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Sponsor: Astellas Pharma Global Development, Inc.
Conditions: Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell, Non-muscle Invasive Bladder Cancer, NMIBC
Interventions: Enfortumab vedotin
Countries: United States, Canada, France, Germany, Spain, United Kingdom
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Gilbert, Arizona, United States
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Chicago, Illinois, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Myrtle Beach, South Carolina, United States
- Chattanooga, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
- Toronto, Ontario, Canada
- Lyon, France
- Paris, France
- Rennes, France
- Göttingen, Germany
- Tübingen, Germany
- Barcelona, Spain
- Barcelona, Spain
- Barcelona, Spain
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