A dose-escalation and dose-expansion study of enfortumab vedotin (ASG-22CE) in combination with pembrolizumab and/or chemotherapy for treatment of patients with locally advanced or metastatic urothelial cancer (SGN22E-002)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Advanced Or Metastatic Urothelial Carcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Patients must have histologically documented locally advanced or metastatic urothelial (previously known as transitional cell) carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Patients with mixed cell types are eligible. Patients with locally advanced disease that is resectable with curative intent are ineligible. 2. Patients in dose-escalation cohorts, Cohort A, Optional Cohort B, and Cohort G must be eligible for checkpoint inhibitor therapy.

You may not be eligible for this study if the following are true:

  • 1) Received any prior treatment with a CPI. A CPI is defined as a PD-1 inhibitor, PD-L1 inhibitor, or PD-L2 inhibitor (including, but not limited to, atezolizumab, pembrolizumab, nivolumab, durvalumab, or avelumab). Patients in Expansion Cohort F may have previously received treatment with a CPI. 2) Received any prior treatment with an agent directed to another stimulatory or co-inhibitory T-cell receptor (including but not limited to CD137 agonists, CTLA-4 inhibitors, or OX-40 agonists). Patients who received prior treatments with these agents may be eligible for Expansion Cohort F. 3) Ongoing sensory or motor neuropathy Grade 2 or higher. 4) Prior treatment with enfortumab vedotin or other MMAE-based ADCs for urothelial cancer.

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