Locally advanced or metastatic urothelial cancer
Conditions
Brief summary
1. (Cohort 1) PFS, measured by the length of time from date of randomization to date of first documentation of disease progression per RECIST v1.1 assessed by BICR or death (due to any cause), whichever occurs first., 1. (Cohort 2) ORR, measured by the percentage of participants who have achieved either confirmed CR or PR per RECIST v1.1 assessed by BICR.
Detailed description
1. (Cohort 1) ORR, measured by the percentage of participants who have achieved either a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 assessed by BICR. - ORR, measured by the percentage of participants who have achieved either a confirmed CR or PR per RECIST v1.1 assessed by Investigator, 2. (Cohort 1) OS, defined as length of time from date of randomization to date of death from any cause., 3. (Cohort 1) DoR, measured by the time from first documentation of objective response (that is subsequently confirmed) per RECIST v1.1 assessed by - BICR to the first documentation of objective tumor progression (per RECIST v1.1), or to death (due to any cause), whichever occurs first - Investigator to the first documentation of objective tumor progression (per RECIST v1.1), or to death (due to any cause), whichever occurs first, 1. (Cohort 2) DoR, measured by the time from first documentation of objective response (that is subsequently confirmed) per RECIST v1.1 assessed by BICR to the first documentation of objective tumor progression (per RECIST v1.1), or to death (due to any cause), whichever occurs first., 2. (Cohort 2) ORR, measured by the percentage of participants who have achieved either confirmed CR or PR per RECIST v1.1 assessed by the Investigator., 3. (Cohort 2) DoR, measured by the time from first documentation of objective response (that is subsequently confirmed) per RECIST v1.1 assessed by Investigator to the first documentation of objective tumor progression (per RECIST v1.1), or to death (due to any cause), whichever occurs first.
Interventions
Sponsors
Bicycletx Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. (Cohort 1) PFS, measured by the length of time from date of randomization to date of first documentation of disease progression per RECIST v1.1 assessed by BICR or death (due to any cause), whichever occurs first., 1. (Cohort 2) ORR, measured by the percentage of participants who have achieved either confirmed CR or PR per RECIST v1.1 assessed by BICR. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. (Cohort 1) ORR, measured by the percentage of participants who have achieved either a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 assessed by BICR. - ORR, measured by the percentage of participants who have achieved either a confirmed CR or PR per RECIST v1.1 assessed by Investigator, 2. (Cohort 1) OS, defined as length of time from date of randomization to date of death from any cause., 3. (Cohort 1) DoR, measured by the time from first documentation of objective response (that is subsequently confirmed) per RECIST v1.1 assessed by - BICR to the first documentation of objective tumor progression (per RECIST v1.1), or to death (due to any cause), whichever occurs first - Investigator to the first documentation of objective tumor progression (per RECIST v1.1), or to death (due to any cause), whichever occurs first, 1. (Cohort 2) DoR, measured by the time from first documentation of objective response (that is subsequently confirmed) per RECIST v1.1 a | — |
Countries
Spain
Outcome results
None listed