Unresectable locally advanced or metastatic urothelial cancer
Conditions
Brief summary
PFS in the overall population and in the PD-L1 positive population. PFS is defined as the time from the first dose of study treatment date until disease progression or death from any cause. Patients who have not progressed and start a new line of treatment will be censored at the date of the last adequate tumor assessment prior to starting the next line of therapy
Detailed description
Overall Survival (OS), Objective response (ORR), Clinical benefit rate (CBR), Duration of response (DOR), PFS from start of first line chemotherapy (cPFS), OS from start of first line chemotherapy (cOS), Adverse events (AE), Treatment related adverse events (TRAEs), Patient reported outcomes through the EORTC QLQ-C30 and EQ-5D-5L questionnaires
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
Sponsors
Grupo Espanol De Oncologia Genitourinaria-Socug, Grupo Espanol De Oncologia Genitourinaria-Socug, Grupo Espanol De Oncologia Genitourinaria-Socug
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS in the overall population and in the PD-L1 positive population. PFS is defined as the time from the first dose of study treatment date until disease progression or death from any cause. Patients who have not progressed and start a new line of treatment will be censored at the date of the last adequate tumor assessment prior to starting the next line of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS), Objective response (ORR), Clinical benefit rate (CBR), Duration of response (DOR), PFS from start of first line chemotherapy (cPFS), OS from start of first line chemotherapy (cOS), Adverse events (AE), Treatment related adverse events (TRAEs), Patient reported outcomes through the EORTC QLQ-C30 and EQ-5D-5L questionnaires | — |
Countries
Spain
Outcome results
None listed