A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 783
- 试验地点
- 164
- 主要终点
- Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)
研究概览
简要总结
The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread
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
- None
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
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)
- •Histologically confirmed stage III (unresectable) or stage IV melanoma
- •Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant and/or neoadjuvant treatment for melanoma with approved agents
排除标准
- •Active brain metastases or leptomeningeal metastases
- •Uveal melanoma
- •Participants with an active, known or suspected autoimmune disease
- •Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Combination
NKTR-214 + Nivolumab
干预措施: NKTR-214 (Biological)
Combination
NKTR-214 + Nivolumab
干预措施: Nivolumab (Biological)
Monotherapy
Nivolumab
干预措施: Nivolumab (Biological)
结局指标
主要结局
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)
时间窗: From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
时间窗: From date of randomization to disease progression (Up to 37 months)
ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Overall Survival (OS)
时间窗: From date of randomization to date of death (Up to 37 months)
OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.
次要结局
- Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)(From date of randomization to disease progression (Up to 37 months))
- Duration of Response (DoR) Per Blinded Independent Central Review (BICR)(From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months))
- Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)(From date of randomization to disease progression (Up to 37 months))
- Objective Response Rate (ORR) Per Investigator(From date of randomization to disease progression (Up to 37 months))
- Progression-free Survival (PFS) Per Investigator(From date of randomization to disease progression, or death, whichever comes first (Up to 37 months))
- Clinical Benefit Rate (CBR) Per Investigator(From date of randomization to disease progression (Up to 37 months))
- Duration of Response (DoR) Per Investigator(From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months))
- Time to Objective Response (TTR) Per Investigator(From date of randomization to disease progression (Up to 37 months))
- Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status(From date of randomization to disease progression (Up to 37 months))
- Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status(From date of randomization to disease progression, or death, whichever comes first (Up to 37 months))
- Overall Survival (OS) by Baseline PD-L1 Status(From date of randomization to date of death (Up to 37 months))
- Number of Participants With Adverse Events (AEs)(From first dose to 30 days post last dose (Average of 11 months and a maximum up to 26 months))
- Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline(From first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months))