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A Study of Enfortumab Vedotin (EV) for Treatment of Patients With Non–Muscle-Invasive Bladder Cancer (NMIBC) Who Are Unresponsive to Bacillus Calmette-Guérin (BCG) Therapy

A phase 1, non-randomized study of intravesical EV for patients with BCG-unresponsive NMIBC

Study Identifier

SGN22E-004 Identifier:


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Study Details

The study will comprise 2 parts. First, dose escalation will find the highest dose of EV that does not cause unacceptable side effects in participants. Second, dose expansion will use the dose found in the first part to test how well the drug works.

Study Phase


Medical Condition

BCG-unresponsive NMIBC

Intervention Type

Sequential Assignment

Inclusion Criteria
  • Histologically confirmed, non–muscle-invasive urothelial carcinoma with carcinoma in situ (CIS) (with or without papillary disease)
  • Must have high-risk BCG-unresponsive disease
    • 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 of maintenance therapy
      • 5 of 6 doses of an initial induction course + at least 2 of 6 doses of a second induction course
  • Predominant histologic component (>50%) must be urothelial (transitional cell) carcinoma
  • Ineligible for or refusal of radical cystectomy
  • Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
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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 program 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
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The safety and efficacy of these investigational compounds, or investigational uses of marketed products, have not been established. For an agent(s) whose safety and efficacy have not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

The EV-104 study is currently enrolling.
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Contacts and Locations


Reference: A study of intravesical enfortumab vedotin for treatment of patients with non-muscle invasive bladder cancer (NMIBC) (08-20-2021). Accessed 04-18-2022.