A Phase 1/2a Study of BMS-986242 Administered in Combination With Nivolumab (BMS-936558, Anti-PD-1) in Advanced Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Number of Participants With Adverse Events (AE)
研究概览
简要总结
The purpose of this study is to investigate safety of experimental medication BMS-986242 and Nivolumab in patients with advanced cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per RECIST v1.1
- •Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting if such a therapy exists
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Ability to swallow tablets
- •Adequate bone marrow and organ function, as defined by the protocol
排除标准
- •Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease (patients with controlled brain metastasis allowed to enroll)
- •Ocular melanoma
- •Any significant acute or chronic medical illness
- •Prior malignancy
- •Other active malignancy requiring concurrent intervention
- •Prior organ allograft or allogeneic bone marrow transplantation
- •Participants with active, known, or suspected autoimmune disease
- •Requirement for daily supplemental oxygen
- •Uncontrolled or significant cardiovascular disease
- •Pre-existing liver disease
- •Gastrointestinal disease known to interfere with absorption
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Dose Escalation
BMS-986242 administered in combination with Nivolumab
干预措施: BMS-986242 (Drug)
Dose Escalation
BMS-986242 administered in combination with Nivolumab
干预措施: Nivolumab (Biological)
Dose Expansion
BMS-986242 administered in combination with Nivolumab
干预措施: BMS-986242 (Drug)
Dose Expansion
BMS-986242 administered in combination with Nivolumab
干预措施: Nivolumab (Biological)
结局指标
主要结局
Number of Participants With Adverse Events (AE)
时间窗: From initiation of study treatment until 100 days after discontinuation of study treatment
The primary objective to establish safety to be measured by the primary endpoint of AEs
Number of Participants With Serious Adverse Events (SAE)
时间窗: From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study
The primary objective to establish safety to be measured by the primary endpoint of SAEs
Number of Participants With Dose Limiting Toxicities (DLT)
时间窗: Approximately 2 years
The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities
Number of Participants With AEs Leading to Discontinuation
时间窗: Approximately 2 years
The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation
Number of Deaths
时间窗: Approximately 2 years
The primary objective to establish safety to be measured by the primary endpoint of deaths
Number of Participants With Laboratory Abnormalities
时间窗: Approximately 2 years
The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities
次要结局
- Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)](Approximately 2 years)
- Maximum Observed Plasma Concentration (Cmax)(Approximately 2 years)
- Time of Maximum Observed Plasma Concentration (Tmax)(Approximately 2 years)
- Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)](Approximately 2 years)
- Apparent Total Body Clearance (CLT/F)(Approximately 2 years)
- Percent Urinary Recovery Over 24 Hours (%UR24)(Approximately 2 years)
- Apparent Elimination Half-life (T-HALF)(Approximately 2 years)
- Apparent Volume of Distribution at Steady State (Vss/F)(Approximately 2 years)
- Percent Urinary Recovery Over 72 Hours (%UR72)(Approximately 2 years)
- Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough)(Approximately 2 years)
- Accumulation Index (AI)(Approximately 2 years)
- Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242(Approximately 2 years)
- Overall Response Rate (ORR)(Approximately 2 years)