A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
NCT ID: NCT05014139
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
37 participants
INTERVENTIONAL
2021-12-07
2025-09-22
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Enfortumab vedotin: Dose escalation cohort
During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.
Enfortumab vedotin
Given into the bladder (intravesically)
Enfortumab vedotin: Dose expansion cohort
During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.
Enfortumab vedotin
Given into the bladder (intravesically)
Interventions
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Enfortumab vedotin
Given into the bladder (intravesically)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Seagen, a wholly owned subsidiary of Pfizer
INDUSTRY
Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Site CA11001
Toronto, Ontario, Canada
Site FR33002
Lyon, , France
Site FR33001
Paris, , France
Site FR33003
Rennes, , France
Site DE49001
Göttingen, , Germany
Site DE49002
Tübingen, , Germany
Site ES34001
Barcelona, , Spain
Site ES34004
Barcelona, , Spain
Site ES34003
Barcelona, , Spain
Site ES34002
Madrid, , Spain
Site UK44002
London, , United Kingdom
Countries
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Other Identifiers
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EV-104
Identifier Type: OTHER
Identifier Source: secondary_id
C5701004
Identifier Type: OTHER
Identifier Source: secondary_id
2023-503388-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
SGN22E-004
Identifier Type: -
Identifier Source: org_study_id
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