Dose-response Analysis of Nivolumab/Relatlimab in the Fixed-dosed Combination 'Opdualag' vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood for Participants With Unresectable or Metastatic Melanoma: A Corollary Study of HCC 24-056 (NCT06246916)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Single-cell analysis of CD4+ T cells
研究概览
简要总结
This translational study will examine the immune effector responses of patients who received a two-drug combination for first line therapy by examining tumor and peripheral blood of participants with unresectable locally advanced or metastatic melanoma.
详细描述
Cutaneous melanoma is an aggressive skin cancer which, in the metastatic setting, has a historic 5-year survival rate of <30%. In 2023, about 97,610 new cases of melanoma were estimated to occur in the US, with about 7,990 deaths. GLOBACON reported 324,635 cases of melanoma globally in 2020, which constituted about 1.7% of all cancers and 57,043 melanoma-associated deaths.
The parent trial of this corollary study is a randomized, open-label, multicenter phase 3 study comparing the anti-tumor activity of fixed-dose combination (FDC) of fianlimab + cemiplimab versus the FDC of relatlimab + nivolumab (referred to as Opdualag™) in participants with unresectable or metastatic melanoma (stage III-IV). This corollary study will explore the immunological response of CD8, CD4, and other immune cells in the blood and tumor microenvironment of patients in response to the provided treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Study participants who meet inclusion criteria for the HCC 24-056 study will be eligible for this study.
- •Participants must be willing to provide additional samples beyond what is required of them in HCC 24-
- •These include:
- •3 additional tumor biopsies
- •3 additional blood draws
- •Participants must have biopsiable non-target disease amenable to at least 3 biopsies.
- •Must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •1. Study participants who do not qualify to enroll in the HCC 24-056 study will not be eligible for this study.
研究组 & 干预措施
fianlimab + cemiplimab
Patients who received fianlimab + cemiplimab treatment under protocol NCT06246916.
干预措施: Fianlimab + Cemiplimab (Drug)
Opdualag (relatlimab + nivolumab)
Patients who received Opdualag (relatlimab + nivolumab) under protocol NCT06246916.
干预措施: Relatlimab + Nivolumab (Drug)
结局指标
主要结局
Single-cell analysis of CD4+ T cells
时间窗: Up to 39 months
Single-cell RNAseq analysis of CD8+ T cells and other immune cells in blood and tumor biopsies.
次要结局
- Immunological response of CD4+ T cells(Up to 39 months)
- Multiplexed immunofluorescence(Up to 39 months)
研究者
John Kirkwood
Professor of Medicine
University of Pittsburgh