Clinical trial • Phase III • Oncology

SACITUZUMAB TIRUMOTECAN for Recurrent ovarian cancer | Platinum-sensitive recurrent ovarian cancer

Phase III trial of SACITUZUMAB TIRUMOTECAN for Recurrent ovarian cancer | Platinum-sensitive recurrent ovarian cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Recurrent ovarian cancer | Platinum-sensitive recurrent ovarian cancer
Trial Stage
Phase III
Drug Modality
ADC | Monoclonal antibody

Key dates

Initial CTIS Submission Date
13-12-2024
First CTIS Authorization Date
26-03-2025

Trial design

Randomised, open-label, standard of care (soc): observation with or without bevacizumab; experimental arms: sacituzumab tirumotecan (mk-2870) maintenance treatment with or without bevacizumab. documented dose information in product entries: mk-2870 up to 4 mg/kg (max daily dose amount); bevacizumab up to 15 mg/kg (max daily dose amount). no detailed dosing schedule specified in the ctis data.-controlled Phase III trial in Austria, Czechia, Finland and others.

Randomised
Yes
Open Label
Yes
Comparator
Standard of Care (SoC): observation with or without bevacizumab; experimental arms: Sacituzumab tirumotecan (MK-2870) maintenance treatment with or without bevacizumab. Documented dose information in product entries: MK-2870 up to 4 mg/kg (max daily dose amount); Bevacizumab up to 15 mg/kg (max daily dose amount). No detailed dosing schedule specified in the CTIS data.
Target Sample Size
266

Eligibility

Recruits 266 No vulnerable population selected (isVulnerablePopulationSelected: false). Trial enrols adult participants only; informed consent is provided by participants. No assent or parental consent provisions for minors are specified in the available CTIS entries..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Trial enrols adult participants only; informed consent is provided by participants. No assent or parental consent provisions for minors are specified in the available CTIS entries.

Inclusion criteria

  • {"criterion_text":"- Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma\n- Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC)\n- Has platinum-sensitive epithelial OC\n- Has provided tissue of a tumor lesion that was not previously irradiated\n- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n- Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)\n- Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n- Has an ECOG performance status of 0 to 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)"}

Exclusion criteria

  • {"criterion_text":"- Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner’s tumor and undifferentiated carcinoma\n- Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids\n- Has an additional malignancy that is progressing or has required active treatment within the past 3 years\n- Has active CNS metastases and/or carcinomatous meningitis\n- Has an active infection requiring systemic therapy\n- Has platinum-resistant OC or platinum-refractory OC\n- Has 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 (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)\n- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease\n- Has received more than 2 prior lines of systemic therapy for OC\n- Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part 1: Number of Participants with One or More Adverse Events (AE)","definition_or_measurement_approach":"Count of participants reporting one or more adverse events (AE) during Part 1 as recorded in study safety reporting."}
  • {"endpoint_text":"- Part 1: Number of Participants who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue the study intervention due to an adverse event during Part 1 as recorded in study documentation."}
  • {"endpoint_text":"- Part 2: Progression-free Survival (PFS)","definition_or_measurement_approach":"Progression-free survival per protocol; main objective describes PFS measured by RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)."}

Secondary endpoints

  • {"endpoint_text":"- Part 2: Overall Survival (OS)","definition_or_measurement_approach":"Overall survival measured from randomization to death from any cause."}
  • {"endpoint_text":"- Part 2: Number of Participants with One or More AEs","definition_or_measurement_approach":"Count of participants reporting one or more adverse events (AE) during Part 2."}
  • {"endpoint_text":"- Part 2: Number of Participants who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study intervention due to an adverse event during Part 2."}
  • {"endpoint_text":"- Part 2: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score","definition_or_measurement_approach":"Mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score."}
  • {"endpoint_text":"- Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score","definition_or_measurement_approach":"Mean change from baseline in the EORTC QLQ-C30 Physical Functioning domain score."}
  • {"endpoint_text":"- Part 2: Change from Baseline in EORTC QLQ-C30 Role Functioning Score","definition_or_measurement_approach":"Mean change from baseline in the EORTC QLQ-C30 Role Functioning domain score."}
  • {"endpoint_text":"- Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 Abdominal/Gastrointestinal Symptom Scale","definition_or_measurement_approach":"Mean change from baseline in the EORTC QLQ-OV28 abdominal/gastrointestinal symptom scale."}

Recruitment

Planned Sample Size
266
Recruitment Window Months
91
Consent Approach
Informed consent documents are provided (multiple country-specific ICFs listed). Consent is obtained from adult participants; multiple localized ICF versions are available per country (documents in local languages per country entries). No assent or parental consent procedures for minors are specified (minors are not included).

Geography

Total Number Of Sites
82
Total Number Of Participants
251

Austria

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
190
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Medical University Of Graz
Department Name
Department for Gynecology
Contact Person Name
Gerda Trutnovsky
Contact Person Email
gerda.trutnovsky@medunigraz.at
Site Name
Johannes Kepler University Linz
Department Name
Department for Gynecology, Obstetrics and Gynecological Endocrinology, Med Campus IV.
Contact Person Name
Caroline Preuss
Site Name
Medical University Of Vienna
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Stephan Polterauer
Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of Gynecology and Obstetrics
Contact Person Name
Irina Tsibulak
Contact Person Email
irina.tsibulak@i-med.ac.at

Czechia

Earliest CTIS Part Ii Submission Date
02-09-2025
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
29
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologická klinika
Contact Person Name
Anna Nohejlová Medková
Contact Person Email
anna.nohejlova@fnmotol.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Gynekologicko-porodnická klinika 1.LF a VFN
Contact Person Name
David Cibula
Contact Person Email
david.cibula@vfn.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
Gynekologicko-porodnická klinika
Contact Person Name
Michal Zikán
Contact Person Email
michal.zikan@bulovka.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
Fakultni Nemocnice Brno
Department Name
Gynekologicko-porodnická klinika
Contact Person Name
Vít Weinberger
Contact Person Email
weinberger.vit@fnbrno.cz

Finland

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
11-09-2025
Processing Time Days
13
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Oulu University Hospital
Department Name
Department of Obstetrics and Gynecology
Contact Person Name
Elina Urpilainen
Contact Person Email
elina.urpilainen@pohde.fi
Site Name
Kuopio University Hospital
Department Name
Obstetrics and Gynecology
Contact Person Name
Maarit Anttila
Contact Person Email
maarit.anttila@kuh.fi
Site Name
Tampere University Hospital
Department Name
Gynecology and Obstetrics
Contact Person Name
Synnove Staff
Contact Person Email
synnove.staff@pirha.fi

Greece

Earliest CTIS Part Ii Submission Date
24-07-2025
Latest Decision Or Authorization Date
22-08-2025
Processing Time Days
29
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
Oncology Unit, 4th Department of Internal Medicine
Contact Person Name
Anna Koumarianou
Contact Person Email
akoumari@yahoo.com
Site Name
Areteio Hospital
Department Name
2nd Surgical Clinic, Oncology Unit
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk

Hungary

Earliest CTIS Part Ii Submission Date
01-09-2025
Latest Decision Or Authorization Date
03-10-2025
Processing Time Days
32
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Nőgyógyászati Osztály
Contact Person Name
Andrea Bagameri
Contact Person Email
bagameristudy@gmail.com
Site Name
University Of Szeged
Department Name
Onkoterápiás Klinika
Contact Person Name
Aniko Maraz
Contact Person Email
dr.aniko.maraz@gmail.com
Site Name
University Of Debrecen
Department Name
Szülészeti és Nőgyógyászati Klinika
Contact Person Name
Robert Poka
Contact Person Email
pokar@med.unideb.hu
Site Name
Semmelweis University
Department Name
Szülészeti és Nőgyógyászati Klinika
Contact Person Name
Szabolcs Mate
Contact Person Email
dr.mate.szabolcs@gmail.com
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Contact Person Name
Judit Kocsis
Contact Person Email
kocsisjucidr@gmail.com

Ireland

Earliest CTIS Part Ii Submission Date
23-09-2025
Latest Decision Or Authorization Date
31-10-2025
Processing Time Days
38
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
St Vincent's University Hospital
Department Name
Medical Oncology Research Department
Contact Person Name
Lynda Mcsorley
Contact Person Email
Lynda.mcsorley@ccrt.ie
Site Name
St James's Hospital
Department Name
Cancer Clinical Trials Unit
Contact Person Name
Karen Cadoo
Contact Person Email
KCadoo@stjames.ie

Italy

Earliest CTIS Part Ii Submission Date
27-08-2025
Latest Decision Or Authorization Date
12-09-2025
Processing Time Days
16
Number Of Sites
11
Number Of Participants
35

Sites

Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Oncologia Medica 1
Contact Person Name
Carmelo Bengala
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 2
Contact Person Name
Valentina Guarneri
Site Name
Fondazione Poliambulanza
Department Name
U.O. Oncologia Medica
Contact Person Name
Chiara Abeni
Contact Person Email
chiara.abeni@poliambulanza.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Oncologia Medica
Contact Person Name
Michele Bartoletti
Contact Person Email
michele.bartoletti@cro.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Ginecologia Oncologica Medica
Contact Person Name
Domenica Lorusso
Contact Person Email
domenica.lorusso@hunimed.eu
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Ginecologia Oncologica
Contact Person Name
Nicoletta Colombo
Contact Person Email
nicoletta.colombo@ieo.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Ginecologia Oncologica
Contact Person Name
Monika Ducceshi
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. DI ONCOLOGIA CLINICA SPERIMENTALE URO-GENITALE
Contact Person Name
Sabrina Cecere
Contact Person Email
s.cecere@istitutotumori.na.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Dipartimento di Scienze della Salute della donna, del bambino e di sanità pubblica
Contact Person Name
Anna Fagotti
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
Istituto Tumori Bari Giovanni Paolo II
Department Name
Oncologia Medica Apparato Urigenitale
Contact Person Name
Claudia Carella
Contact Person Email
c.carella@oncologico.bari.it

Poland

Earliest CTIS Part Ii Submission Date
05-09-2025
Latest Decision Or Authorization Date
10-10-2025
Processing Time Days
35
Number Of Sites
6
Number Of Participants
35

Sites

Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Ginekologii
Contact Person Name
Marcin Misiek
Site Name
Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie
Department Name
Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt
Contact Person Name
Anita Chudecka-Głaz
Contact Person Email
anita.chudecka.glaz@pum.edu.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Ginekologii Onkologicznej
Contact Person Name
Paweł Derlatka
Contact Person Email
katarzyna.derda@pib-nio.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
dklasa@gumed.edu.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
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Ginekologii Onkologicznej
Contact Person Name
Radosław Mądry
Contact Person Email
radoslaw.madry@usk.poznan.pl

Portugal

Earliest CTIS Part Ii Submission Date
08-08-2025
Latest Decision Or Authorization Date
02-09-2025
Processing Time Days
25
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Hospital Da Luz S.A.
Department Name
Medical Oncology
Contact Person Name
Monica Nave
Contact Person Email
mnave@hospitaldaluz.pt
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Marta Ferreira

Romania

Earliest CTIS Part Ii Submission Date
13-06-2025
Latest Decision Or Authorization Date
12-09-2025
Processing Time Days
91
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie Medicala
Contact Person Name
Paul Milan Kubelac
Contact Person Email
office@iocn.ro
Site Name
Spitalul Clinic Filantropia
Department Name
Oncologie Medicala
Contact Person Name
Dragos Mircea Median
Contact Person Email
office@spitalulfilantropia.ro
Site Name
Oncomed S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Daniela Elvira Sirbu
Contact Person Email
office@oncohelp.ro
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncologie Medicala
Contact Person Name
Simona Volovat
Contact Person Email
contact@victoriahospital.ro

Spain

Earliest CTIS Part Ii Submission Date
25-02-2025
Latest Decision Or Authorization Date
26-03-2025
Processing Time Days
30
Number Of Sites
16
Number Of Participants
5

Sites

Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Marta Gil Martín
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Sara Perez Ramírez
Contact Person Email
spramirez@salud.madrid.org
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Contact Person Name
María Jesús Rubio Pérez
Contact Person Email
mjesusrubio63@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Lydia Gaba Garcia
Contact Person Email
lgaba@xn--clnic-0sa.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Luis Manso Sánchez
Contact Person Email
luismansosanchez@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Carmen Garcia Duran
Contact Person Email
cgarciaduran@vhio.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Alfonso Cortes Salgado
Contact Person Email
acsalgado86@gmail.com
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Oncology
Contact Person Name
Anna Carbo Bague
Contact Person Email
acarbo@iconcologia.net
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Gloria Marquina Ospina
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Antonio Gonzalez Martin
Contact Person Email
agonzalezma@unav.es
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 De Valencia
Department Name
Oncology
Contact Person Name
Jose Alejandro Perez Fidalgo
Contact Person Email
japfidalgo@msn.com
Site Name
Hospital Universitario La Paz (additional contact)
Department Name
Oncology
Contact Person Name
Andres Redondo Sanchez
Contact Person Email
aredondo12@gmail.com
Site Name
Hospital Clinic De Barcelona (duplicate entry)
Department Name
Oncology
Contact Person Name
Lydia Gaba Garcia
Contact Person Email
lgaba@xn--clnic-0sa.cat
Site Name
Hospital Universitario 12 De Octubre (duplicate entry)
Department Name
Oncology
Contact Person Name
Luis Manso Sánchez
Contact Person Email
luismansosanchez@gmail.com
Site Name
Institut Catala D'oncologia (L'hospitalet)
Department Name
Oncology
Contact Person Name
Marta Gil Martín

Belgium

Earliest CTIS Part Ii Submission Date
11-09-2025
Latest Decision Or Authorization Date
08-10-2025
Processing Time Days
27
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Oncology
Contact Person Name
Henry Stéphanie
Site Name
UZ Leuven
Department Name
Gynecologic oncology
Contact Person Name
Toon Van Gorp
Contact Person Email
toon.vangorp@uzleuven.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Oncology
Contact Person Name
Gennigens Christine
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Gynecologic oncology
Contact Person Name
Laure-Anne Teuwen
Contact Person Email
laure-anne.teuwen@uza.be
Site Name
AZ Sint-Lucas & Volkskliniek
Department Name
Oncology
Contact Person Name
Serruys Daphne
Contact Person Email
daphne.serruys@azstlucas.be

France

Earliest CTIS Part Ii Submission Date
21-09-2025
Latest Decision Or Authorization Date
27-10-2025
Processing Time Days
36
Number Of Sites
13
Number Of Participants
40

Sites

Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Oncology
Contact Person Name
Frédéric SELLE
Contact Person Email
oncologie@hopital-dcss.org
Site Name
Institut Gustave Roussy
Department Name
Oncology
Contact Person Name
Alexandra LEARY
Site Name
Hospices Civils De Lyon
Department Name
Oncology
Contact Person Name
Benoît YOU
Contact Person Email
benoit.you@chu-lyon.fr
Site Name
Institut Bergonie
Department Name
Oncology
Contact Person Name
Coriolan LEBRETON
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncology
Contact Person Name
Jérôme ALEXANDRE
Contact Person Email
jerome.alexandre@cch.aphp.fr
Site Name
Pole Sante Leonard De Vinci
Department Name
Oncology
Contact Person Name
Pierre COMBE
Contact Person Email
prrcombe@gmail.com
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncology
Contact Person Name
Jean-Sébastien FRENEL
Site Name
Centre Francois Baclesse
Department Name
Oncology
Contact Person Name
Florence JOLY
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Centre Oscar Lambret
Department Name
Oncology
Contact Person Name
Mathilde SAINT-GHISLAIN
Contact Person Email
a-saintghislain@o-lambret.fr
Site Name
Oncopole Claudius Regaud
Department Name
Oncology
Contact Person Name
Laurence GLADIEFF
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
Institut Sainte Catherine
Department Name
Oncology
Contact Person Name
Julien GRENIER

Denmark

Earliest CTIS Part Ii Submission Date
01-10-2025
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
16
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Aalborg University Hospital
Department Name
Department of Oncology
Contact Person Name
Charlotte Haslund
Contact Person Email
cah@rn.dk
Site Name
Region Hovedstaden
Department Name
Department of Oncology
Contact Person Name
Trine Iversen
Site Name
Lillebaelt Hospital
Department Name
Department of Oncology
Contact Person Name
Caroline Thomsen

Sponsor

Primary sponsor

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

Contract research organisations

Name
Clario
Responsibilities
Cardiac safety and other CRO services (multiple entries for Clario in sponsor third parties).
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Q2 Solutions
Name
Signant Health Global LLC

Third parties

  • {"country":"United States","full_name":"Myriad","duties_or_roles":"BRCA Testing","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"Cardiac safety (per entry: Clario, Cardiac Safety)","organisation_type":"Industry"}
  • {"country":"United Kingdom","full_name":"Q2 Solutions","duties_or_roles":"","organisation_type":"SME"}
  • {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario (US address duplicate)","duties_or_roles":"","organisation_type":"Health care"}
  • {"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":"Frontage Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario (additional entry)","duties_or_roles":"","organisation_type":"Industry"}

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 (max daily dose amount reported)
Investigational Product Name
BEVACIZUMAB
Active Substance
BEVACIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Maximum Dose
15 mg/kg (max daily dose amount reported)
Combination Treatment
Yes

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