ISRCTN14498712Active, not recruitingPhase 2
A phase II, open-label, multi-centre, multi-national interventional trial to evaluate the efficacy and safety of erdafitinib (ERDA) monotherapy and ERDA and cetrelimab combination as neoadjuvant treatment in cisplatin-ineligible patients with muscle-invasive bladder cancer whose tumours express FGFR gene alterations
Spanish Oncology Genitourinary Group0 sites600 target enrollmentStarted: April 25, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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 TURBT performed no later than 3 months prior to start the screening visit
- •3. Pure or predominant (=50%) 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 antiPD1/PDL1 systemic therapy
- •5. Prior systemic therapy, radiation therapy, or surgery for bladder cancer
Investigators
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