EUCTR2020-003655-15-PT进行中（未招募）1 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. - A Study of Subcutaneous Nivolumab in Previously Treated Advanced or Metastatic Clear Cell Renal Cell
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 458
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 on the study.
- •Karnofsky PS = 70 at screening.
- •Must agree to follow specific methods of contraception, if applicable.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 275
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 183
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:
- •1.They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization.
- •2.They continue on ART as clinically indicated while enrolled on study.
- •3.CD4 counts and viral load are monitored per standard of care by a local healthcare provider.
- •4.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.
研究者
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