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.
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.
|Treatment||Sacituzumab govitecan, Sacituzumab govitecan and pembrolizumab|
|Clinical Study Identifier||NCT03547973|
|Last Modified on||28 October 2020|
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