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

NCT07566156 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2026-05-11

No results posted yet for this study

Summary

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer. The study will compare these drugs to concurrent chemoradiotherapy that is usually used to treat this cancer (standard of care). The study will enroll patients with muscle-invasive bladder cancer (MIBC) who have cancer that has not spread outside the bladder.

Conditions

Interventions

DRUG

Fluorouracil

500 mg per meter squared of body surface area per day on Days 1-5 (week 1) and Days 22 26 (week 3) administered as continuous IV infusion during radiation in combination with mitomycin C.

DRUG

Mitomycin C

12 mg per meter squared of body surface area administered as an IV bolus on Day 1 during radiation in combination with fluorouracil.

DRUG

Gemcitabine

100 mg per meter squared of body surface area administered once weekly via IV infusion during radiation OR 27 mg per meter squared of body surface area administered twice weekly via IV infusion during radiation

DRUG

Pembrolizumab

IV infusion on Day 1 of every 3-week cycle up to cycle 17.

DRUG

Enfortumab vedotin

Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle up to cycle 9.

RADIATION

Conventional Radiotherapy

64 Gy in 32 fractions over 6.5 weeks administered to the participant's bladder only or the bladder and prophylactically to pelvic nodes.

RADIATION

Hypofractionated Radiotherapy

55 Gy in 20 fractions over 4 weeks administered to the participant's bladder only.

DRUG

Cisplatin

40 mg of cisplatin per meter squared of body surface area, administered once weekly via IV infusion during radiation OR 20 mg of cisplatin per meter squared of body surface area per day on Days 1 and 2 weekly via IV infusion during radiation.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Zejing Wang, MD/PhD · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-11
Primary Completion
2030-03-31
Completion
2032-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07566156 on ClinicalTrials.gov