Clinical Trials /

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

NCT03547973

Description:

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 140 patients are anticipated to be enrolled across approximately 70 sites from North America, Europe and Asia.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer
  • Official Title: Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/ PD-L1 Based Immunotherapy

Clinical Trial IDs

  • ORG STUDY ID: IMMU-132-06
  • NCT ID: NCT03547973

Conditions

  • Urothelial Carcinoma

Interventions

DrugSynonymsArms
Sacituzumab govitecanIMMU-132Cohort 1 and 2

Purpose

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. Approximately 140 patients are anticipated to be enrolled across approximately 50 sites from North America and Europe.

Detailed Description

      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.

      The primary objective is Objective Response Rate (ORR) based on central review.

      The secondary objectives are Duration of Response (DOR) and Progression Free Survival (PFS)
      both based on central review and Overall Survival (OS).

      Patients 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 progression of
      disease requiring termination of further treatment. Enrollment is expected to be completed in
      approximately 8 months. 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
      minimum of 2 years.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1 and 2ExperimentalAll subjects will receive Sacituzumab govitecan (IMMU-132) 10 mg/kg intravenously on Days 1 and 8 of a 21 day cycle. Cohort 1: Patients in third-line therapy of urothelial cancers, after platinum-based regimen (cisplatin or carboplatin) and anti-PD-1/anti-PD-L1 based therapy. Cohort 2: Patients in second line therapy of urothelial cancers, ineligible for cisplatin based therapy and after anti-PD-1/anti-PD-L1 based therapy.
  • Sacituzumab govitecan

Eligibility Criteria

        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):

               1. Received a first-line platinum-containing regimen in the metastatic setting or
                  for inoperable locally advanced disease;

               2. Or received adjuvant platinum-containing therapy following cystectomy for
                  localized muscle-invasive urothelial cancer, with recurrence/progression ≤12
                  months following completion of therapy.

          -  Cohort 1: In addition to above criterion, must have had progression or recurrence of
             urothelial cancer following receipt of an anti-PD-1 /PD-L1 therapy.

          -  Cohort 2: Were ineligible for cisplatin-based therapy for first line metastatic
             disease and have had progression or recurrence of urothelial cancer after a first-line
             therapy for metastatic disease after an anti-PD-1/PD-L1 therapy.

          -  Adequate hematology, chemistry renal and hepatic function and coagulation values
             without ongoing transfusional.

          -  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.

          -  Is currently participating in or has participated in a study of an investigational
             agent or using an investigational device within 4 weeks prior to the first dose of
             trial treatment.

          -  Has a diagnosis of immunodeficiency.

          -  Has had prior irinotecan therapy.

          -  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

          -  Subjects with Gilbert's disease.

          -  Has a known additional malignancy that is progressing or requires active treatment.

          -  Has known active central nervous system (CNS) metastases and/or carcinomatous
             meningitis.

          -  Has active cardiac disease, Myocardial infarction or unstable angina pectoris within 6
             months of the first date of study therapy.

          -  Has active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease)
             and subjects with a history of bowel obstruction.

          -  Has prior history of clinically significant bleeding, intestinal obstruction, or GI
             perforation within 6 months of enrollment.

          -  Must be at least 2 weeks beyond high dose systemic corticosteroids (however, low dose
             corticosteroids ≤ 20 mg prednisone or equivalent daily are permitted provided the dose
             is stable for 4 weeks).

          -  Has an active infection requiring systemic therapy.

          -  Has a known history of Human Immunodeficiency Virus, Hepatitis B or Hepatitis C

          -  Has other concurrent medical or psychiatric conditions
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:2 years
Safety Issue:
Description:ORR will be defined as the rate of the confirmed overall best response, Complete Remission (CR) or Partial Response (PR) and will be centrally reviewed by an independent centralized group of radiology experts.

Secondary Outcome Measures

Measure:Duration of Response (DOR)
Time Frame:2 years
Safety Issue:
Description:DOR will be calculated from the date of the first evaluation showing documented response, PR, or CR, to the date of the first disease progression and will be centrally review by an independent centralized group of radiology experts.
Measure:Progression-Free Survival (PFS)
Time Frame:2 years
Safety Issue:
Description:PFS is defined as the time interval from the first dose start date to the date of disease progression and will be centrally reviewed by an independent centralized group of radiology experts.
Measure:Overall Survival (OS)
Time Frame:2 years
Safety Issue:
Description:OS will be measured from the date of first dose to death from any cause.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Immunomedics, Inc.

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