A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 633
- 试验地点
- 302
- 主要终点
- Objective response by Week 49
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.
详细描述
Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab).
All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment.
The total duration of study participation for each subject will be approximately 26 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.
- •Histologically confirmed unresectable or metastatic melanoma.
- •Subject has no prior systemic treatment for advanced disease.
- •Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
- •Tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or
排除标准
- •Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma.
- •Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug.
- •Subject has active central nervous system (CNS) metastases not previously treated.
- •Ocular melanoma.
- •Subject has active or known immune-mediated disorders.
- •Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways.
- •Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Nivolumab
Subjects will receive Dose A of Nivolumab via IV infusion.
干预措施: Nivolumab (Drug)
ABP 206
Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
干预措施: ABP 206 (Drug)
结局指标
主要结局
Objective response by Week 49
时间窗: Week 49
Objective response at Week 17
时间窗: Week 17
Progression-free survival (PFS)
时间窗: From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)
Overall survival (OS)
时间窗: From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Duration of response (DOR)
时间窗: From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
次要结局
- Number of subjects with treatment-emergent adverse events of interest(Week 1 until Week 105)
- Number of subjects with anti-drug antibodies(Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105)
- Serum concentrations of ABP 206 and nivolumab (Ctrough)(Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105)
- Number of subjects with treatment-emergent adverse events(Week 1 until Week 105)
- Number of subjects with treatment-emergent serious adverse events(Week 1 until Week 105)