A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103)

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103)

Brief 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.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 457 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: multi-cohort, open-label, multicenter study, global
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer
Actual Study Start Date: October 11, 2017
Estimated Primary Completion Date: July 31, 2023
Estimated Study Completion Date: December 31, 2026

Arm:
- Experimental: EV + Pembrolizumab in cisplatin-ineligible 1L and in 2L
- Experimental: Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1L
- Experimental: Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2L
- Experimental: Cohort D: Enfortumab Vedotin + Cisplatin in 1L
- Experimental: Cohort E: Enfortumab Vedotin + Carboplatin in 1L
- Experimental: Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2L
- Experimental: Experimental: Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L
- Experimental: Cohort H: Enfortumab vedotin in MIBC neoadjuvant setting
- Experimental: Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant setting
- Experimental: Randomized Cohort K: Enfortumab Vedotin Monotherapy
- Experimental: Randomized Cohort K: Enfortumab Vedotin + Pembrolizumab
- Experimental: Cohort L: Enfortumab vedotin in MIBC in perioperative setting

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