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

Bristol-Myers Squibb International Corporation0 个研究点目标入组 458 人开始时间: 2021年3月30日最近更新: 2021年8月24日

试验速览

暂无简介。

•- Histological confirmation of renal cell carcinoma (RCC)
•- 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
•- Received no more than 2 prior systemic treatment regimens
•- Progression or intolerance on or after the last treatment regimen received
•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

•- Untreated, symptomatic central nervous system (CNS) metastases.
•- Prior immunotherapy (medications which are target the immune system) known as PDL1 or CTLA4 or any other medications working similarly 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

发起方