Status:
RECRUITING
Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Lead Sponsor:
Spanish Oncology Genito-Urinary Group
Collaborating Sponsors:
Janssen-Cilag Ltd.
Pivotal S.L.
Conditions:
Muscle-invasive Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Gro...
Detailed Description
The aim of the study is to assess the antitumor activity measured as ypT0 rate, defined as no evidence of residual disease based on pathological review of the surgical specimen (pCR) and tumour downst...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Decline or ineligible ("unfit") for cisplatin-based chemotherapy
- Presence of a selected FGFR alteration on analysis of tumour biopsy
- Adequate organ function
- No other malignancy
- Willingness to avoid pregnancy or fathering children
Exclusion
- Clinical evidence of N2-N3 tumours or metastatic bladder cancer.
- Has tumour with any neuroendocrine or small cell component.
- Patients who are not considered fit for cystectomy or reject cystectomy.
- Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )systemic therapy.
- Prior systemic therapy, radiation therapy, or surgery for bladder cancer
Key Trial Info
Start Date :
March 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06511648
Start Date
March 7 2023
End Date
October 1 2029
Last Update
December 19 2025
Active Locations (23)
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1
CLCC Jean Perrin
Clermont-Ferrand, France, 63011
2
CLCC Léon Bérard
Lyon, France, 69008
3
Institut Mutualiste Montsouris
Paris, France, 75014
4
IUCT
Toulouse, France, 31059