A Phase 1 Study of Cabiralizumab (BMS-986227, FPA008) Administered Alone or in Combination With Nivolumab (BMS-936558) in Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- Number of Participants With AEs Leading to Discontinuation - Carbiralizumab Monotherapy
研究概览
简要总结
The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of advanced malignancies.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Performance status 0-1
- •Adequate organ function
- •Cohort M1, 2 and C1: Measurable disease
- •Cohort M1, M2 and C1: Subjects must have histologic or cytologic confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor
- •Cohort C2: Documented refractory or relapsed multiple myeloma
- •Subjects must be refractory to or have relapsed after standard therapies, or have no known effective treatment
排除标准
- •Cohort M1, M2, and C1: Untreated or active central nervous system (CNS) or leptomeningeal metastases
- •Cohort M1, M2, and C1: Subjects with hepatocellular carcinoma (HCC)
- •Cohort C2: Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Number of Participants With AEs Leading to Discontinuation - Carbiralizumab Monotherapy
时间窗: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab monotherapy treatment.
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
时间窗: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
The number of participants that experienced a laboratory abnormality during the course of the study while participating in cabiralizumab monotherapy treatment.
Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy
时间窗: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
The number of participants that experienced an AE during the course of the study while participating in cabiralizumab monotherapy treatment.
Number of Participants Who Died - Carbiralizumab Monotherapy
时间窗: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
The number of participants that died during the course of the study while participating in cabiralizumab monotherapy treatment.
Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab Monotherapy
时间窗: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
The number of participants that experienced a SAE during the course of the study while participating in cabiralizumab monotherapy treatment.
Number of Participants With AEs Meeting Protocol-defined Dose-Limiting Toxicity (DLT) Criteria - Carbiralizumab Monotherapy
时间窗: 28 days (from first day of treatment)
The number of participants that experienced an AE meeting protocol-defined DLT criteria during the course of the study while participating in cabiralizumab monotherapy treatment.
次要结局
- Cmax(Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour))
- Number of Participants With Adverse Events (AEs) - Carbiralizumab and Nivolumab Combo Therapy(From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months)
- Number of Participants With AEs Leading to Discontinuation - Carbiralizumab and Nivolumab Combo Therapy(From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months)
- Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy(From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months)
- Duration of Response (DOR)(From first dose to end of follow-up)
- Ctrough(Cycles 1, 2, 3, 4, 5, 6, 7, 8, 9)
- Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab and Nivolumab Combo Therapy(From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months)
- Number of Participants Who Died - Carbiralizumab and Nivolumab Combo Therapy(From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months)
- AUC(0-T)(Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour))
- Tmax(Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour))
- Best Overall Response (BOR)(From first dose to end of follow-up, assessed up to July 2019, approximately 24 months)
- AI_Ctrough(Cycle 2 (pre-dose), Cycle 8 (pre-dose))
- AUC(TAU)(Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour))
- Incidence of Anti-drug Antibodies (ADA)(Day 1 pre-dose for cycles 2, 3, 5, 9, 13, 21)
- T-HALFeff_Ctrough(Cycle 2 (pre-dose), Cycle 8 (pre-dose))