A NON-INTERVENTIONAL, MULTICENTER, MULTIPLE COHORT STUDY INVESTIGATING THE OUTCOMES AND SAFETY OF ATEZOLIZUMAB UNDER REAL- WORLDCONDITIONS IN PATIENTS TREATED IN ROUTINE CLINICAL PRACTICE
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,400
- 试验地点
- 11
- 主要终点
- To estimate overall survival (OS) at two years and at the end of the study.
研究概览
简要总结
This is a non-interventional, multi-country, multi-center, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real-world setting of routine clinical practice. The study will collect data before, during and after treatment with atezolizumab. As this is a non-interventional study (NIS), treatment choice, including atezolizumab (used according to the SmPC), will be at the discretion of the treating physician per local guidelines and independently of participation in this study. In countries where inclusion is only permitted after the start of treatment, patients may be included after the start of treatment but no later than 28 days after the first administration of atezolizumab. The index date (D1) is the date of administration of the first ever dose of atezolizumab for each patient. During treatment with atezolizumab, patient data will be collected at clinic visits when atezolizumab is administered. No visits will bemandated by the protocol. After cessation of treatment, patient data will be collected from each participant at approximately 3 months, 6 months, 12 months and every 12 months thereafter until the end of the study, coinciding with routine clinical practice visits, or remote contact, and from medical notes, until the earliest of death, loss to follow-up, withdrawal of consent, or end of the study, when data from last routine clinic practice visit will be collected with the exception of withdrawal of consent.The study will be split into separate cohorts based on the approved indications for atezolizumab treatment, excluding cisplatin ineligible patients receiving atezolizumab as first line of therapy (LOT1) for locally advanced/metastatic urothelial cancer (locally advanced/metastatic UC).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed diagnosis for which atezolizumab is locally approved
- •Patient is prescribed atezolizumab therapy for the first time
- •Decision to prescribe atezolizumab must be made and documented prior to inclusion into the study and must follow local clinical practice
- •Patient is 18 years or older at the index date
- •Patient has signed an informed consent form
- •Initiation of atezolizumab is not more than 28 days before signing informed consent.
- •In countries where enrollment is only allowed after starting treatment, enrollment must be preceded by the administration of the first cycle of atezolizumab.
排除标准
- •Treatment with atezolizumab for an indication that is not included in the study cohorts
- •Concomitant anti-cancer therapy at the time of starting atezolizumab on the index date, as per locally approved SmPC
- •Treatment with atezolizumab as part of a clinical trial or as compassionate use as part of an access or compassionate use program.
结局指标
主要结局
To estimate overall survival (OS) at two years and at the end of the study.
时间窗: Timepoint - 2 years & End of study
次要结局
- Secondary Outcome-(Time to loss of clinical benefit - TTLCB, Progression-free survival - PFS, Objective response rate - ORR, Time to response, Duration of response - DoR, Disease control rate - DCR, Duration of DCR, EQ-5D questionnaire evaluation, Patient characteristics, Study site characteristics, Characteristics of atezolizumab treatment, and prior/subsequent cancer-related therapies)
- Safety Outcome-(Incidence, seriousness, severity and relatedness of all AEs)
- Exploratory outcome-(1. PD-L1 testing, type, status, result)