A multicenter observational study to explore the outcomes of use of nivolumab (or anti-pd1) monotherapy in Indian patients with recurrent or metastatic SCCHN in a real- world setting: a retrospective chart review
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Bristol Myers Squibb India Private Limited
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- To assess the real-world overall survival (rwOS) among patients with recurrent or metastatic Squamous cell
概览
简要总结
In India, Head and neck cancers account for about 30% of all cancers in men and around 16% in women. Considered as an emerging public health concern, HNC in Indian population has a distinct demographic profile, risks factors, pathophysiology, and patient characteristics.
The landmark CheckMate 141 study demonstrated prolonged benefits and favorable safety profile with nivolumab monotherapy in Asian population (Japan, Taiwan, Korea, and Hong Kong) with R/M SCCHN. Thus, the regimen was approved across Asia, including India for the treatment of R/M SCCHN after platinum-based therapy, although with limited country-specific data.
As such, the current study aims to gain insights through real-world evidence on the clinical outcomes and safety profile of nivolumab monotherapy (when prescribed at approved dose among Indian patients with R/M SCCHN. This study aims to characterize the clinical outcomes, safety profile, treatment modalities, and demographic/clinical profile among Indian patients with R/M SCCHN on nivolumab monotherapy.
This is a retrospective chart review where electronic medical records will be screened for patients that fit into the eligibility criteria.
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
- •Patients EMR must meet all the following inclusion criteria to participate in the study 1 Adults (male or female) 18 years or older at index date.
- •2 Confirmed documented diagnosis of R M SCCHN (as per treating physician discretion), from any of the following primary anatomic sites (including but not limited to) oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, salivary glands, ocular, and parapharyngeal sites.
- •3 Patients who have received a minimum of 4 cycles of nivolumab monotherapy for R M SCCHN at approved dose of 3 mg per kg every 2 weeks (30 minute intravenous infusion), as per prescribing information (Appendix 1) except in case of disease progression, death, any other reason The 3 mg per kg, 14 day (2 week) period constitutes a cycle.
- •Thus, the overall treatment period for 4 cycles of nivolumab spans around 8 weeks.
- •a Patients who had prior exposure to platinum based chemotherapy for R M SCCHN.
- •b Patients who have up to 6 months of baseline or pre-index period data available in EMR.
- •c Patients who have at least 12 months of follow up data available in EMR from the index date until end of study observation period (31 December 2024) or early discontinuation (patient switching to subsequent therapy, death, lost to follow-up, disease progression or any other reason, whichever occurred first) except in case of death within 12 months from index date.
排除标准
- •Patients EMR meeting any of the following criteria will be excluded from the study 1 Patients who received nivolumab 4monotherapy at a dose other than the approved dose of 3 mg per kg every 2 weeks (as per prescribing information, Appendix 1).
- •2 Patients who received other immunotherapy (immune checkpoint inhibitors such as PD-1 or PD-L1 inhibitors, anti-CTLA-4 agent) before switching to nivolumab monotherapy.
- •3 Patients who received a combination of nivolumab with any other agent (eg, chemotherapy, targeted therapy, etc.).
- •Patients who enrolled in a clinical trial for cancer treatment since the diagnosis of R M SCCHN.
- •4 Patients with a diagnosis of cancer other than R M SCCHN within the past 5 years, that required systemic or other relevant treatment.
- •5 Pregnant or breastfeeding women initiating nivolumab monotherapy for R M SCCHN.
结局指标
主要结局
To assess the real-world overall survival (rwOS) among patients with recurrent or metastatic Squamous cell
时间窗: The clinical outcomes will be assessed at specific time points during the post-index (follow-up) period for (eg, at Month 0, 6, 9, 12, 18, 24, 30, 36, etc. [as available]).
carcinoma of head and neck (R/M SCCHN) treated with nivolumab monotherapy up to 4 years post-index
时间窗: The clinical outcomes will be assessed at specific time points during the post-index (follow-up) period for (eg, at Month 0, 6, 9, 12, 18, 24, 30, 36, etc. [as available]).
follow-up time period.
时间窗: The clinical outcomes will be assessed at specific time points during the post-index (follow-up) period for (eg, at Month 0, 6, 9, 12, 18, 24, 30, 36, etc. [as available]).
次要结局
- To determine rwPFS & real-world overall response rate rwORR, including complete response CR partial response PR stable disease SD & disease progression DP as per iRECIST immune Response Evaluation Criteria In Solid Tumors criteria among patients with recurrent metastatic SCCHN on nivolumab monotherapy during the post index follow up time period(The clinical outcomes will be assessed at specific time points during the post-index (follow-up) period for (eg, at Month 0, 6, 9, 12, 18, 24, 30, 36, etc. [as available]).)
研究者
Disha S R
Bristol Myers Squibb