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

Phase 1

Recruiting

• Conditions: Urinary Bladder Neoplasms; Carcinoma in Situ; Carcinoma Transitional Cell; Non-muscle Invasive Bladder Cancer; NMIBC

• Registration Number: NCT05014139
• Lead Sponsor: Astellas Pharma Global Development, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-8-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Histologically confirmed, non-muscle invasive urothelial carcinoma with carcinoma in<br> situ (CIS) (with or without papillary disease)<br><br> - Predominant histologic component (>50 percent) must be urothelial (transitional<br> cell) carcinoma<br><br> - Participants must have high-risk Bacillus Calmette-Guerin (BCG) - unresponsive<br> disease, defined as (where adequate BCG therapy is defined as one of the following:<br> 5 of 6 doses of an initial induction course + at least 2 of 3 doses maintenance<br> therapy or 5 of 6 doses of an initial induction course + at least 2 of 6 doses of a<br> second induction course):<br><br> - Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive<br> papillary disease/tumor invades the subepithelial connective tissue) disease<br> within 12 months of completion of adequate BCG therapy.<br><br> - Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate<br> BCG therapy, or<br><br> - T1 high-grade disease at the first evaluation following an induction BCG course<br> (at least 5 or 6 doses)<br><br> - Participant must be ineligible for or refusing a radical cystectomy<br><br> - All visible papillary Ta/T1 tumors must be completely resected within 60 days prior<br> to enrollment.<br><br> - Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2.<br><br>Exclusion Criteria:<br><br> - Current or prior history of muscle-invasive urothelial carcinoma or metastatic<br> disease.<br><br> - Nodal or metastatic disease as noted on computed tomography (CT) or magnetic<br> resonance imaging (MRI) within 3 months prior to study treatment<br><br> - Concomitant upper tract urothelial carcinoma as noted on CT or MRI urogram performed<br> within 3 months prior to study treatment<br><br> - Prior or concomitant urothelial carcinoma of the prostatic urethra within 6 months<br> prior to study treatment<br><br> - Participants with tumor-related hydronephrosis<br><br> - Participant has received other systemic anticancer therapy including chemotherapy,<br> biologic therapy, immunotherapy, targeted therapy, endocrine therapy, and/or<br> investigational agent within 4 weeks or intravesical therapy within 6 weeks of first<br> dose of study treatment<br><br> - Participant has had any prior radiation to the bladder for urothelial cancer

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs);Incidence of laboratory abnormalities;Incidence of dose limiting toxicities (DLTs)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of enfortumab vedotin: Area under the concentration-time curve (AUC);PK of enfortumab vedotin: Maximum concentration (Cmax);PK of enfortumab vedotin: Time to maximum concentration concentration (tmax);PK of enfortumab vedotin: Apparent terminal half-life (t1/2);PK of enfortumab vedotin: Trough concentration (Ctrough);Incidence of antitherapeutic antibodies (ATAs) to enfortumab vedotin;Complete response (CR) rate;Duration of CR;Rate of cystectomy;Progression-free survival;Cystectomy-free survival