A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics of GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU Authorized Keytruda® in Participants With Stage II and III Melanoma Requiring Adjuvant Treatment With Pembrolizumab
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 322
- 试验地点
- 61
- 主要终点
- Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d)
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 GME751 compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring adjuvant treatment with pembrolizumab.
详细描述
Eligible subjects will be randomized in a 1:1:1 ratio to receive either GME751, Food and Drug Administration (FDA)-licensed pembrolizumab (Keytruda-US) or European Union (EU)-authorized pembrolizumab (Keytruda-EU). The maximum study duration for a participant will be approximately 28 weeks including screening.
Treatment duration is 24 weeks (4 treatment cycles, each of 6 weeks duration). However, subject should discontinue study participation in case of disease recurrence, unacceptable toxicity or other reasons.
Participants who are benefiting from treatment with pembrolizumab without signs of recurrence or unacceptable toxicity will be eligible for continued pembrolizumab treatment via most suitable option based on the respective country regulations.
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)
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
- •At least 18 years of age
- •Advanced Melanoma
- •Completely removed melanoma by surgery performed within 13 weeks of randomization
- •Adequate organ function
- •Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
排除标准
- •Known history or evidence of ocular or uveal melanoma
- •Known history of hypersensitivity (grade ≥3) to pembrolizumab or its excipients
- •Known History of auto-immune disease
- •Received live vaccine ≤30 days before the first study treatment
- •Prior treatment with anti-PD-1 agents or agent against another stimulatory or co-inhibitory T cell receptor
- •Active autoimmune disease that has necessitated chronic systemic treatment within 2 years before the first study treatment
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
GME751
Subjects will receive GME751 via intravenous (IV) infusion.
干预措施: GME751 (Drug)
Keytruda - EU
Subjects will receive Keytruda-EU via intravenous (IV) infusion.
干预措施: Keytruda - EU (Drug)
Keytruda - US
Subjects will receive Keytruda-US via intravenous (IV) infusion.
干预措施: Keytruda - US (Drug)
结局指标
主要结局
Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d)
时间窗: Day 1 (Postdose) through Day 42
The PK similarity (AUC0-42d) of GME751 compared with pembrolizumab 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
时间窗: Week 19 through Week 24
The PK similarity (AUCtau\_ss) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d)
时间窗: Day 1 (Postdose) through Day 42
The PK similarity (AUC0-42d) of GME751 compared with pembrolizumab 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
时间窗: Week 19 through Week 24
The PK similarity (AUCtau\_ss) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
次要结局
未报告次要终点