NCT03288545

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.

Detailed description

This study will examine the safety and anticancer activity of enfortumab vedotin (EV) given intravenously as monotherapy and in combination with other anticancer therapies as first line (1L) and second line (2L) treatment for patients with urothelial cancer. The primary goal of the study is to determine the safety, tolerability, and efficacy of enfortumab vedotin alone and in combination with pembrolizumab and/or chemotherapy. The study will be conducted in multiple parts: Locally advanced or metastatic urothelial cancer: * Dose escalation * Expansion * Part 1: Cohorts A and Optional B * Part 2: Cohorts D, E, and Optional F * Part 3: Cohort G. * Randomized Cohort K * EV Monotherapy Arm * EV Combination Arm Muscle invasive bladder cancer: * Cohort H * Optional Cohort J * Cohort L

Conditions

• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Urologic Neoplasms
• Renal Pelvis Neoplasms
• Urothelial Cancer
• Ureteral Neoplasms
• Urethral Neoplasms

Interventions

Type	Name	Description
DRUG	enfortumab vedotin (EV)	Intravenous (IV) infusion on days 1 and 8 every 21 days
DRUG	pembrolizumab	IV infusion on day 1 every 21 days
DRUG	cisplatin	IV infusion on day 1 every 21 days
DRUG	carboplatin	IV infusion on day 1 every 21 days
DRUG	gemcitabine	IV infusion on days 1 and 8 every 21 days

Timeline

• Start date: 2017-10-11
• Primary completion: 2026-02-20
• Completion: 2026-02-20
• First posted: 2017-09-20
• Last updated: 2026-03-24

Locations

106 sites across 6 countries: United States, Canada, France, Italy, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study