Clinical trial • Phase III • Oncology

DURVALUMAB for Muscle-invasive bladder cancer | Urothelial carcinoma (bladder)

Phase III trial of DURVALUMAB for Muscle-invasive bladder cancer | Urothelial carcinoma (bladder).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Muscle-invasive bladder cancer | Urothelial carcinoma (bladder)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|ADC|Small molecule

Key dates

Initial CTIS Submission Date
13-06-2024
First CTIS Authorization Date
15-07-2024

Trial design

Randomised, open-label, cystectomy (radical cystectomy) as surgical comparator (arm 3); active interventional comparators are durvalumab + tremelimumab + enfortumab vedotin (arm 1) and durvalumab + enfortumab vedotin (arm 2). dose and schedule not specified in the available data.-controlled Phase III trial in Greece, Germany, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Cystectomy (radical cystectomy) as surgical comparator (Arm 3); active interventional comparators are durvalumab + tremelimumab + enfortumab vedotin (Arm 1) and durvalumab + enfortumab vedotin (Arm 2). Dose and schedule not specified in the available data.
Target Sample Size
393

Eligibility

Recruits 393 Vulnerable population flag set (isVulnerablePopulationSelected = true) in the registry. No detailed description of vulnerable population consent/assent handling is provided in the available CTIS data..

Vulnerable Population
Vulnerable population flag set (isVulnerablePopulationSelected = true) in the registry. No detailed description of vulnerable population consent/assent handling is provided in the available CTIS data.

Inclusion criteria

  • {"criterion_text":"- Participants with histologically or cytologically documented muscle-invasive TCC (also known as UC) of the bladder."}
  • {"criterion_text":"- Participants with transitional cell and mixed transitional / non-transitional cell histologies"}
  • {"criterion_text":"- Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical stage T1N1M0 (participants with T1 stage are allowed only with N1 disease) according to the American Joint Committee on Cancer Staging Manual TCC of the bladder"}
  • {"criterion_text":"- Participants should also have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC or bladder UC"}
  • {"criterion_text":"- Medically fit for cystectomy and able to receive neoadjuvant therapy"}
  • {"criterion_text":"- ECOG performance status of 0, 1, 2 at enrollment"}
  • {"criterion_text":"- Availability of tumor sample prior to study entry"}
  • {"criterion_text":"- Cisplatin-ineligible, as defined by any of the following criteria (based on Galsky et al 2011) or Refuse cisplatin based chemotherapy"}
  • {"criterion_text":"- Must have a life expectancy of at least 12 weeks at randomization"}

Exclusion criteria

  • {"criterion_text":"- Evidence of lymph node (N2-3) or metastatic TCC/UC disease at the time of screening."}
  • {"criterion_text":"- Active infection"}
  • {"criterion_text":"- Uncontrolled intercurrent illness"}
  • {"criterion_text":"- Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies"}
  • {"criterion_text":"- Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs"}
  • {"criterion_text":"- \"Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies\""}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Safety Run-In (SRI):Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical laboratory assessments, ECGs, and WHO/ECOG performance status.","definition_or_measurement_approach":"Evaluated in terms of adverse events (AEs), vital signs, clinical laboratory assessments, ECGs, and WHO/ECOG performance status as stated."}
  • {"endpoint_text":"- Main Study: EFS (per BICR or by central pathology review if a biopsy is required for a suspected new lesion) is defined as the time from randomization to the first occurrence of any of the following events: - recurrence of disease post-radical cystectomy; - the first documented progression in participants who did not receive radical cystectomy; - failure to undergo radical cystectomy in participants with residual disease, or - death due to any cause","definition_or_measurement_approach":"EFS defined as time from randomization to first of: recurrence after radical cystectomy; first documented progression in participants who did not receive radical cystectomy; failure to undergo radical cystectomy in participants with residual disease; or death from any cause. Assessment per BICR or by central pathology review if biopsy required."}

Secondary endpoints

  • {"endpoint_text":"- Pathologic complete response (pCR) rate is defined as the number of participants whose pathological staging was T0N0M0 as assessed per local pathology and central independent review using specimens obtained via cystectomy.","definition_or_measurement_approach":"pCR = pathological staging T0N0M0 assessed by local pathology and central independent review using cystectomy specimens."}
  • {"endpoint_text":"- Main Study: EFS (per BICR or by central pathology review if a biopsy is required for a suspected new lesion) is defined as the time from randomization to the first occurrence of any of the following events: - recurrence of disease post-radical cystectomy, - the first documented progression in participants who did not receive radical cystectomy, - failure to undergo radical cystectomy in participants with residual disease, or - death due to any cause.","definition_or_measurement_approach":"As for primary EFS definition; measured per BICR or central pathology review if biopsy required."}
  • {"endpoint_text":"- Main Study: OS is defined as the length of time from randomization until the date of death due to any cause.","definition_or_measurement_approach":"Overall survival = time from randomization to death from any cause; Kaplan-Meier estimates used for timepoint analyses (e.g., OS5)."}
  • {"endpoint_text":"- Main Study: - pCR rate as defined in the Safety Run-in; - The proportion of participants alive and event-free at 24 months (EFS24; per BICR or by central pathology review if a biopsy is required for a suspected new lesion) is defined as the Kaplan-Meier estimate of EFS at 24 months after randomization •\tOS5 is defined as the Kaplan-Meier estimate of OS at 5 years after randomization","definition_or_measurement_approach":"EFS24 = Kaplan-Meier estimate of EFS at 24 months; OS5 = Kaplan-Meier estimate of OS at 5 years; pCR as defined in SRI."}
  • {"endpoint_text":"- Main Study: DFS (per BICR or by central pathology review if a biopsy is required for a suspected new lesion) defined as the time from the date of radical cystectomy to the first recurrence of disease post radical cystectomy, or death due to any cause, whichever occurs first in MIBC participants who undergo radical cystectomy","definition_or_measurement_approach":"DFS = time from date of radical cystectomy to first recurrence post-cystectomy or death from any cause; assessed per BICR or central pathology review if biopsy required."}
  • {"endpoint_text":"- Main Study: pDS rate is defined as the rate of downstaging to < pT2, including pT0, pTis, pTa, pT1, and N0; - DSS is defined as the time from the date of randomization until death due to bladder cancer; - MFS is defined as the time from date of randomization until the first recognition of distant metastases or death, whichever occurs first; - pCR rate as defined above in the SRI; - EFS, OS, EFS24, OS5, DFS, pDS rate, DSS, MFS defined as secondary endpoints above.","definition_or_measurement_approach":"pDS = downstaging to <pT2 (pT0, pTis, pTa, pT1, N0). DSS = time from randomization to death due to bladder cancer. MFS = time from randomization to first detection of distant metastases or death."}
  • {"endpoint_text":"- Adjusted mean change from baseline and time to definitive clinically meaningful deterioration in EORTC QLQ-C30 scale/item scores (prioritized domains: fatigue and pain, physical functioning, and global health status/QoL)","definition_or_measurement_approach":"Patient-reported outcomes using EORTC QLQ-C30; analysis of adjusted mean change from baseline and time to definitive clinically meaningful deterioration for prioritized domains."}
  • {"endpoint_text":"- Concentration of durvalumab and tremelimumab in serum and PK parameters","definition_or_measurement_approach":"Serum concentrations and pharmacokinetic parameters for durvalumab and tremelimumab measured via PK assays."}
  • {"endpoint_text":"- Presence of ADAs for durvalumab and tremelimumab","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADAs) for durvalumab and tremelimumab using immunogenicity assays."}
  • {"endpoint_text":"- Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical laboratory assessments, ECGs, and WHO/ECOG performance status, as described for the corresponding safety run-in objectives and endpoints","definition_or_measurement_approach":"Safety and tolerability assessment via reporting of AEs, vital signs, labs, ECGs, and WHO/ECOG performance status as per SRI endpoints."}

Recruitment

Planned Sample Size
393
Recruitment Window Months
86
Consent Approach
Informed consent is required from participants. Subject information and informed consent forms (ICFs) are provided in multiple country/language-specific versions (examples in the documents list include Greek, German, English, Portuguese, Polish, Italian, Spanish, French, Dutch). Additional ICFs for pregnant partners and for genetic research are included among available documents. No detailed assent/consent procedures for vulnerable minors are provided in the available CTIS data.

Geography

Total Number Of Sites
93
Total Number Of Participants
284

Greece

Latest Decision Or Authorization Date
22-04-2026
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Athens Medical Center S.A.
Department Name
Medical Oncology Department
Contact Person Name
Marinos Tsiatas
Contact Person Email
mtsiatas@otenet.gr
Site Name
Alexandra Hospital
Department Name
Department of Clinical Therapeutics
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
University General Hospital Attikon
Department Name
2nd Propaeudeutic Department of Internal Medicine
Contact Person Name
Aristotelis Bamias
Contact Person Email
abamias@med.uoa.gr

Germany

Latest Decision Or Authorization Date
24-04-2026
Number Of Sites
16
Number Of Participants
41

Sites

Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Klinik für Urologie und Urochirurgie
Contact Person Name
Frederik Wessels
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Urologische Klinik
Contact Person Name
Jozefina Casuscelli
Site Name
Evangelisches Klinikum Bethel gGmbH
Contact Person Name
Jesco Pfitzenmaier
Contact Person Email
Jesco.Pfitzenmaier@evkb.de
Site Name
Marien Hospital Herne -Universitaetsklinikum der Ruhr-Universitaet Bochum
Department Name
Klinik für Urologie
Contact Person Name
Florian Roghmann
Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Contact Person Name
Tilmann Todenhöfer
Contact Person Email
todenhoefer@studienurologie.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Zentralklinikum Gebäude A1
Contact Person Name
Martin Bögemann
Contact Person Email
martin.boegemann@ukmuenster.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Urologie
Contact Person Name
Günter Niegisch
Site Name
Universitaetsklinikum Magdeburg AöR
Department Name
Klinik für Urologie, Uroonkologie, robotergestütze und fokale Therapie
Contact Person Name
Alexander Fehr
Contact Person Email
alexander.fehr@med.ovgu.de
Site Name
University Hospital Cologne AöR
Department Name
Uro-Onkologisches Zentrum
Contact Person Name
Axel Heidenreich
Contact Person Email
axel.heidenreich@uk-koeln.de
Site Name
Augusta-Kranken-Anstalt gGmbH
Contact Person Name
Robert Radkowski
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Urologie und Urologische Onkologie
Contact Person Name
Christoph von Klot
Contact Person Email
Klot.Christoph@mh-hannover.de
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Universitätsklinik und Poliklinik für Urologie
Contact Person Name
Georgios Gakis
Contact Person Email
Georgios.Gakis@uk-halle.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Klinik und Poliklinik für Urologie und Kinderurologie
Contact Person Name
Maximilian Brandt
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik für Urologie
Contact Person Name
Marco-Julius Schnabel
Contact Person Email
mschnabel@caritasstjosef.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Klinik und Poliklinik für Urologie, Kinderurologie und Andrologie
Contact Person Name
Florian Wagenlehner
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Urologie und Kinderurologie
Contact Person Name
Friedemann Zengerling

Italy

Latest Decision Or Authorization Date
24-04-2026
Number Of Sites
15
Number Of Participants
50

Sites

Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
U.O.C. Oncologia
Contact Person Name
Andrea Zivi
Contact Person Email
andrea.zivi@aovr.veneto.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Oncologia Medica
Contact Person Name
Giampaolo Tortora
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia Medica 1
Contact Person Name
Marco Maruzzo
Contact Person Email
marco.maruzzo@iov.veneto.it
Site Name
Azienda Ospedaliero - Universitaria Consorziale Policlinico
Department Name
U.O.
Contact Person Name
Camillo Porta
Contact Person Email
studiclinici.porta@gmail.com
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
UOC Oncologia
Contact Person Name
Emiliano Tamburini
Contact Person Email
emilianotamburini@icloud.com
Site Name
ASL Napoli 2 Nord - Ospedale Santa Maria delle Grazie
Department Name
U.O.C. Oncologia
Contact Person Name
Gaetano Facchini
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncologia Medica Urogenitale e cervico facciale
Contact Person Name
Franco Nolè
Contact Person Email
franco.nole@ieo.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOC Urologia
Contact Person Name
Giuseppe Simone
Contact Person Email
giuseppe.simone@ifo.it
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
S.C. Oncologia Medica e Translazionale
Contact Person Name
Annalisa Guida
Contact Person Email
a.guida@aospterni.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
S.C. Oncologia Medica
Contact Person Name
Emanuele Naglieri
Contact Person Email
emanuele.naglieri@gmail.com
Site Name
Careggi University Hospital
Department Name
SODc Oncologia Clinica
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
lorenzo.antonuzzo@gmail.com
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
UOC Oncologia Medica
Contact Person Name
Cristina Masini
Contact Person Email
cristina.masini@ausl.re.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
S.C. Oncologia Medica
Contact Person Name
Emilio Francesco Giunta
Contact Person Email
emilio.giunta@irst.emr.it
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
U.O.C. Oncologia Medica
Contact Person Name
Giuseppe Tonini
Contact Person Email
g.tonini@policlinicocampus.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori (additional listed sites)

Portugal

Latest Decision Or Authorization Date
21-04-2026
Number Of Sites
10
Number Of Participants
18

Sites

Site Name
Hospital Da Luz S.A.
Department Name
Oncology
Contact Person Name
João Moreira Pinto
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Medical Oncology
Contact Person Name
Ricardo Luz
Contact Person Email
ricardo.luz@chlc.min-saude.pt
Site Name
Lusiadas S.A.
Department Name
Oncology
Contact Person Name
Daniela Macedo
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Oncology
Contact Person Name
Sandra Custódio
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Oncology
Contact Person Name
Catarina Portela
Contact Person Email
2ca@ccabraga.org
Site Name
Hospital Cuf Tejo S.A.
Department Name
Oncology
Contact Person Name
Mário Fontes e Sousa
Contact Person Email
mario.fontes.sousa@cuf.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Medical Oncology
Contact Person Name
André Mansinho
Contact Person Email
cic@ulssm.min-saude.pt
Site Name
Unidade Local de Saude do Algarve E.P.E.
Department Name
Oncology
Contact Person Name
Cidália Pinto
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Maria Joaquina Maurício
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Urology and Kidney Transplant
Contact Person Name
Arnaldo Figueiredo

Spain

Latest Decision Or Authorization Date
27-04-2026
Number Of Sites
15
Number Of Participants
67

Sites

Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Xavier Garcia Del Muro
Contact Person Email
garciadelmuro@iconcologia.net
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology
Contact Person Name
Teresa Bonfill Abella
Contact Person Email
TBonfill@tauli.cat
Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Contact Person Name
Javier Puente Vazquez
Contact Person Email
javierpuente.hcsc@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Medical Oncology
Contact Person Name
Alberto Torres Zurita
Contact Person Email
albertotorreszurita@gmail.com
Site Name
MD Anderson Cancer Center (Spain)
Department Name
Oncology
Contact Person Name
Ana Lucrecia Ruiz Echeverria
Contact Person Email
alruiz@hospiten.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Rafael Morales-Barrera
Contact Person Email
rmorales@vhio.net
Site Name
Hospital Universitario La Paz
Department Name
Medical Oncology
Contact Person Name
Alvaro Pinto Marin
Contact Person Email
alvaropintomarin@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Medical Oncology
Contact Person Name
Ignacio Duran Martinez
Contact Person Email
ignacioduranmartinez@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology
Contact Person Name
Oscar Reig Torras
Contact Person Email
oreig@clinic.cat
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Medical Oncology
Contact Person Name
Jose Maroto Rey
Contact Person Email
jmaroto@santpau.cat
Site Name
Hospital Universitario De Navarra
Department Name
Medical Oncology
Contact Person Name
Nuria Lainez-Milagro
Site Name
Hospital Universitario La Paz (additional listed sites)
Site Name
Hospital Universitario Clinico San Carlos (additional listed sites)
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Medical Oncology
Contact Person Name
Alfonso Gomez de Liano Lista
Contact Person Email
agomlis@gobiernodecanarias.org

Netherlands

Latest Decision Or Authorization Date
23-04-2026
Number Of Sites
7
Number Of Participants
21

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Medical Oncology
Contact Person Name
Michel van Kruchten
Contact Person Email
m.van.kruchten@umcg.nl
Site Name
Spaarne Gasthuis Stichting
Department Name
Internal Medicine/Oncology
Contact Person Name
Aart Beeker
Contact Person Email
abeeker@spaarnegasthuis.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Medical Oncology
Contact Person Name
Tom van der Hulle
Contact Person Email
T.van_der_Hulle@lumc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Medical Oncology
Contact Person Name
Britt Suelmann
Contact Person Email
B.B.M.Suelmann@umcutrecht.nl
Site Name
Amphia Hospital
Department Name
Internal Medicine
Contact Person Name
Hans Westgeest
Contact Person Email
hwestgeest@amphia.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Medical Oncology
Contact Person Name
Theo van Voorthuizen
Contact Person Email
t.vanvoorthuizen@rijnstate.nl
Site Name
Leids Universitair Medisch Centrum (additional listed sites)

Austria

Latest Decision Or Authorization Date
24-04-2026
Number Of Sites
7
Number Of Participants
17

Sites

Site Name
Noe LGA Gesundheit Thermenregion GmbH
Department Name
Internal Medicine, Hematology and Internal Oncology
Contact Person Name
Birgit Gruenberger
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Urology and Andrology
Contact Person Name
Lukas Lusuardi
Contact Person Email
l.lusuardi@salk.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Urology
Contact Person Name
Ferdinand Luger
Site Name
Medical University Of Graz
Department Name
Internal Medicine
Contact Person Name
Thomas Bauernhofer
Site Name
Medical University of Vienna
Department Name
Urology
Contact Person Name
Shahrokh Shariat
Site Name
Krankenhaus Der Barmherzigen Brueder Wien
Department Name
Internal Medicine
Contact Person Name
Johannes Meran
Contact Person Email
johannes.meran@bbwien.at
Site Name
Universitaetsklinikum Krems
Department Name
Internal Medicine 2
Contact Person Name
Sonia Vallet
Contact Person Email
sonia.vallet@krems.lknoe.at

Poland

Latest Decision Or Authorization Date
24-04-2026
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Układu Moczowego
Contact Person Name
Paweł Wiechno
Contact Person Email
wiechno@gmail.com
Site Name
Pratia S.A.
Department Name
Centrum Medyczne Pratia Poznań
Contact Person Name
Piotr Tomczak
Contact Person Email
md.piotr.tomczak@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Katedra i Klinika Onkologii i Radioterapii
Contact Person Name
Renata Zaucha
Contact Person Email
rzaucha@gumed.edu.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Dzienny Chemioterapii
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med.pl

France

Latest Decision Or Authorization Date
21-04-2026
Number Of Sites
16
Number Of Participants
48

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Medical Oncology
Contact Person Name
Philippe Barthelemy
Contact Person Email
p.barthelemy@icans.eu
Site Name
Centre De Cancerologue Du Grand Montpellier
Contact Person Name
Catherine Becht-Rolly
Contact Person Email
becht@oncoclem.org
Site Name
Centre Leon Berard
Department Name
Oncologie médicale
Contact Person Name
Aude Fléchon
Contact Person Email
aude.flechon@lyon.unicancer.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
Département d'Oncologie Médicale
Contact Person Name
Vincent Massard
Contact Person Email
v.massard@nancy.unicancer.fr
Site Name
Centre Jean Perrin
Department Name
Centre Jean Perrin
Contact Person Name
Laurent Guy
Contact Person Email
lguy@chu-clermontferrand.fr
Site Name
Hôpital de la Timone
Department Name
Département d'Oncologie Médicale
Contact Person Name
Jean Laurent Deville
Contact Person Email
jean-laurent.deville@ap-hm.fr
Site Name
Institut Paoli Calmettes
Contact Person Name
Gwenaëlle Gravis-Mescam
Contact Person Email
gravisg@ipc.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Pôle de Cancérologie, Bâtiment K
Contact Person Name
Pierre Cornillon
Site Name
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Department Name
Service d'Oncologie Médicale
Contact Person Name
Sophie Tartas
Contact Person Email
sophie.tartas@chu-lyon.fr
Site Name
HPM Nord
Department Name
Centre d’oncologie Bourgogne
Contact Person Name
Come De Metz
Contact Person Email
CDEMETZ@clinique-psv.fr
Site Name
CLINIQUE VICTOR PAUCHET de BUTLER
Contact Person Name
Jorge Vesga Villamizar
Site Name
Capio La Croix Du Sud
Contact Person Name
Guillaume Ploussard
Contact Person Email
dr.gploussard@gmail.com
Site Name
Centre Antoine Lacassagne
Contact Person Name
Delphine Borchiellini
Site Name
Hospital Foch
Department Name
Département d'Oncologie Médicale
Contact Person Name
Christine Abraham
Contact Person Email
c.abraham@hopital-foch.com
Site Name
Centre Hospitalier De La Cote Basque
Contact Person Name
Louis François
Contact Person Email
lfrancois@ch-cotebasque.fr

Sponsor

Primary sponsor

Full Name
Astrazeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
Fortrea Inc.
Responsibilities
Monitoring and vendor management
Name
PPD Development LP
Responsibilities
Testing PK Tremelimumab, ADA and nAB
Name
Calyx
Responsibilities
Imaging
Name
Clario (formerly ERT)
Responsibilities
ePRO
Name
Fisher Clinical Services
Responsibilities
Drug Distribution
Name
Signant Health Global LLC
Responsibilities
eConsent and Interactive Response Technology (IRT)
Name
RWS Life Sciences Inc.
Responsibilities
ePRO Translations
Name
Cytel Inc.
Responsibilities
IDMC
Name
Labcorp Central Laboratory Services LP
Responsibilities
pCR Lab
Name
Cellcarta Naperville LLC
Responsibilities
PD-L1 Lab

Third parties

  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"ePRO Translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario (formerly ERT)","duties_or_roles":"ePRO","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Calyx","duties_or_roles":"Imaging","organisation_type":"Industry"}
  • {"country":"United Kingdom","full_name":"Fisher Clinical Services","duties_or_roles":"Drug Distribution","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"pCR Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cellcarta Naperville LLC","duties_or_roles":"PD-L1 Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Testing PK Tremelimumab, ADA and nAB","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Monitoring and vendor management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"IDMC","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eConsent and Interactive Response Technology (IRT)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"Patient Engagement and Lay Language Summary - Print vendor – Thank you Cards","organisation_type":"Patient organisation/association"}

Investigational products

Investigational Product Name
DURVALUMAB
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
18000 mg (max total dose amount as listed)
Investigational Product Name
TREMELIMUMAB
Active Substance
TREMELIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
225 mg (max total dose amount as listed)
Investigational Product Name
ENFORTUMAB VEDOTIN (Padcev)
Active Substance
ENFORTUMAB VEDOTIN
Modality
ADC
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation listed for Padcev formulations)
Maximum Dose
Max total dose amount listed 750 mg (dose UoM mg/kg; max daily 1.25 mg/kg listed)
Combination Treatment
Yes

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