NCT04810078进行中（未招募）3 期
A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy
Bristol-Myers Squibb86 个研究点 分布在 11 个国家目标入组 681 人开始时间: 2021年5月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 681
- 试验地点
- 86
- 主要终点
- Time-averaged serum concentration over 28 days (Cavgd28)
研究概览
简要总结
The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.
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
- •Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features
- •Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV)
- •Measurable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria within 28 days prior to randomization
- •Received no more than 2 prior systemic treatment regimens
- •Intolerance or progression on or after the last treatment regimen received and within 6 months prior to randomization
- •Karnofsky PS ≥ 70 at screening
- •Must agree to follow specific methods of contraception, if applicable
排除标准
- •Untreated, symptomatic central nervous system (CNS) metastases
- •Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization
- •Active, known, or suspected autoimmune disease
- •Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, or a current CD4 count < 350 cells/μL. Participants with HIV are eligible if:
- •They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization
- •They continue on ART as clinically indicated while enrolled on study
- •CD4 counts and viral load are monitored per standard of care by a local health care provider
- •Inclusion of participants with HIV should be based on Investigator clinical judgment in consultation with the Medical Monitor NOTE: Testing for HIV must be performed at sites where mandated locally. HIV-positive participants must be excluded where mandated locally
- •Serious or uncontrolled medical disorders including for example, active severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4 weeks prior to screening. In the case of prior SARS-CoV-2 infection, acute symptoms must have resolved based on investigator clinical judgment and, in consultation with Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment to be eligible
- •Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death ligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
- •Treatment with any live attenuated vaccine within 30 days of first study treatment
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm A
Experimental
干预措施: Nivolumab and rHuPH20 (Biological)
Arm B
Active Comparator
干预措施: Nivolumab (Biological)
Arm C
Experimental
干预措施: Nivolumab and rHuPH20 (Biological)
Arm D
Experimental
干预措施: Nivolumab and rHuPH20 (Biological)
结局指标
主要结局
Time-averaged serum concentration over 28 days (Cavgd28)
时间窗: Up to 28 days
Trough serum concentration at steady-state (Cminss)
时间窗: Up to 4 months
次要结局
- Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up(Up to 2 years 6 months)
- Peak serum concentration at steady-state (Cmaxss)(Up to 4 months)
- Efficacy parameters: TTR by BICR at end of study(Up to 5 years)
- Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up(Up to 3 years)
- Maximum serum concentration after the first dose (Cmax1)(Up to 7 days)
- Trough concentration (Ctrough)(At week 17)
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests(Up to 2 years 3 months)
- Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests(Up to 2 years 3 months)
- Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up(Up to 3 years)
- Efficacy parameters: DCR by BICR at end of study(Up to 5 years)
- Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up(Up to 2 years 6 months)
- Trough serum concentration at day 28 (Cmind28)(At 28 days)
- Steady-state average serum concentration (Cavgss)(Up to 4 months)
- Incidence of adverse events (AEs)(Up to 2 years 3 months)
- Incidence of serious adverse events (SAEs)(Up to 2 years 3 months)
- Incidence of AEs leading to discontinuation(Up to 2 years)
- Incidence of deaths(Up to 5 years)
- Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up(Up to 2 years 6 months)
- Efficacy parameters: DOR by BICR at end of study(Up to 5 years)
- Efficacy parameters: time to objective response (TTR) by BICR with a minimum of 6 months follow-up(Up to 2 years 6 months)
- Efficacy parameters: TTR by BICR with a minimum of 12 months follow-up(Up to 3 years)
- Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up(Up to 2 years 6 months)
- Efficacy parameters: PFS by BICR with a minimum of 12 months follow-up(Up to 3 years)
- Efficacy parameters: PFS by BICR at end of study(Up to 5 years)
- Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up(Up to 2 years 6 months)
- Efficacy parameters: OS at end of study(Up to 5 years)
- Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up(Up to 3 years)
- Efficacy parameters: ORR by BICR at end of study(Up to 5 years)
- Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions/systemic injection reactions(Up to 2 years 3 months)
- Incidence of local injection- or infusion-site reactions(Up to 2 years 3 months)
- Percentage of participants who develop neutralizing antibodies, if applicable(Up to 2 years 3 months)
- Efficacy parameters: OS with a minimum of 12 months follow-up(Up to 3 years)
- Percentage of participants who develop anti-nivolumab antibodies, if applicable(Up to 2 years 3 months)
研究者
研究点 (86)
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