Urothelial cancer
Conditions
Brief summary
Locally Advanced or Metastatic Urothelial Cancer ● Type, incidence, severity, seriousness, and relatedness of AEs ● Type, incidence, and severity of laboratory abnormalities, Randomized Cohort K ● ORR (confirmed) per RECIST Version 1.1 by BICR, Muscle Invasive Bladder Cancer ● pCR rate by central pathology review
Detailed description
ORR (confirmed) per RECIST Version 1.1 by investigator assessment, DOR per RECIST Version 1.1 by BICR, DOR per RECIST Version 1.1 by investigator assessment, DCR per RECIST Version 1.1 by BICR, DCR per RECIST Version 1.1 by investigator assessment, PFS per RECIST Version 1.1 by BICR, PFS per RECIST Version 1.1 by investigator, OS, Type, incidence, severity, seriousness, and relatedness of AEs, Type, incidence, and severity of laboratory abnormalities, Corresponding Additional/Exploratory Endpoints: Selected plasma or serum PK parameters of enfortumab vedotin, MMAE, and TAb, Corresponding Additional/Exploratory Endpoints: Incidence of ATA to enfortumab vedotin, Corresponding Additional/Exploratory Endpoints: Exploratory biomarkers of clinical activity, including relationship of Nectin-4 expression and PD-L1 expression status to response, Corresponding Additional/Exploratory Endpoints: PFS2 by investigator assessment, Corresponding Additional/Exploratory Endpoints: Change from baseline in PRO assessments of the EQ-5D-5L, EORTC QLQ-C30, and BPI-SF, For the EV+Pembro arm: ORR (confirmed) per iRECIST by investigator assessment, For the EV+Pembro arm: DOR per iRECIST by investigator assessment, For the EV+Pembro arm: DCR per iRECIST by investigator assessment, For the EV+Pembro arm: PFS per iRECIST by investigator assessment, ORR (confirmed) per RECIST Version 1.1 by BICR, EFS by BICR (Cohort L only), EFS by investigator assessment, pDS rate by central pathology review, DFS by BICR (Cohort L only), DFS by investigator assessment, Percentage of planned RC+PLND delayed due to treatment-related AEs
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Seagen Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Locally Advanced or Metastatic Urothelial Cancer ● Type, incidence, severity, seriousness, and relatedness of AEs ● Type, incidence, and severity of laboratory abnormalities, Randomized Cohort K ● ORR (confirmed) per RECIST Version 1.1 by BICR, Muscle Invasive Bladder Cancer ● pCR rate by central pathology review | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR (confirmed) per RECIST Version 1.1 by investigator assessment, DOR per RECIST Version 1.1 by BICR, DOR per RECIST Version 1.1 by investigator assessment, DCR per RECIST Version 1.1 by BICR, DCR per RECIST Version 1.1 by investigator assessment, PFS per RECIST Version 1.1 by BICR, PFS per RECIST Version 1.1 by investigator, OS, Type, incidence, severity, seriousness, and relatedness of AEs, Type, incidence, and severity of laboratory abnormalities, Corresponding Additional/Exploratory Endpoints: Selected plasma or serum PK parameters of enfortumab vedotin, MMAE, and TAb, Corresponding Additional/Exploratory Endpoints: Incidence of ATA to enfortumab vedotin, Corresponding Additional/Exploratory Endpoints: Exploratory biomarkers of clinical activity, including relationship of Nectin-4 expression and PD-L1 expression status to response, Corresponding Additional/Exploratory Endpoints: PFS2 by investigator assessment, Corresponding Additional/Exploratory Endpoints: Change from baseline i | — |
Countries
France
Outcome results
None listed