Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder
Conditions
Brief summary
Time from randomization to the first BI-EFS event, including histologically proven presence of muscle-invasive bladder cancer (MIBC), clinical evidence of nodal or metastatic disease (as assessed by RECIST 1.1 criteria), radical cystectomy (RC), or death due to any cause
Detailed description
Time from randomization to first radiologic (as assessed by RECIST 1.1 criteria) or evidence of metastatic disease or death due to any cause, Time from randomization to death, The ORR is defined as the proportion of participants who achieve a CR or PR, Frequency and grade of adverse events (AEs) and according to Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE). NCI PROCTCAE assessments will be done for all urinary and all gastrointestinal items in the NCI PRO-CTCAE item library. Laboratory abnormalities:CTCAE grades and NCI PRO-CTCAE grades comparing baseline to the worst post-baseline value.
Interventions
DRUGsolution à diluer pour perfusion
DRUGJNJ-63723283
DRUGJNJ-17000139
DRUG1 mg/ml
DRUGGemcitabin Accord 100 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Sponsors
Janssen - Cilag International
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomization to the first BI-EFS event, including histologically proven presence of muscle-invasive bladder cancer (MIBC), clinical evidence of nodal or metastatic disease (as assessed by RECIST 1.1 criteria), radical cystectomy (RC), or death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from randomization to first radiologic (as assessed by RECIST 1.1 criteria) or evidence of metastatic disease or death due to any cause, Time from randomization to death, The ORR is defined as the proportion of participants who achieve a CR or PR, Frequency and grade of adverse events (AEs) and according to Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE). NCI PROCTCAE assessments will be done for all urinary and all gastrointestinal items in the NCI PRO-CTCAE item library. Laboratory abnormalities:CTCAE grades and NCI PRO-CTCAE grades comparing baseline to the worst post-baseline value. | — |
Countries
Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Portugal, Spain
Outcome results
None listed