lokaal gevorderd of gemetastaseerde urotheliale blaaskanker bladder cancer locally advanced or metastatic urothelial bladder cancer
Conditions
Interventions
Test product
Atezolizumab is administered at a dose of 1200 mg by IV infusion on Day 1 of
each 21-day cycle.
Comparators
Vinflunine is administered at a dose of 320 mg/m2 by IV infusion on Day 1 o
Atezolizumab
Urothelial Bladder Cancer
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: *Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra);*Representative tumor specimens as specified by the protocol;*Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;*Life expectancy 12 weeks;*Measurable disease, as defined by RECIST v1.1
Exclusion criteria
Exclusion criteria: * Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment;* Active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments;*Leptomeningeal disease;*Pregnant and lactating women;*History of autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Objectives The primary efficacy objective for this study is as follows: - To evaluate the efficacy of atezolizumab treatment compared with chemotherapy treatment with respect to overall survival (OS) in patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy objectives for this study are as follows: - To evaluate the efficacy of atezolizumab compared with chemotherapy with respect to anti-tumor effects as measured by objective response rate (ORR) per investigator with use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) - To evaluate the efficacy of atezolizumab compared with chemotherapy with respect to anti-tumor effects as measured by progression-free survival (PFS) per investigator with use of RECIST v1.1 - To evaluate the efficacy of atezolizumab compared with chemotherapy with respect to anti-tumor effects as measured by duration of objective response (DOR) per RECIST v1.1 Safety Objectives The safety objectives for this study are as follows: - To evaluate the safety and tolerability of atezolizumab compared with chemotherapy - To evaluate the incidence of anti-therapeutic antibodies (ATAs) against atezolizumab and to explore the potential relationship of the immunogenicity response with pharmacokinetics, safety, and efficacy atezolizumab *F. Hoffmann-La Roche Ltd Protocol GO29294, Version 1 12 Pharmacokinetic Objective The pharmacokinetic (PK) objective for this study is as follows: - To characterize the pharmacokinetics of MPDL32820A in patients with locally advanced or metastatic UBC who have progressed during or following a platinum-containing regimen Patient-Reported Outcome Objectives The patient-reported outcome (PRO) objective for this study is as follows: - To evaluate and compare PROs of patient health-related quality of life (HRQoL) between treatment arms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Exploratory Objectives The exploratory objectives for this study are as follows: - To evaluate the efficacy of atezolizumab with respect to anti-tumor effects as measured by PFS, ORR, and DOR per modified Response Evaluation Criteria in S | — |
Countries
The Netherlands
Outcome results
None listed