Real-World Treatment Patterns and Outcomes of Advanced Renal Cell Carcinoma (aRCC) Patients Receiving Nivolumab+Ipilimumab or Pembrolizumab+Lenvatinib in U.S. Oncology Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Participant year of birth
研究概览
简要总结
This observational study aims to describe demographic, clinical characteristics, treatment patterns outcomes of participants with advanced Renal Cell Carcinoma (aRCC) receiving either Nivolumab + Ipilimumab, or Pembrolizumab + Lenvatinib combination therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older with diagnosis of Advanced Renal Cell Carcinoma (aRCC) with predominantly clear-cell histology
- •Received any of the following therapies in the first-line setting:
- •Nivolumab + Ipilimumab between 8/1/2021 and 6 months prior to data collection
- •Pembrolizumab + Lenvatinib between 8/1/2021and 6 months prior to data collection
- •Participant had at least 6 months of follow-up from initiation of index treatment (patients who deceased prior to 6 months since index treatment initiation would still be eligible)
排除标准
- •Receipt of any immunotherapy or tyrosine kinase inhibitor (TKI) therapy as part of a Randomized Controlled Trial (RCT)
- •Participant received any systemic therapy for Advanced Renal Cell Carcinoma (aRCC) prior to index therapy, including neoadjuvant or adjuvant therapy
- •Any active malignancy in the 3 years prior to initiation of 1L therapy for aRCC, except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix, or breast cancer, or localized prostate cancer with a Gleason score ≤3+4 that has been treated more than 12 months prior to full study screening and considered to have a very low risk of recurrence.
结局指标
主要结局
Participant year of birth
时间窗: Baseline
Participant primary payer
时间窗: Baseline
Participant U.S. state of residence
时间窗: Baseline
Participant race
时间窗: Baseline
American Joint Committee on Cancer (AJCC) TNM stage
时间窗: Baseline
Participant renal cell carcinoma (RCC) histology results
时间窗: Baseline
Participant Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
时间窗: Baseline
Participant Karnofsky score (KPS)
时间窗: Baseline
Participant COVID-19 status
时间窗: Baseline
Participant last dose and frequency/schedule of index therapy
时间窗: Index date up to 32 months
Participant sex at birth
时间窗: Baseline
Participant ethnicity
时间窗: Baseline
Participant initial Renal Cell Carcinoma (RCC) diagnoses
时间窗: Baseline
Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis
时间窗: Baseline
Participant biomarker or genetic testing method
时间窗: Baseline
Participant comorbidities and/or chronic conditions
时间窗: Baseline
Participant tumor grade
时间窗: Baseline
Participant molecular and/or genetic mutations reported
时间窗: Baseline
Participant site of metastatic disease
时间窗: Index date
Participant blood test results
时间窗: Index date
Participant radiation therapy prescribed
时间窗: Index date up to 32 months
Participant rationale for dose modifications of index therapy
时间窗: Index date up to 32 months
Participant date of dose modifications of index therapy
时间窗: Index date up to 32 months
Participant Memorial Sloan Kettering Cancer Center (MSKCC) score
时间窗: Index date
Participant treatment regimen received
时间窗: Index date up to 32 months
Participant International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) score
时间窗: index date
Participant smoking status
时间窗: Baseline
Participant surgical history
时间窗: Baseline
Participant treatment initiation and discontinuation dates
时间窗: Index date up to 32 months
Participant initial dose and frequency/schedule of index therapy
时间窗: Index date up to 32 months
Participant index treatment dose modifications
时间窗: Index date up to 32 months
Participant radiation treatment history
时间窗: Baseline
Participant rationale for discontinuation of treatment
时间窗: Index date up to 32 months
Participant total number of radiotherapy cycles
时间窗: Index date up to 32 months
次要结局
未报告次要终点