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



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:August 31, 2018
End Date:May 2020
Contact:Allison gladden
Email:agladden@Immunomedics.com
Phone:973-605-8200

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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

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.

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.

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
We found this trial at
17
sites
Louisville, Kentucky 40207
Principal Investigator: Arash Rezazadeh, MD
Phone: 502-629-6068
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Saby George, MD
Phone: 716-845-3019
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: John C Henegan, MD
Phone: 601-815-4540
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Nancy Davis, MD
Phone: 615-936-5173
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Albuquerque, New Mexico 87109
Principal Investigator: Pranshu Bansal, MD
Phone: 505-842-8171
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Ann Arbor, Michigan 48109
Principal Investigator: Phillip Palmbos, MD
Phone: 734-936-9499
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Houston, Texas 77056
Principal Investigator: Mary Crow, MD
Phone: 832-703-9054
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Nicholas Vogelzang, MD
Phone: 702-952-3712
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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New Haven, Connecticut 06520
Principal Investigator: Daniel Petrylak, MD
Phone: 203-785-5720
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New York, New York 10065
Principal Investigator: Scott T. Tagawa, MD, MS
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New York, New York 10016
Principal Investigator: Arjun Balar, MD
Phone: 929-455-2436
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Omaha, Nebraska 68130
Principal Investigator: Luke Nordquist, MD
Phone: 402-697-2229
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Omaha, NE
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Salt Lake City, Utah 84112
Principal Investigator: Neeraj Agarwal, MD
Phone: 801-213-6125
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Seattle, Washington 98109
Principal Investigator: Petros Grivas, MD
Phone: 206-606-7486
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Stony Brook, New York 11794
Principal Investigator: Yue Zhang, MD
Phone: 631-638-0829
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Tucson, Arizona 85712
Principal Investigator: Christopher Chen, MD
Phone: 562-693-4477
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Whittier, California 90603
Principal Investigator: Edward Thara, MD
Phone: 562-693-4477
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