Recruiting

Phase 3

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

Sponsor:

Astellas Pharma Global Development, Inc.

Code:

NCT07566156

Conditions

Urothelial Cancer

Urinary Bladder Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enfortumab vedotin

Conventional Radiotherapy

Hypofractionated Radiotherapy

Cisplatin

Fluorouracil

Study Details

Brief 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

Urothelial Cancer

Urinary Bladder Neoplasms

Study ID

NCT07566156

Start date

May 11, 2026

Status verified date

Aug, 2026

Completion date

Feb 29, 2032

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0
Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline
Eligible for and agree to receive chemoradiotherapy and one of the protocol-specified radiosensitizing chemotherapy regimens
Fit for systemic therapy and elect bladder preservation, including participants who are ineligible for or have elected not to undergo cystectomy
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria:

Advanced or metastatic disease (N+, M1), non-urothelial carcinoma, diffuse or multifocal CIS, urothelial carcinoma or histological variant at any site outside the urinary bladder within previous 24 months prior to randomization except Ta/T1/CIS of the upper urinary tract including renal pelvis and ureter if the participant had undergone complete nephrectomy
Has received any prior systemic treatment, chemoradiation, and/or radiation for MIBC or NMIBC
Prior pelvic radiation for any reason
Inadequate bladder function
Other active malignancies within 3 years prior to randomization
Previously treated with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs)
Previously treated with a PD(L)-1 inhibitor, defined as a PD-1 inhibitor or PD-L1 inhibitor
Uncontrolled diabetes
Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted
Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection
Received major surgery (defined as requiring general anesthesia and >24 hour inpatient hospitalization) within 4 weeks prior to randomization
Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin
Known genetic disorders associated with radiosensitivity (eg, ataxia telangiectasia, Nijmegen breakage syndrome, Fanconi syndrome)
Active keratitis or corneal ulcerations
History of autoimmune disease that has required systemic treatment in the past 2 years
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Prior allogeneic stem cell or solid organ transplant
Received a live attenuated vaccine within 30 days prior to randomization

Study Design

Enrollment

390 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Enfortumab vedotin + pembrolizumab (EV + P)

active comparator: Arm B

Concurrent Chemoradiotherapy (cCRT)

Interventions

Enfortumab vedotin

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

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.

Hypofractionated Radiotherapy

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

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.

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.

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.

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

Pembrolizumab

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

Primary outcome measure

Bladder-intact Event Free Survival (BI-EFS) by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 45.5 months ]
Overall Survival (OS) [ Time Frame: Up to approximately 60 months ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Samsun Clinic - Ridley-Tree Cancer Center

Recruiting

Santa Barbara, California, United States, 93105

Rocky Mountain Cancer Center

Recruiting

Aurora, Colorado, United States, 80012

Medical Oncology Hematology Consultants

Recruiting

Newark, Delaware, United States, 19713

Illinois Cancer Specialists

Recruiting

Niles, Illinois, United States, 60714

Fort Wayne Medical Oncology and Hematology

Recruiting

Fort Wayne, Indiana, United States, 46825

Missouri Cancer Associates

Recruiting

Columbia, Missouri, United States, 65201

Williamette Valley Cancer Institute and Research Center

Recruiting

Eugene, Oregon, United States, 97401

Compass Oncology - West

Recruiting

Tigard, Oregon, United States, 97223

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology

Recruiting

Austin, Texas, United States, 78705

Texas Oncology - Northeast Texas

Recruiting

Tyler, Texas, United States, 75702

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

More Information

Sponsor

Astellas Pharma Global Development, Inc.

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy
Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases
Urinary Bladder Neoplasms
Cisplatin
Fluorouracil
Mitomycin
Gemcitabine
Muscle Invasive Bladder Cancer
Enfortumab vedotin
Pembrolizumab
Urothelial Cancer
Urothelial Carcinoma
Bladder-sparing
Bladder Preservation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Astellas Pharma Global Development, Inc. on 2026-08-06.