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

Roche Farma S.A. (Soc. Unipersonal) que realiza el ensayo en España y que actúa como representante de F. Hoffmann-La R0 个研究点目标入组 558 人开始时间: 2017年3月29日最近更新: 2017年4月3日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 558

研究概览入排标准研究者记录与标识符相似试验

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

发起方

Roche Farma S.A. (Soc. Unipersonal) que realiza el ensayo en España y que actúa como representante de F. Hoffmann-La R

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