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Clinical Trial 19363

Cancer Type:
Interventions:Enfortumab Vedotin

Study Type: Treatment
Phase of Study: Phase II

  • Jingsong Zhang


Study Title

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 is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer. This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect.


Study Objectives Primary: To determine the antitumor activity of single-agent enfortumab vedotin as measured by confirmed objective response rate (ORR) in patients with locally advanced or metastatic urothelial cancer who have previously received systemic therapy with a CPI. Secondary: To assess duration of response (DOR). To assess disease control rate (DCR). To assess progression-free survival (PFS). To assess overall survival (OS). To assess the safety and tolerability of enfortumab vedotin. To assess the pharmacokinetics (PK) of enfortumab vedotin. To assess the incidence of antitherapeutic antibodies (ATA).

Inclusion Criteria

  • Histologically or cytologically documented transitional cell carcinoma of the urothelium (squamous differentiation or mixed cell types allowed).
  • Metastatic disease or locally advanced disease that is not resectable.
  • Must have received prior treatment with a CPI in the locally advanced or metastatic urothelial cancer setting. A CPI is defined as a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
  • Must either have prior treatment with platinum-containing chemotherapy or be ineligible for treatment with cisplatin at time of enrollment.
  • Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
  • Tumor tissue samples must be available for submission to the sponsor prior to study treatment. Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

  • Exclusion Criteria

  • Ongoing sensory or motor neuropathy Grade ≥2.
  • Active central nervous system (CNS) metastases.
  • Immunotherapy related colitis, uveitis, or pneumonitis.
  • Prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).