A Phase 1 Dose Escalation Study of BMS-982470 (Recombinant Interleukin-21, rIL-21) in Combination With BMS-936558 (Anti-PD-1) in Subjects With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 5
- 主要终点
- Safety, as measured by the rate of adverse events and serious adverse events
研究概览
简要总结
The purpose of this study is to determine whether the combination of the 2 drugs being investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the clinical benefits of two different schedules of the combination.
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 more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- •Inclusion Criteria:
- •All subjects will have locally advanced or metastatic solid tumors
- •For Part 2 (Cohort Expansion):
- •Tumor types will be restricted to clear cell renal cell carcinoma (ccRCC), non-small cell lung cancer (NSCLC), and melanoma
- •At least 1 lesion with measurable disease
- •Only subjects with tumor samples that are PD-L1 positive or negative are eligible
排除标准
- •Uncontrolled central nervous system (CNS) or leptomeningeal metastasis
- •Inadequate liver or kidney function
- •History of autoimmune Disease
研究组 & 干预措施
Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558
Cohort Expansion BMS-982470 (dose selected in Part 1) Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
干预措施: Denenicokin (Biological)
Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558
Cohort Expansion BMS-982470 (dose selected in Part 1) Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
干预措施: Nivolumab (Biological)
Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558
Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: 3 times/week during weeks 1 and 3, Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
干预措施: Nivolumab (Biological)
Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558
Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: 3 times/week during weeks 1 and 3, Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
干预措施: Denenicokin (Biological)
Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558
Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
干预措施: Denenicokin (Biological)
Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558
Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
干预措施: Nivolumab (Biological)
结局指标
主要结局
Safety, as measured by the rate of adverse events and serious adverse events
时间窗: Approximately up to 4.5 years
次要结局
- Efficacy as measured by tumor assessment (RECIST)(Week 6 of for the first 4 cycles, Week 6 of alternate cycle starting with cycle 6, End of Treatment (2 years) and approximately every 12 weeks during follow-up (approximately 1 year))
- Immunogenicity as measured by incidence of specific antidrug antibodies (ADA) to BMS-98470 and BMS-936558(Up to 2 years + 100 days post-treatment follow-up)