A Phase 1b/2 Study of BMS-986442 in Combination With Nivolumab or Nivolumab and Chemotherapies in Participants With Advanced Solid Tumors and Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 32
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Participants must have a life expectancy of at least 3 months at the time of first dose.
排除标准
- •Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
- •Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.
- •Participants with an active, known, or suspected autoimmune disease.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed
干预措施: BMS-986442 (Biological)
Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel
干预措施: Nivolumab (Biological)
Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel
干预措施: Carboplatin (Drug)
Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel
干预措施: Paclitaxel (Drug)
Part A: BMS-986442 + Nivolumab
干预措施: BMS-986442 (Biological)
Part A: BMS-986442 + Nivolumab
干预措施: Nivolumab (Biological)
Part B1: BMS-986442 + Nivolumab
Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)
干预措施: BMS-986442 (Biological)
Part B1: BMS-986442 + Nivolumab
Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)
干预措施: Nivolumab (Biological)
Part B2: BMS-986442 + Nivolumab
Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)
干预措施: BMS-986442 (Biological)
Part B2: BMS-986442 + Nivolumab
Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)
干预措施: Nivolumab (Biological)
Part C: BMS-986442 + Nivolumab + Docetaxel
干预措施: BMS-986442 (Biological)
Part C: BMS-986442 + Nivolumab + Docetaxel
干预措施: Nivolumab (Biological)
Part C: BMS-986442 + Nivolumab + Docetaxel
干预措施: Docetaxel (Drug)
Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed
干预措施: Nivolumab (Biological)
Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed
干预措施: Carboplatin (Drug)
Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed
干预措施: Pemexetred (Drug)
Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel
干预措施: BMS-986442 (Biological)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From first dose to 100 days post last dose (Approximately 6 Months)
Number of Participants with Adverse Events. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. For the reporting of all AEs, including intensity or severity, on case report forms, please follow the definitions in National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Number of Participants With Serious Adverse Events
时间窗: From first dose to 100 days post last dose (Approximately 6 Months)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization
Number of Participants With Adverse Events Leading to Discontinuation
时间窗: From first dose to 100 days post last dose (Approximately 6 Months)
Number of Participants with adverse events leading to discontinuation
Number of Participants With Dose Limiting Toxicities
时间窗: From Cycle 1 day 1 to day 28 (28 Days)
DLTs will be defined based on the incidence, intensity, and duration of the AEs for which no clear alternative cause is identified and will exclude events clearly related to disease progression or intercurrent illness. in addition, the following AEs will be DLTs: * Any death that is not clearly due to the underlying disease or extraneous causes * Any Grade ≥ 3 non-hematological toxicity * Any Grade myocarditis * Any Grade myelitis, encephalitis, myasthenia gravis, or Guillain-Barre syndrome * Grade 4 neutropenia of \> 7 days duration * Grade 4 thrombocytopenia. * Grade 3 thrombocytopenia with clinically significant bleeding. * Febrile neutropenia Any AE that is not clearly due to disease progression or extraneous causes that occurs within the 28-day DLT evaluation window and meets criteria for permanent discontinuation will be considered a DLT.
Number of Participants Who Died
时间窗: From first dose to 100 days post last dose (Approximately 6 Months)
Number of Participants who died
次要结局
- CMax(On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks))
- Tmax(On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks))
- AUC (Tau)(On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks))
- Number of Participants With BMS-986442 Anti Drug Antibody (ADA)(From first dose to 100 days post last dose (Approximately 6 Months))
- Objective Response Rate (ORR) Per Recist v1.1 by Investigator(From first dose to 100 days post last dose (Approximately 6 Months))
- Disease Control Rate (DCR) Per Recist v1.1 by Investigator(From first dose to 100 days post last dose (Approximately 6 Months))
