TERMINATED

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

Conditions

Urinary Bladder Neoplasms Carcinoma in Situ Carcinoma Transitional Cell Non-muscle Invasive Bladder Cancer NMIBC Bladder Cancer Urothelial Cancer Enfortumab vedotin PADCEV Pharmacokinetics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-12-07

Study Completion:2025-09-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05014139

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center

STUDY_DIRECTOR

Pfizer

Study Locations (Sites)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234

United States

Mayo Clinic

Scottsdale, Arizona, 85259

United States

UCLA Department of Medicine - Hematology & Oncology

Los Angeles, California, 90095

United States

University of California, Irvine

Orange, California, 92868

United States

University of California at San Francisco

San Francisco, California, 94134

United States

Stanford Health Care

Stanford, California, 94305

United States

Northwestern University-Feinberg School of Medicine

Chicago, Illinois, 60611

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

Markey Cancer Center / University of Kentucky

Lexington, Kentucky, 40508

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

James Cancer Hospital / Ohio State University

Columbus, Ohio, 43221

United States

Oregon Health and Science University

Portland, Oregon, 98682

United States

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

United States

Erlanger Oncology and Hematology

Chattanooga, Tennessee, 37403

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

MD Anderson

Houston, Texas, 77030

United States

Urology San Antonio

San Antonio, Texas, 78229

United States

Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Astellas Pharma Global Development, Inc.

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-07

Study Completion Date2025-09-22

Study Record Updates

Study Start Date2021-12-07

Study Completion Date2025-09-22

Terms related to this study

Keywords Provided by Researchers

Bladder Cancer
Urothelial Cancer
Enfortumab vedotin
PADCEV
Pharmacokinetics

Additional Relevant MeSH Terms

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