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Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer

Trial Status: Active

This is an international, multi-center, open-label, phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen or anti-PD-1 / PD-L1 based immunotherapy. At least 201 patients are anticipated to be enrolled across approximately 40 sites from North America and Europe.

Inclusion Criteria

  • Patients with histologically confirmed urothelial cancer.
  • ECOG Performance status score of 0 or 1.
  • Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin):
  • Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;
  • Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence/progression ≤12 months following completion of therapy.
  • Cohort 1: In addition to above criterion, have had progression or recurrence of urothelial cancer following receipt of an anti-PD-1 /PD-L1 therapy.
  • Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease and have had progression or recurrence of urothelial cancer after a first-line therapy for metastatic disease with anti-PD-1/PD-L1 therapy. Subject may not have received any platinum for treatment of recurrent, metastatic or advanced disease.
  • Cohort 3: Progression or recurrence of UC following a platinum containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy.
  • Adequate renal and hepatic function.
  • Adequate hematologic parameters without transfusional support.
  • Creatinine clearance ≥30mL/min as calculated by the Cockroft-Gault formula.
  • Subjects must have a 3-month life expectancy.
  • Have measurable disease by CT or MRI as per RECIST 1.1 criteria.

Exclusion Criteria

  • Women who are pregnant or lactating.
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Requires concomitant medication interfering with ABCA1 transporter or UGT1A1
  • Has an active second malignancy.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has known active Hepatitis B or Hepatitis C
  • Has other concurrent medical or psychiatric conditions
  • Cohort 3: Has active autoimmune disease requiring systemic treatment with steroids or other immunosuppressive agent or any condition that in the Investigator's judgment precludes treatment with pembrolizumab
  • Cohort 3: Has received a live vaccine within 30 days prior to the first dose of study drug(s)
  • Cohort 3: Has history or evidence of interstitial lung disease (ILD) or non-infectious pneumonitis
  • Cohort 3: Has received anti-PD-1/PD-L1 therapy previously

Arizona

Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Cheryl Kefauver
Phone: 323-865-0845

Connecticut

New Haven
Yale University
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: APPROVED
Detroit
Wayne State University / Karmanos Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

Texas

San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: ACTIVE
Contact: Sonia Lisa Creighton
Phone: 210-450-1366

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

This is an international, multi-center, open-label, phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen and/or anti-PD-1 / PD-L1 based immunotherapy. The primary objective is Objective Response Rate (ORR) based on central review. The secondary objectives for Cohorts 1 and 2 are Duration of Response (DOR) and Progression Free Survival (PFS) both based on central review and Overall Survival (OS). The secondary objectives for Cohort 3 are Duration of Response (DOR),Clinical Benefit Rate (CBR), and Progression Free Survival (PFS) based on central review by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; Duration of Response (DOR),Clinical Benefit Rate (CBR), and Progression Free Survival (PFS) based on central review for Immune-based therapeutics (iRECIST) criteria, Overall Survival (OS), safety and tolerability of IMMU-132 in combination with pembrolizumab. Subjects will receive IMMU-132 10 mg/kg administered intravenously on Days 1 and 8 of a 21-day cycle to be continued in the absence of unacceptable toxicity or disease progression. In Cohort 3, all subjects will first receive IMMU-132 on Days 1 and 8 of a 21-day cycle followed by pembrolizumab at the standard approved dose (200 mg) only on Day 1 of a 21-day cycle. After discontinuation of treatment, patients will have a 30-day safety follow-up after last dose and then will be followed every 12 weeks for survival for a maximum of 2 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Immunomedics Inc

  • Primary ID IMMU-132-06 - TROPHY U-01
  • Secondary IDs NCI-2018-03421
  • Clinicaltrials.gov ID NCT03547973