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A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC) | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

NCT05014139•Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

Summary

This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.

Detailed Description

The study will be comprised of 2 parts. The first part (dose escalation) will find the highest dose of enfortumab vedotin that does not cause unacceptable side effects in participants. The second part (dose expansion) will use the dose found in the first part to test how well the drug works. All participants will receive enfortumab vedotin. Treatment on the study will occur during the induction and maintenance phases, and participants will enter a follow-up period after completion of the maintenance phase.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed, non-muscle invasive urothelial carcinoma with carcinoma in situ (CIS) (with or without papillary disease)
•Predominant histologic component (\>50 percent) must be urothelial (transitional cell) carcinoma
•Participants must have high-risk Bacillus Calmette-Guerin (BCG) - unresponsive disease, defined as (where adequate BCG therapy is defined as one of the following: 5 of 6 doses of an initial induction course + at least 2 of 3 doses maintenance therapy or 5 of 6 doses of an initial induction course + at least 2 of 6 doses of a second induction course):
•* Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy.
•* Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy, or
•* T1 high-grade disease at the first evaluation following an induction BCG course (at least 5 or 6 doses)
•Participant must be ineligible for or refusing a radical cystectomy
•All visible papillary Ta/T1 tumors must be completely resected within 60 days prior to enrollment.
•Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2.

Exclusion Criteria

•Current or prior history of muscle-invasive urothelial carcinoma or metastatic disease.
•Nodal or metastatic disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) within 3 months prior to study treatment
•Concomitant upper tract urothelial carcinoma as noted on CT or MRI urogram performed within 3 months prior to study treatment
•Prior or concomitant urothelial carcinoma of the prostatic urethra within 6 months prior to study treatment
•Participants with tumor-related hydronephrosis
•Participant has received other systemic anticancer therapy including chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, and/or investigational agent within 4 weeks or intravesical therapy within 6 weeks of first dose of study treatment
•Participant has had any prior radiation to the bladder for urothelial cancer

Locations (32)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Mayo Clinic

Scottsdale, Arizona, United States

UCLA Department of Medicine - Hematology & Oncology

Los Angeles, California, United States

University of California, Irvine

Orange, California, United States

University of California at San Francisco

San Francisco, California, United States

Stanford Health Care

Stanford, California, United States

Northwestern University-Feinberg School of Medicine

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Markey Cancer Center / University of Kentucky

Lexington, Kentucky, United States

Johns Hopkins Medical Center

Baltimore, Maryland, United States

Key Dates

Start Date

December 7, 2021

Primary Completion Date

September 22, 2025

Completion Date

September 22, 2025

Last Updated

November 20, 2025

Enrollment

ACTUAL participants

Conditions

Urinary Bladder NeoplasmsCarcinoma in SituCarcinoma Transitional CellNon-muscle Invasive Bladder CancerNMIBC

Interventions

Enfortumab vedotin

DRUG

Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia

NCT04712851

Cervical Intraepithelial NeoplasiaCervical Squamous Cell Carcinoma In Situ+1 more

View study

RECRUITINGPHASE1/PHASE2

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)

NCT07222488

Bladder CancerUrinary Bladder Neoplasms

View study

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: November 20, 2025Data 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

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Inclusion Criteria

Exclusion Criteria

Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)

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