NCT06976190招募中3 期
A Randomized, Open-label, Multi-center, Phase III Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 446
- 试验地点
- 2
- 主要终点
- Progression Free Survival (PFS) as assessed by BIRC
研究概览
简要总结
This is a randomized, open-label, multi-center, phase III study to evaluate the efficacy and safety, and immunogenicity of MRG003 in combination with pucotenlimab in patients with recurrent or metastatic nasopharyngeal carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to sign the informed consent form and follow the requirements specified in the protocol.
- •Life expectancy ≥ 12 weeks.
- •Patients with histologically and cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) who have failed at least one line of prior systemic therapy.
- •Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •The score of ECOG for performance status is 0 or
- •No severe cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%.
- •Organ functions and coagulation function must meet the basic requirements.
- •Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
排除标准
- •History of hypersensitivity to any component of the investigational product.
- •Received systemic chemotherapy, targeted therapy, biological therapy or immunotherapy for anti-tumor purpose, or major surgery within 3 weeks prior to the first dose of study treatment.
- •Received anti-infection therapy within 2 weeks prior to the randomization
- •Prior treatment with MMAE/MMAF ADC drugs
- •Central nervous system metastasis.
- •Poorly controlled systemic diseases
- •Patients with poorly controlled heart diseases
- •Poorly controlled pleural and peritoneal effusion or pericardial effusion
- •≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment
- •Patients with prior ≥Grade 3 immuno-related adverse events (irAEs)
- •Any clinically significant arteriovenous bleeding, pulmonary embolism, or deep venous thrombosis occurred within 3 months
- •Received allogeneic tissue/solid organ transplantation.
- •Inoculate live vaccine within 30 days before the first dose.
- •Patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 180 days after the last dose of study treatment.
- •History of other primary malignant tumor diseases.
- •Other situations that are not suitable to participate a clinical trial per investigator's judgement
研究组 & 干预措施
MRG003 + Pucotenlimab
Experimental
干预措施: MRG003 + Pucotenlimab (Drug)
Chemotherapy Arm
Active Comparator
Mono-chemotherapy as selected by investigator
干预措施: Gemcitabine, Docetaxel, or Capecitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS) as assessed by BIRC
时间窗: Baseline to study completion (up to 33 months)
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Overall Survival (OS)
时间窗: Baseline to study completion (up to 48 months)
OS is defined as the duration from the start of treatment to death of any cause.
次要结局
- Serious Adverse Events (SAEs)(Baseline to 30 days after the last dose of study treatment)
- Adverse Events (AEs)(Baseline to 30 days after the last dose of study treatment)
- Objective Response Rate (ORR)(Baseline to study completion (up to 48 months))
- Immunogenicity (ADA)(Baseline to 14 days after the last dose.)
- Disease Control Rate (DCR)(Baseline to study completion (up to 48 months))
- Progression Free Survival (PFS) as assessed by investigator(Baseline to study completion (up to 33 months))
研究者
研究点 (2)
Loading locations...
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