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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05014139
Other study ID # SGN22E-004
Secondary ID EV-104
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 7, 2021
Est. completion date May 31, 2028

Study information

Verified date May 2024
Source Astellas Pharma Inc
Contact Seagen, Inc. Trial Information Support
Phone 866-333-7436
Email clinicaltrials@seagen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Enfortumab vedotin
Given into the bladder (intravesically)

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Astellas Pharma Global Development, Inc. Seagen Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Spain,  United Kingdom, 

Outcome

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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