Clinical trial • Phase III • Oncology
DURVALUMAB for Urothelial carcinoma | Bladder cancer
Phase III trial of DURVALUMAB for Urothelial carcinoma | Bladder cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Urothelial carcinoma | Bladder cancer
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 03-06-2024
- First CTIS Authorization Date
- 28-06-2024
Trial design
Randomised, open-label, three arms: (1) durvalumab in combination with standard-of-care (soc) chemotherapy (soc: cisplatin + gemcitabine; if cisplatin-ineligible, carboplatin + gemcitabine) every 3 weeks for 6 cycles; durvalumab administered every 3 weeks concurrent with chemotherapy then durvalumab monotherapy every 4 weeks. (2) durvalumab in combination with tremelimumab + soc chemotherapy (same soc regimens: cisplatin + gemcitabine or carboplatin + gemcitabine) every 3 weeks for 6 cycles. (3) soc chemotherapy alone (cisplatin + gemcitabine or carboplatin + gemcitabine). dose amounts are not specified in the record.-controlled Phase III trial across 43 sites in Spain, Hungary, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Three arms: (1) Durvalumab in combination with standard-of-care (SoC) chemotherapy (SoC: cisplatin + gemcitabine; if cisplatin-ineligible, carboplatin + gemcitabine) every 3 weeks for 6 cycles; durvalumab administered every 3 weeks concurrent with chemotherapy then durvalumab monotherapy every 4 weeks. (2) Durvalumab in combination with Tremelimumab + SoC chemotherapy (same SoC regimens: cisplatin + gemcitabine or carboplatin + gemcitabine) every 3 weeks for 6 cycles. (3) SoC chemotherapy alone (cisplatin + gemcitabine or carboplatin + gemcitabine). Dose amounts are not specified in the record.
- Biomarker Stratified
- True, biomarker: PD-L1 expression (high PD-L1 expression population specified)
- Target Sample Size
- 921
Eligibility
Recruits 921 Vulnerable population selected: True (record field 'isVulnerablePopulationSelected' = true). The trial enrols adults; informed consent is obtained via country-specific adult subject information and informed consent forms (ICFs) and addenda (multiple country ICFs are provided). No assent or minor/child consent procedures are described in the record..
- Pregnancy Exclusion
- Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.
- Vulnerable Population
- Vulnerable population selected: True (record field 'isVulnerablePopulationSelected' = true). The trial enrols adults; informed consent is obtained via country-specific adult subject information and informed consent forms (ICFs) and addenda (multiple country ICFs are provided). No assent or minor/child consent procedures are described in the record.
Inclusion criteria
- {"criterion_text":"- Patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra)"}
- {"criterion_text":"- Patients who have not been previously treated with first-line chemotherapy. Patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred >12 months from the last therapy [for chemoradiation and adjuvant treatment] or >12 months from the last surgery [for neoadjuvant treatment]."}
- {"criterion_text":"- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline."}
- {"criterion_text":"- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment"}
- {"criterion_text":"- Adequate organ and marrow function as defined in the protocol"}
- {"criterion_text":"- Life expectancy ≥12 weeks in the opinion of the investigator"}
- {"criterion_text":"- Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients."}
Exclusion criteria
- {"criterion_text":"- Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, or anti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment."}
- {"criterion_text":"- No severe concomitant condition that requires immunosuppression medication"}
- {"criterion_text":"- Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis"}
- {"criterion_text":"- Patients who may be eligible for or are being considered for radical resection during the course of the study."}
- {"criterion_text":"- Any medical contraindications to platinum (cisplatin or carboplatin) based doublet chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Not specified in the record"}
Secondary endpoints
- {"endpoint_text":"- Progression Free Survival (PFS)","definition_or_measurement_approach":"Not specified in the record"}
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Not specified in the record"}
- {"endpoint_text":"- Alive and Progression Free Patients at 12 Months (APF12)","definition_or_measurement_approach":"Not specified in the record"}
- {"endpoint_text":"- Overall Response Rate (ORR)","definition_or_measurement_approach":"Not specified in the record"}
- {"endpoint_text":"- Disease Control Rate (DCR)","definition_or_measurement_approach":"Not specified in the record"}
- {"endpoint_text":"- Duration of Response (DoR)","definition_or_measurement_approach":"Not specified in the record"}
- {"endpoint_text":"- Time from Randomization to Second Progression PFS (PFS2)","definition_or_measurement_approach":"Not specified in the record"}
- {"endpoint_text":"- Safety","definition_or_measurement_approach":"Not specified in the record"}
- {"endpoint_text":"- Disease related symptoms","definition_or_measurement_approach":"Not specified in the record"}
Recruitment
- Planned Sample Size
- 921
- Recruitment Window Months
- 23
- Consent Approach
- Informed consent obtained via adult subject information and informed consent forms (ICFs). Country-specific ICFs and addenda are provided (documents for multiple countries/languages are listed, including adult ICFs, pregnant partner ICFs, genetics/biological sample addenda and ICF addenda). Consent is provided by the adult participants; no assent process for minors is described in the record.
Geography
- Total Number Of Sites
- 43
- Total Number Of Participants
- 353
Spain
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 17-01-2025
- Processing Time Days
- 217
- Number Of Sites
- 10
- Number Of Participants
- 75
Sites
- Site Name
- Hospital Universitario Lucus Augusti
- Department Name
- Oncology
- Principal Investigator Name
- Sergio Vazquez Estevez
- Principal Investigator Email
- sergio.vazquez.estevez@sergas.es
- Contact Person Name
- Sergio Vazquez Estevez
- Contact Person Email
- sergio.vazquez.estevez@sergas.es
- Site Name
- Hospital Del Mar
- Department Name
- Oncology
- Principal Investigator Name
- Alejo Rodríguez-Vida
- Principal Investigator Email
- arodriguezvida@parcdesalutmar.cat
- Contact Person Name
- Alejo Rodríguez-Vida
- Contact Person Email
- arodriguezvida@parcdesalutmar.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Teresa Alonso Gordoa
- Principal Investigator Email
- talonsogordoa@gmail.com
- Contact Person Name
- Teresa Alonso Gordoa
- Contact Person Email
- talonsogordoa@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Xavier García del Muro Solans
- Principal Investigator Email
- garciadelmuro@iconcologia.net
- Contact Person Name
- Xavier García del Muro Solans
- Contact Person Email
- garciadelmuro@iconcologia.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Begoña Pérez Valderrama
- Principal Investigator Email
- bpvalderrama@gmail.com
- Contact Person Name
- Begoña Pérez Valderrama
- Contact Person Email
- bpvalderrama@gmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Principal Investigator Name
- Javier Puente Vázquez
- Principal Investigator Email
- javier.puente@salud.madrid.org
- Contact Person Name
- Javier Puente Vázquez
- Contact Person Email
- javier.puente@salud.madrid.org
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncology
- Principal Investigator Name
- Ignacio Durán Martínez
- Principal Investigator Email
- ignacioduranmartinez@gmail.com
- Contact Person Name
- Ignacio Durán Martínez
- Contact Person Email
- ignacioduranmartinez@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Rafael Morales Barrera
- Principal Investigator Email
- rmorales@vhio.net
- Contact Person Name
- Rafael Morales Barrera
- Contact Person Email
- rmorales@vhio.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Principal Investigator Name
- José Ángel Arranz Arija
- Principal Investigator Email
- jarranza.oncomed@gmail.com
- Contact Person Name
- José Ángel Arranz Arija
- Contact Person Email
- jarranza.oncomed@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Principal Investigator Name
- Lucia Oliva Fernandez
- Principal Investigator Email
- luciaolifer3@gmail.com
- Contact Person Name
- Lucia Oliva Fernandez
- Contact Person Email
- luciaolifer3@gmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 19-06-2025
- Processing Time Days
- 370
- Number Of Sites
- 6
- Number Of Participants
- 53
Sites
- Site Name
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
- Department Name
- Onkoradiológiai Osztály
- Principal Investigator Name
- András Szigeti
- Principal Investigator Email
- drszigetia2@gmail.com
- Contact Person Name
- András Szigeti
- Contact Person Email
- drszigetia2@gmail.com
- Site Name
- Budapesti Uzsoki Utcai Korhaz
- Department Name
- Onkoradiológiai Osztály
- Principal Investigator Name
- Róbert Farkas
- Principal Investigator Email
- robert.farkas7222@gmail.com
- Contact Person Name
- Róbert Farkas
- Contact Person Email
- robert.farkas7222@gmail.com
- Site Name
- Bacs-Kiskun Varmegyei Oktatokorhaz
- Department Name
- Onkoradiológiai Központ
- Principal Investigator Name
- Zsolt Horváth
- Principal Investigator Email
- horvathzso.study@kmk.hu
- Contact Person Name
- Zsolt Horváth
- Contact Person Email
- horvathzso.study@kmk.hu
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Urogenitális Tumorok és Klinikai Farmakológiai Osztály "Kemoterápia C"
- Principal Investigator Name
- Lajos Géczi
- Principal Investigator Email
- gelajos@oncol.hu
- Contact Person Name
- Lajos Géczi
- Contact Person Email
- gelajos@oncol.hu
- Site Name
- Central Hospital Of Northern Pest Military Hospital
- Department Name
- Onkológiai Osztály
- Principal Investigator Name
- Zsuzsanna Pápai
- Principal Investigator Email
- trial.zspapai@gmail.com
- Contact Person Name
- Zsuzsanna Pápai
- Contact Person Email
- trial.zspapai@gmail.com
- Site Name
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
- Department Name
- Onkológiai Osztály
- Principal Investigator Name
- Anikó Ragályi
- Principal Investigator Email
- szolnok.onkologia@gmail.com
- Contact Person Name
- Anikó Ragályi
- Contact Person Email
- szolnok.onkologia@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 27-06-2025
- Processing Time Days
- 378
- Number Of Sites
- 11
- Number Of Participants
- 80
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Dipartimento uro-ginecologico
- 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
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia Medica 2
- Principal Investigator Name
- Valentina Guadalupi
- Principal Investigator Email
- valentina.guadalupi@istitutotumori.mi.it
- Contact Person Name
- Valentina Guadalupi
- Contact Person Email
- valentina.guadalupi@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliera S. Maria - Terni
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Sergio Bracarda
- Principal Investigator Email
- s.bracarda@aospterni.it
- Contact Person Name
- Sergio Bracarda
- Contact Person Email
- s.bracarda@aospterni.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- SCDU Oncologia Medica
- Principal Investigator Name
- Consuelo Buttigliero
- Principal Investigator Email
- consuelo.buttigliero@gmail.com
- Contact Person Name
- Consuelo Buttigliero
- Contact Person Email
- consuelo.buttigliero@gmail.com
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- U.O.C. Oncologia
- Principal Investigator Name
- Giampaolo Tortora
- Principal Investigator Email
- giampaolo.tortora@policlinicogemelli.it
- Contact Person Name
- Giampaolo Tortora
- Contact Person Email
- giampaolo.tortora@policlinicogemelli.it
- Site Name
- Azienda Ospedaliero Universitaria Parma
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Sebastiano Buti
- Principal Investigator Email
- sbuti@ao.pr.it
- Contact Person Name
- Sebastiano Buti
- Contact Person Email
- sbuti@ao.pr.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- 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
- Azienda Ospedaliera S Maria Di Terni
- Department Name
- S.C. ONCOLOGIA
- Principal Investigator Name
- Annalisa Guida
- Principal Investigator Email
- A.GUIDA@AOSPTERNI.IT
- Contact Person Name
- Annalisa Guida
- Contact Person Email
- A.GUIDA@AOSPTERNI.IT
- Site Name
- Ospedale San Donato
- Department Name
- U.O.C. Oncologia Medica
- Principal Investigator Name
- Alketa Hamzaj
- Principal Investigator Email
- alketa.hamzaj@uslsudest.toscana.it
- Contact Person Name
- Alketa Hamzaj
- Contact Person Email
- alketa.hamzaj@uslsudest.toscana.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- 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
- Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione
- Department Name
- Oncologia
- Principal Investigator Name
- Andrea Premoli
- Principal Investigator Email
- andrea.premoli@icsmaugeri.it
- Contact Person Name
- Andrea Premoli
- Contact Person Email
- andrea.premoli@icsmaugeri.it
Czechia
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 27-06-2025
- Processing Time Days
- 378
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Fakultni Nemocnice Bulovka
- Department Name
- Ústav radiační onkologie
- Principal Investigator Name
- Petra Beran Holečková
- Principal Investigator Email
- petra.holeckova@bulovka.cz
- Contact Person Name
- Petra Beran Holečková
- Contact Person Email
- petra.holeckova@bulovka.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
- 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
- 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 U Sv Anny V Brne
- Department Name
- Oddělení chirurgické onkologie
- Principal Investigator Name
- Jana Katolická
- Principal Investigator Email
- jana.katolicka@fnusa.cz
- Contact Person Name
- Jana Katolická
- Contact Person Email
- jana.katolicka@fnusa.cz
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 19-08-2025
- Processing Time Days
- 431
- Number Of Sites
- 3
- Number Of Participants
- 25
Sites
- Site Name
- MBAL Sveta Marina EAD
- Department Name
- Clinic of medical oncology
- Principal Investigator Name
- Eleonora Dimitrova-Gospodinova
- Principal Investigator Email
- edimitrova_doc@abv.bg
- Contact Person Name
- Eleonora Dimitrova-Gospodinova
- Contact Person Email
- edimitrova_doc@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Department of medical oncology
- Principal Investigator Name
- Bozhil Robev
- Principal Investigator Email
- bostro@abv.bg
- Contact Person Name
- Bozhil Robev
- Contact Person Email
- bostro@abv.bg
- Site Name
- UMHAT Sofiamed OOD
- Department Name
- Department of medical oncology
- Principal Investigator Name
- Velko Minchev
- Principal Investigator Email
- v_minchev@abv.bg
- Contact Person Name
- Velko Minchev
- Contact Person Email
- v_minchev@abv.bg
Poland
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 15-10-2025
- Processing Time Days
- 488
- Number Of Sites
- 8
- Number Of Participants
- 100
Sites
- Site Name
- Med Polonia Sp. z o.o.
- Principal Investigator Name
- Rodryg Ramlau
- Principal Investigator Email
- rodrygramlau@gmail.com
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- rodrygramlau@gmail.com
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworow Ukladu Moczowego
- Principal Investigator Name
- Paweł Wiechno
- Principal Investigator Email
- wiechno@gmail.com
- Contact Person Name
- Paweł Wiechno
- Contact Person Email
- wiechno@gmail.com
- Site Name
- Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
- Principal Investigator Name
- Janusz Kocik
- Principal Investigator Email
- janusz.kocik@poliklinika.net
- Contact Person Name
- Janusz Kocik
- Contact Person Email
- janusz.kocik@poliklinika.net
- Site Name
- Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
- Department Name
- Oddzial Onkologii Klinicznej z Pododdzialem 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
- 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
- Oddział Onkologii Klinicznej im. Dr Ewy Pilickiej z Pododziałem Chemioterapii Dziennej
- Principal Investigator Name
- Elwira Matuszewska
- Principal Investigator Email
- ematuszewska@onkologia.bialystok.pl
- Contact Person Name
- Elwira Matuszewska
- Contact Person Email
- ematuszewska@onkologia.bialystok.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Oddzial Kliniczny Onkologii
- Principal Investigator Name
- Piotr Wysocki
- Principal Investigator Email
- piotr.wysocki@uj.edu.pl
- Contact Person Name
- Piotr Wysocki
- Contact Person Email
- piotr.wysocki@uj.edu.pl
- Site Name
- Kliniki Neuroradiochirurgii Sp. z o.o.
- Principal Investigator Name
- Tadeusz Pieńkowski
- Principal Investigator Email
- tadeusz.pienkowski@cskmswia.pl
- Contact Person Name
- Tadeusz Pieńkowski
- Contact Person Email
- tadeusz.pienkowski@cskmswia.pl
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- IMFINZI 50 mg/mL concentrate for solution for infusion.
- Active Substance
- DURVALUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (marketingAuthorisationNumber: EU/1/18/1322/001)
- Frequency
- Every 3 weeks concurrent with chemotherapy for combination period; then durvalumab monotherapy every 4 weeks (as described in study arms)
- Investigational Product Name
- IMJUDO 20 mg/ml concentrate for solution for infusion.
- Active Substance
- TREMELIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (marketingAuthorisationNumber: EU/1/22/1713/001)
- Combination Treatment
- Yes
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