EUCTR2019-000132-25-FR进行中（未招募）1 期
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 HaveProgressed on Anti-PD-1 Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 403
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test
- •Participants 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.
- •BRAF wild type and mutant participants are eligible
- •Eastern Cooperative Oncology Group (ECOG) 0-1
- •Ability to comply with treatment, patient-reported outcomes (PROs), PK, and pharmacodynamic sample collection and required study follow-up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 181
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 222
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 CTLA-4 or LAG-3 targeted agents
- •Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 and HIV-2 antibody.
研究者
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