NCT06459687招募中3 期
Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study
Lee's Pharmaceutical Limited5 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2024年11月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 440
- 试验地点
- 5
- 主要终点
- Overall survival
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is:
Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab.
Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6~8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).
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
- •Able to understand and voluntarily signed written informed consent. Informed consent must be signed prior to specified study procedure.
- •Age ≥ 18 years and ≤75 years on the date of signing the informed consent, female.
- •ECOG Physical fitness score was 0 or
- •Life expectancy ≥ 3 months.
- •Histologically confirmed cervical cancer that cannot be cured by surgery or radiotherapy/concurrent chemoradiotherapy.
- •Have at least one measurable tumor lesion examined by CT or MRI according to RECIST v1.1 criteria;
- •All subjects must provide archived or freshly obtained tumor tissue samples (formalin-fixed paraffin-embedded [FFPE] tissue wax blocks or at least 5 unstained tumor tissue section samples, preferably newly obtained tumor tissue samples) within the previous 5 years of randomization.
- •Laboratory examination results during the screening period indicate that the subject has good organ function.
- •Effective contraception should be used by fertile female subjects from the signing of informed consent until 180 days after the last administration of the study drug.
排除标准
- •Other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc.
- •Prior anti-angiogenic therapy (e.g., bevacizumab), immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), or targeting immune costimulators (e.g. antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.) and any treatment targeting the immune mechanism of tumor.
- •Active or potentially recurring autoimmune disease.
- •Patients with other active malignant tumors within 3 years prior to randomization.
- •Participants who had participated in other clinical studies and used other clinical trial drugs within 4 weeks before randomization.
- •Major surgery, open biopsy or significant trauma within 4 weeks before randomization; Or an expected major surgical treatment during the study.
- •Anti-tumor therapy within 4 weeks before randomization.
- •Severe infection occurring within 4 weeks prior to randomization.
- •Vaccination within 4 weeks prior to randomization.
- •Received immune-modulating drugs (such as thymosin, interferon, interleukin-2) within 2 weeks before randomization.
- •Use of systemic antibacterial, antiviral, or antifungal drugs within 2 weeks prior to randomization.
- •Subjects requiring systemic treatment with corticosteroids (> 10 mg/ day of prednisone or equivalent doses of corticosteroids) or other immunosuppressive drugs within 2 weeks prior to randomization.
- •Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as determined by the investigator.
- •Central nervous system metastatic or cancerous meningitis.
- •Uncontrolled pleural, pericardial, or peritoneal effusions requiring repeated drainage (more frequently than monthly).
- •Known primary or secondary immunodeficiency, including a positive test for human immunodeficiency virus (HIV) antibodies.
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •Known active tuberculosis; Known active treponema pallidum infection.
- •known history of severe hypersensitivity to other monoclonal antibodies.
- •Known contraindications to cisplatin/carboplatin, paclitaxel, or allergies to any components.
- •Previous and/or current presence of interstitial lung disease, pneumoconiosis, drug-related pneumonia, severe impairment of pulmonary function, etc., that may interfere with the detection and management of suspected drug-related pulmonary toxicity.
- •Subjects with active viral hepatitis B, inactive or asymptomatic carriers of hepatitis B virus (HBV) (positive for hepatitis B surface antigen [HBsAg]) with HBV DNA > 500 IU/mL or > 2500 copies/mL), and subjects with active viral hepatitis C.
- •Active or documented inflammatory bowel disease.
- •Any of the following cardiovascular diseases: a) myocardial infarction, unstable angina pectoris, pulmonary embolism, aortic dissection, deep vein thrombosis, and any arterial thromboembolism event occurred within 6 months before randomization; b) New York Heart Association (NYHA) heart function grade ≥ II heart failure; c) There is a serious arrhythmia that requires drug intervention; Patients with asymptomatic atrial fibrillation with stable ventricular rate were admitted; d)Left ventricular ejection fraction (LVEF) < 50%.
- •NCI CTCAE v5.0 ≥ 2 grade peripheral neuropathy.
- •Not recovered from toxicity of previous antitumor therapy.
- •Pregnant or lactating women.
- •Any condition (such as another serious illness or psychiatric disorder) that the investigator believes may result in a risk for acceptance of the study drug or that would interfere with the evaluation of the study drug or with the safety of the subjects or the interpretation of the study results.
- •Known contraindications to bevacizumab or allergies to any of its components, or the presence of any medical conditions that could affect the safety of bevacizumab administration.
研究组 & 干预措施
Socazolimab+Chemotherapy±Bevacizumab
Experimental
6~8 cycles of Socazolimab (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w.
Followed with Socazolimab (5 mg/kg), Q3w.
干预措施: Socazolimab+cisplatin/carboplatin+paclitaxel+Bevacizumab (Drug)
Placebo+Chemotherapy±Bevacizumab
Placebo Comparator
6~8 cycles of placebo (5 mg/kg) + cisplatin (50 mg/m2) /carboplatin (AUC5) + paclitaxel (175 mg/m2) ± Bevacizumab (15 mg/kg), Q3w.
Followed with placebo (5 mg/kg), Q3w.
干预措施: Placebo+cisplatin/carboplatin+paclitaxel+Bevacizumab (Drug)
结局指标
主要结局
Overall survival
时间窗: From date of randomization to date of death from any cause, assessed up to 100 months.
次要结局
- DoR (assessed by BICR, based on RECIST v1.1)(From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.)
- DCR (assessed by BICR, based on RECIST v1.1)(From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.)
- ORR (assessed by investigators, based on RECIST v1.1)(From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.)
- DCR (assessed by investigators, based on RECIST v1.1)(From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.)
- Safety: adverse events, clinical abnormalties(from written informed concent to 90 days after last dose)
- TTR (assessed by BICR, based on RECIST v1.1)(From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.)
- Immunogenicity(from 30min before first dose to 30 days after last dose)
- Tmax(from 30min before first dose to 30 days after last dose)
- PFS (assessed by BICR, based on RECIST v1.1)(From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.)
- ORR (assessed by BICR, based on RECIST v1.1)(From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.)
- PFS (assessed by investigators, based on RECIST v1.1)(From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.)
- DoR (assessed by investigators, based on RECIST v1.1)(From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.)
- TTR (assessed by investigators, based on RECIST v1.1)(From date of randomization to date of death from any cause or lost of visit, whichever came first, assessed up to 100 months.)
- Cmax(from 30min before first dose to 30 days after last dose)
- T1/2(from 30min before first dose to 30 days after last dose)
- Health-related quality of life (HRQoL)(from screening to end of treatment visit, up to 100 months)
- PD-L1 status(up to 100 months)
研究者
研究点 (5)
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