JPRN-jRCT2080222688已完成3 期
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) COMPARED WITH CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL BLADDER CANCER AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY [IMvigor211]
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 931
研究概览
简要总结
In this randomized study, the primary endpoint was not met in patients with metastatic urothelial carcinoma with PD-L1 expression as IC2/3. This study showed favorable safety profile of atezolizumab in comparison with chemotherapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Age >= 18 years
- •- Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra)
- •- Representative tumor specimens as specified by the protocol
- •- Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •- Life expectancy >= 12 weeks
- •- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •- Adequate hematologic and end organ function
- •- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception as defined by the protocol and to continue its use for 6 months after the last dose of MPDL3280A
排除标准
- •- Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
- •-Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- •- Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
- •- Leptomeningeal disease
- •- Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer
- •- Pregnant and lactating women
- •- Significant cardiovascular disease
- •- Severe infections within 4 weeks prior to randomization
- •- Major surgical procedure other than for diagnosis within 4 weeks prior to randomization
- •- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the MPDL3280A formulation
- •- History of autoimmune disease
- •- Prior allogeneic stem cell or solid organ transplant
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- •- Positive test for HIV and/or active hepatitis B or hepatitis C or tuberculosis
- •- Administration of a live, attenuated vaccine within 4 weeks prior to randomization
- •- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
研究者
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