Clinical trial • Phase III • Oncology
DURVALUMAB for Muscle-invasive bladder cancer
Phase III trial of DURVALUMAB for Muscle-invasive bladder cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Muscle-invasive bladder cancer
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 19-12-2023
- First CTIS Authorization Date
- 26-02-2024
Trial design
Randomised, open-label, arm 1: durvalumab + gemcitabine + cisplatin q3w x 4 cycles (neoadjuvant) followed by durvalumab q4w x 8 (adjuvant); arm 2 (comparator): gemcitabine + cisplatin q3w (neoadjuvant) and no adjuvant treatment.-controlled Phase III trial in Spain, Czechia, France and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Arm 1: Durvalumab + Gemcitabine + Cisplatin Q3W x 4 cycles (neoadjuvant) followed by Durvalumab Q4W x 8 (adjuvant); Arm 2 (comparator): Gemcitabine + Cisplatin Q3W (neoadjuvant) and no adjuvant treatment.
- Target Sample Size
- 652
Eligibility
Recruits 652 Vulnerable population selected; specific vulnerable groups and consent/assent handling not detailed in the available data..
- Vulnerable Population
- Vulnerable population selected; specific vulnerable groups and consent/assent handling not detailed in the available data.
Inclusion criteria
- {"criterion_text":"- Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology"}
- {"criterion_text":"- Patients must be planning to undergo a radical cystectomy"}
- {"criterion_text":"- Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC"}
- {"criterion_text":"- ECOG performance status of 0 or 1 at enrollment."}
- {"criterion_text":"- Availability of tumor sample prior to study entry"}
- {"criterion_text":"- Must have a life expectancy of at least 12 weeks at randomization."}
Exclusion criteria
- {"criterion_text":"- Evidence of lymph node (N2-N3) involvement or metastatic (M1) disease at the time of screening."}
- {"criterion_text":"- Contra-indication to any of the study drugs"}
- {"criterion_text":"- Requires immunosuppression medication for a concomitant condition"}
- {"criterion_text":"- Active or prior documented autoimmune or inflammatory disorders"}
Endpoints
Primary endpoints
- {"endpoint_text":"- pCR\n- EFS","definition_or_measurement_approach":"pCR: pathological complete response; EFS: event-free survival (as named in the protocol/primary endpoint listing)"}
Secondary endpoints
- {"endpoint_text":"- EFS (Event-Free Survival)\n- pCR (Pathological Complete Response)\n- EFS24 (Event-Free Survival at 24 months)\n- Proportion of patients who achieve a pathological response < P2\n- Proportion of subjects with cystectomy\n- Metastasis-free survival\n- Disease-specific survival\n- Overall survival (OS)\n- Overall survival at 5 years\n- Disease-free survival\n- PFS2 (Progression-Free Survival 2)\n- Pharmacokinetics and immunogenicity\n- Safety and tolerability profile","definition_or_measurement_approach":"Endpoints are listed as named in the protocol: EFS (event-free survival), pCR (pathological complete response), EFS24 (EFS assessed at 24 months). Other endpoints (proportion achieving specified pathological response, cystectomy rates, metastasis-free survival, disease-specific survival, OS and OS at 5 years, disease-free survival, PFS2) are outcome measures named in the secondary endpoint listing; PK and immunogenicity measured by standard pharmacokinetic/immunogenicity assays; safety and tolerability by adverse event reporting (detailed measurement definitions not provided in the available extracts)."}
Recruitment
- Planned Sample Size
- 652
- Recruitment Window Months
- 30
- Consent Approach
- Informed consent to be obtained from adult participants using subject information sheets and informed consent forms (adult ICFs). ICFs and related addenda (including pregnant partner addenda, genetic and biological sample addenda) are provided. ICF documents exist in multiple languages as indicated by document titles (English, Spanish, French, Dutch, Polish, German, Italian). No assent process for minors is described in the available material.
Geography
- Total Number Of Sites
- 57
- Total Number Of Participants
- 403
Spain
- Earliest CTIS Part Ii Submission Date
- 25-01-2024
- Latest Decision Or Authorization Date
- 27-02-2024
- Processing Time Days
- 33
- Number Of Sites
- 8
- Number Of Participants
- 77
Sites
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Albert Font Pous
- Principal Investigator Email
- afont@iconcologia.net
- Contact Person Name
- Albert Font Pous
- Contact Person Email
- afont@iconcologia.net
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Ignacio Duran Martinez
- Principal Investigator Email
- ignacioduranmartinez@gmail.com
- Contact Person Name
- Ignacio Duran Martinez
- Contact Person Email
- ignacioduranmartinez@gmail.com
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Alfonso Gomez de Liaño Lista
- Principal Investigator Email
- agomezdeliano84@gmail.com
- Contact Person Name
- Alfonso Gomez de Liaño Lista
- Contact Person Email
- agomezdeliano84@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Cristina Suarez Rodriguez
- Principal Investigator Email
- csuarez@vhio.net
- Contact Person Name
- Cristina Suarez Rodriguez
- Contact Person Email
- csuarez@vhio.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Begoña Perez Valderrama
- Principal Investigator Email
- bpvalderrama@gmail.com
- Contact Person Name
- Begoña Perez Valderrama
- Contact Person Email
- bpvalderrama@gmail.com
- Site Name
- Hospital General Universitario Reina Sofia
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Maria Jose Mendez Vidal
- Principal Investigator Email
- mjosemv@yahoo.es
- Contact Person Name
- Maria Jose Mendez Vidal
- Contact Person Email
- mjosemv@yahoo.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Jose Angel Arranz Arija
- Principal Investigator Email
- jarranza.oncomed@gmail.com
- Contact Person Name
- Jose Angel Arranz Arija
- Contact Person Email
- jarranza.oncomed@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Daniel Castellano Gauna
- Principal Investigator Email
- cdanicas@hotmail.com
- Contact Person Name
- Daniel Castellano Gauna
- Contact Person Email
- cdanicas@hotmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 25-01-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 139
- Number Of Sites
- 5
- Number Of Participants
- 33
Sites
- 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 Thomayerova nemocnice
- Department Name
- Onkologická klinika
- Principal Investigator Name
- Tomáš Büchler
- Principal Investigator Email
- tomas.buchler@ftn.cz
- Contact Person Name
- Tomáš Büchler
- Contact Person Email
- tomas.buchler@ftn.cz
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- Klinika komplexní onkologické péče
- Principal Investigator Name
- Tomáš Pokřivčák
- Principal Investigator Email
- tomas.pokrivcak@mou.cz
- Contact Person Name
- Tomáš Pokřivčák
- Contact Person Email
- tomas.pokrivcak@mou.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Klinika onkologie a radioterapie
- Principal Investigator Name
- Miroslav Hodek
- Principal Investigator Email
- miroslav.hodek@fnhk.cz
- Contact Person Name
- Miroslav Hodek
- Contact Person Email
- miroslav.hodek@fnhk.cz
- Site Name
- Fakultni Nemocnice U Sv Anny V Brne
- Department Name
- Onkologicko-chirurgické oddělení
- Principal Investigator Name
- Jana Katolická
- Principal Investigator Email
- jana.katolicka@fnusa.cz
- Contact Person Name
- Jana Katolická
- Contact Person Email
- jana.katolicka@fnusa.cz
France
- Earliest CTIS Part Ii Submission Date
- 25-01-2024
- Latest Decision Or Authorization Date
- 28-02-2024
- Processing Time Days
- 34
- Number Of Sites
- 7
- Number Of Participants
- 37
Sites
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- Oncologie Medicale
- Principal Investigator Name
- Denis MAILLET
- Principal Investigator Email
- denis.maillet@chu-lyon.fr
- Contact Person Name
- Denis MAILLET
- Contact Person Email
- denis.maillet@chu-lyon.fr
- Site Name
- Centre De Cancerologue Du Grand Montpellier
- Department Name
- Oncologie Medicale
- Principal Investigator Name
- Catherine BECHT
- Principal Investigator Email
- becht@ccgm.fr
- Contact Person Name
- Catherine BECHT
- Contact Person Email
- becht@ccgm.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Urologie
- Principal Investigator Name
- Pierre BIGOT
- Principal Investigator Email
- PiBigot@chu-angers.fr
- Contact Person Name
- Pierre BIGOT
- Contact Person Email
- PiBigot@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Oncologie Medicale
- Principal Investigator Name
- Sheik EMAMBUX
- Principal Investigator Email
- Sheik.EMAMBUX@chu-poitiers.fr
- Contact Person Name
- Sheik EMAMBUX
- Contact Person Email
- Sheik.EMAMBUX@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Oncologie Medicale
- Principal Investigator Name
- Nadine HOUEDE
- Principal Investigator Email
- nadine.houede@chu-nimes.fr
- Contact Person Name
- Nadine HOUEDE
- Contact Person Email
- nadine.houede@chu-nimes.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Oncologie Medicale
- Principal Investigator Name
- Mathieu LARAMAS
- Principal Investigator Email
- Mlaramas@chu-grenoble.fr
- Contact Person Name
- Mathieu LARAMAS
- Contact Person Email
- Mlaramas@chu-grenoble.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Oncologie Medicale
- Principal Investigator Name
- Sylvain LADOIRE
- Principal Investigator Email
- sladoire@cgfl.fr
- Contact Person Name
- Sylvain LADOIRE
- Contact Person Email
- sladoire@cgfl.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 25-01-2024
- Latest Decision Or Authorization Date
- 26-02-2024
- Processing Time Days
- 32
- Number Of Sites
- 6
- Number Of Participants
- 20
Sites
- Site Name
- UZ Leuven
- Department Name
- General Medical Oncology
- Principal Investigator Name
- Herlinde Dumez
- Principal Investigator Email
- Herlinde.dumez@uzleuven.be
- Contact Person Name
- Herlinde Dumez
- Contact Person Email
- Herlinde.dumez@uzleuven.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Medical Oncology
- Principal Investigator Name
- Marlies De Bock
- Principal Investigator Email
- marlies.debock@azdelta.be
- Contact Person Name
- Marlies De Bock
- Contact Person Email
- marlies.debock@azdelta.be
- Site Name
- Grand Hopital De Charleroi
- Department Name
- Oncology & Hematology
- Principal Investigator Name
- Marco Gizzi
- Principal Investigator Email
- marco.gizzi@ghdc.be
- Contact Person Name
- Marco Gizzi
- Contact Person Email
- marco.gizzi@ghdc.be
- Site Name
- CHU De Liege
- Department Name
- Medical Oncology
- Principal Investigator Name
- Brieuc Sautois
- Principal Investigator Email
- brieuc.sautois@chuliege.be
- Contact Person Name
- Brieuc Sautois
- Contact Person Email
- brieuc.sautois@chuliege.be
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Medical Oncology
- Principal Investigator Name
- Philip Debruyne
- Principal Investigator Email
- PHILIP.DEBRUYNE@azgroeninge.be
- Contact Person Name
- Philip Debruyne
- Contact Person Email
- PHILIP.DEBRUYNE@azgroeninge.be
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Barbara Brouwers
- Principal Investigator Email
- Barbara.Brouwers@azsintjan.be
- Contact Person Name
- Barbara Brouwers
- Contact Person Email
- Barbara.Brouwers@azsintjan.be
Italy
- Earliest CTIS Part Ii Submission Date
- 25-01-2024
- Latest Decision Or Authorization Date
- 26-02-2024
- Processing Time Days
- 32
- Number Of Sites
- 8
- Number Of Participants
- 51
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Dipartimento Corp-S di ricerca e assistenziale dei percorsi oncologici del distretto urogenitale
- Principal Investigator Name
- Rosa Tambaro
- Principal Investigator Email
- r.tambaro@istitutotumori.na.it
- Contact Person Name
- Rosa Tambaro
- Contact Person Email
- r.tambaro@istitutotumori.na.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- DAI di Chirurgia e Oncologia
- Principal Investigator Name
- Andrea Zivi
- Principal Investigator Email
- andrea.zivi@aovr.veneto.it
- Contact Person Name
- Andrea Zivi
- Contact Person Email
- andrea.zivi@aovr.veneto.it
- Site Name
- Istituto Tumori Bari Giovanni Paolo II
- Department Name
- SC Oncologia Medica
- Principal Investigator Name
- Emanuele Naglieri
- Principal Investigator Email
- emanuele.naglieri@gmail.com
- Contact Person Name
- Emanuele Naglieri
- Contact Person Email
- emanuele.naglieri@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Dipartimento di Oncologia
- Principal Investigator Name
- Consuelo Buttigliero
- Principal Investigator Email
- consuelo.buttigliero@unito.it
- Contact Person Name
- Consuelo Buttigliero
- Contact Person Email
- consuelo.buttigliero@unito.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Unità di Oncologia Medica
- Principal Investigator Name
- Andrea Necchi
- Principal Investigator Email
- necchi.andrea@hsr.it
- Contact Person Name
- Andrea Necchi
- Contact Person Email
- necchi.andrea@hsr.it
- Site Name
- Careggi University Hospital
- Department Name
- Dipartimento di Medicina sperimentale e clinica
- Principal Investigator Name
- Lorenzo Antonuzzo
- Principal Investigator Email
- antonuzzol@aou-careggi.toscana.it
- Contact Person Name
- Lorenzo Antonuzzo
- Contact Person Email
- antonuzzol@aou-careggi.toscana.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Dipartimento di Oncologia Medica ed Ematologia
- Principal Investigator Name
- Elena Verzoni
- Principal Investigator Email
- elena.verzoni@istitutotumori.mi.it
- Contact Person Name
- Elena Verzoni
- Contact Person Email
- elena.verzoni@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Dipartimento Malattie oncologiche ed ematologiche
- Principal Investigator Name
- Francesco Massari
- Principal Investigator Email
- francesco.massari8@unibo.it
- Contact Person Name
- Francesco Massari
- Contact Person Email
- francesco.massari8@unibo.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 25-01-2024
- Latest Decision Or Authorization Date
- 14-06-2024
- Processing Time Days
- 141
- Number Of Sites
- 3
- Number Of Participants
- 35
Sites
- Site Name
- Amphia Hospital
- Department Name
- Medical Oncology
- Principal Investigator Name
- Hans Westgeest
- Principal Investigator Email
- HWestgeest@amphia.nl
- Contact Person Name
- Hans Westgeest
- Contact Person Email
- HWestgeest@amphia.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Debbie Robbrecht
- Principal Investigator Email
- d.robbrecht@erasmusmc.nl
- Contact Person Name
- Debbie Robbrecht
- Contact Person Email
- d.robbrecht@erasmusmc.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Medical Oncology
- Principal Investigator Name
- Michiel van der Heijden
- Principal Investigator Email
- ms.vd.heijden@nki.nl
- Contact Person Name
- Michiel van der Heijden
- Contact Person Email
- ms.vd.heijden@nki.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 22-02-2024
- Latest Decision Or Authorization Date
- 29-02-2024
- Processing Time Days
- 7
- Number Of Sites
- 9
- Number Of Participants
- 88
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Onkologii i Radioterapii
- Principal Investigator Name
- Renata Zaucha
- Principal Investigator Email
- rzaucha@gumed.edu.pl
- Contact Person Name
- Renata Zaucha
- Contact Person Email
- rzaucha@gumed.edu.pl
- Site Name
- Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku
- Department Name
- Oddzial Onkologii Klinicznej im. Dr Ewy Pileckiej
- Principal Investigator Name
- Elwira Matuszewska
- Principal Investigator Email
- ematuszewska@onkologia.bialysok.pl
- Contact Person Name
- Elwira Matuszewska
- Contact Person Email
- ematuszewska@onkologia.bialysok.pl
- Site Name
- Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
- Department Name
- Pododdzial Chirurgii II -Urologia
- Principal Investigator Name
- Krzysztof Tupikowski
- Principal Investigator Email
- tupikowski.k@dco.com.pl
- Contact Person Name
- Krzysztof Tupikowski
- Contact Person Email
- tupikowski.k@dco.com.pl
- Site Name
- Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
- Department Name
- Oddzial Kliniczny Onkologii i Immunoonkologii z Osrodkiem Dziennym Terapii Onkologicznej
- Principal Investigator Name
- Janusz Kocik
- Principal Investigator Email
- oldcolonel196@gmail.com
- Contact Person Name
- Janusz Kocik
- Contact Person Email
- oldcolonel196@gmail.com
- Site Name
- Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
- Department Name
- Oddzial Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
- Principal Investigator Name
- Mariusz Kwiatkowski
- Principal Investigator Email
- mariusz.kwiatkowski@swk.med.pl
- Contact Person Name
- Mariusz Kwiatkowski
- Contact Person Email
- mariusz.kwiatkowski@swk.med.pl
- Site Name
- Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego
- Department Name
- Oddzial Onkologii Klinicznej
- Principal Investigator Name
- Urszula Sadowska
- Principal Investigator Email
- ula@stolcad.pl
- Contact Person Name
- Urszula Sadowska
- Contact Person Email
- ula@stolcad.pl
- Site Name
- Med Polonia Sp. z o.o.
- Principal Investigator Name
- Rodryg Ramlau
- Principal Investigator Email
- rramlau@gmail.com
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- rramlau@gmail.com
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworow Ukladu Moczowego
- Principal Investigator Name
- Pawel Wiechno
- Principal Investigator Email
- wiechno@gmail.com
- Contact Person Name
- Pawel Wiechno
- Contact Person Email
- wiechno@gmail.com
- Site Name
- Mazowiecki Szpital Specjalistyczny Im.Dr.Jozefa Psarskiego W Ostrolece
- Department Name
- Oddzial Onkologiczny
- Principal Investigator Name
- Agnieszka Domurad
- Principal Investigator Email
- agnieszka.domurad@szpital.ostroleka.pl
- Contact Person Name
- Agnieszka Domurad
- Contact Person Email
- agnieszka.domurad@szpital.ostroleka.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 25-01-2024
- Latest Decision Or Authorization Date
- 26-02-2024
- Processing Time Days
- 32
- Number Of Sites
- 11
- Number Of Participants
- 62
Sites
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik für Urologie der Universität Regensburg am Caritas-Krankenhaus St. Josef
- Principal Investigator Name
- Marco Schnabel
- Principal Investigator Email
- mschnabel@caritasstjosef.de
- Contact Person Name
- Marco Schnabel
- Contact Person Email
- mschnabel@caritasstjosef.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Klinik und Poliklinik für Urologie und Kinderurologie
- Principal Investigator Name
- Hubert Kübler
- Principal Investigator Email
- Kuebler_H@ukw.de
- Contact Person Name
- Hubert Kübler
- Contact Person Email
- Kuebler_H@ukw.de
- Site Name
- Universitat Heidelberg
- Department Name
- Medizinische Fakultät Mannheim der Universität Heidelberg Klinik für Urologie und Urochirugie
- Principal Investigator Name
- Frederik Wessels
- Principal Investigator Email
- frederik.wessels@medma.uni-heidelberg.de
- Contact Person Name
- Frederik Wessels
- Contact Person Email
- frederik.wessels@medma.uni-heidelberg.de
- Site Name
- Marien Hospital Herne Universitatsklinikum Der Ruhr-Universitat Bochum
- Principal Investigator Name
- Florian Roghmann
- Principal Investigator Email
- Florian.Roghmann@elisabethgruppe.de
- Contact Person Name
- Florian Roghmann
- Contact Person Email
- Florian.Roghmann@elisabethgruppe.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Urologie und Kinderurologie
- Principal Investigator Name
- Friedemann Zengerling
- Principal Investigator Email
- Friedemann.Zengerling@uniklinik-ulm.de
- Contact Person Name
- Friedemann Zengerling
- Contact Person Email
- Friedemann.Zengerling@uniklinik-ulm.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik für Urologie, Uro-Onkologie, spezielle urologische und roboter-assistierte Chirurgie
- Principal Investigator Name
- David Pfister
- Principal Investigator Email
- david.pfister@uk-koeln.de
- Contact Person Name
- David Pfister
- Contact Person Email
- david.pfister@uk-koeln.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Urologische und Kinderurologische Universitätsklinik
- Principal Investigator Name
- Peter J. Goebell
- Principal Investigator Email
- peter.goebell@uk-erlangen.de
- Contact Person Name
- Peter J. Goebell
- Contact Person Email
- peter.goebell@uk-erlangen.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Urologische Klinik und Poliklinik
- Principal Investigator Name
- Arne Strauß
- Principal Investigator Email
- arne.strauss@med.uni-goettingen.de
- Contact Person Name
- Arne Strauß
- Contact Person Email
- arne.strauss@med.uni-goettingen.de
- Site Name
- Universitaetsklinikum Magdeburg AöR
- Department Name
- Klinik für Urologie und Kinderurologie
- Principal Investigator Name
- Simon Blaschke
- Principal Investigator Email
- simon.blaschke@med.ovgu.de
- Contact Person Name
- Simon Blaschke
- Contact Person Email
- simon.blaschke@med.ovgu.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Klinik für Urologie und Kinderurologie
- Principal Investigator Name
- Martin Bögemann
- Principal Investigator Email
- martin.boegemann@ukmuenster.de
- Contact Person Name
- Martin Bögemann
- Contact Person Email
- martin.boegemann@ukmuenster.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik und Poliklinik für Urologie und Kinderurologie
- Principal Investigator Name
- Marc-Oliver Grimm
- Principal Investigator Email
- marc-oliver.grimm@med.uni-jena.de
- Contact Person Name
- Marc-Oliver Grimm
- Contact Person Email
- marc-oliver.grimm@med.uni-jena.de
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- DURVALUMAB
- Active Substance
- DURVALUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Frequency
- Q3W (neoadjuvant) and Q4W (adjuvant) as per arm description
- Maximum Dose
- 1500 mg (maxTotalDoseAmount reported)
- Investigational Product Name
- GEMCITABINE
- Active Substance
- GEMCITABINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Frequency
- Q3W (neoadjuvant, combined with cisplatin)
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Frequency
- Q3W (neoadjuvant, combined with gemcitabine)
- Investigational Product Name
- INFLIXIMAB
- Active Substance
- INFLIXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Investigational Product Name
- MYCOPHENOLATE MOFETIL
- Active Substance
- MYCOPHENOLATE MOFETIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Combination Treatment
- Yes
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