Locally Advanced/Metastatic Urothelial Cancer
Conditions
Brief summary
The primary endpoint in Cohorts 1 to 4 is ORR based on central review (Cohorts 1 and 2) or BICR (Cohorts 3 and 4) as assessed by RECIST 1.1 criteria. In Cohort 5, the primary endpoint is PFS based on BICR as assessed by RECIST 1.1 criteria., In Cohort 6, the primary endpoint is ORR based on BICR as assessed by RECIST 1.1 criteria., In Cohort 7, the primary efficacy endpoint is confirmed ORR based on investigator review as assessed by RECIST 1.1 criteria.
Detailed description
Secondary efficacy endpoints for Cohorts 1 and 2 are DOR and PFS based on central review as assessed by RECIST 1.1 criteria and OS. Secondary efficacy endpoints for Cohorts 3 and 4 are DOR, CBR, and PFS based on BICR as assessed by RECIST 1.1 criteria; ORR, DOR, CBR, and PFS based on investigator assessment by RECIST 1.1 criteria; and OS. In Cohorts 3 and 4, ORR, DOR, CBR, and PFS will also be evaluated by the investigator according to iRECIST criteria., In Cohort 5, the secondary efficacy endpoint is OS. In Cohort 6, secondary efficacy endpoints are DOR, CBR, and PFS based on BICR as assessed by RECIST 1.1 criteria; ORR, DOR, CBR, and PFS based on investigator assessment by RECIST 1.1 criteria; and OS. In Cohort 6, ORR, DOR, CBR, and PFS will also be evaluated by the investigator according to iRECIST criteria., In Cohort 7, secondary efficacy endpoints are ORR based on BICR by RECIST 1.1 criteria; DOR, CBR, and PFS based on investigator review and BICR by RECIST 1.1 criteria; and OS. Additionally, ORR, DOR, CBR, and PFS will be evaluated by the investigator according to iRECIST criteria.
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGZimberelimab
DRUGCisplatin 1 mg/ml Concentrate for Solution for Infusion
DRUGTrodelvy 200 mg powder for concentrate for solution for infusion
DRUGsolution à diluer pour perfusion
DRUGDOMVANALIMAB
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint in Cohorts 1 to 4 is ORR based on central review (Cohorts 1 and 2) or BICR (Cohorts 3 and 4) as assessed by RECIST 1.1 criteria. In Cohort 5, the primary endpoint is PFS based on BICR as assessed by RECIST 1.1 criteria., In Cohort 6, the primary endpoint is ORR based on BICR as assessed by RECIST 1.1 criteria., In Cohort 7, the primary efficacy endpoint is confirmed ORR based on investigator review as assessed by RECIST 1.1 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints for Cohorts 1 and 2 are DOR and PFS based on central review as assessed by RECIST 1.1 criteria and OS. Secondary efficacy endpoints for Cohorts 3 and 4 are DOR, CBR, and PFS based on BICR as assessed by RECIST 1.1 criteria; ORR, DOR, CBR, and PFS based on investigator assessment by RECIST 1.1 criteria; and OS. In Cohorts 3 and 4, ORR, DOR, CBR, and PFS will also be evaluated by the investigator according to iRECIST criteria., In Cohort 5, the secondary efficacy endpoint is OS. In Cohort 6, secondary efficacy endpoints are DOR, CBR, and PFS based on BICR as assessed by RECIST 1.1 criteria; ORR, DOR, CBR, and PFS based on investigator assessment by RECIST 1.1 criteria; and OS. In Cohort 6, ORR, DOR, CBR, and PFS will also be evaluated by the investigator according to iRECIST criteria., In Cohort 7, secondary efficacy endpoints are ORR based on BICR by RECIST 1.1 criteria; DOR, CBR, and PFS based on investigator review and BICR by RECIST 1.1 criteria; and OS. | — |
Countries
France, Germany, Greece, Italy, Spain
Outcome results
None listed