Loading clinical trials...

Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer

Phase 2 Trial of Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Urothelial Cancer of the Bladder

NCT06809140•Matthew Galsky

View on ClinicalTrials.gov

Summary

Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (clinical complete response) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., \>cTa disease) will undergo cystectomy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
•2. Age ≥ 18 years at the time of consent.
•3. ECOG Performance Status of 0-1 within 28 days prior to registration.

Exclusion Criteria

•5. Have undergone a standard of care maximal transurethral resection of bladder tumor ≤ 90 days prior C1D1. A maximal TURBT should be performed when feasible and is defined as a macroscopically complete resection of bladder tumor.
•6. All subjects must have adequate transurethral resection of bladder tumor tissue available for submission identified during screening. The specimen must include tumor tissue (i.e., if a restaging maximal TURBT was performed and there was no cancer in the specimen, tissue from the most recent prior TURBT that established the diagnosis of muscle-invasive urothelial cancer of the bladder should be submitted). Tissue from both the restaging TURBT and the prior diagnostic TURBT may be requested. Subjects without available archival tissue must be discussed with the sponsor-investigator.
•7. Be deemed eligible to undergo radical cystectomy and pelvic lymph node dissection
•8. Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.
•* Absolute neutrophil count (ANC): ≥ 1.5 x 10\^9/L
•* Hemoglobin (Hgb): ≥ 9 g/dL
•* Platelets: ≥ 100 x 10\^9/L
•* Creatinine clearance: ≥ 30 mL/min
•* Bilirubin: ≤ 1.5 ×ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN
•* Aspartate aminotransferase (AST): ≤ 2.5 × ULN
+24 more criteria

Locations (5)

City of Hope

Duarte, California, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 7, 2025

Primary Completion Date

November 1, 2027

Completion Date

November 1, 2029

Last Updated

February 23, 2026

Enrollment

ESTIMATED participants

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

Interventions

Enfortumab vedotin

DRUG

Pembrolizumab

DRUG

Contacts

Matthew Galsky, MD

CONTACT

212-659-5452 matthew.galsky@mssm.edu

Ahran Lee

CONTACT

317-634-5842 alee@hoosiercancer.org

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

NCT05987241

Muscle Invasive Bladder Urothelial CarcinomaMuscle Invasive Renal Pelvis Urothelial Carcinoma+5 more

View study

RECRUITINGPHASE2

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

NCT07061964

Muscle Invasive Bladder Urothelial CarcinomaStage II Bladder Cancer AJCC v8+1 more

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study

Irinotecan Liposomes Combined with Epirubicin in Recurrent Non-muscle Invasive Bladder Urothelium Carcinoma After Anthracyclines Treatment

Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy

A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.