Open Actively Recruiting

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


Brief 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.

Primary Purpose
Study Type
Phase 1


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

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

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
Bladder Cancer
Ankush Sachdeva
  • UCLA Westwood
For Providers
For detailed technical eligibility, visit