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 Squibb89 个研究点 分布在 10 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
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
- 89
- 主要终点
- Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale
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
- •For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- •Inclusion Criteria:
- •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 B
Active Comparator
干预措施: Nivolumab (Biological)
Arm A
Experimental
干预措施: Nivolumab and rHuPH20 (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
Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale
时间窗: Pre-dose (Day 1 to Day 28)
Plasma samples were collected to assess the serum concentration.
Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale
时间窗: Pre-dose (Day 1 to Day 28)
Plasma samples were collected to assess the serum concentration.
次要结局
- Objective Response Rate (ORR) Per BICR(From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months))
- Trough Serum Concentration of Nivolumab at Day 28 (Cmind28)(Pre-dose at Day 28)
- Maximum Serum Concentration of Nivolumab After the First Dose (Cmax1)(Post dose (Day 1))
- Peak Serum Concentration of Nivolumab at Steady State (Cmaxss)(Pre-dose (Day 1 to Day 28))
- Time-averaged Serum Concentration of Nivolumab at Steady State (Cavgss)(Pre-dose (Day 1 to Day 28))
- Trough Serum Concentration of Nivolumab (Ctrough)(Pre-dose at Week 17)
- Time to Maximum Serum Concentration of Nivolumab at Day 1 (Tmax1)(Post dose (Day 1))
- Trough Serum Concentration of Nivolumab at Steady State (Cminss)(Pre dose (Day 1 to Day 28))
- Number of Participants With Adverse Events, Serious Adverse Events, AEs Leading to Discontinuation and Death(First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months))
- Number of Participants With Grade 3/4 Laboratory Abnormalities(First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months))
- Disease Control Rate (ORR) Per BICR(From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months))
- Time to Response (TTR) Per BICR(From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months))
- Duration of Response (DoR) Per BICR(From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months))
- Overall Survival(From first dose to the date of death (up to approximately 26 months))
- Number of Participants With Drug-Related Local Injection- or Infusion-Site Reactions(First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 27 months))
- Number of Participants With Incidence of Anti-nivolumab Antibodies(First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months))
研究者
研究点 (89)
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