
30-06-2025
Processing Time Days
18
Number Of Sites
8
Number Of Participants
37

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
Department Name
Klinika Ginekologii Onkologicznej
Contact Person Name
Mariusz Bidziński
Contact Person Email
katarzyna.derda@pib-nio.pl
Site Name
Uniwersyteckie Centrum Kliniczne (Gdansk)
Department Name
Klinika Położnictwa i Ginekologii, Ginekologii Onkologicznej i Endokrynologii Ginekologicznej
Contact Person Name
Dagmara Klasa-Mazurkiewicz
Contact Person Email
dklasa@gumed.edu.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
Department Name
III Klinika Radioterapii i Chemioterapii
Contact Person Name
Rafał Tarnawski
Contact Person Email
cwbk@gliwice.nio.gov.pl
Site Name
Wielkopolskie Centrum Onkologii Im. Marii Slodowskiej-Curie
Department Name
Oddział Radioterapii i Onkologii Ginekologicznej
Contact Person Name
Bartosz Urbański
Contact Person Email
clinicaltrials@wco.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Ginekologii Onkologicznej
Contact Person Name
Radosław Mądry
Contact Person Email
radoslaw.madry@usk.poznan.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Ginekologicznej-Gynaecological Cancer Unit
Contact Person Name
Beata Maćkowiak-Matejczyk
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Ginekologii
Contact Person Name
Marcin Misiek
Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej i Radioterapii
Contact Person Name
Lubomir Bodnar
Contact Person Email
bbk@szpital.siedlce.pl

Finland

Earliest CTIS Part Ii Submission Date
22-05-2025
Latest Decision Or Authorization Date
30-06-2025
Processing Time Days
39
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Kuopio University Hospital
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Henna Kärkkäinen
Site Name
Turku University Hospital
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Sakari Hietanen
Contact Person Email
sakari.hietanen@varha.fi
Site Name
Tampere University Hospital
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Annika Auranen
Contact Person Email
annika.auranen@pirha.fi
Site Name
HUS-Yhtymae
Department Name
Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Contact Person Name
Heini Lassus
Contact Person Email
heini.lassus@hus.fi

Denmark

Earliest CTIS Part Ii Submission Date
22-05-2025
Latest Decision Or Authorization Date
24-06-2025
Processing Time Days
33
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Region Sjaelland
Department Name
Department of Oncology
Contact Person Name
Zaza Ujmajuridze
Contact Person Email
zu@regionsjaelland.dk
Site Name
Aalborg University Hospital
Department Name
Department of Oncology
Contact Person Name
Anne Krejbjerg Motavaf
Contact Person Email
anne.krejbjerg@rn.dk
Site Name
Region Hovedstaden
Department Name
Department of Oncology
Contact Person Name
Katrine Toubro Gad
Contact Person Email
katrine.toubro.gad@regionh.dk
Site Name
Region Midtjylland
Department Name
Department of Oncology
Contact Person Name
Kristina Bak Kristoffersen

Netherlands

Earliest CTIS Part Ii Submission Date
06-06-2025
Latest Decision Or Authorization Date
01-07-2025
Processing Time Days
25
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
Medical Oncology
Contact Person Name
Inge Baas
Contact Person Email
oncostudies@umcutrecht.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Medical Oncology
Contact Person Name
Tonneke Beijers

France

Earliest CTIS Part Ii Submission Date
22-05-2025
Latest Decision Or Authorization Date
25-06-2025
Processing Time Days
34
Number Of Sites
11
Number Of Participants
50

Sites

Site Name
Institut Curie
Department Name
Oncologie médicale
Contact Person Name
Diana BELLO ROUFAI
Contact Person Email
diana.belloroufai@curie.fr
Site Name
Centre Francois Baclesse
Department Name
Gynécologie et urologie
Contact Person Name
Florence JOLY
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Oncopole Claudius Regaud
Department Name
Oncologie médicale
Contact Person Name
Laurence GLADIEFF
Site Name
CHU Besancon
Department Name
Oncologie médicale
Contact Person Name
Laura MANSI
Contact Person Email
lmansi@chu-besancon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncologie médicale
Contact Person Name
Jérôme ALEXANDRE
Contact Person Email
jerome.alexandre@aphp.fr
Site Name
Hopital Prive Des Cotes D'armor
Department Name
Oncologie médicale
Contact Person Name
Anne-Claire HARDY-BESSARD
Contact Person Email
Ac.hardy@cario-sante.fr
Site Name
Centre Leon Berard
Department Name
Oncologie médicale
Contact Person Name
Olivia LE SAUX
Site Name
Institut Paoli Calmettes
Department Name
Oncologie médicale
Contact Person Name
Renaud SABATIER
Contact Person Email
sabatierr@ipc.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie médicale
Contact Person Name
Jean-Sébastien FRENEL
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Oncologie médicale
Contact Person Name
Antoine ANGELERGUES
Contact Person Email
aangelergues@hopital-dcss.org
Site Name
Institut Bergonie
Department Name
Oncologie médicale
Contact Person Name
Coriolan LEBRETON

Greece

Earliest CTIS Part Ii Submission Date
20-03-2025
Latest Decision Or Authorization Date
27-06-2025
Processing Time Days
99
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
University General Hospital Attikon
Department Name
2nd Propaedeutic Internal Medicine Department - Oncology Unit
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Alexandra Hospital
Department Name
Oncology Unit, Department of Clinical Therapeutics
Contact Person Name
Michalis Liontos
Contact Person Email
mliontos@gmail.com
Site Name
St. Luke's Hospital S.A.
Department Name
Medical Oncology Department Section Z3
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com
Site Name
Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center S.A.
Department Name
A' Oncology Clinic
Contact Person Name
Christos Papadimitriou
Contact Person Email
chr_papadim@yahoo.gr
Site Name
Areteio Hospital
Department Name
Oncology Department
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk

Sweden

Earliest CTIS Part Ii Submission Date
26-05-2025
Latest Decision Or Authorization Date
31-07-2025
Processing Time Days
66
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Uppsala University Hospital
Department Name
KFUE, Blod och tumörsjukdommar
Contact Person Name
Anthoula Koliadi
Contact Person Email
anthoula.koliadi@akademiska.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO hematologi, onkologi och strålningsfysik
Contact Person Name
Susanne Malander
Contact Person Email
susanne.malander@skane.se

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Q Squared Solutions Limited

Third parties

  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging vendor","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-2870
Active Substance
SACITUZUMAB TIRUMOTECAN
Modality
ADC
Routes Of Administration
Other/Not specified (POWDER FOR SOLUTION FOR INJECTION listed)
Authorisation Status
Investigational (no marketing authorisation listed)
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous
Authorisation Status
Marketing authorisation (EU) EU/1/15/1024/002
Combination Treatment
Yes

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