ENVASARC: A Pivotal Trial Of Envafolimab, And Envafolimab In Combination With Ipilimumab, In Patients With Advanced Or Metastatic Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma Who Have Progressed On Prior Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 207
- 试验地点
- 30
- 主要终点
- Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review
研究概览
简要总结
This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.
详细描述
This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally advanced, unresectable or metastatic UPS/MFS who have progressed on one or two lines of chemotherapy. Patients were previously assigned at random into one of two cohorts: cohort A of 80 patients who received single agent envafolimab (300 mg every 3 weeks by subcutaneous (SC) injection) or cohort B of 80 patients who received envafolimab (300 mg every 3 weeks by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses). Following amendment #3, patients will be assigned at random into one of two cohorts: cohort C of 80 patients who will receive single agent envafolimab (600 mg every 3 weeks by subcutaneous (SC) injection) or cohort D of 80 patients who will receive envafolimab 600 mg every 3 weeks by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses). Following amendment #4, enrollment into cohort D was terminated and no further interim analyses will be conducted on this cohort.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed locally advanced or metastatic undifferentiated pleomorphic sarcoma (UPS) or grade ≥ 2 myxofibrosarcoma (MFS)
- •Documented progression following systemic chemotherapy
- •At least one measurable lesion
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •Adequate hematologic and organ function
排除标准
- •More than two prior lines of chemotherapy for UPS/MFS
- •Prior immune checkpoint inhibitor or immunomodulatory therapy
- •Active autoimmune disease that has required systemic treatment
- •Major surgery within 4 weeks of dosing of investigational agent
- •Active additional malignancy
- •Pericardial effusion, pleural effusion, or ascites
- •Central nervous system metastases and/or carcinomatous meningitis
- •Active hepatitis or cirrhosis
- •Interstitial lung disease
- •Unwilling to apply highly effective contraception during the study
- •Other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study
研究组 & 干预措施
Cohort A
Patients treated with 300 mg of single agent envafolimab every three weeks
干预措施: Envafolimab (Biological)
Cohort B
Patients treated with envafolimab in combination with ipilimumab. Envafolimab will be given at 300 mg every three weeks. Ipilimumab will be given at 1 mg/kg every three weeks for a total of four doses.
干预措施: Envafolimab (Biological)
Cohort B
Patients treated with envafolimab in combination with ipilimumab. Envafolimab will be given at 300 mg every three weeks. Ipilimumab will be given at 1 mg/kg every three weeks for a total of four doses.
干预措施: Ipilimumab (Drug)
Cohort C
Patients treated with 600 mg of single agent envafolimab every three weeks
干预措施: Envafolimab (Biological)
Cohort D
Patients treated with envafolimab in combination with ipilimumab. Envafolimab will be given at 600 mg every three weeks. Ipilimumab will be given at 1 mg/kg every three weeks for a total of four doses.
干预措施: Envafolimab (Biological)
Cohort D
Patients treated with envafolimab in combination with ipilimumab. Envafolimab will be given at 600 mg every three weeks. Ipilimumab will be given at 1 mg/kg every three weeks for a total of four doses.
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review
时间窗: 40 months
次要结局
- Duration of response (DR) assessed by blinded independent central review(40 months)
- Disease control rate (DCR) assessed by blinded independent central review(40 months)
- Overall survival (OS)(40 months)
- Characterize ipilimumab PK in patients given ipilimumab with envafolimab(40 months)
- Characterize envafolimab pharmacokinetics (PK) in patients receiving envafolimab as a single agent and in combination with ipilimumab(40 months)
- Progression free survival (PFS) assessed by blinded independent central review(40 months)
- Characterize the immunogenicity of envafolimab and ipilimumab(40 months)
- Objective response rate (ORR) by investigator assessment(40 months)
- Progression free survival (PFS) by investigator assessment(40 months)