NCT02857426已完成2 期
A Phase 2, Open-label, Single-arm, Two-cohort Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Relapsed/Refractory Primary Testicular Lymphoma (PTL)
Bristol-Myers Squibb27 个研究点 分布在 9 个国家目标入组 66 人开始时间: 2016年10月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 27
- 主要终点
- BICR-Assessed Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Pathologically confirmed PCNSL or PTL who failed or did not respond to at least 1 line of systemic therapy
- •Measurable disease requirements on scans:
- •PCNSL subjects should have at least one measurable extranodal brain lesion; PTL subjects should have at least 1 measurable extranodal lesion or nodal lesion
- •Have tumor tissue for PD-L1 expression testing
- •Must have a Karnofsky performance status of 70-100
排除标准
- •a) Intraocular PCNSL without evidence of brain disease b) PCNSL patients who cannot undergo MRI assessments c) PCNSL patients with systemic disease
- •Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder
- •Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •PCNSL, and PTL subjects with brain or spinal cord lesion who have received doses of more than 2 mg/day of dexamethasone or equivalent within the 14 days period prior to the first dose of nivolumab are excluded
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Nivolumab for population with PTL
Experimental
Specified dose on specified days
干预措施: Nivolumab (Drug)
Nivolumab for population with PCNSL
Experimental
Specified dose on specified days
干预措施: Nivolumab (Drug)
结局指标
主要结局
BICR-Assessed Objective Response Rate (ORR)
时间窗: Up to approximately 51 months
Percentage of participants with a confirmed objective response rate (ORR) by blinded independent central review (BICR) assessment was analyzed and reported for both PCNSL and PTL patient populations. This endpoint is further defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, divided by the number of treated participants within each cohort.
次要结局
- BICR-Assessed Progression Free Survival (PFS)(Up to approximately 51 months)
- Investigator-Assessed Objective Response Rate (ORR)(Up to approximately 51 months)
- Investigator-Assessed Duration of Response (DOR)(Up to approximately 51 months)
- Overall Survival (OS)(Up to approximately 51 months)
研究者
研究点 (27)
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