Urinary Bladder Neoplasms Clinical Trial
Official title:
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
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.
Status | Recruiting |
Enrollment | 58 |
Est. completion date | May 31, 2028 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Site CA11001 | Toronto | Ontario |
France | Site FR33002 | Lyon | |
France | Site FR33001 | Paris | |
Germany | Site DE49001 | Goettingen | |
Germany | Site DE49002 | Tübingen | |
Spain | Site ES34001 | Barcelona | |
Spain | Site ES34003 | Barcelona | |
Spain | Site ES34004 | Barcelona | |
Spain | Site ES34002 | Madrid | |
United Kingdom | Site UK44002 | London | |
United States | Johns Hopkins Medical Center | Baltimore | Maryland |
United States | Erlanger Oncology and Hematology | Chattanooga | Tennessee |
United States | Northwestern University-Feinberg School of Medicine | Chicago | Illinois |
United States | James Cancer Hospital / Ohio State University | Columbus | Ohio |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
United States | MD Anderson | Houston | Texas |
United States | Markey Cancer Center / University of Kentucky | Lexington | Kentucky |
United States | UCLA Department of Medicine - Hematology & Oncology | Los Angeles | California |
United States | Carolina Urologic Research Center | Myrtle Beach | South Carolina |
United States | Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York |
United States | University of California, Irvine | Orange | California |
United States | Urology San Antonio | San Antonio | Texas |
United States | University of California at San Francisco | San Francisco | California |
United States | Mayo Clinic | Scottsdale | Arizona |
United States | Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Global Development, Inc. | Seagen Inc. |
United States, Canada, France, Germany, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events (AEs) | An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. | Approximately 1 year | |
Primary | Incidence of laboratory abnormalities | To be summarized using descriptive statistics. | Approximately 1 year | |
Primary | Incidence of dose limiting toxicities (DLTs) | To be summarized using descriptive statistics. | Approximately 7 weeks | |
Secondary | Pharmacokinetics (PK) of enfortumab vedotin: Area under the concentration-time curve (AUC) | AUC will be recorded from the PK blood samples collected. | Approximately 1 year | |
Secondary | PK of enfortumab vedotin: Maximum concentration (Cmax) | Cmax will be recorded from the PK blood samples collected. | Approximately 1 year | |
Secondary | PK of enfortumab vedotin: Time to maximum concentration concentration (tmax) | Tmax will be recorded from the PK blood samples collected. | Approximately 1 year | |
Secondary | PK of enfortumab vedotin: Apparent terminal half-life (t1/2) | T1/2 will be recorded from the PK blood samples collected. | Approximately 1 year | |
Secondary | PK of enfortumab vedotin: Trough concentration (Ctrough) | Ctrough will be recorded from the PK blood samples collected. | Approximately 1 year | |
Secondary | Incidence of antitherapeutic antibodies (ATAs) to enfortumab vedotin | Blood samples for ATA analysis will be collected. | Approximately 1 year | |
Secondary | Complete response (CR) rate | CR rate is defined as the proportion of subjects achieving CR. | Up to 24 months | |
Secondary | Duration of CR | The time from first documented CR to the first evidence of recurrence, progression, or death due to any cause. | Up to 5 years | |
Secondary | Rate of cystectomy | The proportion of subjects who subsequently undergo cystectomy. | Up to 5 years | |
Secondary | Progression-free survival | The time from start of study treatment to the first evidence of progression or death due to any cause. | Up to 5 years | |
Secondary | Cystectomy-free survival | The time from start of study treatment to cystectomy or death due to any cause. | Up to 5 years |
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