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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03547973
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.

Tracking Information
First Submitted Date  ICMJE April 26, 2018
First Posted Date  ICMJE June 6, 2018
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE August 31, 2018
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
Overall Response Rate (ORR) [ Time Frame: 2 years ]
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 based on Recist 1.1 by an independent centralized group of radiology experts.
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
Overall Response Rate (ORR) [ Time Frame: 2 years ]
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.
Change History Complete list of historical versions of study NCT03547973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • Duration of Response (DOR) [ Time Frame: 2 years ]
    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 reviewed by an independent centralized group of radiology experts.
  • Progression-Free Survival (PFS) [ Time Frame: 2 years ]
    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.
  • Overall Survival (OS) [ Time Frame: 2 years ]
    OS will be measured from the date of first dose to death from any cause.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • Duration of Response (DOR) [ Time Frame: 2 years ]
    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.
  • Progression-Free Survival (PFS) [ Time Frame: 2 years ]
    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.
  • Overall Survival (OS) [ Time Frame: 2 years ]
    OS will be measured from the date of first dose to death from any cause.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer
Official Title  ICMJE 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
Brief Summary

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.

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 and/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).

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 progression of disease requiring termination of further treatment. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urothelial Carcinoma
Intervention  ICMJE Drug: Sacituzumab govitecan
All subjects will receive Sacituzumab govitecan (IMMU-132) 10 mg/kg intravenously on Days 1 and 8 of a 21 day cycle.
Other Name: IMMU-132
Study Arms  ICMJE Experimental: Cohort 1 and 2

All subjects will receive Sacituzumab govitecan (IMMU-132) 10 mg/kg intravenously on Days 1 and 8 of a 21 day cycle.

Cohort 1: Subjects with urothelial cancers, after platinum-based regimen (cisplatin or carboplatin) and anti-PD-1/anti-PD-L1 based therapy.

Cohort 2: Subjects in second line therapy of urothelial cancers, ineligible for platinum-based therapy and anti-PD-1/anti-PD-L1 based therapies failure.

Intervention: Drug: Sacituzumab govitecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2018)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Allison Gladden 862-260-3506 agladden@Immunomedics.com
Contact: Margaret Siemon-Hryczyk, 973-605-8200 msiemonh@Immunomedics.com
Listed Location Countries  ICMJE Belgium,   Czechia,   France,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03547973
Other Study ID Numbers  ICMJE IMMU-132-06 - TROPHY U-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Immunomedics, Inc.
Study Sponsor  ICMJE Immunomedics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Trishna Goswami, MD Immunomedics, Inc.
PRS Account Immunomedics, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP