A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 28
- 主要终点
- Number of Participants with AEs resulting in Death
研究概览
简要总结
The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of relatlimab in combination with ipilimumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Must have documented progression while on a prior anti-programmed cell death protein 1 (PD-1) containing regimen limited to Nivolumab or Pembrolizumab
- •Must have histologically confirmed advanced unresectable (Stage III) or metastatic (Stage IV) melanoma, as per (AJCC) staging system
- •Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
- •Eastern Cooperative Oncology Group (ECOG) 0-1
排除标准
- •History of uveal melanoma
- •Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
- •Prior treatment with ipilimumab, relatlimab, or any other cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) or lymphocyte-activation gene 3 (LAG-3) targeted agents
研究组 & 干预措施
Part 1: Dose Escalation Phase
干预措施: Relatlimab (Drug)
Part 1: Dose Escalation Phase
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Number of Participants with AEs resulting in Death
时间窗: Up to end of study (approximately 2.4 years)
Number of Participants with AEs resulting in Discontinuation
时间窗: Up to end of study (approximately 2.4 years)
Number of Participants with Serious Adverse Events (SAEs)
时间窗: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Number of Participants With Adverse Events Including Dose Limiting Toxicity
时间窗: Up to 28 days after last study drug dose (approximately up to 2 years)
Number of Participants with Adverse Events (AEs)
时间窗: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])
Number of Participants with AEs resulting in Laboratory Abnormalities
时间窗: Up to end of study (approximately 2.4 years)
次要结局
未报告次要终点