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A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

Status
Active
Cancer Type
Bladder Cancer
Trial Phase
Phase II
Eligibility
18 and older, Male and Female
Study Type
Treatment
NCD ID
NCT02108652
Protocol IDs
GO29293 (primary)
Study Sponsor
Hoffmann-La Roche
NCI Full Details

Summary

This phase II, single-arm study was designed to evaluate the effect of MPDL3280A treatment in patients with locally advanced or metastatic urothelial bladder ca ncer. Patients will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of pa tients who are treatment-naïve and ineligible for platinum-containing therapy. C ohort 2 will contain patients who have progressed during or following a prior pl atinum-based chemotherapy regimen. Patients in both cohorts will be given a 1200 mg intravenous (IV) dose of MPDL3280A on Day 1 of 21-day cycles. Treatment may continue for up to 16 cycles or 12 months, whichever is first, in the absence of toxicity or disease progression. Patients will be followed for up for 2 years. Patients who complete the initial treatment stage of up to 16 cycles may be eli gible for MPDL3280A re-treatment upon subsequent disease progression during the follow-up period and without intervening systemic anti-cancer therapy.
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