Last updated on April 2019

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

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 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.

Clinical Study Identifier: NCT03547973

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