# Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)

Source: https://onco.cc/trials/nct07566156/  
OnCo record `nct07566156` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Enfortumab vedotin, Cisplatin, Mitomycin C, Gemcitabine and Pembrolizumab in bladder & urothelial cancer, run by Astellas Pharma Global Development, Inc., now recruiting.

## Summary

Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309) is a phase 3 interventional study registered as NCT07566156 by Astellas Pharma Global Development, Inc., with 390 participants planned, started 2026-05-11 and due to reach its primary completion in 2030-03-31. Interventions recorded: Enfortumab vedotin, Conventional Radiotherapy, Hypofractionated Radiotherapy, Cisplatin, Fluorouracil and Mitomycin C.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT07566156
- Phase: 3
- Setting: 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
- Sponsor: Astellas Pharma Global Development, Inc.
- Enrolled: 390

## Sources

- ClinicalTrials.gov NCT07566156: https://clinicaltrials.gov/study/NCT07566156

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- drugs: [Cisplatin](https://onco.cc/drugs/cisplatin/), [Enfortumab vedotin](https://onco.cc/drugs/enfortumab-vedotin/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Mitomycin C](https://onco.cc/drugs/mitomycin/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Astellas](https://onco.cc/companies/astellas/), [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)

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