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

• Status: Not yet recruiting
• Trial end date: 2028-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

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:

• Persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy. (Ta/T1: noninvasive papillary disease/tumor invades the subepithelial connective tissue). 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

• 5 of 6 doses of an initial induction course + at least 2 of 6 doses of a second induction course

• 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

• Subject has had any prior radiation to the bladder for urothelial cancer