临床试验/NCT03138512

NCT03138512已完成3 期

A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

Bristol-Myers Squibb198 个研究点分布在 6 个国家目标入组 1,641 人开始时间: 2017年7月7日最近更新: 2024年12月18日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 1,641
试验地点: 198
主要终点: Disease-Free Survival (DFS) by BICR - Treatment Part A and B

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

详细描述

The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

•Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy
•Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0
•Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features
•Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
•Women must agree to follow methods of contraception, if applicable

排除标准

•Participants with an active known or suspected autoimmune disease
•Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
•Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
•Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
•History of allergy or hypersensitivity to study drug components
•Participants with a condition requiring systemic treatment with corticosteroids
•Participants who have received a live/attenuated vaccine within 30 days of first treatment
•Other protocol-defined inclusion/exclusion criteria apply

研究组 & 干预措施

Part A, Arm A: nivolumab + ipilimumab

Experimental

干预措施: nivolumab (Biological)

Part A, Arm A: nivolumab + ipilimumab

Experimental

干预措施: ipilimumab (Biological)

Part A, Arm B: nivolumab placebo + ipilimumab placebo

Placebo Comparator

干预措施: nivolumab placebo (Drug)

Part A, Arm B: nivolumab placebo + ipilimumab placebo

Placebo Comparator

干预措施: ipilimumab placebo (Drug)

Part B, Arm A: nivolumab + ipilimumab

Experimental

干预措施: nivolumab (Biological)

Part B, Arm A: nivolumab + ipilimumab

Experimental

干预措施: ipilimumab (Biological)

Part B, Arm B: nivolumab placebo + ipilimumab placebo

Placebo Comparator

干预措施: nivolumab placebo (Drug)

Part B, Arm B: nivolumab placebo + ipilimumab placebo

Placebo Comparator

干预措施: ipilimumab placebo (Drug)

Part B, Arm C: nivolumab + ipilimumab placebo

Experimental

干预措施: nivolumab (Biological)

Part B, Arm C: nivolumab + ipilimumab placebo

Experimental

干预措施: ipilimumab placebo (Drug)

结局指标

主要结局

Disease-Free Survival (DFS) by BICR - Treatment Part A and B

时间窗: From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)

Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.

次要结局

Overall Survival (OS) - Treatment Part A and B(From randomization to the date of death (up to approximately 72 months))
Overall Survival (OS) Rate (5 Years) - Treatment Part A and B(At 5 years)
Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B(From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months))
Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B(From randomization to the date of death (up to approximately 72 months))
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A(From first dose to 30 days post last dose (up to approximately 40 weeks))
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B(From first dose to 30 days post last dose (up to approximately 40 weeks))
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A(From first dose to 100 days post last dose (up to approximately 50 weeks))
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B(From first dose to 100 days post last dose (up to approximately 50 weeks))
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A(From first dose to 30 days post last dose (up to approximately 40 weeks))
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B(From first dose to 30 days post last dose (up to approximately 40 weeks))
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A(From first dose to 100 days post last dose (up to approximately 50 weeks))
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B(From first dose to 100 days post last dose (up to approximately 50 weeks))

研究者

发起方

Bristol-Myers Squibb

申办方类型

Industry

责任方

Sponsor

研究点 (198)

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