Clinical trial • Phase III • Oncology

SACITUZUMAB TIRUMOTECAN for Triple-negative breast cancer

Phase III trial of SACITUZUMAB TIRUMOTECAN for Triple-negative breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Triple-negative breast cancer
Trial Stage
Phase III
Drug Modality
ADC | Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
21-02-2024
First CTIS Authorization Date
11-06-2024

Trial design

Randomised, open-label, treatment of physician’s choice (tpc): pembrolizumab (keytruda 25 mg/ml concentrate for infusion; dosing per label/not specified in provided data) or pembrolizumab plus capecitabine (capecitabine oral; dose unit mg/m2; max daily dose amount listed as 2500 mg/m2 in product data; schedule not specified).-controlled Phase III trial in Finland, Norway, Belgium and others.

Randomised
Yes
Open Label
Yes
Comparator
Treatment of Physician’s Choice (TPC): pembrolizumab (KEYTRUDA 25 mg/mL concentrate for infusion; dosing per label/not specified in provided data) or pembrolizumab plus capecitabine (capecitabine oral; dose unit mg/m2; max daily dose amount listed as 2500 mg/m2 in product data; schedule not specified).
Target Sample Size
870

Eligibility

Recruits 870 No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is obtained using country-specific subject information and informed consent forms (L1_ICF_Main consent) and optional consent modules (eg, prescreening, pregnancy follow-up, genetic consent); documents are provided per country and in multiple languages. No assent procedures or specific vulnerable-person consent/assent handling are described in the provided data..

Pregnancy Exclusion
For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for MK-2870, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention.
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is obtained using country-specific subject information and informed consent forms (L1_ICF_Main consent) and optional consent modules (eg, prescreening, pregnancy follow-up, genetic consent); documents are provided per country and in multiple languages. No assent procedures or specific vulnerable-person consent/assent handling are described in the provided data.

Inclusion criteria

  • {"criterion_text":"-Has centrally confirmed triple negative breast cancer (TNBC), as defined by the most recent American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guidelines."}
  • {"criterion_text":"-Has no evidence of locoregional or distant relapse, as assessed by the treating physician."}
  • {"criterion_text":"-Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) and/or local treatment guidelines for TNBC."}
  • {"criterion_text":"-Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery."}
  • {"criterion_text":"-Has non-pathologic complete response at surgery."}
  • {"criterion_text":"-Is able to continue on adjuvant pembrolizumab."}
  • {"criterion_text":"-Randomization must be conducted within 16 weeks from surgical resection."}
  • {"criterion_text":"-Completed adjuvant radiation therapy (if indicated) and recovered before randomization."}
  • {"criterion_text":"-Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status."}
  • {"criterion_text":"-If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for MK-2870 and 95 days for capecitabine [no restriction for pembrolizumab]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception"}
  • {"criterion_text":"-For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for MK-2870, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention."}
  • {"criterion_text":"-Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia)."}
  • {"criterion_text":"-Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)."}
  • {"criterion_text":"-An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment."}
  • {"criterion_text":"-Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization."}

Exclusion criteria

  • {"criterion_text":"-Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available."}
  • {"criterion_text":"-Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization."}
  • {"criterion_text":"-Received prior radiotherapy within 3 weeks of start of study intervention, or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention."}
  • {"criterion_text":"-Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed."}
  • {"criterion_text":"-Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration."}
  • {"criterion_text":"-Known additional malignancy that is progressing or has required active treatment within the past 5 years."}
  • {"criterion_text":"-Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication."}
  • {"criterion_text":"-Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed."}
  • {"criterion_text":"-History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease."}
  • {"criterion_text":"-Active infection requiring systemic therapy."}
  • {"criterion_text":"-HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease."}
  • {"criterion_text":"-Has Grade >2 peripheral neuropathy."}
  • {"criterion_text":"-Concurrent active Hepatitis B and Hepatitis C virus infection."}
  • {"criterion_text":"-History of allogeneic tissue/solid organ transplant."}
  • {"criterion_text":"-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 (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)."}
  • {"criterion_text":"-Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention."}
  • {"criterion_text":"-Received prior treatment with a TROP2-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC."}
  • {"criterion_text":"-Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, PARP inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy."}
  • {"criterion_text":"-Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting MK-2870 is 2 weeks."}
  • {"criterion_text":"-Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: Received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Invasive Disease-Free Survival (iDFS)","definition_or_measurement_approach":"iDFS per investigator assessment"}

Secondary endpoints

  • {"endpoint_text":"-Overall Survival (OS)","definition_or_measurement_approach":"OS (time to death from any cause)"}
  • {"endpoint_text":"-Distant Recurrence-Free Survival (DRFS)","definition_or_measurement_approach":"DRFS per investigator assessment"}
  • {"endpoint_text":"-Change from Baseline in European Organisation for 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) Combined Score","definition_or_measurement_approach":"Mean change from baseline in EORTC QLQ-C30 combined global health status and QoL score"}
  • {"endpoint_text":"-Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score","definition_or_measurement_approach":"Mean change from baseline in EORTC QLQ-C30 physical functioning score (Items 1–5)"}
  • {"endpoint_text":"-Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score","definition_or_measurement_approach":"Mean change from baseline in EORTC QLQ-C30 role functioning score (Items 6–7)"}
  • {"endpoint_text":"-Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue (Items 10, 12, 18) Score","definition_or_measurement_approach":"Mean change from baseline in EORTC QLQ-C30 fatigue score (Items 10, 12, 18)"}
  • {"endpoint_text":"-Number of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants experiencing ≥1 AE"}
  • {"endpoint_text":"-Number of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study intervention because of an AE"}

Recruitment

Planned Sample Size
870
Recruitment Window Months
162
Consent Approach
Informed consent obtained from participants using country-specific main consent forms (L1_ICF_Main consent) and optional consent modules (e.g., optional prescreening, optional limited screening consent, optional pregnancy follow-up, genetic consent). Consent documents are provided in multiple languages and per-country packs (examples include EN, FR, DE, NL, FI, NO, PL, IT, ES, SV, PT, EL). Consent is provided by adult participants; no assent procedures for minors are described.

Geography

Total Number Of Sites
160
Total Number Of Participants
870

Finland

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
13-06-2024
Processing Time Days
27
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
HUS-Yhtymae
Department Name
HUS, Comprehensive Cancer Center
Principal Investigator Name
Peeter Karihtala
Principal Investigator Email
peeter.karihtala@hus.fi
Contact Person Name
Peeter Karihtala
Contact Person Email
peeter.karihtala@hus.fi
Site Name
Tampere University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Minna Tanner
Principal Investigator Email
minna.tanner@pirha.fi
Contact Person Name
Minna Tanner
Contact Person Email
minna.tanner@pirha.fi
Site Name
Turku University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Antti Ellonen
Principal Investigator Email
antti.ellonen@varha.fi
Contact Person Name
Antti Ellonen
Contact Person Email
antti.ellonen@varha.fi
Site Name
Kuopio University Hospital
Department Name
Department of Oncology, Cancer Center
Principal Investigator Name
Paivi Auvinen
Principal Investigator Email
paivi.auvinen@pshyvinvointialue.fi
Contact Person Name
Paivi Auvinen
Site Name
Kuopio University Hospital
Department Name
Department of Oncology, Cancer Center
Principal Investigator Name
Paivi Auvinen
Principal Investigator Email
paivi.auvinen@pshyvinvointialue.fi
Contact Person Name
Paivi Auvinen

Norway

Earliest CTIS Part Ii Submission Date
19-05-2024
Latest Decision Or Authorization Date
14-06-2024
Processing Time Days
26
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Helse Stavanger HF
Department Name
Kreftavdelingen
Principal Investigator Name
Bjørnar Gilje
Principal Investigator Email
bjornar.gilje@sus.no
Contact Person Name
Bjørnar Gilje
Contact Person Email
bjornar.gilje@sus.no
Site Name
Drammen Sykehus
Department Name
Onkologisk poliklinikk
Principal Investigator Name
Ailina Porojnicu
Principal Investigator Email
alinacp@vestreviken.no
Contact Person Name
Ailina Porojnicu
Contact Person Email
alinacp@vestreviken.no
Site Name
Oslo University Hospital HF
Department Name
Cancer Department
Principal Investigator Name
Anne Barbro Sætersdal
Principal Investigator Email
asd@ous-hf.no
Contact Person Name
Anne Barbro Sætersdal
Contact Person Email
asd@ous-hf.no

Belgium

Earliest CTIS Part Ii Submission Date
13-05-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
29
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Az Maria Middelares Gent
Department Name
Medical oncology
Principal Investigator Name
Félix Gremonprez
Principal Investigator Email
felix.gremonprez@azmmsj.be
Contact Person Name
Félix Gremonprez
Contact Person Email
felix.gremonprez@azmmsj.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Service oncologie médicale
Principal Investigator Name
François Duhoux
Principal Investigator Email
francois.duhoux@uclouvain.be
Contact Person Name
François Duhoux
Contact Person Email
francois.duhoux@uclouvain.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Clinique du sein Godinne
Principal Investigator Name
Fanny Collette
Principal Investigator Email
fanny.collette@chuuclnamur.uclouvain.be
Contact Person Name
Fanny Collette

Portugal

Earliest CTIS Part Ii Submission Date
05-06-2024
Latest Decision Or Authorization Date
18-06-2024
Processing Time Days
13
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Unidade Local De Saude De Amadora Sintra E.P.E.
Department Name
Oncology Department
Principal Investigator Name
Sofia Braga
Principal Investigator Email
sofia.braga@hff.min-saude.pt
Contact Person Name
Sofia Braga
Contact Person Email
sofia.braga@hff.min-saude.pt
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical Oncology Departament
Principal Investigator Name
Maria Neves
Principal Investigator Email
maria.cassiano.neves@ipoporto.min-saude.pt
Contact Person Name
Maria Neves
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Oncology Department
Principal Investigator Name
Rita Sousa
Principal Investigator Email
arita.sousa@gmail.com
Contact Person Name
Rita Sousa
Contact Person Email
arita.sousa@gmail.com
Site Name
Champalimaud Clinical Centre
Department Name
Breast Unit
Principal Investigator Name
Berta Sousa
Principal Investigator Email
berta.sousa@fundacaochampalimaud.pt
Contact Person Name
Berta Sousa

Austria

Earliest CTIS Part Ii Submission Date
13-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
35
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Medical University Of Vienna
Department Name
Univ. Klinik für Innere Medizin I, Klin. Abteilung für Onkolgie
Principal Investigator Name
Rupert Bartsch
Principal Investigator Email
rupert.bartsch@meduniwien.ac.at
Contact Person Name
Rupert Bartsch
Site Name
Johannes Kepler University Linz
Department Name
Hämatologie und internistische Onkologie , Med Campus III
Principal Investigator Name
Caroline Preuss
Principal Investigator Email
caroline.preuss@kepleruniklinikum.at
Contact Person Name
Caroline Preuss
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Universitätsklinik für Innere Medizin III
Principal Investigator Name
Lukas Weiss
Principal Investigator Email
lu.weiss@salk.at
Contact Person Name
Lukas Weiss
Contact Person Email
lu.weiss@salk.at
Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Abteilung für Innere Medizin IV
Principal Investigator Name
Sonja Heibl
Principal Investigator Email
sonja.heibl@klinikum-wegr.at
Contact Person Name
Sonja Heibl
Contact Person Email
sonja.heibl@klinikum-wegr.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitätsklinik für Gynäkologie & Geburtshilfe
Principal Investigator Name
Daniel Egle
Principal Investigator Email
daniel.egle@tirol-kliniken.at
Contact Person Name
Daniel Egle
Contact Person Email
daniel.egle@tirol-kliniken.at

Czechia

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
12-06-2024
Processing Time Days
15
Number Of Sites
7
Number Of Participants
30

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologická klinika 2. LF UK a FN Motol
Principal Investigator Name
Vlastimila Čmejlová
Principal Investigator Email
vlastimila.cmejlova@fnmotol.cz
Contact Person Name
Vlastimila Čmejlová
Contact Person Email
vlastimila.cmejlova@fnmotol.cz
Site Name
University Hospital Olomouc
Department Name
Onkologická klinika
Principal Investigator Name
Bohuslav Melichar
Principal Investigator Email
bohuslav.melichar@fnol.cz
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Onkologická klinika
Principal Investigator Name
Milan Brychta
Principal Investigator Email
milan.brychta@fnkv.cz
Contact Person Name
Milan Brychta
Contact Person Email
milan.brychta@fnkv.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Onkologická klinika 1.LF UK a FNT
Principal Investigator Name
Eugen Kubala
Principal Investigator Email
eugen.kubala@ftn.cz
Contact Person Name
Eugen Kubala
Contact Person Email
eugen.kubala@ftn.cz
Site Name
Nemocnice Ceske Budejovice a.s.
Department Name
Onkologické oddělení
Principal Investigator Name
Taťána Karpianusová
Principal Investigator Email
karpianusova.tatana@nemcb.cz
Contact Person Name
Taťána Karpianusová
Contact Person Email
karpianusova.tatana@nemcb.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Onkologická klinika
Principal Investigator Name
Martina Zimovjanová
Principal Investigator Email
martina.zimovjanova@vfn.cz
Contact Person Name
Martina Zimovjanová
Contact Person Email
martina.zimovjanova@vfn.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komlexní onkologické péče
Principal Investigator Name
Katarína Petráková
Principal Investigator Email
petrakova@mou.cz
Contact Person Name
Katarína Petráková
Contact Person Email
petrakova@mou.cz

Italy

Earliest CTIS Part Ii Submission Date
10-04-2024
Latest Decision Or Authorization Date
12-06-2024
Processing Time Days
63
Number Of Sites
14
Number Of Participants
68

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medical Oncology & Haematology
Principal Investigator Name
Claudio Zamagni
Principal Investigator Email
zamagniclaudio.sper@aosp.bo.it
Contact Person Name
Claudio Zamagni
Contact Person Email
zamagniclaudio.sper@aosp.bo.it
Site Name
Careggi University Hospital
Department Name
Dipartimento di radioterapia oncologica
Principal Investigator Name
Lorenzo Livi
Principal Investigator Email
lorenzo.livi@unifi.it
Contact Person Name
Lorenzo Livi
Contact Person Email
lorenzo.livi@unifi.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O Oncologia
Principal Investigator Name
Deborah Cosentini
Principal Investigator Email
deborah.cosentini@unibs.it
Contact Person Name
Deborah Cosentini
Contact Person Email
deborah.cosentini@unibs.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Oncologia Clinica Sperimentale di Senologia
Principal Investigator Name
Michelino De Laurentiis
Principal Investigator Email
m.delaurentiis@istitutotumori.na.it
Contact Person Name
Michelino De Laurentiis
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Oncologia
Principal Investigator Name
Alessandra Gennari
Principal Investigator Email
alessandra.gennari@med.uniupo.it
Contact Person Name
Alessandra Gennari
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Dipertimento di Oncologia Medica
Principal Investigator Name
Fabio Puglisi
Principal Investigator Email
fabio.puglisi@cro.it
Contact Person Name
Fabio Puglisi
Contact Person Email
fabio.puglisi@cro.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Divisione di Senologia Medica
Principal Investigator Name
Marco Angelo Oscar Colleoni
Principal Investigator Email
marco.colleoni@ieo.it
Contact Person Name
Marco Angelo Oscar Colleoni
Contact Person Email
marco.colleoni@ieo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Dipertimento di Oncologia Medica
Principal Investigator Name
Ida Paris
Principal Investigator Email
Ida.paris@policlinicogemelli.it
Contact Person Name
Ida Paris
Site Name
Universita' Degli Studi Di Napoli Federico II
Department Name
Dipartimento di Medicina Clinica e Chirurgia
Principal Investigator Name
Grazia Arpino
Principal Investigator Email
grazia.arpino@unina.it
Contact Person Name
Grazia Arpino
Contact Person Email
grazia.arpino@unina.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Centro Ricerca Fase 1
Principal Investigator Name
Marina Elena Cazzaniga
Principal Investigator Email
marinaelena.cazzaniga@irccs-sangerardo.it
Contact Person Name
Marina Elena Cazzaniga
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia Medica
Principal Investigator Name
Antonino Musolino
Principal Investigator Email
antonino.musolino@irst.emr.it
Contact Person Name
Antonino Musolino
Contact Person Email
antonino.musolino@irst.emr.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Struttura Complessa Oncologia Medica 1
Principal Investigator Name
Claudio Vernieri
Principal Investigator Email
claudio.vernieri@istitutotumori.mi.it
Contact Person Name
Claudio Vernieri
Site Name
Humanitas Istituto Clinico Catanese S.p.A.
Department Name
Oncologia Medica Universitaria
Principal Investigator Name
Paolo Vigneri
Principal Investigator Email
paolo.vigneri@humanitascatania.it
Contact Person Name
Paolo Vigneri
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica
Principal Investigator Name
Giampaolo Bianchini
Principal Investigator Email
bianchini.giampaolo@hsr.it
Contact Person Name
Giampaolo Bianchini
Contact Person Email
bianchini.giampaolo@hsr.it

France

Earliest CTIS Part Ii Submission Date
04-04-2024
Latest Decision Or Authorization Date
13-06-2024
Processing Time Days
70
Number Of Sites
21
Number Of Participants
115

Sites

Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncology
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 Hospitalier De Pau
Department Name
Oncology
Principal Investigator Name
Kévin BOURCIER
Principal Investigator Email
kevin.bourcier@ch-pau.fr
Contact Person Name
Kévin BOURCIER
Contact Person Email
kevin.bourcier@ch-pau.fr
Site Name
Centre Henri Becquerel
Department Name
Medical oncology
Principal Investigator Name
Marianne LEHEURTEUR
Principal Investigator Email
Marianne.leheurteur@chb.unicancer.fr
Contact Person Name
Marianne LEHEURTEUR
Site Name
Hopital Tenon
Department Name
Medical oncology
Principal Investigator Name
Xavier BARTHERE
Principal Investigator Email
xavier.barthere@aphp.fr
Contact Person Name
Xavier BARTHERE
Contact Person Email
xavier.barthere@aphp.fr
Site Name
Centre Jean Perrin
Department Name
Oncology
Principal Investigator Name
Marie-Ange Mouret-Reynier
Contact Person Name
Marie-Ange Mouret-Reynier
Site Name
Centr Georges Francois Leclerc
Department Name
Oncology
Principal Investigator Name
Isabelle Desmoulins
Principal Investigator Email
idesmoulins@cgfl.fr
Contact Person Name
Isabelle Desmoulins
Contact Person Email
idesmoulins@cgfl.fr
Site Name
IHFB Cognacq Jay
Department Name
Medical oncology
Principal Investigator Name
Nathalie PEREZ STAUB
Principal Investigator Email
nathalie.perez-staub@cognacq-jay.fr
Contact Person Name
Nathalie PEREZ STAUB
Site Name
Centre Antoine Lacassagne
Department Name
Medical oncology
Principal Investigator Name
Caroline BAILLEUX
Principal Investigator Email
caroline.bailleux@nice.unicancer.fr
Contact Person Name
Caroline BAILLEUX
Site Name
Hopital Prive Drome-Ardeche
Department Name
Medical oncology
Principal Investigator Name
Louis DOUBLET
Principal Investigator Email
louis.doublet@ramsaysante.fr
Contact Person Name
Louis DOUBLET
Contact Person Email
louis.doublet@ramsaysante.fr
Site Name
Centre Hospitalier Universitaire De Nantes
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
Site Name
Institut Paoli Calmettes
Department Name
Oncology
Principal Investigator Name
Anthony GONCALVES
Principal Investigator Email
goncalvesa@ipc.unicancer.fr
Contact Person Name
Anthony GONCALVES
Contact Person Email
goncalvesa@ipc.unicancer.fr
Site Name
Centre Leon Berard
Department Name
Medical oncology
Principal Investigator Name
Olivier TREDAN
Principal Investigator Email
olivier.tredan@lyon.unicancer.fr
Contact Person Name
Olivier TREDAN
Site Name
Centre Francois Baclesse
Department Name
Service de pathologie mammaire
Principal Investigator Name
George Emile
Principal Investigator Email
g.emile@baclesse.unicancer.fr
Contact Person Name
George Emile
Contact Person Email
g.emile@baclesse.unicancer.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Oncology
Principal Investigator Name
Thomas GRELLETY
Principal Investigator Email
tgrellety@ch-cotebasque.fr
Contact Person Name
Thomas GRELLETY
Contact Person Email
tgrellety@ch-cotebasque.fr
Site Name
Nouvelle Clinique Des Dentellieres
Department Name
Oncology
Principal Investigator Name
Géraldine LAURIDANT
Principal Investigator Email
lauridant@lesdentellieres.com
Contact Person Name
Géraldine LAURIDANT
Contact Person Email
lauridant@lesdentellieres.com
Site Name
Clinique Tivoli Ducos
Department Name
Oncology
Principal Investigator Name
Delphine GARBAY
Principal Investigator Email
d.garbay@tivoli-oncologie.fr
Contact Person Name
Delphine GARBAY
Contact Person Email
d.garbay@tivoli-oncologie.fr
Site Name
Centre Hospitalier De Pau
Department Name
Oncology
Principal Investigator Name
Kévin BOURCIER
Principal Investigator Email
kevin.bourcier@ch-pau.fr
Contact Person Name
Kévin BOURCIER
Contact Person Email
kevin.bourcier@ch-pau.fr

Poland

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
14-06-2024
Processing Time Days
14
Number Of Sites
10
Number Of Participants
50

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej
Principal Investigator Name
Zbigniew Nowecki
Principal Investigator Email
nowotworypiersi@nio.gov.pl
Contact Person Name
Zbigniew Nowecki
Contact Person Email
nowotworypiersi@nio.gov.pl
Site Name
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
Department Name
Oddział Onkologii Klinicznej im. dr E. Pileckiej z pododdziałem Chemioterapii Dziennej
Principal Investigator Name
Kinga Hermanowicz-Szamatowicz
Principal Investigator Email
bco@onkologia.bialystok.pl
Contact Person Name
Kinga Hermanowicz-Szamatowicz
Contact Person Email
bco@onkologia.bialystok.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Szpital Morski im. PCK Oddział Onkologii Klinicznej
Principal Investigator Name
Iwona Danielewicz
Principal Investigator Email
info.onkocwbk@szpitalepomorskie.eu
Contact Person Name
Iwona Danielewicz
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Onkologii Klinicznej Dział Chemioterapii
Principal Investigator Name
Żubrowska Justyna
Principal Investigator Email
badania.kliniczne@onkol.kielce.pl
Contact Person Name
Żubrowska Justyna
Site Name
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Department Name
Poradnia Onkologiczna
Principal Investigator Name
Sylwina Socha
Principal Investigator Email
s.socha@szpitalonkologiczny.pl
Contact Person Name
Sylwina Socha
Contact Person Email
s.socha@szpitalonkologiczny.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
Department Name
Centrum Diagnostyki i Leczenia Chorób Piersi
Principal Investigator Name
Michał Jarząb
Principal Investigator Email
agnieszka.lagiewka@gliwice.nio.gov.pl
Contact Person Name
Michał Jarząb
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Krakow)
Department Name
Klinika Onkologii Klinicznej
Principal Investigator Name
Aleksandra Grela-Wojewoda
Principal Investigator Email
aleksandra.grela@krakow.nio.gov.pl
Contact Person Name
Aleksandra Grela-Wojewoda
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Principal Investigator Name
Bogdan Żurawski
Principal Investigator Email
badania.kliniczne@co.bydgoszcz.pl
Contact Person Name
Bogdan Żurawski
Site Name
Zachodniopomorskie Centrum Onkologii
Department Name
Ośrodek Badań Klinicznych
Principal Investigator Name
Katarzyna Hetman
Principal Investigator Email
szpital@onkologia.szczecin.pl
Contact Person Name
Katarzyna Hetman
Contact Person Email
szpital@onkologia.szczecin.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy (duplicate or regional site)
Department Name
Ambulatorium Chemioterapii
Principal Investigator Name
Bogdan Żurawski
Principal Investigator Email
badania.kliniczne@co.bydgoszcz.pl
Contact Person Name
Bogdan Żurawski

Sweden

Earliest CTIS Part Ii Submission Date
01-08-2025
Latest Decision Or Authorization Date
13-08-2025
Processing Time Days
12
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Onkologikliniken
Principal Investigator Name
Karolina Frida Larsson
Principal Investigator Email
karolina.f.larsson@vgregion.se
Contact Person Name
Karolina Frida Larsson
Contact Person Email
karolina.f.larsson@vgregion.se
Site Name
Uppsala University Hospital
Department Name
Onkologikliniken, Akademiska Sjukhusest, Uppsala
Principal Investigator Name
Aglaia Schiza
Principal Investigator Email
aglaia.maleka@akademiska.se
Contact Person Name
Aglaia Schiza
Contact Person Email
aglaia.maleka@akademiska.se
Site Name
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen
Department Name
Onkologmottagning, Södra Älvsborgs Sjukhus
Principal Investigator Name
Zakaria Einbeigi
Principal Investigator Email
zakaria.einbeigi@vgregion.se
Contact Person Name
Zakaria Einbeigi
Contact Person Email
zakaria.einbeigi@vgregion.se
Site Name
Capio S:t Goerans Sjukhus AB
Department Name
Klinisk forskningsenhet (KFE) Kirurg- och onkologklinken, Capio S:t Görans sjukhus
Principal Investigator Name
Anna Stillström
Principal Investigator Email
anna.stillstrom@capiostgoran.se
Contact Person Name
Anna Stillström
Site Name
Karolinska University Hospital
Department Name
Tema Cancer, ME Bröst-, endokrina tumörer och sarkom
Principal Investigator Name
Theodoros Foukakis
Principal Investigator Email
theodoros.foukakis@ki.se
Contact Person Name
Theodoros Foukakis
Contact Person Email
theodoros.foukakis@ki.se

Denmark

Earliest CTIS Part Ii Submission Date
01-09-2025
Latest Decision Or Authorization Date
04-09-2025
Processing Time Days
3
Number Of Sites
7
Number Of Participants
23

Sites

Site Name
Aalborg University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Sophie Dufraise Tchikou Yammeni
Principal Investigator Email
s.yammeni@rn.dk
Contact Person Name
Sophie Dufraise Tchikou Yammeni
Contact Person Email
s.yammeni@rn.dk
Site Name
Region Hovedstaden
Department Name
Department of Oncology
Principal Investigator Name
Mogens Karsboel Boisen
Principal Investigator Email
Mogens.Karsboel.Boisen@regionh.dk
Contact Person Name
Mogens Karsboel Boisen
Site Name
Odense University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Jeanette Dupont Rønlev
Principal Investigator Email
ouh.ode.r.ctis@rsyd.dk
Contact Person Name
Jeanette Dupont Rønlev
Contact Person Email
ouh.ode.r.ctis@rsyd.dk
Site Name
Lillebaelt Hospital
Department Name
Department of Oncology
Principal Investigator Name
Hanne Holm
Principal Investigator Email
Hanne.Spangsberg.Holm@rsyd.dk
Contact Person Name
Hanne Holm
Contact Person Email
Hanne.Spangsberg.Holm@rsyd.dk
Site Name
Region Midtjylland
Department Name
Department of Oncology
Principal Investigator Name
Christian Tang Axelsen
Principal Investigator Email
CHRAXE@rm.dk
Contact Person Name
Christian Tang Axelsen
Contact Person Email
CHRAXE@rm.dk
Site Name
Aalborg University Hospital (duplicate entry)
Department Name
Department of Oncology
Principal Investigator Name
Louise Skau Rasmussen
Principal Investigator Email
loskr@rn.dk
Contact Person Name
Louise Skau Rasmussen
Contact Person Email
loskr@rn.dk
Site Name
Region Syddanmark
Department Name
Department of Oncology
Principal Investigator Name
Erik Hugger Jakobsen
Principal Investigator Email
Erik.Hugger.Jakobsen@rsyd.dk
Contact Person Name
Erik Hugger Jakobsen
Contact Person Email
Erik.Hugger.Jakobsen@rsyd.dk

Spain

Earliest CTIS Part Ii Submission Date
13-05-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
29
Number Of Sites
13
Number Of Participants
73

Sites

Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Rafael Villanueva Vazquez
Principal Investigator Email
contacfortrialsicolh@iconcologia.cat
Contact Person Name
Rafael Villanueva Vazquez
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Principal Investigator Name
Silvia Antolin Novoa
Principal Investigator Email
Silvia.Antolin.Novoa@sergas.es
Contact Person Name
Silvia Antolin Novoa
Contact Person Email
Silvia.Antolin.Novoa@sergas.es
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Principal Investigator Name
José Ángel García Saenz
Principal Investigator Email
jagsaenz@yahoo.com
Contact Person Name
José Ángel García Saenz
Contact Person Email
jagsaenz@yahoo.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Principal Investigator Name
Joaquin Gavila Gregori
Principal Investigator Email
jgavila@fivo.org
Contact Person Name
Joaquin Gavila Gregori
Contact Person Email
jgavila@fivo.org
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Begoña Bermejo Heras
Principal Investigator Email
begobermejo@gmail.com
Contact Person Name
Begoña Bermejo Heras
Contact Person Email
begobermejo@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Francisco Javier Salvador Boffil
Principal Investigator Email
jsalvad2002@yahoo.es
Contact Person Name
Francisco Javier Salvador Boffil
Contact Person Email
jsalvad2002@yahoo.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
María Fernandez Abad
Principal Investigator Email
mariafernandezabad@hotmail.com
Contact Person Name
María Fernandez Abad
Contact Person Email
mariafernandezabad@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Ester Zamora Adelantado
Principal Investigator Email
ezamora@vhio.net
Contact Person Name
Ester Zamora Adelantado
Contact Person Email
ezamora@vhio.net
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Principal Investigator Name
Blanca Cantos Sánchez de Ibargüen
Principal Investigator Email
blanca.cantos@salud.madrid.org
Contact Person Name
Blanca Cantos Sánchez de Ibargüen
Contact Person Email
blanca.cantos@salud.madrid.org
Site Name
Hospital Beata Maria Ana
Department Name
Oncology
Principal Investigator Name
Javier Cortes Castán
Principal Investigator Email
Javier.cortes@maj3.health
Contact Person Name
Javier Cortes Castán
Contact Person Email
Javier.cortes@maj3.health
Site Name
Institut Catala D'oncologia (duplicate regional site)
Department Name
Oncology
Principal Investigator Name
Rafael Villanueva Vazquez
Principal Investigator Email
contacfortrialsicolh@iconcologia.cat
Contact Person Name
Rafael Villanueva Vazquez
Site Name
Complexo Hospitalario Universitario A Coruna (regional)
Department Name
Oncology
Principal Investigator Name
Silvia Antolin Novoa
Principal Investigator Email
Silvia.Antolin.Novoa@sergas.es
Contact Person Name
Silvia Antolin Novoa
Contact Person Email
Silvia.Antolin.Novoa@sergas.es
Site Name
Hospital Clinico San Carlos (regional)
Department Name
Oncology
Principal Investigator Name
José Ángel García Saenz
Principal Investigator Email
jagsaenz@yahoo.com
Contact Person Name
José Ángel García Saenz
Contact Person Email
jagsaenz@yahoo.com

Ireland

Earliest CTIS Part Ii Submission Date
06-05-2024
Latest Decision Or Authorization Date
14-06-2024
Processing Time Days
39
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
University Hospital Galway
Department Name
Oncology
Principal Investigator Name
Maccon Keane
Principal Investigator Email
maccon.keane@hse.ie
Contact Person Name
Maccon Keane
Contact Person Email
maccon.keane@hse.ie
Site Name
Bon Secours Hospital Cork
Department Name
Oncology
Principal Investigator Name
Conleth Murphy
Principal Investigator Email
cgmurphy@bonsecours.ie
Contact Person Name
Conleth Murphy
Contact Person Email
cgmurphy@bonsecours.ie
Site Name
St Vincent's University Hospital
Department Name
Oncology
Principal Investigator Name
Janice Walshe
Principal Investigator Email
Janice.walshe@ccrt.ie
Contact Person Name
Janice Walshe
Contact Person Email
Janice.walshe@ccrt.ie

Greece

Earliest CTIS Part Ii Submission Date
13-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
35
Number Of Sites
6
Number Of Participants
36

Sites

Site Name
Athens Medical Center S.A.
Department Name
4th Department of Medical Oncology
Principal Investigator Name
Ippokratis Korantzis
Principal Investigator Email
ippokratis.korantzis@gmail.com
Contact Person Name
Ippokratis Korantzis
Contact Person Email
ippokratis.korantzis@gmail.com
Site Name
General University Hospital Of Larissa
Department Name
Oncology department
Principal Investigator Name
Emmanouil Saloustros
Principal Investigator Email
esaloustros@yahoo.gr
Contact Person Name
Emmanouil Saloustros
Contact Person Email
esaloustros@yahoo.gr
Site Name
General University Hospital Of Patras
Department Name
Oncology Unit
Principal Investigator Name
Aggelos Koutras
Principal Investigator Email
angkoutr@otenet.gr
Contact Person Name
Aggelos Koutras
Contact Person Email
angkoutr@otenet.gr
Site Name
Athens Medical Center S.A. (Thessaloniki)
Department Name
3rd Department of Oncology
Principal Investigator Name
Konstantinos Papazisis
Principal Investigator Email
k.papazisis@oncomedicare.com
Contact Person Name
Konstantinos Papazisis
Contact Person Email
k.papazisis@oncomedicare.com
Site Name
Areteio Hospital
Department Name
Oncology Unit, B'Surgery Department
Principal Investigator Name
Flora Zagouri
Principal Investigator Email
florazagouri@yahoo.co.uk
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
Henry Dunant Hospital Center
Department Name
1st Oncology clinic-INTERNAL MEDICINE DEPARTMENT
Principal Investigator Name
Avraam Assi
Principal Investigator Email
avraamassi@gmail.com
Contact Person Name
Avraam Assi
Contact Person Email
avraamassi@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
30-05-2024
Latest Decision Or Authorization Date
12-06-2024
Processing Time Days
13
Number Of Sites
24
Number Of Participants
107

Sites

Site Name
Franziskus Hospital Harderberg
Department Name
Zentrum für Onkologie und Hämatologie MVZ II
Principal Investigator Name
Kerstin Lüdtke-Heckenkamp
Principal Investigator Email
nicole.weimer@niels-stensen-kliniken.de
Contact Person Name
Kerstin Lüdtke-Heckenkamp
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik fuer Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Tjoung-Won Park-Simon
Principal Investigator Email
gynaekologische-onkologie@mh-hannover.de
Contact Person Name
Tjoung-Won Park-Simon
Site Name
Klinikum Ernst von Bergmann gGmbH
Department Name
Klinik für Gynäkologie und Geburtshilfe
Principal Investigator Name
Dorothea Fischer
Principal Investigator Email
info@klinikumevb.de
Contact Person Name
Dorothea Fischer
Contact Person Email
info@klinikumevb.de
Site Name
Agaplesion Diakonieklinikum Hamburg gGmbH
Department Name
Frauenklinik
Principal Investigator Name
Celalettin Ugur
Principal Investigator Email
frauenklinik.dkh@agaplesion.de
Contact Person Name
Celalettin Ugur
Contact Person Email
frauenklinik.dkh@agaplesion.de
Site Name
Universitaetsklinikum Magdeburg AöR
Department Name
Universitaetsklinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin
Principal Investigator Name
Atanas Ignatov
Principal Investigator Email
ufk-studiensekr@med.ovgu.de
Contact Person Name
Atanas Ignatov
Contact Person Email
ufk-studiensekr@med.ovgu.de
Site Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Department Name
Gynaekologie
Principal Investigator Name
Sebastian Jud
Principal Investigator Email
waladkhani@mutterhaus.de
Contact Person Name
Sebastian Jud
Contact Person Email
waladkhani@mutterhaus.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik fuer Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Paul Gaß
Principal Investigator Email
frauenklinik@skc.de
Contact Person Name
Paul Gaß
Contact Person Email
frauenklinik@skc.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Tanja Fehm
Contact Person Name
Tanja Fehm
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Senologie/ Interdisziplinäres Brustzentrum
Principal Investigator Name
Jennifer Spönlein
Principal Investigator Email
senostudien@kem-med.com
Contact Person Name
Jennifer Spönlein
Contact Person Email
senostudien@kem-med.com
Site Name
Medizinische Studiengesellschaft Nord-West GmbH
Department Name
Haematologie und Onkologie
Principal Investigator Name
Mark-Peter Ufen
Principal Investigator Email
info@onkologie-westerstede.de
Contact Person Name
Mark-Peter Ufen
Contact Person Email
info@onkologie-westerstede.de
Site Name
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR
Department Name
Haematologie & Onkologie
Principal Investigator Name
Matthias Zaiss
Principal Investigator Email
info@onkologie-freiburg.de
Contact Person Name
Matthias Zaiss
Contact Person Email
info@onkologie-freiburg.de
Site Name
Praxisnetzwerk Haematologie und internistische Onkologie Ueberoertliche Berufsausuebungsgemeinschaft
Department Name
Haematologie und intern. Onkologie
Principal Investigator Name
Andreas Diel
Principal Investigator Email
studie@onkologie-rheinsieg.de
Contact Person Name
Andreas Diel
Contact Person Email
studie@onkologie-rheinsieg.de
Site Name
Marien-Hospital Witten
Department Name
Zentrum fuer Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Monika Graeser
Principal Investigator Email
Katja.Fritz@elisabethgruppe.de
Contact Person Name
Monika Graeser
Contact Person Email
Katja.Fritz@elisabethgruppe.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Frauenklinik
Principal Investigator Name
Peter Fasching
Principal Investigator Email
fk-studienzentrale@uk-erlangen.de
Contact Person Name
Peter Fasching
Site Name
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Claudia Hänle
Principal Investigator Email
studma01@rkh-gesundheit.de
Contact Person Name
Claudia Hänle
Contact Person Email
studma01@rkh-gesundheit.de
Site Name
Caritas Traegergesellschaft Saarbruecken mbH (CTS)
Department Name
Klinik fuer Frauenheilkunde/Brustzentrum Saar Mitte
Principal Investigator Name
Mustafa Deryal
Contact Person Name
Mustafa Deryal
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Universitäts-Frauenklinik
Principal Investigator Name
Andreas Hartkopf
Principal Investigator Email
Andreas.hartkopf@med.uni-tuebingen.de
Contact Person Name
Andreas Hartkopf
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Klinik und Poliklinik für Geburtshilfe und Frauengesundheit
Principal Investigator Name
Markus Schmidt
Principal Investigator Email
gyn.uct-studien@unimedizin-mainz.de
Contact Person Name
Markus Schmidt
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Frauenheilkunde und Geburtshilfe
Principal Investigator Name
Marika Henriette Princk
Principal Investigator Email
info@uksh.de
Contact Person Name
Marika Henriette Princk
Contact Person Email
info@uksh.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe Brustzentrum Studienzentrale Raum
Principal Investigator Name
Nadia Harbeck
Principal Investigator Email
nadia.harbeck@med.uni-muenchen.de
Contact Person Name
Nadia Harbeck

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
IQVIA Limited
Name
ICON
Responsibilities
Central imaging

Third parties

  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"ICON","duties_or_roles":"Central imaging","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-2870
Active Substance
SACITUZUMAB TIRUMOTECAN
Modality
ADC
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Investigational medicinal product (IMP) - biological; product entry shows prodAuthStatus 1
Maximum Dose
4 mg/kg daily max or product maxDailyDoseAmount 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
Marketing authorisation exists (EU/1/15/1024/002) - prodAuthStatus 2
Maximum Dose
maxDailyDoseAmount 400 mg (as listed in product info)
Investigational Product Name
CAPECITABINE
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Marketing authorisation status present for product dictionary but 'marketingAuthNumber':'-' in part1; prodAuthStatus 2
Maximum Dose
maxDailyDoseAmount 2500 mg/m2
Investigational Product Name
Auxiliary/Supportive medicines (DEXAMETHASONE, PARACETAMOL, H2-RECEPTOR ANTAGONISTS, ANTIHISTAMINES)
Active Substance
DEXAMETHASONE ACETATE; BUCLIZINE HYDROCHLORIDE, PARACETAMOL, CODEINE PHOSPHATE; H2-RECEPTOR ANTAGONISTS
Modality
Small molecule / Chemical
Routes Of Administration
OTHER USE / ORAL USE
Combination Treatment
Yes

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