NCT04623333Unknown2 期
A Single-arm, Open-label, Multicenter, Phase II Study of TQB2450 Injection in Subjects With PD-L1 Positive Recurrent or Metastatic Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR) evaluated by Independent Review Committee (IRC)
研究概览
简要总结
This is a study to evaluate the efficacy and safety of TQB2450 injection in the treatment of PD-L1 positive recurrent or metastatic cervical cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Understood and signed an informed consent form;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months;
- •Diagnosed as recurrent or metastatic cervical cancer;
- •Has received ≥first-line platinum-containing chemotherapy, and disease progress or recur during or after treatment;
- •PD-L1 positive, and the combined positive score (CPS) ≥1;
- •Has at least one measurable lesion;
- •Adequate laboratory indicators;
- •Serum or urine pregnancy tests are negative within 7 days before randomization; Men and women should agree to use effective contraception during the study period and after the end of the study period within 6 months.
排除标准
- •Combined diseases and medical history: a) Has diagnosed and/or treated additional malignancy within 3 years prior to first dose;b) Diagnosed as other special pathological types, such as mucinous adenocarcinoma, clear cell adenocarcinoma, neuroendocrine tumor and so on;c) Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;d) Has received major surgical treatment, open biopsy and so on within 28 days before the start of the study;e) Has a unhealed wound or fracture for a long time; f) Has cerebrovascular accident, deep vein thrombosis and pulmonary embolism within 6 months before the study; g) Has a history of psychotropic substance abuse and unable to quit or mental disorders; h)Has any serious and / or uncontrolled disease; 2.Tumor-related symptoms and treatment: a) Has received surgery, chemotherapy, radiotherapy or other anticancer therapy within 4 weeks before the start of the study; b) Has received proprietary Chinese medicine with anti-tumor indications in the NMPA approved drug instructions within 2 weeks before the start of the study; c) Has received immunotherapeutic drugs against PD-1, PD-L1, CTLA-4 and other related drugs; d) Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; e) Has symptomatic central nervous system (CNS) disease and/or cancerous meningitis, pia mater disease;
- •Related to treatment of research: a) Has received attenuated live vaccine within 28 days before first dose or planned to received attenuated live vaccine during the study period; b) Has severe hypersensitivity reactions after using monoclonal antibodies; c) Has active autoimmune diseases requiring systemic treatment occurred within 2 years before the study; d) Has a history of active tuberculosis; 4.Has Participated in other clinical trials within 4 weeks before first dose. 5.According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
TQB2450 injection
Experimental
TQB2450 1200mg administered intravenously (IV) on Day 1 of each 21-day cycle.
干预措施: TQB2450 (Drug)
结局指标
主要结局
Overall response rate (ORR) evaluated by Independent Review Committee (IRC)
时间窗: up to 12 months
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on IRC.
次要结局
- Disease Control Rate (DCR)(up to 12 months)
- Overall survival (OS)(up to 18 months)
- DOR rate (≥ 6 months)(up to 12 months)
- Overall response rate (ORR) evaluated by investigator(up to 12 months)
- Progression free survival (PFS)(up to 12 months)
- Duration of response (DOR)(up to 12 months)
研究者
研究点 (1)
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