Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
- Conditions
- Muscle-invasive Bladder Cancer
- Registration Number
- NCT06511648
- Lead Sponsor
- Spanish Oncology Genito-Urinary Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Written informed consent stating that he or she understands the purpose of the study<br> and the procedures involved and agrees to participate in the study.<br><br> 2. Histologically confirmed diagnosis of MIBC (Stage T2-4a N0/N1 M0) obtained via a<br> diagnostic or maximal Transurethral Resection of Bladder Tumor (TURBT) performed no<br> later than 3 months prior to start the screening visit.<br><br> 3. Pure or predominant (=50%) urotelial Cancer (UC) histology as determined at the<br> local site.<br><br> 4. Age = 18 years.<br><br> 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1<br><br> 6. Decline or ineligible (unfit) for cisplatin-based chemotherapy<br><br> 7. Presence of a selected FGFR alteration on analysis of tumour biopsy<br><br> 8. Adequate organ function<br><br> 9. No other malignancy<br><br> 10. Willingness to avoid pregnancy or fathering children<br><br>Exclusion Criteria:<br><br> 1. Clinical evidence of N2-N3 tumours or metastatic bladder cancer.<br><br> 2. Has tumour with any neuroendocrine or small cell component.<br><br> 3. Patients who are not considered fit for cystectomy or reject cystectomy.<br><br> 4. Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1/PDL1 )systemic<br> therapy.<br><br> 5. Prior systemic therapy, radiation therapy, or surgery for bladder cancer
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete response (pCR);Pathological downstaging response <ypT2
- Secondary Outcome Measures
Name Time Method Rate of pathological downstaging (pDS);Event-free Survival rate.;Overall Survival;Overall Response Rate;Adverse events.;Rate of delay of surgery