2022-500823-61-00招募中2 期
A Phase 1/2 Study of BMS-986408 Alone and in Combination with Nivolumab or with Nivolumab and Ipilimumab in Participants with Advanced Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 9
- 主要终点
- Incidence of DLTs, AEs, SAEs, AEs leading to discontinuation, and deaths.
研究概览
简要总结
To characterize the safety and tolerability, and to establish the MTD, maximum administered dose, and/or RP2D(s), and optimal schedule of oral BMS-986408, administered as monotherapy and in combination with nivolumab or nivolumab and ipilimumab, to participants with advanced cancer
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Males or females ≥ 18 years of age
- •Participants in Groups A and B must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.
- •Participants in Groups C, D and E must have a histologically or cytologically confirmed, advanced, unresectable/metastatic malignancy measurable by RECIST v1.1, with the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-(L)1 or anti-CTLA-4 agents, and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.
排除标准
- •An active, known or suspected autoimmune disease
- •Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
- •Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug
- •Untreated central nervous system (CNS) metastases or leptomeningeal metastasis
- •Women who are breastfeeding or are pregnant.
结局指标
主要结局
Incidence of DLTs, AEs, SAEs, AEs leading to discontinuation, and deaths.
Incidence of DLTs, AEs, SAEs, AEs leading to discontinuation, and deaths.
次要结局
- Summary measures of BMS-986408 PK parameters in plasma, such as, but not limited to, Cmax, Tmax, and AUC (0-T), from concentration-time data during BMS-986408 monotherapy and in combination with nivolumab or nivolumab and ipilimumab.
- ORR and DOR per RECIST v1.1.
研究者
GSM-CT
Scientific
Bristol-Myers Squibb International Corporation
研究点 (9)
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