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临床试验/NCT02899299
NCT02899299已完成3 期

A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma

Bristol-Myers Squibb107 个研究点 分布在 9 个国家目标入组 605 人开始时间: 2016年11月29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
已完成
发起方
入组人数
605
试验地点
107
主要终点
Overall Survival (OS)

研究概览

简要总结

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and Females at least 18 years of age
  • Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
  • ECOG Performance status of 0 or 1
  • Available tumor sample for testing
  • Acceptable blood work

排除标准

  • Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas
  • Prior chemotherapy for pleural mesothelioma
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 oranti-CTLA-4 antibody
  • History of other malignancy unless the subject has been disease-free for at least 3 years
  • Active, untreated central nervous system (CNS) metastasis
  • Other protocol defined inclusion/exclusion criteria could apply

研究组 & 干预措施

Nivolumab and Ipilimumab

Experimental

Specified dose on specified days

干预措施: Nivolumab (Biological)

Nivolumab and Ipilimumab

Experimental

Specified dose on specified days

干预措施: Ipilimumab (Biological)

Pemetrexed and Cisplatin (or Carboplatin)

Active Comparator

Specified dose on specified days

干预措施: Pemetrexed (Drug)

Pemetrexed and Cisplatin (or Carboplatin)

Active Comparator

Specified dose on specified days

干预措施: Cisplatin (Drug)

Pemetrexed and Cisplatin (or Carboplatin)

Active Comparator

Specified dose on specified days

干预措施: Carboplatin (Drug)

结局指标

主要结局

Overall Survival (OS)

时间窗: From randomization to the date of death (Up to 40 Months)

Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.

次要结局

  • Objective Response Rate (ORR) According to PD-L1 Expression Level(From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months))
  • Disease Control Rate (DCR)(From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months)
  • Progression Free Survival (PFS)(From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months))
  • Overall Survival (OS) According to PD-L1 Expression Level(From randomization date to the date of death (Up to 76 Months))
  • Progression Free Survival (PFS) According to PD-L1 Expression Level(From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months))
  • Objective Response Rate (ORR)(From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months))

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (107)

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