NCT03980314已完成1 期
A Randomized, Double-Blind, Parallel, Phase 1 Study to Compare the Pharmacokinetics of BMSCHO1-Nivolumab Process D to Nivolumab Process C After Complete Resection of Stage IIIa/b/c/d or Stage IV Melanoma
Bristol-Myers Squibb37 个研究点 分布在 14 个国家目标入组 261 人开始时间: 2019年6月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 261
- 试验地点
- 37
- 主要终点
- Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h)
研究概览
简要总结
The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically confirmed stage IIIa/b/c/d or stage IV melanoma
- •Complete resection of Stage III disease that is documented on the surgical and pathology reports or complete resection of Stage IV disease with margins negative for disease that is documented on the pathology report
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
排除标准
- •Prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured
- •Any significant acute or chronic medical illness that is uncontrolled
- •History of ocular/uveal melanoma
- •Active, known or suspected autoimmune disease
- •Systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm A (Process C)
Active Comparator
干预措施: Nivolumab (Drug)
Arm B (Process D)
Experimental
干预措施: Nivolumab (Drug)
结局指标
主要结局
Area under the concentration-time curve in one dosing interval (AUC[TAU]) (336 h)
时间窗: Over the dosing interval at Week 1 and Week 17
次要结局
- Observed serum concentration at the end of a dosing interval (Ctau)(Over the dosing interval at Week 1 and Week 17)
- Number of Participants With Adverse Events leading to Discontinuation(Up to 65 weeks)
- Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)(Through Week 51 Day 1)
- Number of Participants With Serious Adverse Events (SAEs)(Up to 65 weeks)
- Number of Participants with AEs leading to death(Up to 65 weeks)
- Maximum Observed Plasma Concentration (Cmax)(Over the dosing interval at Week 1 and Week 17)
- Time of maximum observed plasma concentration (Tmax)(Over the dosing interval at Week 1 and Week 17)
- Number of Participants With Adverse Events (AEs)(Up to 65 weeks)
- Number of Participants With Clinically Significant Laboratory Abnormalities(Up to 65 weeks)
研究者
研究点 (37)
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