The Phase Ib/II, Open-label, Multicenter Study of IBI310 (Anti-CTLA4 mAb) in Combination With Sintilimab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma That Failed Prior Anti-PD-1/PD-L1 Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR(Objective response rate)
研究概览
简要总结
This is a phase 1b/II, open label, multicenter study of IBI310 (Anti-CTLA4 mAb) in combination with Sintilimab in patients with recurrent/metastatic Nasopharyngeal Carcinoma that failed prior Anti-PD-1/PD-L1 therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years;
- •ECOG 0 ~ 1;
- •Histologically/cytologically confirmed R/M NPC;
- •Failed to prior Anti-PD-1 resistance;
- •Adequate organ and bone marrow function;
- •Expected survival ≥12 weeks;
- •Female subjects of childbearing age or male patients whose sex partners are women of childbearing age should take effective contraceptive measures throughout the treatment period and within 6 months after the last administration;
- •Subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol.
- •At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).
排除标准
- •Had tumors other than NPC within the past 5 years.
- •Had allogeneic organ or stem cell transplantation.
- •The presence of uncontrolled life-threatening illness
- •Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- •Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
- •HIV positive.
- •Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
- •Severe, uncontrolled medical conditions and infections.
- •At the same time using other test drugs or in other clinical trials.
- •Refusal or inability to sign informed consent to participate in the trial.
- •Other treatment contraindications.
- •Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
- •Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
- •Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.
研究组 & 干预措施
Sintilimab and IBI310 (single arm)
The test group will be treated with either (IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
干预措施: Sintilimab (Drug)
Sintilimab and IBI310 (single arm)
The test group will be treated with either (IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
干预措施: IBI310 (Drug)
结局指标
主要结局
ORR(Objective response rate)
时间窗: Up to 2 years
Investigator evaluated ORR per RECIST V1.1
次要结局
- OS (Overall Survival)(Up to 2 years)
- DOR(Duration of Response)(Up to 2 years)
- PFS (Progress Free Survival)(Up to 2 years)
- DCR(Disease control rate)(Up to 2 years)
- ADAs(Up to 2 years)
- TEAE(Treatment Emergent Adverse Event)/SAE(Serious Adverse Event)(Up to 2 years)
- Changes of Quality of life, according to EORTC QLQ-C30(Up to 2 years)
- TTR(Time to progress)(Up to 2 years)
- Changes of Quality of life, according to EORTC QLQ-H&N35(Up to 2 years)