NCT06601335招募中3 期
A Randomized, Controlled, Multicenter Phase 3 Study of AK112 in Combination With AK117 Versus Pembrolizumab as First Line Treatment for a Programmed Cell Death-ligand 1 (PD-L1) Positive Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
Akeso2 个研究点 分布在 1 个国家目标入组 510 人开始时间: 2024年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 510
- 试验地点
- 2
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a phase 3 study. All subjects arerecurrent or metastatic head and neck squamous Cell Carcinoma (R/M HNSCC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 combined with AK117 versus pembrolizumab combined with placebo in patients with R/M HNSCC whose tumors have programmed cell death-ligand 1 (PD-L1) positive [Combined Positive Score (CPS) greater than or equal to 1].
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
- •Be able and willing to provide written informed consent.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Have a life expectancy of at least 3 months.
- •Has histologically confirmed diagnosis of R/M HNSCC primarily located in oropharynx, oral cavity, hypopharynx, or larynx, which is considered incurable by local therapies.
- •Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.
- •No prior systemic treatment for R/M HNSCC.
- •At least one measurable noncerebral lesion according to RECIST 1.
- •PD-L1 positive (CPS ≥ 1).
- •Has adequate organ function.
- •All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
- •Able to to comply with all requirements of study participation (including all study procedures).
排除标准
- •Has squamous cell carcinoma of the primary site, such as nasopharynx, nasal cavity, sinuses, salivary glands, thyroid or parathyroid, skin, or of unknown primary origin.
- •Had other malignant tumors within the 5 years prior to enrollment.
- •Has a significant risk of bleeding assessed by the investigator based on imaging.
- •Radiologically documented evidence of major blood vessel invasion or tumor invading organs or there is a risk of esophagotracheal or esophagopleural fistula, or major blood vessel encasement that the investigator determines will pose a significantly increased risk of bleeding.
- •Has known active central nervous system (CNS) metastases.
- •Has pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
- •Previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, and any other treatments targeting the immune mechanisms of tumors.
- •Previously received radiation therapy for head or neck within 8 weeks prior to enrollment, received palliative radiation therapy for non-head or non-neck within 3 weeks prior to enrollment.
- •Has a history severe bleeding tendency or coagulation dysfunction.
- •Has a history myocarditis, cardiomyopathy, and malignant arrhythmia.
- •Has a history arterial or venous thromboembolism events, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy occurred within 6 months prior to enrollment.
- •Pregnant or lactating female.
研究组 & 干预措施
AK117 in combination with AK112
Experimental
干预措施: AK117 in combination with AK112 (Drug)
Placebo in combination with Pembrolizumab
Active Comparator
干预措施: Placebo in combination with Pembrolizumab (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 2 years
OS is the time from randomization to death due to any cause.
次要结局
- Progression Free Survival (PFS)(Up to approximately 2 years)
- Objective Response Rate (ORR)(Up to approximately 2 years)
- Adverse Events (AEs)(Up to approximately 2 years)
- Cmax(Up to approximately 2 years)
- Cmin(Up to approximately 2 years)
- Anti-drug antibodies (ADA)(Up to approximately 2 years)
研究者
研究点 (2)
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