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

Conditions

• Urinary Bladder Neoplasms
• Urothelial Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Enfortumab vedotin — DRUG
  Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle up to cycle 9.
• Conventional Radiotherapy — RADIATION
  64 Gy in 32 fractions over 6.5 weeks administered to the participant's bladder only or the bladder and prophylactically to pelvic nodes.
• Hypofractionated Radiotherapy — RADIATION
  55 Gy in 20 fractions over 4 weeks administered to the participant's bladder only.
• Cisplatin — DRUG
  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.
• Fluorouracil — DRUG
  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.
• Mitomycin C — DRUG
  12 mg per meter squared of body surface area administered as an IV bolus on Day 1 during radiation in combination with fluorouracil.
• Gemcitabine — DRUG
  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
• Pembrolizumab — DRUG
  IV infusion on Day 1 of every 3-week cycle up to cycle 17.

Study Details

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.

Key Dates

Start date

May 11, 2026

Status verified

Jun 2026

Primary completion

Mar 31, 2030

Completion

Feb 29, 2032

Study Design

Enrollment

390 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  Enfortumab vedotin + pembrolizumab (EV + P)
• Active Comparator: Arm B
  Concurrent Chemoradiotherapy (cCRT)

Primary Outcome Measure

Bladder-intact Event Free Survival (BI-EFS) by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 45.5 months ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (9)

Find similar trials in Santa Barbara, CA

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