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Combination of Ipi/Nivo Plus Sacituzumab Govitecan in Metastatic Cisplatin Ineligible Urothelial Carcinoma Patients
The purpose of this study is to see how well the study drugs called Ipilimumab plus Nivolumab (IPI-NIVO) work when added to another study drug called Sacituzumab Govitecan for people who have metastatic bladder cancer.
Phase I: Feasibility and tolerability of IPI-NIVO combined with sacituzumab as first-line therapy for cisplatin-ineligible patients with metastatic urothelial carcinoma Phase II: To evaluate measurable disease overall response rate (ORR) of IPI-NIVO combined with sacituzumab as first-line therapy for cisplatin-ineligible patients with metastatic urothelial carcinoma. Phase I: 1. Measurable disease overall response rate (ORR) 2. Duration of response (DOR) 3. Progression-free survival (PFS) 4. Overall Survival (OS). Phase II 1) To evaluate progression-free survival (PFS). 2) Duration of response (DOR) 3) To evaluate Overall Survival (OS).4) To evaluate toxicities
BMS-936558 (Nivolumab); Ipilimumab (); Nivolumab (Opdivo); Sacituzumab Govitecan (); Yervoy (Ipilimumab)
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