metastatic urothelial carcinoma
Conditions
Brief summary
Comparison between treatment arms will be performed using a one-sided log-rank test, and the treatment effect will be quantified using the hazard ratio (HR) estimated from a Cox proportional hazards model, along with corresponding confidence intervals.
Detailed description
Investigator-assessed PFS, Objective response rates (ORR), Duration of response (DR), Disease control rate (DCR) assessed per RECIST v1.1 by BICR and investigator., Safety: Adverse events (AEs) and laboratory abnormalities as graded by Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, Patient-Reported Outcomes: patient-reported bladder cancer symptom, functioning, global quality of life (QOL), and Time to Deterioration (TTD) using the NCCN- FACT FBlSI; health status using the EQ-5D., Overall Survival (OS), 1-year PFS based on BICR assessment per RECIST v1.1.
Interventions
DRUGAVELUMAB
Sponsors
G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between treatment arms will be performed using a one-sided log-rank test, and the treatment effect will be quantified using the hazard ratio (HR) estimated from a Cox proportional hazards model, along with corresponding confidence intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator-assessed PFS, Objective response rates (ORR), Duration of response (DR), Disease control rate (DCR) assessed per RECIST v1.1 by BICR and investigator., Safety: Adverse events (AEs) and laboratory abnormalities as graded by Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, Patient-Reported Outcomes: patient-reported bladder cancer symptom, functioning, global quality of life (QOL), and Time to Deterioration (TTD) using the NCCN- FACT FBlSI; health status using the EQ-5D., Overall Survival (OS), 1-year PFS based on BICR assessment per RECIST v1.1. | — |
Outcome results
None listed