A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 295
- 试验地点
- 17
- 主要终点
- Number of Participants With Laboratory Abnormalities in Specific Liver Tests
研究概览
简要总结
The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •For Dose Escalation:
- •Subjects with any previously treated advanced (metastatic or refractory) solid tumor
- •For Cohort Expansion:
- •Subjects must have a previously treated advanced solid tumor to be eligible
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
- •Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
排除标准
- •Known central nervous system metastases or central nervous system as the only source of disease
- •Other concomitant malignancies (with some exceptions per protocol)
- •Active, known or suspected autoimmune disease
- •Uncontrolled or significant cardiovascular disease
- •History of active or chronic hepatitis (e.g. Hep B or C)
- •Impaired liver or bone marrow function
- •Major surgery less than 1 month before start of the study
研究组 & 干预措施
BMS-986156 + nivolumab (nivo): Dose Escalation
干预措施: BMS-986156 (Drug)
BMS-986156: Dose Escalation
干预措施: BMS-986156 (Drug)
BMS-986156 + nivolumab (nivo): Dose Escalation
干预措施: Nivolumab (Drug)
BMS-986156: Dose Expansion
干预措施: BMS-986156 (Drug)
BMS-986156 + nivolumab (nivo): Dose Expansion
干预措施: BMS-986156 (Drug)
BMS-986156 + nivolumab (nivo): Dose Expansion
干预措施: Nivolumab (Drug)
BMS986156 + Nivo: Cohort Expansion
干预措施: BMS-986156 (Drug)
BMS986156 + Nivo: Cohort Expansion
干预措施: Nivolumab (Drug)
结局指标
主要结局
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
时间窗: From first treatment to 100 days post last dose. Approximately 29 months
Number of Participants with laboratory abnormalities in specific liver tests. ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase
Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths
时间窗: From first treatment to 100 days post last dose. Approximately 29 months
Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths. AEs and laboratory values will be graded according to the NCI CTCAE version 4.03.
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
时间窗: From first treatment to 100 days post last dose. Approximately 29 months
Number of Participants with laboratory abnormalities in specific thyroid tests. TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number
次要结局
- Duration of Response(From first dose to disease progression after a response (Approximately 50 Months))
- Number of Participants With Anti-Drug Antibody Response(At Cycle 3 Day 1; where each treatment cycle was 8 weeks)
- Overall Response Rate(From first dose to CR and PR (Approximately 50 Months))
- Best Overall Response(From first dose to a response or progressive disease (Approximately 50 Months))
- Progression Free Survival (PFS)(From first dose to disease progression (Approximately 50 Months))