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C5701009 - A Phase 3, Open-label, Randomized Study To Evaluate Enfortumab Vedotin in Combination with Pembrolizumab in Adult participants with Muscle-Invasive Bladder Cancer Who Are Ineligible for or have elected not to undergo cystectomy

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525612-34-00
Enrollment
88
Registered
2026-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-16

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

BI-EFS assessed by blinded independent central review (BICR), overall survival (OS)

Detailed description

BI-EFS assessed by investigator, Clinical complete response (cCR) assessed by BICR and investigator, Metastatic-free survival (MFS) assessed by BICR and investigator, Time to Cystectomy, Disease free survival (DFS) assessed by BICR and investigator, Cystectomy-free survival (CFS), • Type, incidence, relatedness, severity and seriousness of adverse events (AEs) • Type, incidence and severity of laboratory abnormalities

Interventions

DRUGPadcev 30 mg powder for concentrate for solution for infusion
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
BI-EFS assessed by blinded independent central review (BICR), overall survival (OS)—

Secondary

MeasureTime frame
BI-EFS assessed by investigator, Clinical complete response (cCR) assessed by BICR and investigator, Metastatic-free survival (MFS) assessed by BICR and investigator, Time to Cystectomy, Disease free survival (DFS) assessed by BICR and investigator, Cystectomy-free survival (CFS), • Type, incidence, relatedness, severity and seriousness of adverse events (AEs) • Type, incidence and severity of laboratory abnormalities—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 17, 2026