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

Summary

Participation Requirements

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 objecti...

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. Cohort 4: DOR, CBR, and PFS based on central review by RECIST 1.1 criteria ORR, DOR, CBR, PFS based on investigator review by RECIST 1.1 criteria OS Safety and tolerability of sacituzumab govitecan in combination with cisplatin Cohort 5: DOR, CBR, and PFS based on central review by RECIST 1.1 criteria ORR, DOR, CBR, and PFS based on investigator review by RECIST 1.1 criteria OS Safety and tolerability of sacituzumab govitecan in combination with cisplatin and avelumab

Tracking Information