A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 256
- 试验地点
- 76
- 主要终点
- Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.
详细描述
Eligible subjects will be randomized in a 1:1:1 ratio to receive either ABP 206, Food and Drug Administration (FDA)-licensed nivolumab, or European Union (EU)-authorized nivolumab.
The treatment period is in alignment with the maximum treatment duration for OPDIVO® (nivolumab, reference product) in the adjuvant setting for melanoma.
All subjects will be treated until recurrence of disease, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1 year of treatment.
The total duration of study participation for each subject will be approximately 13 months.
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
- Double (Participant, Investigator)
盲法说明
The study is double-blinded; therefore, the investigators, study personnel (with the exception of the data monitoring committee, authorized unblinded sponsor and contract research organization staff, and unblinded site pharmacy staff), and the study subjects will remain blinded to treatment allocation. ABP 206 and nivolumab will be coded and labeled to protect blinding.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Completely removed melanoma by surgery performed within 12 weeks of randomization
- •Advanced Melanoma
- •Tumor tissue from the resected site of the disease must be available for biomarker analyses in order to be randomized
- •Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
排除标准
- •Previous anti-cancer treatment
- •Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug
- •Ocular or uveal melanoma or history of carcinomatosis meningitis
- •History of auto-immune disease
- •Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the investigational product
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
ABP 206
Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
干预措施: ABP 206 (Drug)
FDA-licensed Nivolumab
Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.
干预措施: FDA-licensed Nivolumab (Drug)
EU-authorized Nivolumab
Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion.
干预措施: EU-authorized Nivolumab (Drug)
结局指标
主要结局
Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)
时间窗: Day 1 (Postdose) through Day 28
The PK similarity (AUC0-28d) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS)
时间窗: Week 17 through Week 21
The PK similarity (AUCtau\_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
次要结局
- Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1)(Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study))
- Maximum Observed Serum Concentration at Steady State (Cmax_ss)(Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study))
- Serum Concentrations at Predose (Ctrough)(Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study))
- Number of Subjects With Treatment-Emergent Serious Adverse Events(Week 1 (First dose of study drug) through Week 53 (End of Study))
- Number of Subjects With Treatment-Emergent Adverse Events(Week 1 (First dose of study drug) through Week 53 (End of Study))
- Number of Subjects With Treatment-emergent Adverse Events-of-interest(Week 1 (First dose of study drug) through Week 53 (End of Study))
- Number of Subjects With Anti-drug Antibodies (ADAs)(Predose on Week 1 (Baseline), Weeks 5, 9, 17, 21, 29, 41, and at Week 53 (End of Study))
- Recurrence-free Survival (RFS)(Randomization through 12 months (or until RFS criteria is met))
- Time to reach Cmax following the first dose (Tmax_dose 1)(Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study))
- Time to reach Cmax at steady state (Tmax_ss)(Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study))
- Serum Concentrations (Ctrough)(At Week 5 (Pre-dose), and at Weeks 17 and 21 (Pre-dose))