2023-507389-15-00已完成2 期
A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of RO7198457 in Combination With Pembrolizumab Versus Pembrolizumab in Patients with Previously Untreated Advanced Melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 14
- 主要终点
- 1. Progression Free Survival
研究概览
简要总结
To evaluate the efficacy of RO7198457 plus pembrolizumab compared with pembrolizumab alone on the basis of progression free survival
研究设计
- 分配方式
- Randomized
- 主要目的
- Experimental: Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma, as defined by the AJCC v8.0
- •ECOG Performance Status of 0 or 1
- •Life expectancy ≥ 12 weeks
- •Adequate hematologic and end-organ function
- •Measurable disease per RECIST v1.1
- •Naive to prior systemic anti-cancer therapy for advanced melanoma, with the exceptions as specified in the protocol
排除标准
- •Ocular/uveal melanoma
- •Known clinically significant liver disease
- •Previous splenectomy
- •Any anti-cancer therapy with the exceptions as specified in the protocol
- •History of autoimmune disease
- •Positive test for HIV infection
结局指标
主要结局
1. Progression Free Survival
1. Progression Free Survival
次要结局
- 1. Objective Response Rate
- 2. Overall Survival
- 3. Duration of Response
- 4. Mean change from baseline in Health-Related Quality of Life (HRQoL) scores as assessed through use of the two-item Global Health Status (GHS)/HRQoL subscale (Questions 29 and 30) of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) at specified timepoints
- 5. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
- 6. Change from baseline in targeted vital signs
- 7. Change from baseline in targeted clinical laboratory test results
研究者
US Program Manager Product Development Regulatory
Scientific
Genentech Inc.
研究点 (14)
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