EUCTR2016-003092-22-FR进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH ENZALUTAMIDE VERSUS ENZALUTAMIDE ALONE IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AFTER FAILURE OF AN ANDROGEN SYNTHESIS INHIBITOR AND FAILURE OF, INELIGIBILITY FOR, OR REFUSAL OF A TAXANE REGIME
F. Hoffman-La Roche Ltd.0 个研究点目标入组 558 人开始时间: 2017年5月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 558
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
- Male
入选标准
- •- Eastern Cooperative Oncology Group performance status of 0 or 1
- •- Life expectancy >= 3 months
- •- Histologically confirmed adenocarcinoma of the prostate
- •- Progressive, castrate-resistant disease prior to screening by prostate-specific antigen (PSA) or imaging per prostate cancer working group 3 (PCWG3) criteria during or following the direct prior line of therapy in the setting of medical or surgical castration
- •- One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or ineligibility of a taxane-containing regimen
- •- One prior regimen/line of an androgen synthesis inhibitor for mCRPC
- •- Availability of a representative tumor specimen from a site not previously irradiated that is suitable for determination of programmed death ligand 1 (PD L1) status via central testing
- •- Adequate hematologic and end organ function
- •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 223
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 335
排除标准
- •Cancer-specific exclusions
- •- Treatment with any approved anti-cancer therapy, including chemotherapy, immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of abiraterone), within 4 weeks prior to initiation of study treatment
- •- Treatment with abiraterone within 2 weeks prior to study treatment
- •- Structurally unstable bone lesions suggesting impending fracture
- •- Known or suspected brain metastasis or active leptomeningeal disease
- •General medical exclusions
- •- Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study
- •Exclusion criteria related to atezolizumab
- •- Active or history of autoimmune disease or immune deficiency
- •- Prior allogeneic stem cell or solid organ transplantation
- •- History of pulmonary fibrosis/inflammation
- •- Positive HIV test, active hepatitis B or C virus infection, or active tuberculosis
- •- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti Cytotoxic T Lymphocyte-Associated (CTLA) 4, anti programmed death 1 (PD 1), and anti PD L1 therapeutic antibodies
- •- Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment
- •- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study
- •Exclusion criteria related to enzalutamide
- •- History of seizure or any condition that may predispose to seizure including history of unexplained loss of consciousness or transient ischemic attack within 12 months prior to study treatment
- •- Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhibitor
研究者
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