A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 5
- 主要终点
- Incidence of serious adverse events (SAEs)
研究概览
简要总结
The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Histologically or cytologically confirmed advanced unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
- •Must have experienced radiographically documented progressive disease on or after the most recent therapy
- •Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- •Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
排除标准
- •Primary central nervous system (CNS) malignancy
- •Other active malignancy requiring concurrent intervention
- •Uncontrolled or significant cardiovascular disease
- •Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab
干预措施: BMS-986301 (Drug)
Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab
干预措施: Nivolumab (Biological)
Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)
干预措施: BMS-986301 (Drug)
Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)
干预措施: Nivolumab (Biological)
Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)
干预措施: Ipilimumab (Biological)
Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study
干预措施: BMS-986301 (Drug)
Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study
干预措施: Nivolumab (Biological)
Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study
干预措施: Ipilimumab (Biological)
Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study
干预措施: BMS-986301 (Drug)
Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study
干预措施: Nivolumab (Biological)
Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study
干预措施: Ipilimumab (Biological)
Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab
干预措施: BMS-986301 (Drug)
Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab
干预措施: Nivolumab (Biological)
Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab
干预措施: Ipilimumab (Biological)
Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab
干预措施: Ipilimumab (Biological)
结局指标
主要结局
Incidence of serious adverse events (SAEs)
时间窗: From Baseline until study exit (up to approximately 2 years)
Incidence of deaths
时间窗: From Baseline until study exit (up to approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
时间窗: From Baseline until disease progression (approximately 2 years)
Incidence of dose-limiting toxicity (DLTs)
时间窗: Cycle 1 (28 days)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
时间窗: From Baseline until disease progression (approximately 2 years)
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
时间窗: From Baseline until disease progression (approximately 2 years)
Incidence of adverse events (AEs)
时间窗: From Baseline until study exit (up to approximately 2 years)
Incidence of AEs leading to discontinuation
时间窗: From Baseline until study exit (up to approximately 2 years)
次要结局
未报告次要终点