Platform Trial Evaluating Safety and Efficacy of BI 754091 Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours.

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追踪信息

首次提交日期 ^ICMJE

October 2, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

November 1, 2018

预计主要完成日期

May 21, 2021 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

The primary endpoint of the trial is objective response (OR), defined as best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the Investigator[ Time Frame: Up to 32 months ]

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Duration of response (DoR), defined as the time from first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death among patients with OR[ Time Frame: Up to 32 months ]
Disease control (DC), defined as best overall response of CR, PR, or stable disease (SD) according to RECIST v1.1 as assessed by the Investigator[ Time Frame: Up to 32 months ]
Progression-free survival (PFS), defined as the time from first treatment until PD or death from any cause, whichever occurs earlier[ Time Frame: Up to 32 months ]

描述性信息

简略标题 ^ICMJE

Platform Trial Evaluating Safety and Efficacy of BI 754091 Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours.

正式标题 ^ICMJE

An Open-label, Phase II, Platform Trial Evaluating Safety and Efficacy of Multiple Anti-PD-1 Based Combination Regimens in PD-(L)1 naïve and PD-(L)1 Pretreated Patient Populations With Advanced and/or Metastatic Solid Tumours Who Have Had at Least One Line of Systemic Therapy

简要概况

The aim of this study is to assess the efficacy of BI 754091 in combination with other checkpoint inhibitors or anticancer medications in diverse tumour type cohorts.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

Phase 2

研究设计 ^ICMJE

分配: Randomized
干预模型: Sequential Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: BI 754091
Solution for infusion
Drug: BI 754111
Solution for infusion

研究工具

Experimental: Cohort 1
Module A
Experimental: Cohort 2
Module A
Experimental: Cohort 3
Module A

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

110

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

May 21, 2021

预计主要完成日期

May 21, 2021 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria Master Protocol: - Provision of signed and dated, written Master informed consent form (ICF) prior to any trial-specific procedures, sampling, or analyses. - Patient ≥18 years of age at the time of signature of the ICF. - Eastern Cooperative Oncology Group (ECOG) score: 0 to 1. - Patient must agree to a pre-treatment biopsy (if archival tissue is not available) and on-treatment tumour biopsy. - Life expectancy of at least 12 weeks after the start of the treatment according to the Investigator's judgement. - Male or female patients. Women of childbearing potential (WOCBP)1 and men able to father a child must be willing and able to use highly effective methods of birth control (that result in a low failure rate of less than 1% per year when used consistently and correctly) during trial participation and for at least 6 months after the last administration of trial medication. Module A: -Histologically confirmed diagnosis of one of the following cohorts: - Cohort 1 GEC - Locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro oesophageal adenocarcinoma (GEC) (defined as primary tumour localisation below the gastro oesophageal junction (GEJ) with prior anti-PD-1 or anti-PD-L1 based treated tumour. - Cohort 2 Patients with secondary resistance to anti-PD-1 or anti-PD-L1 based therapy: Any advanced or metastatic solid tumour with previously anti-PD-1 or anti-PD-L1 based treatment who progressed after achieving benefit - Cohort 3 Patients with primary resistance to anti-PD-1 or anti-PD-L1 based therapy: Select advanced or metastatic solid tumour types with previous anti-PD- 1/PD-L1 based treated tumour without achieving benefit. - All patients must have measurable lesions according to RECIST v1.1 - Patient must agree to pre- and on-treatment tumour biopsies. If archived tumour tissue is available from the last treatment failure, sections may be supplied instead of a pre-treatment biopsy. Exclusion Criteria Master Protocol: - Any investigational treatment anti-tumour treatment within 4 weeks or within 5 half-life periods (whichever is shorter) prior to the initiation of trial treatment. - A maximum of one anti-PD-(L)1-based treatment regimen prior to entering study - Major surgery ('major' according to the Investigator's assessment) performed within 12 weeks prior to first trial treatment or planned within 12 months after screening, e.g., hip replacement. - Known history of severe hypersensitivity reactions to other mAbs or known hypersensitivity to the trial drugs or their excipients. - Known presence of symptomatic central nervous system (CNS) metastases, unless asymptomatic and off corticosteroids and/or anticonvulsant therapy for at least 2 weeks prior to start of treatment. - Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study treatment. - Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy, or a patient removed from previous anti-PD-1 or anti-PD-L1 therapy because of a severe immune-related adverse event (irAE). Module A: - Previous treatment with an anti-LAG-3 agent - The use of systemic steroids - Autoimmune disease

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

，

研究赞助商 ^ICMJE

Boehringer Ingelheim

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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