NCT02253992终止1 期
A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Advanced/Metastatic Solid Tumors and B-cell Non-Hodgkins Lymphoma
Bristol-Myers Squibb29 个研究点 分布在 4 个国家目标入组 232 人开始时间: 2014年9月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 232
- 试验地点
- 29
- 主要终点
- The Incidence of Adverse Events.
研究概览
简要总结
The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •For Dose Escalation:
- •Subjects with any previously treated advanced (metastatic or refractory) solid tumor type and B-cell non-Hodgkin lymphoma
- •For Cohort Expansion:
- •Subjects must have a previously treated advanced solid tumor or B cell non-Hodgkin's lymphoma to be eligible
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •For certain subjects, willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
- •Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
排除标准
- •Known central nervous system metastases or central nervous system as the only source of disease
- •Other concomitant malignancies (with some exceptions per protocol)
- •Active, known or suspected autoimmune disease
- •Uncontrolled or significant cardiovascular disease
- •History of hepatitis (B or C)
- •History of active or latent tuberculosis
结局指标
主要结局
The Incidence of Adverse Events.
时间窗: From day 1 until 100 days after participant last dose of study drug.
The Incidence of Death.
时间窗: From day 1 until 100 days after participant last dose of study drug.
The Incidence of Seriuos Adverse Events.
时间窗: From day 1 until 100 days after participant last dose of the study drug.
次要结局
- Area Under the Concentration-time Curve in One Dosing Interval (AUCTAU)(Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days)
- Objective Response Rate (ORR)(Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.)
- Area Under the Plasma Concentration-time Curve, 0 to Time of Last Quantifiable Concentration (AUC(0-T)(Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.)
- Best Overall Response (BOR)(Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.)
- Progression-free Survival Rate (PFSR)(Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.)
- Trough Observed Plasma Concentration(Ctrough)(Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.)
- Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab(Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.)
- Duration of Response (DOR)(Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years)
- Maximum Observed Serum Concentration (Cmax)(Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.)
- Time of Maximum Observed Serum Concentration (Tmax)(Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.)
- End of Infusion Concentration (Ceoinf)(Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.)
研究者
研究点 (29)
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