Summary

for people ages 18 years and up (full criteria)
at UC Davis UC Irvine
study started
estimated completion:

Description

Summary

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. Patients who sign up for this trial must also fall into one of these categories: - Patients have already received treatment with platinum-containing chemotherapy - Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.

Official 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

Details

This study will examine the safety and anticancer activity of enfortumab vedotin given intravenously to patients with locally advanced or metastatic urothelial cancer who previously received a CPI and either previously received platinum-containing chemotherapy (Cohort 1) or are platinum-naïve and cisplatin-ineligible (Cohort 2). Patients who received platinum in the adjuvant/neoadjuvant setting and did not progress within 12 months of completion will be considered platinum-naïve. Approximately 100 patients are expected to be enrolled in each cohort. The primary goal of the study is to determine the confirmed ORR of enfortumab vedotin.

Keywords

Carcinoma, Transitional Cell Urinary Bladder Neoplasms Urologic Neoplasms Renal Pelvis Neoplasms Urothelial Cancer Ureteral Neoplasms Urethral Neoplasms Enfortumab vedotin Metastatic Urothelial Cancer ASG-22CE Locally Advanced Urothelial Cancer Antibody-Drug Conjugate Nectin-4 Platinum-naïve Cisplatin-ineligible Antineoplastic Agents Drug Therapy ASG-22ME Neoplasms Pelvic Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically documented urothelial carcinoma (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. Patients who received CPI therapy in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or within 3 months of therapy completion are eligible.
  • Must either have prior treatment with platinum-containing chemotherapy (Cohort 1) or be platinum-naïve and ineligible for treatment with cisplatin at time of enrollment(Cohort 2).
  • 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.

You CAN'T join if...

  • Ongoing sensory or motor neuropathy Grade ≥2.
  • Active central nervous system (CNS) metastases.
  • Immunotherapy related myocarditis, colitis, uveitis, or pneumonitis.
  • Prior enrollment in an enfortumab vedotin study or prior treatment with other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).
  • Uncontrolled tumor-related pain or impending spinal cord compression.

Locations

  • University of California Davis accepting new patients
    Davis California 95616 United States
  • Chao Family Comprehensive Cancer Center University of California Irvine accepting new patients
    Orange California 92868 United States
  • University of California Irvine - Newport accepting new patients
    Orange California 92868 United States
  • Kaiser Permanente San Francisco accepting new patients
    San Francisco California 94115 United States
  • Keck Medical Center / Newport Beach accepting new patients
    Newport Beach California 92663 United States
  • Kaiser Permanente South San Francisco accepting new patients
    South San Francisco California 94080 United States
  • Keck Medical Center / University of Southern California accepting new patients
    Los Angeles California 90033 United States
  • Kaiser Permanente Oakland accepting new patients
    Oakland California 94611 United States
  • Kaiser Permanente San Leandro accepting new patients
    San Leandro California 94577 United States
  • Kaiser Permanente Sacramento accepting new patients
    Sacramento California 95825 United States
  • Kaiser Permanente Walnut Creek accepting new patients
    Walnut Creek California 94596 United States
  • Kaiser Permanente Medical Center Northern California accepting new patients
    Vallejo California 94589 United States
  • Kaiser Permanente Roseville accepting new patients
    Roseville California 95661 United States
  • Kaiser Permanente Santa Clara accepting new patients
    Santa Clara California 95051 United States
  • Kaiser Permanente San Jose accepting new patients
    San Jose California 95119 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Astellas Pharma Global Development, Inc.
ID
NCT03219333
Phase
Phase 2
Study Type
Interventional
Last Updated
July 6, 2018