A Study of Intravesical Enfortumab Vedotin for Treatment of Patients with Non-Muscle Invasive Bladder Cancer (NMIBC)
Details
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.
Eligibility
You can join if...
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)
-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