2023-503280-42-00招募中3 期
A Phase 3, Open-label, Randomized, Noninferiority Trial of the Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Had Received Prior Systemic Therapy
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 26
- 主要终点
- Time-averaged serum concentration over 28 days (Cavgd28)
研究概览
简要总结
To demonstrate PK noninferiority of SC nivolumab vs IV nivolumab administration
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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 healthcare 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 a 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 co stimulation or checkpoint pathways.
- •Treatment with any live attenuated vaccine within 30 days of first study treatment
- •Other protocol-defined inclusion/exclusion criteria apply.
结局指标
主要结局
Time-averaged serum concentration over 28 days (Cavgd28)
Time-averaged serum concentration over 28 days (Cavgd28)
Trough serum concentration at steady-state (Cminss)
Trough serum concentration at steady-state (Cminss)
次要结局
- - Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
- - Trough serum concentration at day 28 (Cmind28) [ Time Frame: At 28 days ]
- - Maximum serum concentration after the first dose (Cmax1) [ Time Frame: Up to 7 days ]
- - Peak serum concentration at steady-state (Cmaxss) [ Time Frame: Up to 4 months ]
- - Steady-state average serum concentration (Cavgss) [ Time Frame: Up to 4 months ]
- - Observed trough nivolumab serum concentration (Ctrough) at Week 17 [ Time Frame: At Week 17 ]
- - Incidence of adverse events (AEs) [ Time Frame: Up to 2 years 3 months ]
- - Incidence of serious adverse events (SAEs) [ Time Frame: Up to 2 years 3 months ]
- - Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years ]
- - Incidence of deaths [ Time Frame: Up to 5 years ]
- - Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 2 years 3 months ]
- - Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [ Time Frame: Up to 2 years 3 months ]
- - Efficacy parameters: disease control rate (DCR) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
- - Efficacy parameters: DCR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
- - Efficacy parameters: DCR by BICR at end of study [ Time Frame: Up to 5 years ]
- - Efficacy parameters: duration of response (DOR) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
- - Efficacy parameters: DOR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
- - Efficacy parameters: DOR by BICR at end of study [ Time Frame: Up to 5 years
- - Efficacy parameters: time to objective response (TTR) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
- - Efficacy parameters: TTR by BICR with a minimum of 12 months followup [ Time Frame: Up to 3 years ]
- - Efficacy parameters: TTR by BICR at end of study [ Time Frame: Up to 5 years ]
- - Efficacy parameters: progression-free survival (PFS) by BICR with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
- - Efficacy parameters: PFS by BICR with a minimum of 12 months followup [ Time Frame: Up to 3 years ]
- - Efficacy parameters: PFS by BICR at end of study [ Time Frame: Up to 5 years ]
- - Efficacy parameters: overall survival (OS) with a minimum of 6 months follow-up [ Time Frame: Up to 2 years 6 months ]
- - Efficacy parameters: OS with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
- - Efficacy parameters: OS at end of study [ Time Frame: Up to 5 years ]
- - Efficacy parameters: ORR by BICR with a minimum of 12 months follow-up [ Time Frame: Up to 3 years ]
- - Efficacy parameters: ORR by BICR at end of study [ Time Frame: Up to 5 years ]
- - Incidence of anaphylactic, hypersensitivity, and systemic infusion reactions [ Time Frame: Up to 2 years 3 months ]
- - Incidence of local injection- or infusion-site reactions [ Time Frame: Up to 2 years 3 months ]
- - Percentage of participants who develop anti-nivolumab antibodies, if applicable [ Time Frame: Up to 2 years 3 months ]
- - Percentage of participants who develop neutralizing antibodies, if applicable [ Time Frame: Up to 2 years 3 months ]
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (26)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study of Subcutaneous Nivolumab in Previously Treated Advanced or Metastatic Clear Cell Renal Cell CarcinomaMetastatic Clear Cell Renal Cell CarcinomaMedDRA version: 21.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-003655-15-PLBristol-Myers Squibb International Corporation495
进行中（未招募）
1 期
A Study of Subcutaneous Nivolumab in Previously Treated Advanced or Metastatic Clear Cell Renal Cell CarcinomaMetastatic Clear Cell Renal Cell CarcinomaMedDRA version: 21.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864EUCTR2020-003655-15-FRBristol-Myers Squibb International Corporation458
进行中（未招募）
1 期
A Study of Subcutaneous Nivolumab in Previously Treated Advanced or Metastatic Clear Cell Renal Cell CarcinomaMetastatic Clear Cell Renal Cell CarcinomaMedDRA version: 21.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864EUCTR2020-003655-15-PTBristol-Myers Squibb International Corporation458
进行中（未招募）
1 期
A Study of Subcutaneous Nivolumab in Previously Treated Advanced or Metastatic Clear Cell Renal Cell CarcinomaEUCTR2020-003655-15-CZBristol-Myers Squibb International Corporation458
进行中（未招募）
1 期
A Study of Subcutaneous Nivolumab in Previously Treated Advanced or Metastatic Clear Cell Renal Cell CarcinomaMetastatic Clear Cell Renal Cell CarcinomaMedDRA version: 21.1Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-003655-15-FIBristol-Myers Squibb International Corporation495