A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 (Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) + Chemotherapy (Carboplatin/Cisplatin and Paclitaxel) vs Chemotherapy (Carboplatin/Cisplatin and Paclitaxel)in Patients With Advanced Cervical Cancer
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of HLX10(Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) plus chemotherapy compared to the efficacy and safety of placebo plus chemotherapy in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Chemotherapy regimens include: paclitaxel plus cisplatin and paclitaxel plus carboplatin.
The primary study hypotheses are that the combination of HLX10 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the IRRC or, 2) Overall Survival (OS).
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation)
- •Has measurable disease per RECIST 1.1 as assessed by IRRC
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization
- •Has adequate organ function
排除标准
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has a known additional malignancy that is progressing or has required active treatment within the past 2 years.
- •Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- •Has an active infection requiring systemic therapy
- •Has a known history of human immunodeficiency virus (HIV) infection
- •Has received prior therapy with an anti-PD-1, anti-PD-L1 or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4）
研究组 & 干预措施
HLX10
HLX10 + chemotherapy
干预措施: HLX10 (Drug)
HLX10
HLX10 + chemotherapy
干预措施: Paclitaxel (Drug)
HLX10
HLX10 + chemotherapy
干预措施: Cisplatin (Drug)
HLX10
HLX10 + chemotherapy
干预措施: Carboplatin (Drug)
Placebo
Placebo + chemotherapy
干预措施: Paclitaxel (Drug)
Placebo
Placebo + chemotherapy
干预措施: Cisplatin (Drug)
Placebo
Placebo + chemotherapy
干预措施: Carboplatin (Drug)
Placebo
Placebo + chemotherapy
干预措施: Placebo to HLX10 (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 2 years
OS is defined as the time from randomization to death due to any cause.
Progression-free survival (PFS) (assessed by the independent radiology review committee [IRRC] based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
时间窗: up to approximately 1 years
Baseline until disease progression or death, whichever occurs first
次要结局
未报告次要终点