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

Launched by ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC. · Aug 16, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called enfortumab vedotin for patients with non-muscle invasive bladder cancer (NMIBC). NMIBC is a type of bladder cancer that hasn't spread into the muscle of the bladder wall. The researchers want to see if this drug can help treat NMIBC and what side effects it may cause. In this study, enfortumab vedotin will be delivered directly into the bladder using a thin tube called a catheter.

To take part in this trial, participants must have a confirmed diagnosis of NMIBC and have already received a specific type of treatment that didn't work for them, known as Bacillus Calmette-Guerin (BCG) therapy. Candidates must also have had their visible tumors removed recently and cannot have certain other types of cancer or complications. Those who join the trial will receive this treatment and will be monitored for how well it works and any side effects. This trial is currently looking for participants aged 65 and older, and both men and women can take part.

Gender

ALL

Eligibility 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