Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine UCSD UCSF
Dates
study started
completion around

Description

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.

Official Title

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

Details

Keywords

Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms, Renal Pelvis Neoplasms, Urothelial Cancer, Ureteral Neoplasms, Urethral Neoplasms, ASG-22ME, ASG-22CE, Antibody-drug conjugate, Antineoplastic agents, CPI, Enfortumab vedotin, MIBC, Locally advanced urothelial cancer, Cisplatin, Drug therapy, Carboplatin, Metastatic urothelial cancer, Nectin-4, Gemcitabine, Muscle invasive bladder cancer, Checkpoint Inhibitors, Pembrolizumab, PD-1 inhibitor, Neoplasms, Transitional Cell Carcinoma, Pelvic Neoplasms, enfortumab vedotin (EV), EV + Pembrolizumab in cisplatin-ineligible 1L and in 2L, EV + Pembrolizumab in cisplatin-ineligible 1L, Enfortumab Vedotin + Cisplatin in 1L, Enfortumab Vedotin + Carboplatin in 1L, Enfortumab Vedotin + Platinum + Pembrolizumab in 1L, Enfortumab vedotin in MIBC neoadjuvant setting, Enfortumab vedotin in MIBC in perioperative setting

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Astellas Pharma Global Development, Inc.
ID
NCT03288545
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 348 people participating
Last Updated