Clinical trial • Phase III • Oncology

SACITUZUMAB TIRUMOTECAN for Metastatic cervical cancer (PD-L1 CPS ≥1)

Phase III trial of SACITUZUMAB TIRUMOTECAN for Metastatic cervical cancer (PD-L1 CPS ≥1).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic cervical cancer (PD-L1 CPS ≥1)
Trial Stage
Phase III
Drug Modality
ADC | Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
04-09-2025
First CTIS Authorization Date
14-01-2026

Trial design

Randomised, open-label, standard of care (soc) as first-line maintenance treatment (comparator described as soc; specific soc regimens/doses not specified in ctis part i summary)-controlled Phase III trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Standard of Care (SoC) as first-line maintenance treatment (comparator described as SoC; specific SoC regimens/doses not specified in CTIS Part I summary)
Biomarker Stratified
True, biomarker PD-L1 (combined positive score, CPS) ≥1 (eligibility restricted by PD-L1 CPS ≥1)
Target Sample Size
713

Eligibility

Recruits 713 The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). Consent is obtained from adult participants via site-specific informed consent forms; no assent procedures or minor-specific consent are described in the CTIS record..

Vulnerable Population
The trial does not select vulnerable populations (isVulnerablePopulationSelected: false). Consent is obtained from adult participants via site-specific informed consent forms; no assent procedures or minor-specific consent are described in the CTIS record.

Inclusion criteria

  • {"criterion_text":"- Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix"}
  • {"criterion_text":"- Has persistent, recurrent, or newly diagnosed metastatic cervical cancer that is not amenable to curative treatment (surgery and/or radiation)"}
  • {"criterion_text":"- If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy"}
  • {"criterion_text":"- If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load"}
  • {"criterion_text":"- If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load"}
  • {"criterion_text":"- Has an Eastern Cooperative Oncology Group performance status of 0 or 1"}
  • {"criterion_text":"- Has tumor programmed cell death ligand 1 expression of combined positive score ≥1"}

Exclusion criteria

  • {"criterion_text":"- Has HIV infection with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis, or chronic diarrhea)"}
  • {"criterion_text":"- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease"}
  • {"criterion_text":"- Has received prior systemic anticancer therapy other than what is specified in this protocol"}
  • {"criterion_text":"- Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sacituzumab tirumotecan"}
  • {"criterion_text":"- Has a diagnosis of immunodeficiency"}
  • {"criterion_text":"- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years"}
  • {"criterion_text":"- Has known active central nervous system metastases and/or carcinomatous meningitis"}
  • {"criterion_text":"- Has a history of stem cell/solid organ transplant"}
  • {"criterion_text":"- Has not adequately recovered from major surgery or has ongoing surgical complications"}
  • {"criterion_text":"- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease"}
  • {"criterion_text":"- Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants experiencing one or more adverse events during Part 1 Safety Run-in"}
  • {"endpoint_text":"- Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment due to an adverse event during Part 1 Safety Run-in"}
  • {"endpoint_text":"- Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Blinded Independent Central Review","definition_or_measurement_approach":"PFS assessed per RECIST 1.1 by Blinded Independent Central Review (time from randomization to progression or death)"}
  • {"endpoint_text":"- Part 2 Maintenance Treatment: Overall Survival (OS)","definition_or_measurement_approach":"Overall survival (time from randomization to death from any cause)"}

Secondary endpoints

  • {"endpoint_text":"- Part 2 Maintenance Treatment: Progression-free Survival 2 (PFS2) as Assessed by the Investigator","definition_or_measurement_approach":"PFS2 assessed by the investigator (time from randomization to second progression or death as per investigator)"}
  • {"endpoint_text":"- Part 2 Maintenance Treatment: Number of Participants Who Experience One or More AEs","definition_or_measurement_approach":"Count of participants with one or more adverse events during Part 2 Maintenance"}
  • {"endpoint_text":"- Part 2 Maintenance Treatment: Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment due to an adverse event during Part 2 Maintenance"}
  • {"endpoint_text":"- Part 2 Maintenance Treatment: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status and Quality of Life Combined Score","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 global health status/quality of life combined score"}
  • {"endpoint_text":"- Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Physical Functioning Combined Score","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 physical functioning combined score"}
  • {"endpoint_text":"- Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 role functioning combined score"}
  • {"endpoint_text":"- Part 2 Maintenance Treatment: Change from Baseline in EORTC Quality of Life Questionnaire-Cervical Cancer Module (QLQ-CX24) Combined Score","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-CX24 combined score (cervical cancer module)"}

Recruitment

Planned Sample Size
713
Recruitment Window Months
88
Consent Approach
Informed consent is obtained from adult participants using site-specific main consent (L1 ICF) and optional consent modules. Main consent and optional documents are available in multiple country/language versions (examples in the CTIS documents: English, German, French, Spanish, Italian, Hungarian, Czech, Danish, Dutch, Polish, Swedish, Greek). No assent or minor-specific consent procedures are described in the CTIS record.

Geography

Total Number Of Sites
72
Total Number Of Participants
317

Austria

Earliest CTIS Part Ii Submission Date
17-12-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
33
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitätsklinik für Gynäkologie und Geburtshilfe
Contact Person Name
Irina Tsibulak
Contact Person Email
irina.tsibulak@i-med.ac.at
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Universitätsklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Horst Koch
Contact Person Email
ho.koch@salk.at
Site Name
Medical University Of Vienna
Department Name
Universitätsklinik für Frauenheilkunde
Contact Person Name
Stephan Polterauer
Site Name
Medical University Of Graz
Department Name
Universitätsklinik für Frauenheilkunde und Geburtshilfe
Contact Person Name
Taja Bracic
Contact Person Email
taja.bracic@medunigraz.at

Belgium

Earliest CTIS Part Ii Submission Date
28-11-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
47
Number Of Sites
6
Number Of Participants
25

Sites

Site Name
Grand Hopital De Charleroi
Department Name
Dept. of Gynaecology/Oncology
Contact Person Name
Alix Devaux
Contact Person Email
alix.devaux@ghdc.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Dept. of Medical Oncology
Contact Person Name
Jean-François Baurain
Site Name
Institut Jules Bordet
Department Name
Dept. of Medical Oncology
Contact Person Name
Laura Polastro
Contact Person Email
laura.polastro@hubruxelles.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Dept. of Medical Oncology
Contact Person Name
Hannelore Denys
Contact Person Email
hannelore.denys@ugent.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Dept. of Medical Oncology
Contact Person Name
Laure-Anne Teuwen
Contact Person Email
laure-anne.teuwen@uza.be
Site Name
UZ Leuven
Department Name
Dept. of Gynaecology/Oncology
Contact Person Name
Toon Van Gorp
Contact Person Email
toon.vangorp@uzleuven.be

Czechia

Earliest CTIS Part Ii Submission Date
03-11-2025
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
73
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Gynekologicko-porodnicka klinika, Onkologicke centrum
Principal Investigator Name
David Cibula
Principal Investigator Email
david.cibula@vfn.cz
Contact Person Name
David Cibula
Contact Person Email
david.cibula@vfn.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Gynekologicko-porodnicka klinika, Onkogynekologicke oddeleni
Contact Person Name
Jan Kummel
Contact Person Email
jan.kummel@fno.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Gynekologicko-porodnicka klinika, FN Brno a LF MU
Contact Person Name
Vit Weinberger
Contact Person Email
weinberger.vit@fnbrno.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Onkologicka klinika FNKV a 3 LF UK
Contact Person Name
Klaudia Grafnetter
Contact Person Email
klaudia.reginacova@fnkv.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Komplexni onkologicke centrum, Oddeleni onkologie a radioterapie
Contact Person Name
Vojtech Tlusty
Contact Person Email
vojtech.tlusty@nnj.agel.cz

Denmark

Earliest CTIS Part Ii Submission Date
28-11-2025
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
48
Number Of Sites
2
Number Of Participants
16

Sites

Site Name
Odense University Hospital
Department Name
Department of Oncology
Contact Person Name
Trine Jørgensen
Contact Person Email
trine.joergensen@rsyd.dk
Site Name
Rigshospitalet
Department Name
Department of Oncology
Contact Person Name
Hanne Mathiesen

France

Earliest CTIS Part Ii Submission Date
16-12-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
34
Number Of Sites
10
Number Of Participants
50

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d’Oncologie
Principal Investigator Name
Claire GERVAIS
Principal Investigator Email
claire.gervais@aphp.fr
Contact Person Name
Claire GERVAIS
Contact Person Email
claire.gervais@aphp.fr
Site Name
Institut Gustave Roussy
Department Name
Département de médecine
Contact Person Name
Alexandra LEARY
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service d’Oncologie Médicale
Contact Person Name
Lauriane EBERST
Contact Person Email
l.eberst@icans.eu
Site Name
Centre Francois Baclesse
Department Name
Service de Gynecologie et du Sein
Contact Person Name
Coraline DUBOT POITELON
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Service d’Oncologie
Contact Person Name
Laura DEIANA
Contact Person Email
laura.deiana@chu-brest.fr
Site Name
Centre D'Oncologie Et De Radiotherapie 37
Department Name
Service d’Oncologie médicale
Contact Person Name
Pierre COMBE
Contact Person Email
p.combe@cort27.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Service d’Oncologie
Contact Person Name
Elise DELUCHE
Contact Person Email
Elise.deluche@chu-limoges.fr
Site Name
Hospices Civils De Lyon
Department Name
Service d’Oncologie Médicale
Contact Person Name
Benoit YOU
Contact Person Email
benoit.you@chu-lyon.fr
Site Name
Oncopole Claudius Regaud
Department Name
Service d’Oncologie Médicale
Contact Person Name
Laurence GLADIEFF
Site Name
Institut Bergonie
Department Name
Service d’Oncologie Médicale
Contact Person Name
Coriolan LEBRETON

Hungary

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
62
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Nőgyógyászati Osztály
Principal Investigator Name
Zoltán Novák
Principal Investigator Email
novak.zoltan@oncol.hu
Contact Person Name
Zoltán Novák
Contact Person Email
novak.zoltan@oncol.hu
Site Name
University Of Debrecen
Department Name
Szülészeti és Nőgyógyászati Klinika
Contact Person Name
Robert Poka
Contact Person Email
pokar@med.unideb.hu

Ireland

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
63
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
St James's Hospital
Department Name
Oncology
Contact Person Name
Karen Cadoo
Contact Person Email
kcadoo@stjames.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Oncology
Principal Investigator Name
Donal Brennan
Principal Investigator Email
CTRU@mater.ie
Contact Person Name
Donal Brennan
Contact Person Email
CTRU@mater.ie
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

Spain

Earliest CTIS Part Ii Submission Date
21-11-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
59
Number Of Sites
8
Number Of Participants
35

Sites

Site Name
Hospital Universitario La Paz
Department Name
Oncology
Principal Investigator Name
Andres Redondo Sanchez
Principal Investigator Email
aredondo12@gmail.com
Contact Person Name
Andres Redondo Sanchez
Contact Person Email
aredondo12@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Jose Alejandro Perez Fidalgo
Principal Investigator Email
japfidalgo@msn.com
Contact Person Name
Jose Alejandro Perez Fidalgo
Contact Person Email
japfidalgo@msn.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Ginecologic Oncology
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
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Luis Manso Sánchez
Principal Investigator Email
luismansosanchez@gmail.com
Contact Person Name
Luis Manso Sánchez
Contact Person Email
luismansosanchez@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Pilar Barretina Ginesta
Principal Investigator Email
contactfortrialsicogir@iconcologia.net
Contact Person Name
Pilar Barretina Ginesta
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Principal Investigator Name
María Jesús Rubio Pérez
Principal Investigator Email
mjesusrubio63@gmail.com
Contact Person Name
María Jesús Rubio Pérez
Contact Person Email
mjesusrubio63@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Eva Maria Guerra Alia
Principal Investigator Email
evamaria.guerra@salud.madrid.org
Contact Person Name
Eva Maria Guerra Alia
Site Name
Hospital Universitario Ramon Y Cajal (additional listed sites in Spain)
Department Name
Oncology (see CTIS record for site-level details)

Sweden

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
120
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Karolinska University Hospital
Department Name
Gynekologisk onkologi
Principal Investigator Name
Kristina Hellman
Principal Investigator Email
kristina.hellman@ki.se
Contact Person Name
Kristina Hellman
Contact Person Email
kristina.hellman@ki.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO hematologi, onkologi och strålningsfysik
Principal Investigator Name
Maria Bjurberg
Principal Investigator Email
maria.bjurberg@skane.se
Contact Person Name
Maria Bjurberg
Contact Person Email
maria.bjurberg@skane.se
Site Name
Region Oestergoetland
Department Name
Onkologiska kliniken
Principal Investigator Name
Gabriel Lindahl
Principal Investigator Email
gabriel.lindahl@regionostergotland.se
Contact Person Name
Gabriel Lindahl
Site Name
Uppsala University Hospital
Department Name
Onkologi
Principal Investigator Name
Anthoula Koliadi
Principal Investigator Email
anthoula.koliadi@akademiska.se
Contact Person Name
Anthoula Koliadi
Contact Person Email
anthoula.koliadi@akademiska.se

Poland

Earliest CTIS Part Ii Submission Date
28-11-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
52
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Ginekologii
Principal Investigator Name
Marcin Misiek
Principal Investigator Email
badania.kliniczne@onkol.kielce.pl
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
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
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
Department Name
III Klinika Radioterapii i Chemioterapii
Principal Investigator Name
Rafał Tarnawski
Principal Investigator Email
cwbk@gliwice.nio.gov.pl
Contact Person Name
Rafał Tarnawski
Contact Person Email
cwbk@gliwice.nio.gov.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
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
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Położnictwa i Ginekologii, Ginekologii Onkologicznej i Endokrynologii Ginekologicznej
Principal Investigator Name
Dagmara Klasa-Mazurkiewicz
Principal Investigator Email
dklasa@gumed.edu.pl
Contact Person Name
Dagmara Klasa-Mazurkiewicz
Contact Person Email
dklasa@gumed.edu.pl

Germany

Earliest CTIS Part Ii Submission Date
01-12-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
46
Number Of Sites
9
Number Of Participants
25

Sites

Site Name
Universitaetsklinikum Koeln AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Gynäkologische Onkologie
Principal Investigator Name
Florin-Andrei Taran
Principal Investigator Email
sandra.scher@uk-koeln.de
Contact Person Name
Florin-Andrei Taran
Contact Person Email
sandra.scher@uk-koeln.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik und Poliklinik für Gynäkologie
Principal Investigator Name
Linn Wölber
Principal Investigator Email
lwoelber@uke.de
Contact Person Name
Linn Wölber
Contact Person Email
lwoelber@uke.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik für Gynäkologie und Gynäkologische Onkologie
Principal Investigator Name
Lucia Otten
Principal Investigator Email
verena.loescher@ukbonn.de
Contact Person Name
Lucia Otten
Contact Person Email
verena.loescher@ukbonn.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Pauline Wimberger
Principal Investigator Email
Pauline.Wimberger@uniklinikum-dresden.de
Contact Person Name
Pauline Wimberger
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Gynäkologie und Geburtsmedizin
Principal Investigator Name
Philipp Meyer-Wilmes
Principal Investigator Email
gynaekologie@ukaachen.de
Contact Person Name
Philipp Meyer-Wilmes
Contact Person Email
gynaekologie@ukaachen.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Frauenheilkunde
Principal Investigator Name
Bahriye Aktas
Contact Person Name
Bahriye Aktas
Site Name
Universitaetsklinikum Jena
Department Name
Frauenklinik
Principal Investigator Name
Dirk Bauerschlag
Principal Investigator Email
Dirk.Bauerschlag@med.uni-jena.de
Contact Person Name
Dirk Bauerschlag
Site Name
Charite Universitaetsmedizin Berlin
Department Name
Campus Virchow-Klinikum
Principal Investigator Name
Malte Renz
Principal Investigator Email
malte.renz@charite.de
Contact Person Name
Malte Renz
Contact Person Email
malte.renz@charite.de
Site Name
Universitaetsklinikum Bonn/other listed German sites
Department Name
See CTIS record for site details

Greece

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
119
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
General Hospital Of Athens Alexandra
Department Name
Oncology-Hematology Department Unit of Plasma cell dyscrasias, UoA
Principal Investigator Name
Michail Liontos
Principal Investigator Email
mlionto@gmail.com
Contact Person Name
Michail Liontos
Contact Person Email
mlionto@gmail.com
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Propedeutic Internal Medicine Clinic - Oncology Department
Principal Investigator Name
Amanda Psyrri
Principal Investigator Email
florazagouri@yahoo.co.uk
Contact Person Name
Amanda Psyrri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
Areteio Hospital
Department Name
Oncology Unit, B' Surgery Department National and Kapodistrian UoA
Principal Investigator Name
Flora Zagouri
Principal Investigator Email
psyrri237@yahoo.com
Contact Person Name
Flora Zagouri
Contact Person Email
psyrri237@yahoo.com

Italy

Earliest CTIS Part Ii Submission Date
24-11-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
95
Number Of Sites
11
Number Of Participants
45

Sites

Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Department Name
U.O Oncologia Medica
Principal Investigator Name
Giuseppa Scandurra
Principal Investigator Email
giusy.scandurra@gmail.com
Contact Person Name
Giuseppa Scandurra
Contact Person Email
giusy.scandurra@gmail.com
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Ginecologia Oncologica
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
Humanitas Mirasole S.p.A.
Department Name
U.O. Ginecologia Oncologica Medica
Principal Investigator Name
Domenica Lorusso
Principal Investigator Email
domenica.lorusso@hunimed.eu
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Dipartimento di Oncologia Clinica
Principal Investigator Name
Michele Bartoletti
Principal Investigator Email
michele.bartoletti@cro.it
Contact Person Name
Michele Bartoletti
Contact Person Email
michele.bartoletti@cro.it
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
UO Oncologia
Principal Investigator Name
Grazia Artioli
Principal Investigator Email
grazia.artioli@aulss2.veneto.it
Contact Person Name
Grazia Artioli
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
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Ginecologia Oncologica
Principal Investigator Name
Monika Ducceschi
Principal Investigator Email
monika.ducceschi@istitutotumori.mi.it
Contact Person Name
Monika Ducceschi
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 2
Principal Investigator Name
Valentina Guarneri
Principal Investigator Email
valentina.guarneri@iov.veneto.it
Contact Person Name
Valentina Guarneri
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
SCDU Ginecologia e Ostetricia, Ginecologi Oncologica
Principal Investigator Name
Annamaria Ferrero
Principal Investigator Email
a.ferrero0505@gmail.com
Contact Person Name
Annamaria Ferrero
Contact Person Email
a.ferrero0505@gmail.com
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
S.C. Ostetricia e Ginecologia
Principal Investigator Name
Rossella Franzini
Principal Investigator Email
rossella.franzini@gmail.com
Contact Person Name
Rossella Franzini
Contact Person Email
rossella.franzini@gmail.com
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
SC Oncologia Medica
Principal Investigator Name
Alberto Farolfi
Principal Investigator Email
alberto.farolfi@irst.emr.it
Contact Person Name
Alberto Farolfi
Contact Person Email
alberto.farolfi@irst.emr.it

Sponsor

Primary sponsor

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

Contract research organisations

Name
WCG Clinical Inc.
Responsibilities
sponsorDuties codes: [12]; contact: jgallagher@wcgclinical.com
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Bioclinica Inc.
Responsibilities
Imaging
Name
Frontage Laboratories Inc.
Responsibilities
laboratory services / testing (sponsorDuties code: 4)

Third parties

  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: [12]; contact: jgallagher@wcgclinical.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"sponsorDuties codes: [3]; contact: abrar.mohammed@signanthealth.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact: ariela.edelman@roche.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation - ECOA (sponsorDuties code: 15, value: 'Translation - ECOA'); contact: alfernandez@transperfect.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics","duties_or_roles":"sponsorDuties codes: [4]; contact: dorina.lopez@neogenomics.com","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: [15], value: 'Imaging'; contact: Lisa.Rossell-Seed@Clario.com","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"sponsorDuties codes: [2]; contact: Katy.iglehart@onestudyteam.com","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Signant Health LLC (second entry)","duties_or_roles":"sponsorDuties codes: [15], value: 'ECOA'; contact: roberto.sosa@signanthealth.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]; contacts: yke@frontagelab.com, RGrabert@frontagelab.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics (PO Box entry)","duties_or_roles":"sponsorDuties codes: [4]; contact: dorina.lopez@neogenomics.com","organisation_type":"Industry"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [4]; contact: Ashley.Fink@labcorp.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Moonlight Imaging","duties_or_roles":"sponsorDuties codes: [15], value: 'Recruitment & Retention'; contact: robin@moonlightimaging.com","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties codes: [15], value: 'Payment Facilitator'; contact: Joe.Benedict@greenphire.com","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sponsorDuties codes: [15], value: 'EUB services (call center and medical services)'; contact: +MSDEMU@parexel.com","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
Authorisation Status
Investigational
Maximum Dose
4 mg/kg
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 INFUSION
Authorisation Status
Authorised
Maximum Dose
400 mg
Investigational Product Name
Avastin 25 mg/ml concentrate for solution for infusion. / MVASI 25 mg/mL concentrate for solution for infusion
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
OTHER USE
Route
OTHER USE
Authorisation Status
Authorised
Investigational Product Name
PACLITAXEL
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised
Maximum Dose
175 mg/m2
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised
Maximum Dose
750 mg
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised
Maximum Dose
50 mg/m2
Combination Treatment
Yes

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