Erdafitinib alone or in combination with cetrelimab as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer whose tumours express FGFR gene alterations and are ineligible for receiving cisplatin treatment
- Conditions
- Muscle-invasive bladder cancerCancer
- Registration Number
- ISRCTN14498712
- Lead Sponsor
- Spanish Oncology Genitourinary Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 600
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The following primary endpoints are assessed after a maximum of 30 weeks from the start of treatment (first follow-up visit) on specimens obtained during radical cystectomy:<br>1. Pathological complete response (pCR), defined as the proportion of patients whose pathological staging was ypT0N0M0, measured using specimens obtained post-radical cystectomy following the study intervention<br>2. Pathological downstaging <ypT2, referring to patients whose pathological staging following radical cystectomy is ypT0, ypTa, ypTis or ypT1. A local pathological assessment will be done on specimens obtained during radical cystectomy (for coprimary endpoints). Thereafter, during the follow-up period, pathological assessments will be scheduled according to local standards and as clinically indicated.<br>
- Secondary Outcome Measures
Name Time Method