Last updated on October 2020

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


Brief description of study

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.

Detailed Study 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 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.

Clinical Study Identifier: NCT03547973

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Weill Cornell Medicine

New York, NY United States
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Urology Cancer Center

Omaha, NE United States
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Woodlands Medical Specialists

Pensacola, FL United States
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Winship Cancer Institute

Atlanta, GA United States
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Norton Cancer Institute

Louisville, KY United States
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Northwell Health

Lake Success, NY United States
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Stony Brook Medicine Cancer Care

Stony Brook, NY United States
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Houston Methodist Hospital

Houston, TX United States
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Huntsman Cancer Hospital

Salt Lake City, UT United States
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Blue Ridge Cancer Care

Roanoke, VA United States
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Gustave Roussy

Villejuif, France
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Institut Curie

Paris Cedex 05, France
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Hopital Foch

Suresnes, France
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Centre Le'on Be'rard

Lyon Cedex 08, France
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National Cancer Center

Goyang-si, Korea, Republic of
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Severance Hospital

Seoul, Korea, Republic of
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Asan Medical Center

Seoul, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Recruitment Status: Open


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