A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of JPB898 (Proposed Nivolumab Biosimilar) and US-licensed and EU-authorized Opdivo® in Combination With Yervoy® in Participants With Untreated Advanced (Unresectable/Metastatic) Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sandoz
- 入组人数
- 52
- 试验地点
- 22
- 主要终点
- Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU
研究概览
简要总结
The purpose of the study is to demonstrate similar PK and efficacy and to show comparable safety and immunogenicity between JPB898, Opdivo-EU, and Opdivo-US, all administered in combination with Yervoy-EU (induction phase only), in participants with advanced (unresectable Stage III or metastatic 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65+ years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants must be 18 years or older.
- •Histologically confirmed melanoma.
- •Unresectable or metastatic melanoma measurable by Computerized tomography (CT) or Magnetic resonance imaging (MRI).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Known Programmed cell death ligand 1 (PD-L1) and BRAF mutational status or consent to testing.
- •Sexually active participants must agree to use effective contraception.
排除标准
- •Active brain or leptomeningeal metastases unless stable for 8 weeks.
- •Ocular melanoma.
- •Prior active malignancy within the last year untreated or still requiring treatment.
- •Severe and uncontrolled conditions, active Hepatitis B/C, Human immunodeficiency virus (HIV), or autoimmune diseases requiring systemic treatment.
- •Previous treatment with specific immune checkpoint inhibitors, systemic anticancer therapy, or radiotherapy for melanoma.
研究组 & 干预措施
JPB898
Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase.
干预措施: JPB898 (Induction and Maintenance) (Drug)
JPB898
Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase.
干预措施: Yervoy-EU (Induction) (Drug)
Opdivo-EU
Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
干预措施: Opdivo-EU (Induction) (Drug)
Opdivo-EU
Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
干预措施: Yervoy-EU (Induction) (Drug)
Opdivo-EU
Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
干预措施: Opdivo-EU (Maintenance) (Drug)
Opdivo-US
Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
干预措施: Opdivo-US (Induction) (Drug)
Opdivo-US
Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
干预措施: Yervoy-EU (Induction) (Drug)
Opdivo-US
Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
干预措施: Opdivo-EU (Maintenance) (Drug)
结局指标
主要结局
Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU
时间窗: Days 1 to 22
Area under the serum concentration-time curve measured from the time of dosing of the first dose to the second dose (AUCtrunc) after the first dose
Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU between JPB898 and Opdivo-US/-EU
时间窗: Days 64 to 85
Area under the serum concentration-time curve measured from the time of dosing to the last measurable serum concentration in the dosing interval, tau (AUCtau) after the fourth dose
Demonstrate efficacy similarity for Best overall response (BOR) between JPB898 and Opdivo-US/-EU defined as the best overall response based on blinded central tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
时间窗: BOR (Complete response (CR) or partial response (PR)) from baseline up to 28 weeks
The assessment of response for the primary efficacy is based on tumor response data as per blinded independent central review and according to RECIST 1.1
次要结局
未报告次要终点
研究者
Biosimilar Clinical Trials Information Point
Scientific
H e x a l AG