A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects 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
- 418
- 试验地点
- 29
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, 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
- Double (Participant, Investigator)
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
- •Men and women ≥18 years of age
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as per the staging system of the American Joint Committee on Cancer
- •Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1
- •Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
- •Known BRAF wild-type, as per regionally acceptable V600 mutational status testing. BRAF mutant patients and those with indeterminate or unknown BRAF status are not permitted to randomize
排除标准
- •Active brain metastases or leptomeningeal metastases
- •Ocular melanoma
- •Any active, known, or suspected autoimmune disease
研究组 & 干预措施
Nivolumab, 3 mg/kg
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may switch to nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
干预措施: Placebo matching Dacarbazine (Drug)
Nivolumab, 3 mg/kg
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may switch to nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
干预措施: BMS-936558 (Nivolumab) (Biological)
Dacarbazine, 1000 mg/m^2
Participants received dacarbazine, 1000 mg/m^2, solution administered IV every 3 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may cross-over to nivolumab open label treatment, either 3 mg/kg every 2 weeks or 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
干预措施: Placebo matching BMS-936558 (Nivolumab) (Biological)
Dacarbazine, 1000 mg/m^2
Participants received dacarbazine, 1000 mg/m^2, solution administered IV every 3 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may cross-over to nivolumab open label treatment, either 3 mg/kg every 2 weeks or 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
干预措施: Dacarbazine (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.
OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.
Overall Survival (OS) Rate
时间窗: From randomization to 6 months and or to 12 months
OS rate is calculated as the percentage of participants alive at the indicated timepoints
次要结局
- Objective Response Rate (ORR)(Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 94 months)
- Progression-free Survival (PFS)(From date of randomization up to date of disease progression or death, up to approximately 84 months)
- Progression-free Survival (PFS) Rate(From randomization to the specified timepoints, up to 84 months)
- Change From Baseline in Health-related Quality of Life (HRQoL) Scores(At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months)
- Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level(From date of randomization to date of disease progression or death, up to approximately 94 months)