A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination With Tremelimumab in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
研究概览
简要总结
A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.
详细描述
This is a Phase II, open-label, multi-center study to determine the efficacy and safety of MEDI4736 evaluated as single agent or in combination with tremelimumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) whose disease has progressed on fluoropyrimidine containing or gemcitabine-containing first-line chemotherapy.This study will consist of Part A, lead-in, as well as a possible expansion Part B.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen
- •Eastern Cooperative Oncology Group 0 or 1
- •At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) scan and that is suitable for accurate repeated measurements
排除标准
- •Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy for cancer treatment.
- •History of leptomeningeal carcinomatosis
- •Ascites requiring intervention
- •Brain metastases or spinal cord compression.
研究组 & 干预措施
MEDI4736 monotherapy
MEDI4736 via IV infusion.
干预措施: MEDI4736 monotherapy (Drug)
tremelimumab+MEDI4736
MEDI4736+tremelimumab via IV infusion.
干预措施: tremelimumab+MEDI4736 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
时间窗: From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)
ORR was defined as the percentage of patients with at least one visit response of confirmed complete response (CR) or partial response (PR). CR was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have had reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, taking as reference the baseline sum of diameters. A confirmed response meant that a response of CR/PR was recorded at 1 visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit and not less than 4 weeks after the visit when response was first observed with no evidence of progression between the initial and CR/PR confirmation visits. Results are reported as percentage of patients with a confirmed response and percentage of patients with confirmed or unconfirmed responses (i.e., including single visit responses).
次要结局
- PFS Rate at 3 Months and at 6 Months(From date of first infusion until confirmed disease progression or death (up to 3 months and 6 months))
- Overall Survival (OS)(From date of first infusion until death (up to approximately 18 months for the data analysis cut-off))
- Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1(From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off))
- Survival Status, Presented as OS Rate, at 6 Months and at 12 Months(From date of first infusion until death (up to 6 months and 12 months))
- Disease Control Rate (DCR) Using Investigator Assessments According to RECIST 1.1(From date of first infusion until confirmed disease progression or death (up to 3 months, 6 months and 12 months))
- PK of Tremelimumab(Blood samples were collected pre-dose on Day 1 (Week 0), Week 4 and Week 12, post-dose on Day 1 and Week 12, and additionally at 3 months after the last dose (follow-up).)
- Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736)(Immunogenicity samples were collected on Day 1 (Week 0), Week 4, Week 12 and Week 24, and additionally at 3 months and 6 months after the last dose (follow-up).)
- Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1(From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off))
- Pharmacokinetics (PK) of Durvalumab (MEDI4736)(Blood samples were collected pre-dose on Day 1 (Week 0), Week 4, Week 12 and Week 24, post-dose on Day 1, Week 12 and Week 24, and additionally at 3 months after the last dose (follow-up).)
- Presence of ADAs for Tremelimumab(Immunogenicity samples were collected on Day 1 (Week 0), Week 4 and Week 12, and additionally at 3 months and 6 months after the last dose (follow-up).)