Clinical Trial TitleAn open-label, randomized phase 3 study to evaluate enfortumab vedotin vs chemotherapy in subjects with previously treated locally advanced or metastatic urothelial cancer (EV-301).
Clinical Trial Protocol Description:
The main purpose of this study is to collect information to determine if the drug called enfortumab vedotin (EV) is effective, safe and comparable to one of the following standard treatments: docetaxel or paclitaxel. Subjects will be randomly assigned to EV infusion Days 1, 8, and 15 of every 28-day cycle OR standard chemotherapy chosen by the study doctor given on Day 1 of every 21-day cycle. Treatment continues until progression or intolerable side effects.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically or cytologically confirmed urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with urothelial carcinoma (transitional cell) with squamous differentiation or mixed cell types are eligible.
- Have experienced radiographic progression or relapse during or after a checkpoint inhibitor (CPI) (anti-programmed cell death protein 1 (PD1) or anti-programmed death-ligand 1 (PD-L1)) for locally advanced or metastatic disease. Subjects who discontinued CPI treatment due to toxicity are eligible provided that the subjects have evidence of disease progression following discontinuation. The CPI need not be the most recent therapy. Subjects for whom the most recent therapy has been a non-CPI based regimen are eligible if the subjects have progressed/relapsed during or after the subjects most recent therapy. Locally advanced disease must not be amenable to resection with curative intent per the treating physician.
- Have received a platinum containing regimen (cisplatin or carboplatin) in the metastatic/locally advanced, neoadjuvant or adjuvant setting. If platinum was administered in the adjuvant/neoadjuvant setting subject must have progressed within 12 months of completion.
- Have radiologically documented metastatic or locally advanced disease at baseline.
You will be excluded from the study if any of the following criteria apply to you:
- Have preexisting sensory or motor neuropathy Grade ≥ 2.
- Have active central nervous system (CNS) metastases.
This is a partial list of inclusion and exclusion criteria.