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

• ClinicalTrials.gov Identifier: NCT03547973
• Recruitment Status: Recruiting
• First Posted: June 6, 2018
• Last Update Posted: April 19, 2019
• Sponsor: Immunomedics, Inc.
• Information provided by (Responsible Party): Immunomedics, Inc.

Tracking Information

• First Submitted Date: April 26, 2018
• First Posted Date: June 6, 2018
• Last Update Posted Date: April 19, 2019
• Actual Study Start Date: August 31, 2018
• Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: 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

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: Interventional
• Study Phase: Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Urothelial Carcinoma

Intervention

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

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 5, 2018): 140
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2020
• Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)

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 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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Allison Gladden; 862-260-3506; agladden@Immunomedics.com

Contact: Margaret Siemon-Hryczyk,; 973-605-8200; msiemonh@Immunomedics.com

• Listed Location Countries: Belgium, Czechia, France, Korea, Republic of, United States

Administrative Information

• NCT Number: NCT03547973
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Immunomedics, Inc.
• Study Sponsor: Immunomedics, Inc.
• Collaborators: Not Provided

Investigators

• Study Chair: Trishna Goswami, MD; Immunomedics, Inc.

• PRS Account: Immunomedics, Inc.
• Verification Date: April 2019