A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 8
- 主要终点
- Number of Participants With Adverse Events and Deaths
研究概览
简要总结
The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.
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
- •Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1
- •Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor
- •Eastern cooperative oncology group performance status of 0 or 1
- •Women of childbearing potential must agree to follow methods of contraception
排除标准
- •Participants with active, known or suspected autoimmune disease
- •Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
- •Uncontrolled or significant cardiovascular disease
- •History of or with active interstitial lung disease or pulmonary fibrosis
- •Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study
- •History of allergy or hypersensitivity to study drug components
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
BMS-986315 + cetuximab
干预措施: cetuximab (Biological)
BMS-986315 + nivolumab
干预措施: nivolumab (Biological)
BMS-986315 + cetuximab
干预措施: BMS-986315 (Biological)
BMS-986315
干预措施: BMS-986315 (Biological)
BMS-986315 + nivolumab
干预措施: BMS-986315 (Biological)
结局指标
主要结局
Number of Participants With Adverse Events and Deaths
时间窗: From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Number of Participants With Dose Limiting Toxicities (DLTs)
时间窗: From first dose (Day 1) untill Day 28
A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.
次要结局
- Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) of BMS-986315(Cycle 1 Day 1)
- Concentration in a Dosing Interval (Ctau) of BMS-986315(Cycle 1 Day 1)
- Objective Response Rate (ORR)(From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months))
- Duration of Response (DoR)(From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months))
- Progression Free Survival (PFS) Rate(At 6 months)
- Maximum Plasma Concentration (Cmax) of BMS-986315(Cycle 1 Day 1)
- Time to Maximum Plasma Concentration (Tmax) of BMS-986315(Cycle 1 Day 1)
- Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of BMS-986315(Cycle 1 Day 1)
- Number of Participants With Anti-Drug Antibody (ADA)(Cycle 1 Day 1)
