A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell
About this trial
This is an interventional treatment trial for Urinary Bladder Neoplasms focused on measuring Bladder Cancer, Urothelial Cancer, Enfortumab vedotin, PADCEV, Pharmacokinetics
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
Sites / Locations
- UCLA Department of Medicine - Hematology & OncologyRecruiting
- University of California, IrvineRecruiting
- University of California at San FranciscoRecruiting
- Johns Hopkins Medical CenterRecruiting
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
- Duke University Medical Center
- University of Texas Southwestern Medical CenterRecruiting
- MD AndersonRecruiting
- Site CA11001Recruiting
- Site FR33001Recruiting
- Site ES34001Recruiting
- Site ES34003Recruiting
- Site ES34002Recruiting
- Site UK44002Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Enfortumab vedotin: Dose escalation cohort
Enfortumab vedotin: Dose expansion cohort
During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.
During the induction phase, participants will receive enfortumab vedotin once a week for 6 weeks. During the maintenance phase, participants will receive enfortumab vedotin once a month for 9 doses.