A Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytruda® as an Adjuvant Treatment in Participants With Stage IIB/C-III Melanoma Following Complete Resection
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
研究概览
简要总结
This is a multicenter, randomized, double-blind, parallel-group, 2 treatment group, repeated dose study to compare the PK, efficacy, safety, and immunogenicity of AVT32-DRL_PB (proposed Keytruda® biosimilar) versus Keytruda (pembrolizumab) when administered as monotherapy in participants with fully resected Stage IIB/C or Stage III melanoma requiring adjuvant treatment with pembrolizumab. Eligible participants will be randomized in a 1:1 ratio to the AVT32-DRL_PB or Keytruda treatment group and stratified by sex (female versus male) and body weight category (≤75 kg versus >75 kg). Study treatments will be administered every 3 weeks (Q3W) as an intravenous (IV) infusion over 30 minutes (1 administration Q3W is 1 treatment cycle). The administered pembrolizumab dose will be 200 mg Q3W for both treatment groups.
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
- •Participants (male/female) ≥18 years of age at the time of signing the ICF.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment.
- •Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma
排除标准
- •Have had a solid organ transplant or bone marrow (stem cell) transplant that used donor stem cells (allogenic).
- •Has received prior systemic anticancer therapy for melanoma including investigational agents.
- •Participants with a history of mucosal or uveal melanoma, even if diagnosis and treatment were completed >5 years ago.
研究组 & 干预措施
AVT32-DRL_PB
AVT32-DRL_PB will be administered during double blind period and open label period
干预措施: AVT32-DRL_PB (Biological)
Keytruda
Keytruda will be administered during double blind period
干预措施: Keytruda (Biological)
结局指标
主要结局
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
时间窗: Cycle 1 (each cycle is 21 days)
AUC0-3w (Cycle 1)
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
时间窗: Cycle 6 (each cycle is 21 days)
AUCtau,ss (Cycle 6)
次要结局
未报告次要终点