NCT03024996终止3 期
A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 778
- 试验地点
- 186
- 主要终点
- Investigator-assessed Disease-Free Survival (DFS)
研究概览
简要总结
This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status of less than or equal to (</=) 1
- •Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology that has not been previously treated in the adjuvant or neoadjuvant setting and classified as being at high risk of RCC recurrence
- •Radical or partial nephrectomy with lymphadenectomy in select participants
- •Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization. Confirmation of disease-free status will be assessed by an independent central radiologic review of imaging data.
- •Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to randomization. Applicable only to metastasectomy participants
- •Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery
排除标准
- •Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau
- •Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
- •Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days or five half-lives of the investigational agent, whichever is longer, prior to enrollment
- •Malignancies other than RCC within 5 years prior to Cycle 1, Day 1
- •History of autoimmune disease
- •Participants with prior allogeneic stem cell or solid organ transplantation
- •History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
- •Positive test for HIV
- •Participants with active hepatitis B or hepatitis C
- •Active tuberculosis
- •Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
- •Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
- •Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
- •Prior treatment with cluster of differentiation (CD)137 agonists, anti-cytotoxic T-lymphocyte-associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibody or pathway-targeting agents
- •Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization
- •Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to randomization or anticipated need for systemic immunosuppressive medications during the study
研究组 & 干预措施
Atezolizumab
Experimental
Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
干预措施: Atezolizumab (Drug)
Placebo
Placebo Comparator
Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
干预措施: Placebo (Other)
结局指标
主要结局
Investigator-assessed Disease-Free Survival (DFS)
时间窗: From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)
Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.
次要结局
- Independent Review Facility (IRF)-Assessed DFS(From baseline until first documented recurrence event (up to approximately 64 months))
- Overall Survival (OS)(From baseline up to death due to any cause (up to approximately 64 months))
- Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3(From baseline until first occurrence of DFS event (up to approximately 64 months))
- IRF-assessed Event-free Survival (EFS)(From baseline until first documented recurrence event (up to approximately 64 months))
- Disease-Specific Survival(From baseline up to death due to RCC (up to approximately 64 months))
- IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3(From baseline until first occurrence of DFS event (up to approximately 64 months))
- Distant Metastasis-Free Survival(From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months))
- Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3(Up to 3 years)
- Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab(Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days))
- Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3(Up to 3 years)
- Maximum Serum Concentration (Cmax) of Atezolizumab(Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days))
- Percentage of Participants With Adverse Events(From baseline up to death due to any cause (up to approximately 71 months))
- Minimum Serum Concentration (Cmin) of Atezolizumab(Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days))
研究者
研究点 (186)
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