A Phase III, Randomized, Double-Blind, Multi-center Study to Investigate the Efficacy and Safety of Camrelizumab+Gemcitabine+Cisplatin Versus Placebo+Gemcitabine+Cisplatin in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with recurrent/metastatic nasopharyngeal carcinoma who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of camrelizumab in combination with gemcitabine and cisplatin with placebo in combination with gemcitabine and cisplatin in study population in China. camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.
详细描述
In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Treatment cycles of chemotherapy will be at most 6 weeks which will be decided by investigators. Progression-free survival (PFS) determined by the Independent Review Committee (IRC) will be the primary outcome measures.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤75 years;
- •Subjects with histopathological diagnosis of nasopharyngeal carcinoma;
- •Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment;
- •Has not received prior systemic treatment;
- •Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
- •Subject must have a measurable target lesion based on RECIST v1.1;
排除标准
- •Allergic to monoclonal antibodies, any camrelizumab components, gemcitabine, cisplatin and other platinum drugs;
- •Prior therapy as follow:
- •Anti-PD-1 or anti-PD-L1;
- •Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
- •Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalent for replacement therapy;
- •Received major operations or serious injuries within 4 weeks of the first dose of study medication;
- •Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
- •Pregnancy or breast feeding;
研究组 & 干预措施
Camrelizumab + Gemcitabine + Cisplatin
subject will receive camrelizumab 200mg every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, at most 6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles
干预措施: Camrelizumab (Drug)
Camrelizumab + Gemcitabine + Cisplatin
subject will receive camrelizumab 200mg every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, at most 6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles
干预措施: Gemcitabine (Drug)
Camrelizumab + Gemcitabine + Cisplatin
subject will receive camrelizumab 200mg every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, at most 6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles
干预措施: Cisplatin (Drug)
Placebos + Gemcitabine + Cisplatin
subject will receive placebos every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, at most 6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles
干预措施: Placebos (Drug)
Placebos + Gemcitabine + Cisplatin
subject will receive placebos every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, at most 6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles
干预措施: Gemcitabine (Drug)
Placebos + Gemcitabine + Cisplatin
subject will receive placebos every 3 weeks, cisplatin 80mg/m2 on Day 1 of each 21 day, at most 6 cycles, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to 24 month
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee according to RECIST v1.1 or death from any cause, whichever occurs first.
次要结局
- Progression-free survival(up to 24 month)
- Objective Response Rate (ORR)(up to 24 month)
- Disease Control Rate (DCR) Disease Control Rate (DCR)(up to 24 month)
- Duration of Response (DoR)(up to 24 month)
- 2 years Overall Survival (OS) rate(up to 24 month)
- Adverse Events (AEs)(up to 24 month)