SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 412
- 试验地点
- 1
- 主要终点
- Prognosis of PD-L1 positive status in the patient population with available tumor sample
研究概览
简要总结
This is a retrospective international, multi-center, non-interventional cohort study based on use of data derived from established medical records and secondary analysis of archival tumor samples. The study will collect data on patient and tumor characteristics, PD-L1 status, patterns of treatment, and clinical outcomes, in up to 600 adult patients with recurrent/metastatic SCCHN. SCCHN of interest for this study are defined as the diseases falling into specific ICD-10 or International Classification of Diseases, Ninth Revision (ICD-9) codes (Table 1), depending on anatomical sub-site of the primary tumor.
For patient selection, the date of diagnosis of recurrent/metastatic disease will be used as the index date. The patient selection period extends from the 1st March 2011 to the 30th June 2015. This allows for the inclusion of patients with tumor samples of approximately ≤ 5 years age, and ensures approximately 10 months follow-up for living patients recruited at last day of the enrollment window. All patients with a diagnosis of recurrent/metastatic SCC of the oral cavity (tongue, gum, floor of mouth, and other/unspecified part of the mouth), oropharynx, hypopharynx, or larynx during that period will be considered for inclusion in the study (Figure 1). Patients will be identified and followed up through their medical records until death or end of data collection in approximately 20 centers in the US, Asia and Europe.
Patients' demographic, clinical characteristics, and medical history will be described. Clinical outcomes including PFS, best response, duration of response, and ORR will be described for the first line and second line of therapy (if any), and OS will be collected A mandatory archived tumor samples will be used to determine PD-L1 status. If a patient has more than one suitable tissue sample, the most recent sample will be used as the mandatory tissue sample. Where available, additional tumor samples obtained at any other time points of the disease will be also collected (optional).
The enrolment target is up to 600 patients. Statistical analyses will be performed for the whole cohort, per PD-L1 status and for predefined subgroups.
详细描述
Background/Rationale:
Programmed cell death protein 1 (PD-1) is an immune inhibitory receptor that interacts with two ligands, programmed death ligand 1 (PD-L1) and ligand 2 (PD-L2). PD-1 pathway is a major immune checkpoint which has been implicated in adaptive immune resistance of squamous cell carcinoma of the head and neck (SCCHN) tumors, particularly in those associated with human papillomavirus (HPV) infection. Based on an internal analysis performed by AstraZeneca (AZ), it is reported that approximately 25% of cases of SCCHN express PD-L1. Tumoral PD-L1 expression status correlates closely with response to anti-PD-1/anti PD-L1 antibodies Durvalumab (MEDI4736) is an immunoglobulin G1 kappa monoclonal antibody with high affinity and selectivity for PD-L1 and no binding to PD-L2, which is in development for the treatment of patients with recurrent or metastatic SCCHN.
This non-interventional study (NIS) aims to generate and provide data on the prognostic value of PD-L1 status in patients with recurrent/metastatic SCCHN.
Objectives and Hypotheses:
Primary objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Prognosis of PD-L1 positive status in the patient population with available tumor sample
时间窗: From diagnosis to index day, expected to be up to 36 months
PD-L1 status: positive-negative status measured on tumor slides. Positivity corresponds to more than 25% of tumor cells with membrane positivity for PD-L1. The primary objective of this study is to estimate the prognostic value of PD-L1 status in terms of OS in patients with recurrent/metastatic SCCHN
次要结局
- Exposure to risk factors - alcohol (e.g. Number of participants with alcohol consumption and amount of consumption per day)(At index date, approximately +/- 2 months)
- Disease characteristics -performance status ECOG criteria(At index date approximately +/- 2 months)
- Lines of therapy description (e.g. Treatment lines patterns per participants' population)(From First line therapy to end of data collection, expected to be up to 120 months)
- Exposure to risk factors - tobacco (e.g. Number of participants with current or past tobacco consumption and amount of consumption per day)(At index date, approximately +/- 2 months)
- Disease characteristics - performance status WHO criteria(At index date approximately +/- 2 months)
- Exposure to risk factors - Human Immunodeficiency Virus (e.g. Number of participants positive for Human Immunodeficiency Virus)(At index date, approximately +/- 2 months)
- Exposure to risk factors - Human papillomavirus (e.g. Number of participants positive for Human papillomavirus)(At index date, approximately +/- 2 months)
- Clinical outcomes - Survival rate(From index date to end of data collection, expected to be up to 85 months)
- Complications (from second line therapy for recurrent/metastatic SCCHN)(Complications (from second line therapy for recurrent/metastatic SCCHN) During or shortly after second line therapy, expected to be up to 3 months)
- Disease characteristics -performance status Karnofsky criteria(At index date approximately +/- 2 months)
- Clinical outcomes -Best response to treatment line(From First line therapy to end of data collection, expected to be up to 100 months)