Precision Promise Platform Trial for Metastatic Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 25
- 主要终点
- Overall Survival
研究概览
简要总结
Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer.
Primary Objectives
- To compare each investigational arm versus standard of care (SOC) for superiority in overall survival in first and/or second line metastatic ductal adenocarcinoma (metastatic pancreatic cancer) participants and determine which, if any, participants benefit from each investigational arm.
Secondary Objectives
- To determine short and long-term safety signals of each investigational arm in metastatic pancreatic cancer participants vs. SOC.
- To determine progression-free survival (PFS) for each investigational arm vs. SOC.
- To determine rates of overall response, CR, and PR; duration of overall response, CR or PR (whichever occurs first).
- To determine rates of clinical benefit; duration of clinical benefit.
详细描述
Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer. The goal of the platform is to find effective therapies for pancreatic cancer. The platform will test multiple investigational drugs and combinations compared to standard of care therapy in first and second line metastatic participants. Bayesian response-adaptive randomization will be used to assign participants to arms based on their performance in subtypes of the disease. The primary endpoint is overall survival.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gemcitabine combined with nab-paclitaxel
Arm is closed to recruitment.
The following are recommended parameters for infusion timing and sequence, although institutional variation in the administration of the regimen are permitted as long as drug dosing and modification guidelines are followed.
干预措施: Gemcitabine combined with nab-paclitaxel (Drug)
mFOLFIRINOX
Arm is closed to recruitment.
Oxaliplatin 85 mg/m2, Leucovorin 400 mg/m2, Irinotecan 150 mg/m2, 5-Fluorouracil 2400 mg/m2 46-48 hour infusion
干预措施: Dose -mFOLFIRINOX (Drug)
pamrevlumab (FibroGen)
Arm is closed to recruitment.
Experimental: Pamrevlumab in combination with gemcitabine/nab-paclitaxel.
Participants enrolled to this treatment arm will receive treatment with pamrevlumab in combination with gemcitabine and nab-paclitaxel.
Gemcitabine and nab-paclitaxel are FDA approved therapies for metastatic pancreatic cancer and will be supplied or obtained according to local clinical study agreements and in accordance with local guidelines.
干预措施: Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel (Drug)
Canakinumab and Spartalizumab
Arm is closed to recruitment.
Canakinumab and Spartalizumab in Combination with Nab-Paclitaxel and Gemcitabine.
Participants enrolled to this treatment arm will receive treatment with Canakinumab and Spartalizumab in combination with nab-paclitaxel and gemcitabine.
干预措施: Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine (Drug)
结局指标
主要结局
Overall Survival
时间窗: 0 weeks
Overall survival (OS) is defined from the time of initiation of treatment until death due to any cause. Participants still alive at the time of an analysis will be considered censored at their date of last contact.
次要结局
- Progression free survival (PFS)(From initiation of therapy to clinically determined disease progression or death due to any cause, whichever came first, assessed up to 24 months.)
- Performance Status(From screening through study completion, an average of 2 years.)
- Overall Response Rate (ORR)(From initiation of treatment to clinically determined tumor size reduction for a minimum of 4 weeks)
- Duration of Overall Response Rate (ORR)(From date of first occurrence of a documented objective response to date of clinically determined disease progression or death due to any cause, whichever came first, assessed up to 24 months.)
- Duration of Clinical Benefit(From screening through last dose of therapy, assessed up to 24 months.)