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C5701003 - An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503421-19-00
Acronym
C5701003
Enrollment
703
Registered
2023-11-10
Start date
2020-08-26
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial cancer

Brief summary

1. PFS per RECIST v1.1 by BICR., 2. OS.

Detailed description

1. ORR per RECIST v1.1 by BICR., 2. TTPP., 3. Mean change from baseline in worst pain at Week 26., 4. PFS per RECIST v1.1 by investigator assessment., 5. ORR per RECIST v1.1 by investigator assessment., 6. DOR per RECIST v1.1 by BICR., 7. DOR per RECIST v1.1 by investigator assessment., 8. DCR per RECIST v1.1 by BICR., 9. DCR per RECIST v1.1 by investigator assessment., 10. Mean scores and change from baseline of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30), and EuroQOL 5-dimensions (EQ-5D-5L), visual analogue scale (VAS), and utility scores., 11. Type, incidence, relatedness, severity and seriousness of AEs., 12. Type, incidence and severity of laboratory abnormalities., 13. Treatment discontinuation rate due to AEs.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGGemcitabin AqVida 38 mg/ml Pulver zur Herstellung einer Infusionslösung
DRUGCisplatin 1 mg/ml Concentrate for Solution for Infusion
DRUGCISPLATINE ACCORD 1 mg/ml
DRUGsolution à diluer pour perfusion
DRUGPadcev 30 mg powder for concentrate for solution for infusion
DRUGCarboplatin 10 mg/ml concentrate for solution for infusion
DRUGCARBOPLATINE ACCORD 10 mg/ml
DRUGsolution pour perfusion

Sponsors

Seagen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. PFS per RECIST v1.1 by BICR., 2. OS.—

Secondary

MeasureTime frame
1. ORR per RECIST v1.1 by BICR., 2. TTPP., 3. Mean change from baseline in worst pain at Week 26., 4. PFS per RECIST v1.1 by investigator assessment., 5. ORR per RECIST v1.1 by investigator assessment., 6. DOR per RECIST v1.1 by BICR., 7. DOR per RECIST v1.1 by investigator assessment., 8. DCR per RECIST v1.1 by BICR., 9. DCR per RECIST v1.1 by investigator assessment., 10. Mean scores and change from baseline of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30), and EuroQOL 5-dimensions (EQ-5D-5L), visual analogue scale (VAS), and utility scores., 11. Type, incidence, relatedness, severity and seriousness of AEs., 12. Type, incidence and severity of laboratory abnormalities., 13. Treatment discontinuation rate due to AEs.—

Countries

Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026