A Phase 1/2 Study of the Safety and Efficacy of Ulocuplumab Combined With Nivolumab in Subjects With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 试验地点
- 7
- 主要终点
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs
研究概览
简要总结
The purpose of this study is to determine whether the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.
详细描述
- Intervention model: Single group for Stage 1 DLT, then Parallel
- Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •SCLC or PAC that is advanced or has spread to other parts of the body
- •Treated with at least one other chemotherapy that did not work or where cancer relapsed
- •Minimal limitations on activities of daily living as measured by Eastern Cooperative Oncology Group (ECOG) score of 0-1
排除标准
- •Patients with cancer that spread to the brain
- •Active, known or suspected autoimmune disease
- •Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
研究组 & 干预措施
BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC)
Small cell lung cancer (SCLC)
干预措施: Ulocuplumab (Drug)
BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC)
Small cell lung cancer (SCLC)
干预措施: Nivolumab (Drug)
BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC)
Pancreatic cancer (PAC)
干预措施: Ulocuplumab (Drug)
BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC)
Pancreatic cancer (PAC)
干预措施: Nivolumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs
时间窗: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.
Objective Response Rate (ORR) Per RECIST 1.1 Criteria
时间窗: From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)
ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.
Overall Survival (OS)
时间窗: From date of randomization to date of death (assessed up to study completion, approximately 18 months)
If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause.
Number of Participants With Laboratory Abnormalities
时间窗: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm.
Number of Participants With Electrocardiogram Abnormalities
时间窗: From first dose to date of last dose plus 30 days
The number of participants experiencing electrocardiogram abnormalities was reported for each arm
次要结局
- Progression-Free Survival (PFS)(From first dose to date of progression (assessed up to January 2017, approximately 18 months))