Muscle-invasive bladder cancer (MIBC)
Conditions
Sponsors
Spanish Oncology Genito Urinary Group (SOGUG)
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
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. 5)Prior FGFR-targeted or antiPD1/PDL1 systemic therapy. 6)Prior systemic therapy, radiation therapy, or surgery for bladder cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the antitumor activity measured as pT0N0 rate, defined as no evidence of residual disease based on pathological review of the surgical specimen •To assess the percentage of pathological downstaging response ;Secondary Objective: •To evaluate the percentage of tumour downstaging •To estimate the event-free survival (EFS) •To estimate the overall survival (OS). •To evaluate the Objective Response Rate (ORR) after neoadjuvant treatment •To assess the safety profile and tolerability of both schemes •To calculate the rate of delay of surgery. ;Primary end point(s): Primary endpoint(s) •Pathological complete response (pCR). •Pathological downstaging <ypT2. ;Timepoint(s) of evaluation of this end point: After a maximum of 30 weeks from the start of treatment (First Follow- up visit ) on specimens obtained during radical cystectomy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints •Rate of pathological downstaging (pDS) •Event-free Survival rate. •OS. •ORR according to RECIST, after neoadjuvant treatment. •Adverse events. •Rate of delay of surgery (classed as a delay event if performed > 6 weeks after last dose of treatment). ;Timepoint(s) of evaluation of this end point: During treatment and follow-up period. | — |
Countries
France, Italy, Spain, United Kingdom
Contacts
Public ContactIsabel Grau Miró
Spanish Oncology Genito Urinary Group (SOGUG)
Outcome results
None listed