NCT07797153尚未招募3 期
A Randomized, Controlled, Open-Label, Multi-center, Phase III Study of JSKN033 Versus Investigator's Choice of Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer Who Have Failed Platinum-Based Chemotherapy and PD-1/L1 Inhibitor Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 368
- 试验地点
- 2
- 主要终点
- Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1
研究概览
简要总结
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN033 versus investigator's choice of chemotherapy in patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy and PD-1/L1 inhibitor therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation and written informed consent.
- •≥18 years;
- •ECOG performance status score of 0 or
- •Expected survival of more than 3 months.
- •Histologically or cytologically confirmed recurrent or metastatic cervical cancer.
- •At least one measurable lesion in the baseline.
- •Adequate organ function.
- •Provide primary or metastatic tumor samples.
- •Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures.
排除标准
- •Tumors with histologic components other than squamous-cell carcinoma and adenocarcinoma.
- •Other-malignancy diagnosed within 3 years prior to randomization.
- •Active central nervous system metastases.
- •Baseline imaging showing tumor invasion, compression of, or arising from vital organs.
- •Prior treatment with topoisomerase I inhibitors or topoisomerase I inhibitor based antibody-drug conjugates.
- •Inadequate washout from prior therapy before randomization.
- •Risk factors for ILD.
- •Significant cardiovascular or cerebrovascular disease.
- •Clinically-significant gastrointestinal abnormalities.
- •History of genital-tract fistula.
- •Uncontrolled pleural effusion.
- •Active or prior autoimmune-disease .
- •Uncontrolled infection.
- •Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤
- •History of ≥Grade 3 immune-related adverse events irAEs.
- •Previous allogeneic bone-marrow or solid organ transplantation.
- •Allergic reactions or hypersensitivity to any component of JSKN033 or the assigned chemotherapy agent.
- •Pregnant or lactating female participants, or women planning pregnancy during the study.
- •Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.
研究组 & 干预措施
Active Comparator
Active Comparator
Investigator's Choice of Chemotherapy: Docetaxel, Topotecan, Gemcitabine or Pemetrexed.
干预措施: Docetaxel (Drug)
Experimental
Experimental
JSKN033
干预措施: JSKN033 (Drug)
Active Comparator
Active Comparator
Investigator's Choice of Chemotherapy: Docetaxel, Topotecan, Gemcitabine or Pemetrexed.
干预措施: Topotecan (Drug)
Active Comparator
Active Comparator
Investigator's Choice of Chemotherapy: Docetaxel, Topotecan, Gemcitabine or Pemetrexed.
干预措施: Gemcitabine (GEM) (Drug)
Active Comparator
Active Comparator
Investigator's Choice of Chemotherapy: Docetaxel, Topotecan, Gemcitabine or Pemetrexed.
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1
时间窗: Up to approximately 27 months
PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
Overall Survival (OS)
时间窗: Up to approximately 27 months
OS was defined as the time from randomization until the date of death from any cause
次要结局
- Plasma Concentration of Envotumab(Up to approximately 27 months)
- Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1(Up to approximately 27 months)
- Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1(Up to approximately 27 months)
- Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1(Up to approximately 27 months)
- PFS evaluated by the Investigator as per RECIST 1.1(Up to approximately 27 months)
- ORR evaluated by the Investigator as per RECIST 1.1(Up to approximately 27 months)
- DoR evaluated by the Investigator as per RECIST 1.1(Up to approximately 27 months)
- DCR evaluated by the Investigator as per RECIST 1.1(Up to approximately 27 months)
- Number and Severity of Treatment-emergent Adverse Events (TEAEs)(Up to approximately 27 months)
- Patient-reported Quality of Life-European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)(Up to approximately 27 months)
- Patient-reported Quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer 24 (EORTC QLQ-CX24)(Up to approximately 27 months)
- Plasma Concentrations of JSKN003(Up to approximately 27 months)
- Plasma Concentration of Total Antibody(Up to approximately 27 months)
- Plasma Concentration of Free Payload(Up to approximately 27 months)
- Incidence and Titer of Anti-Drug Antibodies(Up to approximately 27 months)
- Incidence and Titer of Neutralizing Antibodies(Up to approximately 27 months)
研究者
研究点 (2)
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