NCT05002569终止3 期
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma
Bristol-Myers Squibb210 个研究点 分布在 2 个国家目标入组 1,093 人开始时间: 2021年10月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,093
- 试验地点
- 210
- 主要终点
- Recurrence Free Survival (RFS)
研究概览
简要总结
The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
- •Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Adolescent participants between 12 and < 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%
- •Complete resection must be performed within 90 days prior to randomization
- •All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
- •Tumor tissue must be provided for biomarker analyses
排除标准
- •History of ocular melanoma
- •Untreated/unresected CNS metastases or leptomeningeal metastases
- •Active, known, or suspected autoimmune disease
- •Participants with serious or uncontrolled medical disorder
- •Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
- •Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
- •History of myocarditis, regardless of etiology.
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm B: Nivolumab
Experimental
Monotherapy
干预措施: Nivolumab (Biological)
Arm A: Nivolumab Plus Relatlimab
Experimental
Combination
干预措施: Nivolumab + Relatlimab Fixed Dose Combination (Biological)
结局指标
主要结局
Recurrence Free Survival (RFS)
时间窗: Approximately 27.5 Months
RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma) or death due to any cause, whichever occurs first.
次要结局
- Overall Survival (OS)(Approximately 27.5 Months)
- Distant Metastasis Free Survival (DMFS)(Approximately 27.5 Months)
- Progression Free Survival on Next-Line Systemic Therapy (PFS2)(Approximately 27.5 Months)
- Number of Participants With Safety Related Events(Approximately 27.5 Months)
- Number of Participants With Select AEs(Approximately 27.5 Months)
- Number of Participants With Endocrine Related Immune Mediated AEs(Approximately 27.5 Months)
- Number of Participants With Non-endocrine Related Immune Mediated AEs(Approximately 27.5 Months)
- Laboratory Abnormalities for Specific Thyroid Tests(Approximately 27.5 Months)
研究者
研究点 (210)
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