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Clinical Trial 19363

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT03219333

Phase: Phase II
Prinicipal Investigator:

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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).




Enfortumab Vedotin ()

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 > Anticipated life expectancy of greater than or equal to 3 months as assessed by the investigator.

  • Exclusion Criteria

  • Ongoing sensory or motor neuropathy Grade ≥2.
  • Active central nervous system (CNS) metastases.
  • Ongoing clinically significant toxicity associated with prior treatment. Patients with /= grade 3 immunotherapy related hypothyroidism or panhypopituitarisms are excluded. Patients with immunotherapy related myocarditis, colitis, uveitis, or pneumonitis are excluded. Patients with other immunotherapy related adverse events requiring high doses of steroids (>20 mg/day of prednisone or equivalent) are excluded
  • Immunotherapy related colitis, uveitis, or pneumonitis.
  • Prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).
  • History of malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Some exceptions apply.
  • Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.
  • Patients with a positive hepatitis B surface antigen and/or antihepatitis B core antibody. Patients with a negative polymerase chain reaction (PCR) assay are permitted with appropriate antiviral prophylaxis.
  • Active hepatitis C infection or known human immunodeficiency virus (HIV) infection. Patients who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of ≥12 weeks.
  • Documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) within 6 months prior to the first dose of enfortumab vedotin.
  • Radiotherapy or major surgery within 2 weeks prior to first dose of study drug.
  • Chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 2 weeks prior to first dose of study drug.
  • Known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin.
  • Patients with active keratitis or corneal ulcerations.
  • Patients with uncontrolled diabetes.
  • Other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up.

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.