Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer: a Multicenter, Single-arm, Prospective Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
To evaluated the efficacy and safety of caldonirimab plus nimotuzumab as second-line or later therapy for recurrent or metastatic cervical cancer
详细描述
Caldonirimab, a PD-1/CTLA-4 bispecific antibody, has shown promising efficacy and tolerable toxicity in the first-line treatment of recurrent or metastatic cervical cancer. In this study, patients with recurrent or metastatic cervical cancer, after failure of first-line platinum-containing chemotherapy or intolerance to chemotherapy, will be included in this study according to the prescribed criteria in the protocal. Nimotuzumab 400 mg/time, intravenous injection, q2w, a total of 8 times; Caldonirimab 6 mg/Kg, q2w. Assess objective response rate; disease control rate; duration of overall response and safety ( adverse event).
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age≥18 & ≤
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Subjects must have histologically or cytologically confirmed recurrent or metastatic carcinoma of the cervix
- •Patients have received at least one systemic therapy or who cannot tolerate chemotherapy in the recurrent or metastatic setting
- •Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
- •Has adequate organ function.
- •Life expectancy ≥3 months.
排除标准
- •Concurrent enrollment in another clinical study;
- •Clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent;
- •Had received caldonirimab or nimotuzumab before;
- •Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome.
- •Known active hepatitis B or C infections (known positive hepatitis B surface antigen [HBsAg] result or positive hepatitis C virus [HCV] antibody with detectable HCV ribonucleic acid [RNA] results).
- •Patients with clinically significant cardio-cerebrovascular disease
- •Known allergy or reaction to any component of the two drugs.
研究组 & 干预措施
Caldonirimab and nimotuzumab
Caldonirimab combined with nimotuzumab therapy
干预措施: Caldonirimab and Nimotuzumab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 2 years
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1
次要结局
- Disease control rate (DCR)(2 years)
- Duration of response (DoR)(2 years)
- Adverse events (AEs)(90 days)
- Progression-free survival (PFS)(2 years)
研究者
Liu Zi
Professor
Health Science Center of Xi'an Jiaotong University