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Phase I

A Phase 1b Dose-escalation and Dose-expansion Study of Enfortumab Vedotin (ASG-22CE) in Combination With Immune Checkpoint Inhibitor (CPI) Therapy for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer

  • Study HIC#:2000021537
  • Last Updated:07/15/2021

This is a study that will test how an experimental drug (enfortumab vedotin) combined with a kind of anticancer drug called an immune checkpoint inhibitor (CPI) 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.

Patients will get the drugs twice every 21-day cycle. Patients will get enfortumab vedotin plus the CPI on day 1. Patients will get enfortumab vedotin only on day 8.

This study will look at the side effects of giving the two drugs with each other. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with treatment.

  • Age18 years and older
  • GenderBoth
  • Start Date04/02/2018
  • End Date06/30/2023

Trial Purpose and Description

This study will examine the safety and anticancer activity of enfortumab vedotin given intravenously in combination with CPI therapy to patients with locally advanced or metastatic urothelial cancer. The primary goal of the study is to determine the safety and tolerability of enfortumab vedotin in combination with CPI therapy.

The study will be conducted in 2 parts: dose escalation (enfortumab vedotin + pembrolizumab) and dose expansion (cohorts of enfortumab vedotin + CPI [either pembrolizumab or atezolizumab]).

Eligibility Criteria

Inclusion Criteria:

  • Histologically or cytologically documented transitional cell carcinoma of the urothelium (squamous differentiation or mixed cell types allowed).
  • Locally advanced disease that is not resectable or metastatic disease.
  • Eligible to receive treatment with a CPI.
  • Either ineligible for first-line cisplatin-based chemotherapy or have disease progression during or following treatment with at least one platinum-containing regimen.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2.

Exclusion Criteria:

  • Received any prior treatment with a CPI.
  • Received any prior treatment with CD137 agonists or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors.
  • Ongoing sensory or motor neuropathy Grade 2 or higher.
  • Active central nervous system (CNS) metastases.
  • Ongoing clinically significant toxicity (Grade 2 or greater) associated with prior treatment (including radiotherapy or surgery).
  • Patients with conditions requiring high doses of steroids or other immunosuppressive medications are excluded.
  • Prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).