NCT06327698尚未招募2 期
Efficacy and Safety of Cadonilimab in Combination With Anlotinib in the Treatment of Locally Progressive or Metastatic Melanoma With First-Line Therapy Failure: A Single-arm, Open-label, Multicenter Phase II Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Response Rate
研究概览
简要总结
This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of cadonilimab (AK104) in combination with anlotinib in the treatment of locally advanced or metastatic melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Has a histologically confrmed diagnosis of malignant melanoma
- •Previously received failed first-line treatment for melanoma
- •Patients may have a history of liver metastases, but the metastases should be less than 3
- •Patients with treatment-asymptomatic brain metastases may be included, must be free of disease progression on computed tomography (CT) or magnetic resonance imaging (MRI), stable for at least 3 months, and free of steroid medication for at least 4 weeks
- •Those with at least 1 measurable lesion (RECIST version 1.1)
- •Non-lactating patients
- •Good organ function
排除标准
- •Previous (within 5 years) or concurrent other malignant tumors, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer without recurrence > 3 years after radical resection
- •Has an active or potentially recurrent autoimmune disease
- •History of severe allergic reaction to any monoclonal antibody and/or component of the study drug
- •Known presence of active tuberculosis TB
- •Currently receiving cancer treatment (chemotherapy, radiotherapy, immunotherapy, or biologic therapy)
- •Received a live vaccine within 30 days prior to the first dose, or plans to receive a live vaccine during the study
- •Known history of psychiatric illness, substance abuse, alcoholism, or drug abuse
研究组 & 干预措施
Combination+ Anlotinib
Experimental
Cadonilimab (AK104) (10 mg/kg, Q3W, administered on the frst day of each cycle, Q3W, until there is no clinical beneft) + anlotinib (8 mg, QD, 2 weeks off for 1 week)
干预措施: Cadonilimab (Drug)
Combination+ Anlotinib
Experimental
Cadonilimab (AK104) (10 mg/kg, Q3W, administered on the frst day of each cycle, Q3W, until there is no clinical beneft) + anlotinib (8 mg, QD, 2 weeks off for 1 week)
干预措施: anlotinib (Drug)
结局指标
主要结局
Response Rate
时间窗: from the frst drug administration up to two years
ORR is the proportion of patients with best response of complete response (CR) and PR
次要结局
- Safety and tolerability(from the frst drug administration up to two years)
- Disease Control Rate (DCR)(from the frst drug administration up to two years)
- Progression-free Survival (PFS)(from the frst drug administration up to two years)
研究者
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