Clinical trial • Phase III • Oncology

SACITUZUMAB TIRUMOTECAN for Epithelial ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer

Phase III trial of SACITUZUMAB TIRUMOTECAN for Epithelial ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Epithelial ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer
Trial Stage
Phase III
Drug Modality
ADC|Monoclonal antibody

Key dates

Initial CTIS Submission Date
15-12-2025
First CTIS Authorization Date
28-04-2026

Trial design

Randomised, open-label, sacituzumab tirumotecan (mk-2870) maintenance treatment with or without bevacizumab (avastin/mvasi) versus standard of care; listed doses in product data: sacituzumab tirumotecan up to 4 mg/kg iv, bevacizumab up to 15 mg/kg iv; schedule not specified in record.-controlled Phase III trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Sacituzumab tirumotecan (MK-2870) maintenance treatment with or without bevacizumab (Avastin/MVASI) versus Standard of Care; listed doses in product data: sacituzumab tirumotecan up to 4 mg/kg IV, bevacizumab up to 15 mg/kg IV; schedule not specified in record.
Target Sample Size
597

Eligibility

Recruits 597 Vulnerable population not selected; participants are adult female patients only. Informed consent documents (L1_ICF_Main consent and optional/addendum consents) are provided; no assent procedures or other vulnerable-population consent processes are described in the record..

Vulnerable Population
Vulnerable population not selected; participants are adult female patients only. Informed consent documents (L1_ICF_Main consent and optional/addendum consents) are provided; no assent procedures or other vulnerable-population consent processes are described in the record.

Inclusion criteria

  • {"criterion_text":"- Has histologically confirmed FIGO Stage III or Stage IV epithelial ovarian, primary peritoneal, or fallopian tube cancer.\n- Has completed primary debulking surgery or interval debulking surgery.\n- Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, or complete response per protocol.\n- Has provided tumor tissue that is not previously irradiated.\n- Has well-controlled human immunodeficiency virus (HIV) with antiretroviral therapy if HIV-infected.\n- Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.\n- Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection."}

Exclusion criteria

  • {"criterion_text":"- Has nonepithelial cancers, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.\n- Has active infection requiring systemic therapy.\n- Has concurrent and active HBV and HCV infections.\n- Has HIV infection and a history of Kaposi’s sarcoma and/or multicentric Castleman’s disease.\n- Has not recovered from major surgery or has ongoing surgical complications.\n- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n- Has a history of severe eye disease.\n- Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.\n- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n- Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, or has current pneumonitis/ILD.\n- Had prior systemic anticancer therapy.\n- Had a live or live-attenuated vaccine within 30 days of randomization.\n- Has a known additional malignancy that is progressing or required active treatment within the past 3 years."}

Endpoints

Primary endpoints

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

Secondary endpoints

  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Second Progression-Free Survival (PFS2)","definition_or_measurement_approach":"PFS2 as determined by the investigator"}
  • {"endpoint_text":"- Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Combined Score (Items 29 and 30) Using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)","definition_or_measurement_approach":"Mean change from baseline of GHS/QoL score using EORTC QLQ-C30 (items 29 and 30)"}
  • {"endpoint_text":"- Change From Baseline in Physical Functioning Combined Score (Items 1 to 5) Using EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline in physical functioning combined score (items 1–5) using EORTC QLQ-C30"}
  • {"endpoint_text":"- Change From Baseline in Role Functioning Combined Score (Items 6 and 7) Using EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline in role functioning combined score (items 6 and 7) using EORTC QLQ-C30"}
  • {"endpoint_text":"- Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score (Items 31 to 36) Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28)","definition_or_measurement_approach":"Change from baseline in abdominal/GI symptoms combined score (items 31–36) using EORTC QLQ-OV28"}

Recruitment

Planned Sample Size
597
Recruitment Window Months
84
Consent Approach
Informed consent is obtained from participants using subject information and informed consent forms (L1_ICF_Main consent and country-specific consent documents). Optional and addendum consents are provided (e.g., optional limited screening consent, addendum for disease progression, pregnancy follow-up). Country- and language-specific ICFs are available (examples in the record: English, French, Dutch, German, Czech, Danish, Finnish, Italian, Spanish, Swedish, Norwegian (NN), Polish, Hungarian, Greek). No assent processes for minors are described.

Geography

Total Number Of Sites
84
Total Number Of Participants
349

Austria

Earliest CTIS Part Ii Submission Date
14-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
16
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitätsklinik für Gynäkologie und Geburtshilfe
Principal Investigator Name
Katharina Leitner
Principal Investigator Email
katharina.leitner@i-med.ac.at
Contact Person Name
Katharina Leitner
Contact Person Email
katharina.leitner@i-med.ac.at
Site Name
Johannes Kepler University Linz
Department Name
Universitätsklinik für Hämatologie und internistische Onkologie
Principal Investigator Name
Heike Kathleen Schwarz
Principal Investigator Email
h.schwarz@kepleruniklinkum.at
Contact Person Name
Heike Kathleen Schwarz
Contact Person Email
h.schwarz@kepleruniklinkum.at
Site Name
Medical University Of Vienna
Department Name
Universitätsklinik für Gynäkologie
Principal Investigator Name
Nicole Concin
Principal Investigator Email
nicole.concin@meduniwien.ac.at
Contact Person Name
Nicole Concin
Contact Person Email
nicole.concin@meduniwien.ac.at

Belgium

Earliest CTIS Part Ii Submission Date
31-03-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
29
Number Of Sites
4
Number Of Participants
32

Sites

Site Name
UZ Leuven
Department Name
Gynaecology
Principal Investigator Name
Toon Van Gorp
Principal Investigator Email
toon.vangorp@uzleuven.be
Contact Person Name
Toon Van Gorp
Contact Person Email
toon.vangorp@uzleuven.be
Site Name
Grand Hopital De Charleroi
Department Name
Oncology
Principal Investigator Name
Sarah Lefèvre
Principal Investigator Email
sarah.lefevre@ghdc.be
Contact Person Name
Sarah Lefèvre
Contact Person Email
sarah.lefevre@ghdc.be
Site Name
Institut Jules Bordet
Department Name
Oncology
Principal Investigator Name
Laura Polastro
Principal Investigator Email
laura.polastro@hubruxelles.be
Contact Person Name
Laura Polastro
Contact Person Email
laura.polastro@hubruxelles.be
Site Name
Az Maria Middelares Gent
Department Name
Oncology
Principal Investigator Name
Christof Vulsteke
Principal Investigator Email
christof.vulsteke@mijnziekenhuis.be
Contact Person Name
Christof Vulsteke

Czechia

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
29
Number Of Sites
7
Number Of Participants
28

Sites

Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Gynekologicko-porodnicka klinika
Principal Investigator Name
Michael Halaska
Principal Investigator Email
michael.halaska@fnkv.cz
Contact Person Name
Michael Halaska
Contact Person Email
michael.halaska@fnkv.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Gynekologicko-porodnicka klinika
Principal Investigator Name
Jan Kümmel
Principal Investigator Email
jan.kummel@fno.cz
Contact Person Name
Jan Kümmel
Contact Person Email
jan.kummel@fno.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Gynekologicko-porodnicka klinika
Principal Investigator Name
Vít Weinberger
Principal Investigator Email
weinberger.vit@fnbrno.cz
Contact Person Name
Vít Weinberger
Contact Person Email
weinberger.vit@fnbrno.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologická klinika
Principal Investigator Name
Anna Nohejlova Medkova
Principal Investigator Email
anna.nohejlova@fnmotol.cz
Contact Person Name
Anna Nohejlova Medkova
Contact Person Email
anna.nohejlova@fnmotol.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
Gynekologicko porodnicka klinika 1 LF a VFN
Principal Investigator Name
Michal Zikan
Principal Investigator Email
michal.zikan@bulovka.cz
Contact Person Name
Michal Zikan
Contact Person Email
michal.zikan@bulovka.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Porodnicka a gynekologicka klinika
Principal Investigator Name
Munachiso Ndukwe
Principal Investigator Email
munachiso.ndukwe@fnhk.cz
Contact Person Name
Munachiso Ndukwe
Contact Person Email
munachiso.ndukwe@fnhk.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Gynekologicko porodnicka klinika 1 LF a VFN
Principal Investigator Name
David Cibula
Principal Investigator Email
david.cibula@vfn.cz
Contact Person Name
David Cibula
Contact Person Email
david.cibula@vfn.cz

Denmark

Earliest CTIS Part Ii Submission Date
01-04-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
27
Number Of Sites
4
Number Of Participants
17

Sites

Site Name
Region Hovedstaden
Department Name
Department of Oncology
Principal Investigator Name
Trine Zeeberg Iversen
Principal Investigator Email
Trine.Zeeberg.Iversen@regionh.dk
Contact Person Name
Trine Zeeberg Iversen
Site Name
Aalborg University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Charlotte Aaquist Haslund
Principal Investigator Email
cah@rn.dk
Contact Person Name
Charlotte Aaquist Haslund
Contact Person Email
cah@rn.dk
Site Name
Region Midtjylland
Department Name
Department of Oncology
Principal Investigator Name
Kristina Bak Kristoffersen
Principal Investigator Email
kristina.kristoffersen@auh.rm.dk
Contact Person Name
Kristina Bak Kristoffersen
Site Name
Odense University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Anja Ør Knudsen
Principal Investigator Email
ouh.ode.r.ctis@rsyd.dk
Contact Person Name
Anja Ør Knudsen
Contact Person Email
ouh.ode.r.ctis@rsyd.dk

Finland

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
29
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Turku University Hospital
Department Name
Department of Obstetrics and Gynecology
Principal Investigator Name
Sakari Hietanen
Principal Investigator Email
sakari.hietanen@varha.fi
Contact Person Name
Sakari Hietanen
Contact Person Email
sakari.hietanen@varha.fi
Site Name
Oulu University Hospital
Department Name
Department of Obstetrics and Gynecology
Principal Investigator Name
Elina Urpilainen
Principal Investigator Email
elina.urpilainen@pohde.fi
Contact Person Name
Elina Urpilainen
Contact Person Email
elina.urpilainen@pohde.fi
Site Name
Kuopio University Hospital
Department Name
Department of Obstetrics and Gynecology
Principal Investigator Name
Maarit Anttila
Principal Investigator Email
maarit.anttila@kuh.fi
Contact Person Name
Maarit Anttila
Contact Person Email
maarit.anttila@kuh.fi
Site Name
Tampere University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Synnove Staff
Principal Investigator Email
synnove.staff@pirha.fi
Contact Person Name
Synnove Staff
Contact Person Email
synnove.staff@pirha.fi

France

Earliest CTIS Part Ii Submission Date
20-04-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
8
Number Of Sites
13
Number Of Participants
50

Sites

Site Name
Hopital Prive Des Cotes D'armor
Department Name
CARIO Medical Oncology
Principal Investigator Name
Jérome MARTIN-BABAU
Principal Investigator Email
j.martin@cario-sante.fr
Contact Person Name
Jérome MARTIN-BABAU
Contact Person Email
j.martin@cario-sante.fr
Site Name
Institut Paoli Calmettes
Department Name
Medical oncology
Principal Investigator Name
Renaud SABATIER
Principal Investigator Email
sabatierr@ipc.unicancer.fr
Contact Person Name
Renaud SABATIER
Contact Person Email
sabatierr@ipc.unicancer.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Oncology
Principal Investigator Name
Elise DELUCHE
Principal Investigator Email
elise.deluche@chu-limoges.fr
Contact Person Name
Elise DELUCHE
Contact Person Email
elise.deluche@chu-limoges.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Medical oncology
Principal Investigator Name
Lauriane EBERST
Principal Investigator Email
l.eberst@icans.eu
Contact Person Name
Lauriane EBERST
Contact Person Email
l.eberst@icans.eu
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Medical oncology
Principal Investigator Name
Hélène VEGAS
Principal Investigator Email
h.vegas@chu-tours.fr
Contact Person Name
Hélène VEGAS
Contact Person Email
h.vegas@chu-tours.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Principal Investigator Name
Isabelle-Laure RAY-COQUARD
Principal Investigator Email
isabelle.ray-cocquard@lyon.unicancer.fr
Contact Person Name
Isabelle-Laure RAY-COQUARD
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Institut de Cancérologie et d’Imagerie
Principal Investigator Name
Laura DEIANA
Principal Investigator Email
laura.deiana@chu-brest.fr
Contact Person Name
Laura DEIANA
Contact Person Email
laura.deiana@chu-brest.fr
Site Name
Centre Oscar Lambret
Department Name
Medical oncology
Principal Investigator Name
Mathilde SAINT-GHISLAIN
Principal Investigator Email
m-saintghislain@o-lambret.fr
Contact Person Name
Mathilde SAINT-GHISLAIN
Contact Person Email
m-saintghislain@o-lambret.fr
Site Name
Institut Gustave Roussy
Department Name
Medical oncology
Principal Investigator Name
Alexandra LEARY
Principal Investigator Email
h.vegas@chu-tours.fr
Contact Person Name
Alexandra LEARY
Contact Person Email
h.vegas@chu-tours.fr
Site Name
Centre Jean Perrin
Department Name
Oncology
Principal Investigator Name
Elsa KALBACHER
Principal Investigator Email
elsa.kalbacher@clermont.unicancer.fr
Contact Person Name
Elsa KALBACHER
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical oncology
Principal Investigator Name
Stanislas QUESADA
Principal Investigator Email
stanislas.quesada@icm.unicancer.fr
Contact Person Name
Stanislas QUESADA
Site Name
Oncopole Claudius Regaud
Department Name
Medical oncology
Principal Investigator Name
Laurence GLADIEFF
Principal Investigator Email
gladieff.laurence@iuct-oncopole.fr
Contact Person Name
Laurence GLADIEFF
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical oncology
Principal Investigator Name
Jean-Sébastien FRENEL
Principal Investigator Email
jean-sebastien.frenel@ico.unicancer.fr
Contact Person Name
Jean-Sébastien FRENEL

Germany

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
30
Number Of Sites
7
Number Of Participants
25

Sites

Site Name
Klinikum Lippe GmbH
Department Name
Universitätsklinik für Frauenheilkunde und Geburtshilfe Gynäkologie und gynäkologische Onkologie
Principal Investigator Name
Beyhan Ataseven
Principal Investigator Email
Beyhan.Ataseven@klinikum-lippe.de
Contact Person Name
Beyhan Ataseven
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Gynäkologie
Principal Investigator Name
Eva Roser
Principal Investigator Email
Eva-Roser@charite.de
Contact Person Name
Eva Roser
Contact Person Email
Eva-Roser@charite.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Frauenklinik
Principal Investigator Name
Dirk Bauerschlag
Principal Investigator Email
Dirk.Bauerschlag@med.uni-jena.de
Contact Person Name
Dirk Bauerschlag
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Frauenklinik, Klinik für Gynäkologie und Geburtsmedizin
Principal Investigator Name
Elmar Stickeler
Principal Investigator Email
estickeler@ukaachen.de
Contact Person Name
Elmar Stickeler
Contact Person Email
estickeler@ukaachen.de
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Pauline Wimberger
Principal Investigator Email
Pauline.Wimberger@ukdd.de
Contact Person Name
Pauline Wimberger
Contact Person Email
Pauline.Wimberger@ukdd.de
Site Name
Universitaet Leipzig
Department Name
Department für Frauen- und Kindermedizin
Principal Investigator Name
Bahriye Aktas
Contact Person Name
Bahriye Aktas
Site Name
Klinikum Kassel GmbH
Department Name
Frauenklinik, Gynäkologie
Principal Investigator Name
Gabriele Feisel-Schwickardi
Principal Investigator Email
studienbuero-gynaekologie@gnh.net
Contact Person Name
Gabriele Feisel-Schwickardi

Greece

Earliest CTIS Part Ii Submission Date
19-01-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
100
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
St. Luke's Hospital S.A.
Department Name
Medical Oncology Department
Principal Investigator Name
Eleni Fountzilas
Principal Investigator Email
elenafou@gmail.com
Contact Person Name
Eleni Fountzilas
Contact Person Email
elenafou@gmail.com
Site Name
General Hospital Of Athens Alexandra
Department Name
Oncology Unit, Department of Clinical Therapeutics
Principal Investigator Name
Michalis Liontos
Principal Investigator Email
mliontos@gmail.com
Contact Person Name
Michalis Liontos
Contact Person Email
mliontos@gmail.com
Site Name
Areteio Hospital
Department Name
B' Surgical Department, Oncology Unit
Principal Investigator Name
Flora Zagouri
Principal Investigator Email
florazagouri@yahoo.co.uk
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk

Hungary

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
31
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Semmelweis University
Department Name
Szülészeti és Nőgyógyászati Klinika
Principal Investigator Name
Szabolcs MÁTÉ
Principal Investigator Email
dr.mate.szabolcs@gmail.com
Contact Person Name
Szabolcs MÁTÉ
Contact Person Email
dr.mate.szabolcs@gmail.com
Site Name
University Of Debrecen
Department Name
Szülészeti és Nőgyógyászati Klinika
Principal Investigator Name
Róbert PÓKA
Principal Investigator Email
pokar@med.unideb.hu
Contact Person Name
Róbert PÓKA
Contact Person Email
pokar@med.unideb.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Onkoradiológiai Osztály
Principal Investigator Name
Kofi AGYEMANG-PREMPEH
Principal Investigator Email
Kofi@axelero.hu
Contact Person Name
Kofi AGYEMANG-PREMPEH
Contact Person Email
Kofi@axelero.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Principal Investigator Name
Judit KOCSIS
Principal Investigator Email
kocsisjucidr@gmail.com
Contact Person Name
Judit KOCSIS
Contact Person Email
kocsisjucidr@gmail.com
Site Name
Orszagos Onkologiai Intezet
Department Name
Nőgyógyászati Osztály
Principal Investigator Name
Andrea BAGAMÉRI
Principal Investigator Email
bagameristudy@gmail.com
Contact Person Name
Andrea BAGAMÉRI
Contact Person Email
bagameristudy@gmail.com

Ireland

Earliest CTIS Part Ii Submission Date
10-04-2026
Latest Decision Or Authorization Date
01-05-2026
Processing Time Days
21
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Cork University Hospital
Department Name
Oncology
Principal Investigator Name
Dearbhaile Collins
Principal Investigator Email
dearbhaile.collins@hse.ie
Contact Person Name
Dearbhaile Collins
Contact Person Email
dearbhaile.collins@hse.ie
Site Name
St Vincent's University Hospital
Department Name
Oncology
Principal Investigator Name
Lynda McSorley
Principal Investigator Email
lyndamcsorley@svhg.ie
Contact Person Name
Lynda McSorley
Contact Person Email
lyndamcsorley@svhg.ie
Site Name
St James's Hospital
Department Name
Oncology
Principal Investigator Name
Karen Cadoo
Principal Investigator Email
kcadoo@stjames.ie
Contact Person Name
Karen Cadoo
Contact Person Email
kcadoo@stjames.ie

Italy

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
30
Number Of Sites
8
Number Of Participants
38

Sites

Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Dipartimento di Ginecologia Oncologica
Principal Investigator Name
Monika Ducceschi
Principal Investigator Email
monika.ducceschi@istitutotumori.mi.it
Contact Person Name
Monika Ducceschi
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Ginecologia Oncologica
Principal Investigator Name
Anna Fagotti
Principal Investigator Email
Anna.fagotti@policlinicogemelli.it
Contact Person Name
Anna Fagotti
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Ginecologia Oncologia medica
Principal Investigator Name
Nicoletta Colombo
Principal Investigator Email
nicoletta.colombo@ieo.it
Contact Person Name
Nicoletta Colombo
Contact Person Email
nicoletta.colombo@ieo.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Ostetricia e Ginecologia
Principal Investigator Name
Germana Tognon
Principal Investigator Email
germanatognon@gmail.com
Contact Person Name
Germana Tognon
Contact Person Email
germanatognon@gmail.com
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
S.C.D.U. Ostetricia e Ginecologia
Principal Investigator Name
Annamaria Ferrero
Principal Investigator Email
Annamaria.ferrero@unito.it
Contact Person Name
Annamaria Ferrero
Contact Person Email
Annamaria.ferrero@unito.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Dipartimento Interaziendale Oncologico ed Emato-oncologico
Principal Investigator Name
Roberto Sabbatini
Principal Investigator Email
sabbatini@unimore.it
Contact Person Name
Roberto Sabbatini
Contact Person Email
sabbatini@unimore.it
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 2
Principal Investigator Name
Valentina Guarneri
Principal Investigator Email
valentina.guarneri@unipd.it
Contact Person Name
Valentina Guarneri
Contact Person Email
valentina.guarneri@unipd.it
Site Name
Alessandro Manzoni Hospital
Department Name
Dipartimento Area Oncologica
Principal Investigator Name
Federica Villa
Principal Investigator Email
fe.villa@asst-lecco.it
Contact Person Name
Federica Villa
Contact Person Email
fe.villa@asst-lecco.it

Spain

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
29
Number Of Sites
12
Number Of Participants
45

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología
Principal Investigator Name
Lorena Fariñas Madrid
Principal Investigator Email
lfarinas@vhio.net
Contact Person Name
Lorena Fariñas Madrid
Contact Person Email
lfarinas@vhio.net
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Oncología Médica
Principal Investigator Name
Marta Gil Martín
Principal Investigator Email
contactfortrialsICOLH@iconcologia.net
Contact Person Name
Marta Gil Martín
Site Name
Hospital Clinico San Carlos
Department Name
Oncología
Principal Investigator Name
Gloria Marquina Ospina
Principal Investigator Email
gloria.marquina@salud.madrid.org
Contact Person Name
Gloria Marquina Ospina
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncología Médica
Principal Investigator Name
Ignacio Romero Noguera
Principal Investigator Email
iromero@fivo.org
Contact Person Name
Ignacio Romero Noguera
Contact Person Email
iromero@fivo.org
Site Name
Hospital Universitario La Paz
Department Name
Oncología
Principal Investigator Name
Andrés Redondo
Principal Investigator Email
aredondo12@gmail.com
Contact Person Name
Andrés Redondo
Contact Person Email
aredondo12@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncología
Principal Investigator Name
María Jesús Rubio
Principal Investigator Email
mjesusrubio63@gmail.com
Contact Person Name
María Jesús Rubio
Contact Person Email
mjesusrubio63@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncología
Principal Investigator Name
María Quindós Varela
Principal Investigator Email
maria.quindos.varela@sergas.es
Contact Person Name
María Quindós Varela
Contact Person Email
maria.quindos.varela@sergas.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncología Médica
Principal Investigator Name
Alfonso Cortés Salgado
Principal Investigator Email
alfonso.cortes@salud.Madrid.org
Contact Person Name
Alfonso Cortés Salgado
Site Name
Clinica Universidad De Navarra
Department Name
Oncología Médica
Principal Investigator Name
Antonio Gonzalez Martin
Principal Investigator Email
agonzalezma@unav.es
Contact Person Name
Antonio Gonzalez Martin
Contact Person Email
agonzalezma@unav.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncología y Hematología
Principal Investigator Name
Jose Alejandro Pérez Fidalgo
Principal Investigator Email
japfidalgo@msn.com
Contact Person Name
Jose Alejandro Pérez Fidalgo
Contact Person Email
japfidalgo@msn.com
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Oncología Médica
Principal Investigator Name
Anna Carbó Bague
Principal Investigator Email
contactfortrialsicogir@iconcologia.net
Contact Person Name
Anna Carbó Bague
Site Name
Hospital Clinic De Barcelona
Department Name
Oncología Médica
Principal Investigator Name
Lidia Gaba Garcia
Principal Investigator Email
lgaba@clinic.cat
Contact Person Name
Lidia Gaba Garcia
Contact Person Email
lgaba@clinic.cat

Sweden

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
29
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Karolinska University Hospital
Department Name
ME Bäcken
Principal Investigator Name
Josefin Fernebro
Principal Investigator Email
josefin.fernebro@regionstockholm.se
Contact Person Name
Josefin Fernebro
Site Name
Region Oestergoetland / Universitetssjukhuset I
Department Name
Onkologiska kliniken
Principal Investigator Name
Gabriel Lindahl
Principal Investigator Email
gabriel.lindahl@regionostergotland.se
Contact Person Name
Gabriel Lindahl

Norway

Earliest CTIS Part Ii Submission Date
14-04-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
14
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Oslo Universitetssykehus HF
Department Name
Radiumhospitalet, Departmen of Gynecological Oncology
Principal Investigator Name
Kristina Lindemann
Principal Investigator Email
klinde@ous-hf.no
Contact Person Name
Kristina Lindemann
Contact Person Email
klinde@ous-hf.no
Site Name
Helse Stavanger HF
Department Name
The Cancer Department
Principal Investigator Name
Elisabeth Nilsen
Principal Investigator Email
elisabeth.berge.nilsen@sus.no
Contact Person Name
Elisabeth Nilsen
Contact Person Email
elisabeth.berge.nilsen@sus.no
Site Name
Sorlandet Sykehus HF
Department Name
Kvinneklinikken
Principal Investigator Name
Ingvild Vistad
Principal Investigator Email
ingvild.vistad@sshf.no
Contact Person Name
Ingvild Vistad
Contact Person Email
ingvild.vistad@sshf.no

Poland

Earliest CTIS Part Ii Submission Date
16-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
14
Number Of Sites
6
Number Of Participants
22

Sites

Site Name
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
Department Name
Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt
Principal Investigator Name
Anita Chudecka-Głaz
Principal Investigator Email
anitagl@poczta.onet.pl
Contact Person Name
Anita Chudecka-Głaz
Contact Person Email
anitagl@poczta.onet.pl
Site Name
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Department Name
Oddział Radioterapii i Onkologii Ginekologicznej
Principal Investigator Name
Bartosz Urbański
Principal Investigator Email
clinicaltrials@wco.pl
Contact Person Name
Bartosz Urbański
Contact Person Email
clinicaltrials@wco.pl
Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej i Radioterapii
Principal Investigator Name
Lubomir Bodnar
Principal Investigator Email
bbk@szpital.siedlce.pl
Contact Person Name
Lubomir Bodnar
Contact Person Email
bbk@szpital.siedlce.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Ginekologicznej - Gynaecological Cancer Unit
Principal Investigator Name
Beata Maćkowiak-Matejczyk
Principal Investigator Email
ginekologia@onkologia.bialystok.pl
Contact Person Name
Beata Maćkowiak-Matejczyk
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Ginekologii Onkologicznej
Principal Investigator Name
Radosław Mądry
Principal Investigator Email
radoslaw.madry@usk.poznan.pl
Contact Person Name
Radosław Mądry
Contact Person Email
radoslaw.madry@usk.poznan.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Ginekologii Onkologicznej
Principal Investigator Name
Anna Dańska-Bidzińska
Principal Investigator Email
katarzyna.derda@pib-nio.pl
Contact Person Name
Anna Dańska-Bidzińska
Contact Person Email
katarzyna.derda@pib-nio.pl

Sponsor

Primary sponsor

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

Contract research organisations

Name
Bioclinica Inc.
Responsibilities
Central imaging
Name
IQVIA Limited
Responsibilities
4
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Signant Health Global LLC
Responsibilities
3

Third parties

  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"7","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Myriad Genetics Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-2870
Active Substance
SACITUZUMAB TIRUMOTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Maximum Dose
4 mg/kg
Investigational Product Name
Avastin 25 mg/ml concentrate for solution for infusion.
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
EU/1/04/300/001
Maximum Dose
15 mg/kg
Investigational Product Name
MVASI 25 mg/mL concentrate for solution for infusion
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
EU/1/17/1246/001
Maximum Dose
15 mg/Kg
Combination Treatment
Yes

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