A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 16
- 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 assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected 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
- 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
- •Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins
- •Complete resection performed within 12 weeks prior to randomization or treatment assignment
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
排除标准
- •History of uveal or mucosal melanoma
- •Untreated/unresected CNS metastases or leptomeningeal metastases
- •Active, known or suspected autoimmune disease
- •Serious or uncontrolled medical disorder 4 weeks prior to screening
- •Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible
- •Prior immunotherapy treatments for any prior malignancies are not permitted
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm A: Subcutaneous Nivolumab
干预措施: Nivolumab/rHuPH20 (Biological)
Arm B: Intravenous Nivolumab
干预措施: Nivolumab (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 up to 14 Months)
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.
Number of Participants With Serious Adverse Events
时间窗: From first dose to 100 days post last dose (Approximately up to 14 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 Treatment Related Adverse Events
时间窗: From first dose to 100 days post last dose (Approximately up to 14 Months)
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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom or disease.
Number of Participants With Treatment Related Serious Adverse Events
时间窗: From first dose to 100 days post last dose (Approximately up to 14 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.
次要结局
未报告次要终点