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- SGN22E-001: A single-arm, open-label, multicenter study of enfortumab vedotin (ASG-22CE) for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor (CPI) therapy
Clinical Trial
SGN22E-001: A single-arm, open-label, multicenter study of enfortumab vedotin (ASG-22CE) for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor (CPI) therapy
This study seeks to find out if enfortumab vedotin (an experimental drug) will treat urothelial cancer in patients who have already been treated with an anticancer drug called an immune checkpoint inhibitor (CPI). We also want to find out about the side effects of enfortumab vedotin.
- Urinary System
- ASG-22CE
- Cancer
- Enfortumab Vedotin
- Immune Checkpoint Inhibitor (CPI)
- Locally Advanced Cancer
- Metastatic Urothelial Cancer
- Multicenter
Eligibility Criteria
- Patients must be 18 years of age or older Patients must have histologically documented urothelial (previously known as transitional cell) carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Patients with squamous differentiation or mixed cell types are eligible. Patient must have received prior treatment with a CPI in the locally advanced or metastatic urothelial cancer setting. Patients who received CPI therapy in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or within 3 months of therapy completion are eligible. A CPI is defined as a PD-1 inhibitor or PD-L1 inhibitor (including, but not limited to: atezolizumab, pembrolizumab, durvalumab, avelumab, and nivolumab).
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