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Testing enfortumab vedotin for non-muscle invasive bladder cancer

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

Phase 1 Interventional Astellas Pharma Inc · NCT05014139

This study is testing a new drug called enfortumab vedotin to see if it helps people with non-muscle invasive bladder cancer feel better and stay safe during treatment.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment58 (estimated)
Ages18 Years and up
SexAll
SponsorAstellas Pharma Inc Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation, enfortumab
Locations32 sites (Gilbert, Arizona and 31 other locations)
Trial IDNCT05014139 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of enfortumab vedotin in patients with non-muscle invasive bladder cancer (NMIBC). It consists of two parts: a dose escalation phase to determine the highest tolerable dose and a dose expansion phase to assess the drug's efficacy. Participants will receive the treatment via a catheter directly into the bladder, followed by a follow-up period after the maintenance phase. The study aims to provide insights into the pharmacokinetics and side effects of the drug.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed non-muscle invasive urothelial carcinoma, particularly those with high-risk BCG-unresponsive disease.

Not a fit: Patients with muscle-invasive bladder cancer or those who have not received adequate prior BCG therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with high-risk NMIBC who are unresponsive to standard therapies.

How similar studies have performed: Other studies have shown promising results with similar intravesical therapies, but this specific approach with enfortumab vedotin is novel.

Eligibility criteria

Show full inclusion / exclusion 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 (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

Where this trial is running

Gilbert, Arizona and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Urinary Bladder NeoplasmsCarcinoma in SituCarcinoma Transitional CellNon-muscle Invasive Bladder CancerNMIBCBladder CancerUrothelial CancerEnfortumab vedotin
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.