EUCTR2016-003092-22-GB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 771 人开始时间: 2017年3月23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
- 771
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
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
- •- Progression on prior regimen/line of an androgen synthesis inhibitor for prostate cancer
- •- 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 186
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 585
排除标准
- •Cancer-specific exclusions
- •- Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhibitor (e.g. apalutamide, ODM 201)
- •- 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 within 12 months prior to study treatment, including unexplained loss of consciousness or transient ischemic attack
研究者
相似试验
进行中（未招募）
1 期
A Study of Atezolizumab (Anti PD L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostrate Cancer After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane RegimeMetastatic Castration-Resistant Prostrate Cancer (mCRPC)MedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-003092-22-CZF. Hoffman-La Roche GmbH771
进行中（未招募）
1 期
A Study of Atezolizumab (Anti PD L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostrate Cancer After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane RegimeMetastatic Castration-Resistant Prostrate Cancer (mCRPC)MedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-003092-22-FRF. Hoffman-La Roche Ltd.558
进行中（未招募）
1 期
A Study of Atezolizumab Versus Placebo Given with Paclitaxel, Carboplatin, and Bevacizumab to Patients with Newly-Diagnosed Stage III/IV Ovarian, Fallopian Tube, Or Primary Peritoneal CancerOvarian cancer (OC), fallopian tube cancer (FTC), primary peritoneal cancer (PPC)MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-003472-52-SEF. Hoffman-La Roche Ltd.1,301
进行中（未招募）
1 期
A Study of Atezolizumab (Anti PD L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostrate Cancer After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane RegimeMetastatic Castration-Resistant Prostrate Cancer (mCRPC)MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-003092-22-ITF. HOFFMANN - LA ROCHE LTD.771
进行中（未招募）
1 期
A Study of Atezolizumab (Anti PD L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostrate Cancer After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane RegimeMetastatic Castration-Resistant Prostrate Cancer (mCRPC)MedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-003092-22-HUF. Hoffman-La Roche Ltd.771