Actively Recruiting
Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Led by Spanish Oncology Genito-Urinary Group · Updated on 2025-12-19
90
Participants Needed
23
Research Sites
342 weeks
Total Duration
On this page
Sponsors
S
Spanish Oncology Genito-Urinary Group
Lead Sponsor
J
Janssen-Cilag Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express Fibroblast Growth Factor Receptor (FGFR )gene alterations and are ineligible for or refuse cisplatin based neoadjuvant chemotherapy.
CONDITIONS
Official Title
Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in the study
- Histologically confirmed muscle-invasive bladder cancer (Stage T2-4a N0/N1 M0) diagnosed within 3 months before screening
- Pure or mainly (≥50%) urothelial cancer histology
- Age 18 years or older
- ECOG performance status of 0 or 1
- Declined or not eligible for cisplatin-based chemotherapy
- Presence of selected FGFR gene alteration in tumor biopsy
- Adequate organ function
- No other malignancies
- Willingness to avoid pregnancy or fathering children
You will not qualify if you...
- Evidence of N2-N3 lymph node involvement or metastatic bladder cancer
- Tumor with neuroendocrine or small cell components
- Not fit for or refusing bladder removal surgery (cystectomy)
- Previous treatment with FGFR-targeted therapy or immune checkpoint inhibitors
- Prior systemic therapy, radiation, or surgery for bladder cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
CLCC Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
2
CLCC Léon Bérard
Lyon, France, 69008
Withdrawn
3
Institut Mutualiste Montsouris
Paris, France, 75014
Actively Recruiting
4
IUCT
Toulouse, France, 31059
Actively Recruiting
5
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
6
IRCCS San Raffaele Hospital and Scientific Institute
Milan, Italy, 20132
Actively Recruiting
7
A.O. Ordine Mauriziano, Ospedale Umberto I
Turi, Italy, 10128
Withdrawn
8
Ospedale Molinette
Turin, Italy, 10126
Actively Recruiting
9
Hospital Clínic De Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
10
Hospital De Sabadell (Parc Taulí)
Barcelona, Catalonia, Spain, 08208
Actively Recruiting
11
Complexo Hospitalario Universitario A Coruña
A Coruña, Galicia, Spain, 15006
Actively Recruiting
12
Hospital Universitario Lucus Augusti
Lugo, Galicia, Spain, 27003
Actively Recruiting
13
ICO l' Hospitalet
Barcelona, Spain, 08908
Not Yet Recruiting
14
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
15
Hospital Universitario de Toledo
Toledo, Spain, 45007
Actively Recruiting
16
Fundación Instituto Valenciano De Oncología
Valencia, Spain, 46009
Actively Recruiting
17
Hospital Clínico Universitario De Valladolid
Valladolid, Spain, 47003
Actively Recruiting
18
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
19
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, United Kingdom, LA1 4RP
Withdrawn
20
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
21
Barts Health NHS Trust
London, United Kingdom, W6 8JA
Actively Recruiting
22
Charing Cross Hospital
London, United Kingdom
Actively Recruiting
23
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2SJ
Actively Recruiting
Research Team
I
Isabel Grau
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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