A 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

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A 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 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 enrolling in two parallel cohorts. Cohort 1: Single-arm, open-label, two-stage design, phase II study of IMMU-132 in third-line therapy of urothelial cancers, after platinum-based and PD-1 / PD-L1 based therapies failure. Cohort 2: Single-arm, open-label, phase II study of IMMU-132 in second-line therapy of urothelial cancers, ineligible for platinum-based therapy.

Clinical Study Identifier: s18-00380

ClinicalTrials.gov Identifier: NCT03547973

Principal Investigator: Scot Niglio.

Other Investigators: Victor Ricardo Adorno Febles, Wei Phin Tan, Katie S. Murray, Minas Platon Economides, Laura Catherine Bauer, Hank Ng, David R. Wise.

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Perlmutter Cancer Center

Clinical Trials & Research Studies