A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 405
- 试验地点
- 41
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel
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
- 否
入选标准
- •Men & women ≥ 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- •Histologically confirmed Stage III (unresectable)/Stage IV melanoma
- •Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- •Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens
- •Pre-treatment fresh core, excision or punch tumor biopsy
- •Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available
排除标准
- •Any treatment in a BMS-936558 (Nivolumab) trial
- •Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
- •Active, known or suspected autoimmune disease
- •Unknown BRAF status
- •Active brain metastasis or leptomeningeal metastasis
- •Ocular melanoma
- •Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1 (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)
研究组 & 干预措施
BMS-936558 3 mg/kg (IV)
BMS-936558 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: BMS-936558 (Biological)
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Dacarbazine (Drug)
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Carboplatin (Drug)
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 96 months
Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.
Objective Response Rate (ORR)
时间窗: From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)
Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1
次要结局
- Progression Free Survival (PFS)(From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months))
- Objective Response Rate (ORR) by Baseline PD-L1 Expression(From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months))
- Overall Survival (OS) by PD-L1 Positive(Up to 96 months)
- Mean Change From Baseline in Health-related Quality of Life (HRQoL)(From Baseline (Day1) to second Follow-Up (Up to 96 months))
- Overall Survival (OS) by PD-L1 Negative(Up to 96 months)