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

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Urinary Bladder Neoplasms
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Scottsdale

Mayo Clinic, Scottsdale, Arizona, United States, 85259

Los Angeles

UCLA Department of Medicine - Hematology & Oncology, Los Angeles, California, United States, 90095

Orange

University of California, Irvine, Orange, California, United States, 92868

San Francisco

University of California at San Francisco, San Francisco, California, United States, 94134

Stanford

Stanford Health Care, Stanford, California, United States, 94305

Chicago

Northwestern University-Feinberg School of Medicine, Chicago, Illinois, United States, 60611

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Lexington

Markey Cancer Center / University of Kentucky, Lexington, Kentucky, United States, 40508

Baltimore

Johns Hopkins Medical Center, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Astellas Pharma Global Development, Inc.,

Janet Trowbridge, MD, STUDY_DIRECTOR, Seagen Inc.

Study Record Dates

2028-05-31