An open-label randomized controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab with or without chemotherapy versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer

Are you eligible to participate in this study?

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

  • Conditions:
    Urothelial Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Subjects must have histologically documented, unresectable locally advanced or metastatic urothelial carcinoma. 2) Subjects must have measurable disease by investigator assessment according to RECIST v1.1. 3) Subjects must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma.

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

  • 1) Subjects who have previously received enfortumab vedotin or other MMAE-based ADCs. 2) Subjects who have received prior treatment with a PD-(L)-1 inhibitor for any malignancy, including earlier stage UC, defined as a PD-1 inhibitor or PD-L1 inhibitor (including, but not limited to, atezolizumab, pembrolizumab, nivolumab, durvalumab, or avelumab). 3) Subjects who have previously 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).


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