NCT05932212招募中2 期
A Multicenter, Open-label, Phase II Study of AK104 in the Treatment of Recurrent or Metastatic Vulvar Cancer
Akeso6 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年8月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Objective response rate (ORR) assessed by investigator.
研究概览
简要总结
This is a multicenter, open-label, phase II clinical study, aiming to the evaluate the efficacy and safety of AK104 (an anti- PD-1 and CTLA-4 bispecific antibody), alone or combined with chemotherapy, in subjects with recurrent or metastatic vulvar cancer not amenable to curative surgery or radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >=18 and <=
- •ECOG of 0 or
- •Life expectancy ≥ 3 months. Histologically confirmed vulvar cancer (squamous cell carcinoma or adenosquamous carcinoma), not amenable to curative surgery or radical radiotherapy.
- •For Cohort A, subjects should have experienced failure on at least one previous systemic therapy, or intolerance to standard therapy.
- •At least one measurable tumor lesion per RECIST v1.
- •Adequate organ function as assessed in the laboratory tests. Female subjects of childbearing potential must have a negative serum pregnancy test prior to the the first administration and agree to use effective methods of contraception
排除标准
- •Subjects with other histopathological types of vulvar cancer, such as melanoma, sarcoma, etc.
- •Systemic or curative (surgery or radiotherapy) anti-tumor therapy within 4 weeks prior to the first administration.
- •Previous treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.).
- •Active or potentially recurrent autoimmune disease.
研究组 & 干预措施
Cohort A: AK104
Experimental
AK104 monotherapy
干预措施: AK104 (Drug)
Cohort B: AK104+chemotherapy
Experimental
AK104 combined with platinum-based chemotherapy (paclitaxel+ cisplatin or carboplatin)
干预措施: AK104+ Paclitaxel+Cisplatin or Carboplatin (Drug)
结局指标
主要结局
Objective response rate (ORR) assessed by investigator.
时间窗: Up to approximately 1 years
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1
次要结局
- serum concentrations of AK104(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Adverse Events (AEs)(Up to approximately 2 years)
- Progression-free survival (PFS) Assessed by investigator(Up to approximately 2 years)
- Duration of Response (DOR) Assessed by investigator(Up to approximately 2 years)
- Disease control rate (DCR) Assessed by investigator(Up to approximately 1 years)
- Time to Response (TTR) Assessed by investigator(Up to approximately 1 years)
- Antidrug antibodies (ADA) of AK104(Up to approximately 2 years)
研究者
研究点 (6)
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