Metastatic urothelial cancer
Conditions
Brief summary
Phase 2: Will be assessed by reviewing all available data, including efficacy, safety, tolerability, and pharmacokinetic data., Phase 3: Efficacy will be evaluated by comparing progression-free survival (time from start of treatment until worsening of disease or death, whichever comes first) and overall survival (how long a patient lives) between iza-bren and PBC.
Detailed description
Phase 2 and 3: Additional efficacy endpoints will be tested in both groups of patients, including what proportion of participants respond to treatment (objective response rate), how long until participants respond to treatment (time to response), how long a participants’ response to treatment lasts (duration of response), time without cancer growing (progression free survival) and how long patients survive (overall survival)., In Phase 3 only, the time it takes for participants to report a decline in their quality of life will be measured and compared.
Interventions
DRUGPEGFILGRASTIM
DRUGCARBOPLATIN
DRUGCISPLATIN
DRUGGEMCITABINE
DRUGBL-B01D1
Sponsors
Bristol-Myers Squibb Services Unlimited Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2: Will be assessed by reviewing all available data, including efficacy, safety, tolerability, and pharmacokinetic data., Phase 3: Efficacy will be evaluated by comparing progression-free survival (time from start of treatment until worsening of disease or death, whichever comes first) and overall survival (how long a patient lives) between iza-bren and PBC. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2 and 3: Additional efficacy endpoints will be tested in both groups of patients, including what proportion of participants respond to treatment (objective response rate), how long until participants respond to treatment (time to response), how long a participants’ response to treatment lasts (duration of response), time without cancer growing (progression free survival) and how long patients survive (overall survival)., In Phase 3 only, the time it takes for participants to report a decline in their quality of life will be measured and compared. | — |
Countries
Austria, Belgium, France, Germany, Ireland, Italy, Norway, Romania, Spain, Sweden
Outcome results
None listed