Bladder Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

58

Study ID:

NCT05014139

Recruitment Status:

Recruiting

Sponsor:

Astellas Pharma Global Development, Inc.

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There are 10 Locations for this study

See Locations Near You

University of California, Irvine
Orange California, 92868, United States
University of California at San Francisco
San Francisco California, 94134, United States
Johns Hopkins Medical Center
Baltimore Maryland, 21287, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York New York, 10016, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
MD Anderson
Houston Texas, 77030, United States
Site CA11001
Toronto Ontario, M5G 2, Canada
Site FR33001
Paris , 75013, France
Site ES34001
Barcelona , 08025, Spain

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

58

Study ID:

NCT05014139

Recruitment Status:

Recruiting

Sponsor:


Astellas Pharma Global Development, Inc.

How clear is this clinincal trial information?

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