| Trial Design: |
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A Phase II, multicenter, open-label,
single‑arm study designed to evaluate the effect of MPDL3280A treatment in patients with locally advanced or metastatic UBC |
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| Primary Endpoint: |
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Objective response rate |
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| Secondary Endpoints: |
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Duration of response |
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Progression-free survival |
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Overall survival |
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Safety: incidence of adverse events |
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Incidence of antitherapeutic antibodies to MPDL3280A |
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Maximum serum concentration (Cmax) of MPDL3280A |
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| Key Inclusion Criteria2: |
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Documented locally advanced or metastatic transitional cell carcinoma of the urothelium |
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Representative tumor specimens |
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ECOG performance status of 0-1 |
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Life expectancy ≥12 weeks |
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Measurable disease, as defined by RECIST v1.1 |
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Adequate hematologic and end-organ function |
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Refractory or ineligible for platinum-based chemotherapy |
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| Key Exclusion Criteria2: |
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History of autoimmune disease |
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Active hepatitis B or hepatitis C |
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HIV-positive |
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Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 |
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Prior treatment with CD137 agonists, or immune checkpoint blockade therapies, including anti‑CTLA4, anti‑PD1, and anti‑PDL1 |
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