Brief Title: Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of adverse events (AEs)

Primary Outcome 1 - Timeframe: Approximately 1 year

Primary Outcome 2 - Measure: Incidence of laboratory abnormalities

Primary Outcome 2 - Timeframe: Approximately 1 year

Primary Outcome 3 - Measure: Incidence of dose limiting toxicities (DLTs)

Primary Outcome 3 - Timeframe: Approximately 7 weeks

CONDITION

• Urinary Bladder Neoplasms
• Carcinoma in Situ
• Carcinoma Transitional Cell
• Non-muscle Invasive Bladder Cancer
• NMIBC

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Janet Trowbridge, MD

Role: Study Director

Affiliation: Seagen Inc.

Overall Contact

Name: Janet Trowbridge, MD

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

LOCATION