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

Stopped early · Phase 1

Conditions studied: Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell, Non-muscle Invasive Bladder Cancer, NMIBC

In brief

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.

Key facts

Study ID

NCT05014139

Run by

Astellas Pharma Global Development, Inc.

People needed

37

Starts

2021-12-07

Expected to finish

2025-09-22

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Site ES34002 — Madrid, Spain
• Site DE49002 — Tübingen, Germany
• Site ES34001 — Barcelona, Spain
• Site ES34004 — Barcelona, Spain
• 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
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• James Cancer Hospital / Ohio State University — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Erlanger Oncology and Hematology — Chattanooga, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• MD Anderson — Houston, Texas, United States
• Urology San Antonio — San Antonio, Texas, United States
• Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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