A Clinical Study to Evaluate the Safety and Efficacy of Iparomlimab/Tuvonralimab Injection (QL1706, a Bifunctional Mabpair Product of Anti-PD-1 and Anti-CTLA-4 Antibodies) in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 2-year PFS rate
研究概览
简要总结
This study is a clinical study to evaluate the safety and efficacy of Iparomlimab/Tuvonralimab Injection (QL1706, a Bifunctional Mabpair Product of Anti-PD-1 and Anti-CTLA-4 Antibodies) in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- •Cervical cancer of other histology (e.g., neuroendocrine carcinoma, sarcoma)
- •Evidence of distant metastasis
- •Prior total hysterectomy (subtotal or cervical-sparing surgery allowed)
- •Unable or unwilling to receive brachytherapy
- •Prior treatment with immune checkpoint inhibitors or other tumor immunotherapy
- •Systemic corticosteroid (>10 mg/day prednisone or equivalent) or immunosuppressive therapy within 2 weeks (exceptions: inhaled/topical ≤10 mg/day, physiologic replacement ≤10 mg/day, premedication for hypersensitivity).
- •Immunomodulatory drugs within 2 weeks (e.g., thymosin, interferons, IL-2)
研究组 & 干预措施
Arm 1
Participants will receive 1 cycle of Iparomlimab/Tuvonralimab induction therapy followed by concurrent chemotherapy and radiotherapy. Iparomlimab/Tuvonralimab will be administered by intravenous infusion at a dose of 5 mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator or withdraw consent or have completed 2 years of Iparomlimab/Tuvonralimab treatment.
干预措施: Iparomlimab/Tuvonralimab (Drug)
Arm 1
Participants will receive 1 cycle of Iparomlimab/Tuvonralimab induction therapy followed by concurrent chemotherapy and radiotherapy. Iparomlimab/Tuvonralimab will be administered by intravenous infusion at a dose of 5 mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator or withdraw consent or have completed 2 years of Iparomlimab/Tuvonralimab treatment.
干预措施: Cisplatin (Drug)
Arm 1
Participants will receive 1 cycle of Iparomlimab/Tuvonralimab induction therapy followed by concurrent chemotherapy and radiotherapy. Iparomlimab/Tuvonralimab will be administered by intravenous infusion at a dose of 5 mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator or withdraw consent or have completed 2 years of Iparomlimab/Tuvonralimab treatment.
干预措施: Brachytherapy and External Beam Radiotherapy (Radiation)
Arm 2
Participants will receive Iparomlimab/Tuvonralimab combined with concurrent chemotherapy and radiotherapy.
Iparomlimab/Tuvonralimab will be administered by intravenous infusion at a dose of 5 mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator or withdraw consent or have completed 2 years of Iparomlimab/Tuvonralimab treatment.
干预措施: Iparomlimab/Tuvonralimab (Drug)
Arm 2
Participants will receive Iparomlimab/Tuvonralimab combined with concurrent chemotherapy and radiotherapy.
Iparomlimab/Tuvonralimab will be administered by intravenous infusion at a dose of 5 mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator or withdraw consent or have completed 2 years of Iparomlimab/Tuvonralimab treatment.
干预措施: Cisplatin (Drug)
Arm 2
Participants will receive Iparomlimab/Tuvonralimab combined with concurrent chemotherapy and radiotherapy.
Iparomlimab/Tuvonralimab will be administered by intravenous infusion at a dose of 5 mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator or withdraw consent or have completed 2 years of Iparomlimab/Tuvonralimab treatment.
干预措施: Brachytherapy and External Beam Radiotherapy (Radiation)
结局指标
主要结局
2-year PFS rate
时间窗: up to 24 months
次要结局
- ORR(Up to approximately 24 months)
- PFS(Up to approximately 24 months)
- DoR(Up to approximately 24 months)
- OS(Up to approximately 36 months)
- DCR(Up to approximately 24 months)
研究者
LING YING WU
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences