Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Written informed consent stating that he or she understands the purpose of the study
and the procedures involved and agrees to participate in the study.
2. Histologically confirmed diagnosis of MIBC (Stage T2-4a N0/N1 M0) obtained via a
diagnostic or maximal Transurethral Resection of Bladder Tumor (TURBT) performed no
later than 3 months prior to start the screening visit.
3. Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the
local site.
4. Age ≥ 18 years.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Decline or ineligible ("unfit") for cisplatin-based chemotherapy
7. Presence of a selected FGFR alteration on analysis of tumour biopsy
8. Adequate organ function
9. No other malignancy
10. Willingness to avoid pregnancy or fathering children
Exclusion Criteria:
1. Clinical evidence of N2-N3 tumours or metastatic bladder cancer.
2. Has tumour with any neuroendocrine or small cell component.
3. Patients who are not considered fit for cystectomy or reject cystectomy.
4. Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )systemic
therapy.
5. Prior systemic therapy, radiation therapy, or surgery for bladder cancer
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CLCC Jean Perrin
Address:
City:
Clermont-Ferrand
Zip:
63011
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Hakim Mahammedi, MD and PhD
Email:
hakim.mahammedi@clermont.unicancer.fr
Facility:
Name:
CLCC Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Contact:
Last name:
Aude Flechon, MD, PhD
Email:
aude.flechon@lyon.unicancer.fr
Facility:
Name:
Institut Mutualiste Montsouris
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Mostefa Bennamoun, MD, PhD
Email:
Mostefa.Bennamoun@imm.fr
Facility:
Name:
IUCT
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Damien Poussel, MD, PhD
Email:
pouessel.damien@iuct-oncopole.fr
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Yohann Loriot, MD, PhD
Email:
Yohann.LORIOT@gustaveroussy.fr
Facility:
Name:
IRCCS San Raffaele Hospital and Scientific Institute
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Andrea Necchi, MD, PhD
Email:
necchi.andrea@hsr.it
Facility:
Name:
Ospedale Molinette
Address:
City:
Turin
Zip:
10126
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Paolo Gontero, MD, PhD
Email:
paolo.gontero@unito.it
Facility:
Name:
A.O. Ordine Mauriziano, Ospedale Umberto I
Address:
City:
Turi
Zip:
10128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giorgio Valabrega, MD, PhD
Email:
giorgio.valabrega@unito.it
Facility:
Name:
Hospital Clínic De Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Oscar Reig, MD, PhD.
Contact backup:
Last name:
OREIG@clinic.cat
Facility:
Name:
Hospital De Sabadell (Parc Taulí)
Address:
City:
Barcelona
Zip:
08208
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Teresa Bonfill, MD, PhD.
Email:
TBonfill@tauli.cat
Facility:
Name:
Complexo Hospitalario Universitario A Coruña
Address:
City:
Coruña
Zip:
15006
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Aurea Molina, MD, PhD
Contact backup:
Email:
aurea.molina.diaz@sergas.es
Facility:
Name:
Hospital Universitario Lucus Augusti
Address:
City:
Lugo
Zip:
27003
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Sergio Vázque, MD, PhD
Contact backup:
Email:
sergio.vazquez.estevez@sergas.es
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Guillermo De Velasco, MD, PhD
Email:
guillermoantonio.velasco@salud.madrid.org
Facility:
Name:
Fundación Instituto Valenciano De Oncología
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria José Juan, MD, Phd
Email:
mjuanfi81@hotmail.com
Facility:
Name:
University Hospitals of Morecambe Bay NHS Foundation Trust
Address:
City:
Lancaster
Zip:
LA1 4RP
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Alison Birtle, MD, PhD
Email:
Alison.birtle@lthtr.nhs.uk
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Vincent Khoo, MD, PhD
Email:
VincentPA.Khoo@rmh.nhs.uk
Facility:
Name:
Barts Health NHS Trust
Address:
City:
London
Zip:
W6 8JA
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Tomas Powles, MD, PhD
Email:
thomas.powles1@nhs.net
Facility:
Name:
Charing Cross Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Naveed Sarwar, MD, PhD
Email:
naveed.sarwar1@nhs.net
Facility:
Name:
Sheffield Teaching Hospitals NHS Foundation Trust
Address:
City:
Sheffield
Zip:
S10 2SJ
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Syed Hussain, MD, PhD
Email:
syed.hussain@sheffield.ac.uk
Start date:
March 7, 2023
Completion date:
March 2029
Lead sponsor:
Agency:
Spanish Oncology Genito-Urinary Group
Agency class:
Other
Collaborator:
Agency:
Janssen-Cilag Ltd.
Agency class:
Industry
Collaborator:
Agency:
Pivotal S.L.
Agency class:
Industry
Source:
Spanish Oncology Genito-Urinary Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06511648
