A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate GLS-010 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 424
- 试验地点
- 2
- 主要终点
- overall survival (OS)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled phase III study to evaluate GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.
详细描述
This is a randomized, double-blind, placebo-controlled phase III study，aimed to evaluate the efficacy and safety of GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed the informed consent form.
- •Women aged ≥ 18 and ≤ 75 years.
- •ECOG of 0 or
- •Life expectancy ≥ 12 weeks.
- •Cervical cancer patients with histologically confirmed PD-L1 positive (CPS ≥ 1),.The histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma.
- •No prior systemic therapy for persistent, recurrent or metastatic ([FIGO] Stage IVB) disease,not amenable to curative surgery or concurrent chemoradiotherapy.
- •At least one measurable tumor lesion per RECIST v1.1; lesions previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy.
- •Subjects must have adequate organ function.
- •Female subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. Female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 6 months after the last dose of study drug.
排除标准
- •Patients with the opportunity to be cured by surgery and radiotherapy.
- •Received with concurrent chemoradiotherapy, adjuvant chemotherapy,neo- adjuvant chemotherapy within 4 weeks prior to randomization.
- •Active central nervous system (CNS) metastasis.
- •Patients with other malignancies prior to randomization. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast cancer) that have been cured are not excluded.
- •Has an active autoimmune disease that has required systemic treatment.
- •With active serious infections.
- •Subjects with HIV infection ,active hepatitis B virus infection, active hepatitis C virus infection,active tuberculosis infection,active syphilis .
- •Has not recovered adequately from toxicity and/or complications from surgery prior to randomization.
- •Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab.
- •Have received any investigational treatment in other clinical trials within 4 weeks prior to randomization.
- •Pregnant or lactating women,or women may become pregnant during treatment.
- •Has had an allogeneic tissue/solid organ/ hematopoietic stem cells transplant.
- •History of nervous system and mental disease. History of drug abuse.
- •The patient is not suitable to participate the study in the opinion of the investigator.
研究组 & 干预措施
GLS-010+chemotherapy± bevacizumab
GLS-010 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
干预措施: paclitaxel (Drug)
GLS-010+chemotherapy± bevacizumab
GLS-010 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
干预措施: cisplatin (Drug)
Placebo+chemotherapy± bevacizumab
Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
干预措施: cisplatin (Drug)
GLS-010+chemotherapy± bevacizumab
GLS-010 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
干预措施: carboplatin (Drug)
Placebo+chemotherapy± bevacizumab
Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
干预措施: paclitaxel (Drug)
Placebo+chemotherapy± bevacizumab
Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
干预措施: carboplatin (Drug)
Placebo+chemotherapy± bevacizumab
Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
干预措施: bevacizumab (Drug)
GLS-010+chemotherapy± bevacizumab
GLS-010 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
干预措施: Placebo (Drug)
Placebo+chemotherapy± bevacizumab
Placebo in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
干预措施: Placebo (Drug)
GLS-010+chemotherapy± bevacizumab
GLS-010 in combination with cisplatin or carboplatin and paclitaxel± bevacizumab
干预措施: GLS-010 (Drug)
结局指标
主要结局
overall survival (OS)
时间窗: Up to 2 years
OS is defined as the time from randomization to death due to any cause.
次要结局
- progression-free survival (PFS)(Up to 2 years)
- Number of subjects with adverse events (AEs)(From the time of signed informed consent to 90 days after end of treatment.)
- Objective Response Rate (ORR)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Quality of life (QoL)(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
- Time to Response（TTR）(Up to 2 years)