An Open-label, Single-Arm, Phase 2 Study to Evaluate Enfortumab Vedotin plus Pembrolizumab for Bladder Preservation in Participants with Muscle-invasive Bladder Cancer (EV-209).

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524488-18-00

Enrollment

Registered

2026-06-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-23

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

Conditions

Muscle-invasive Bladder Cancer

Brief summary

Overall cCR rate after treatment with enfortumab vedotin in combination with pembrolizumab as assessed by investigator (FAS) - 2-year BI-EFS rate after treatment with enfortumab vedotin in combination with pembrolizumab as assessed by investigator (FAS1 analysis set)

Detailed description

Overall cCR rate after 4 cycles of treatment with enfortumab vedotin in combination with pembrolizumab as assessed by investigator (FAS) - 2-year BI-EFS rate after treatment with enfortumab vedotin in combination with pembrolizumab as assessed by investigator (FAS2 analysis set), OS (FAS1 analysis set), DFS as assessed by investigator (FAS1 analysis set), MFS as assessed by investigator (FAS1 analysis set), Type, incidence, relatedness, severity and seriousness of safety variables (AEs and laboratory tests), Treatment discontinuation rate due to AEs

Interventions

DRUGPadcev 30 mg powder for concentrate for solution for infusion

DRUGKEYTRUDA 395 mg solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall cCR rate after treatment with enfortumab vedotin in combination with pembrolizumab as assessed by investigator (FAS) - 2-year BI-EFS rate after treatment with enfortumab vedotin in combination with pembrolizumab as assessed by investigator (FAS1 analysis set)	—

Secondary

Measure	Time frame
Overall cCR rate after 4 cycles of treatment with enfortumab vedotin in combination with pembrolizumab as assessed by investigator (FAS) - 2-year BI-EFS rate after treatment with enfortumab vedotin in combination with pembrolizumab as assessed by investigator (FAS2 analysis set), OS (FAS1 analysis set), DFS as assessed by investigator (FAS1 analysis set), MFS as assessed by investigator (FAS1 analysis set), Type, incidence, relatedness, severity and seriousness of safety variables (AEs and laboratory tests), Treatment discontinuation rate due to AEs	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 24, 2026