A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 706
- 主要终点
- Overall Survival (OS) Rate at 6 Months
研究概览
简要总结
The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in participants with unresectable or metastatic 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have histologically or cytologically confirmed melanoma
- •Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy
- •A minimum of 1 measurable lesion by CT or MRI
- •Provide a baseline tumor biopsy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
排除标准
- •Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy)
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting
- •Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer)
- •Has an active infection requiring systemic therapy
- •Has known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
- •Has known history of or is positive for Hepatitis B or Hepatitis C
- •Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
研究组 & 干预措施
Pembrolizumab + Epacadostat
Pembrolizumab + Epacadostat
干预措施: pembrolizumab + epacadostat (Drug)
Pembrolizumab + Placebo
Pembrolizumab + Placebo
干预措施: pembrolizumab + placebo (Drug)
结局指标
主要结局
Overall Survival (OS) Rate at 6 Months
时间窗: Assessed every 9 weeks of study participation which is estimated to be 24 months. The OS rate at Month 6 was calculated.
Defined as time from date of randomization to date of death due to any cause. OS was calculated using product-limit (Kaplan-Meier) method for censored data.
Progression-free Survival
时间窗: Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
Progression-free survival, defined as the time from date of randomization until the earliest date of disease progression, as determined by independent central review of objective radiographic disease assessments per RECIST 1.1, or death from any cause, whichever comes first.
次要结局
- Objective Response Rate (ORR)(Assessed every 9 weeks for duration of study participation which is estimated to be 24 months)
- Safety and Tolerability, as Assessed by Percentage of Participants With Adverse Events(Through up to 90 days after end of treatment, up to 27 months)
- Duration of Response (DOR)(Assessed every 9 weeks for duration of study participation which is estimated to be 24 months)
- Apparent Oral Clearance (CL/F) of Epacadostat(Through up to 30 days after the end of treatment, up to 25 months)
- Apparent Volume of Distribution (Vd/F) of Epacadostat(Through up to 30 days after the end of treatment, up to 25 months)
- Clearance (CL) of Pembrolizumab(Through up to 30 days after the end of treatment, up to 25 months)
- Volume of Distribution (V) of Pembrolizumab(Through up to 30 days after the end of treatment, up to 25 months)
- Formation of Anti-pembrolizumab Antibodies(Through up to 30 days after the end of treatment, up to 25 months)