A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 588
- 试验地点
- 212
- 主要终点
- Overall Survival (OS)
概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).
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
- Double (Participant, Investigator)
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 with a KRAS G12D mutation
- •No prior systemic treatment in the metastatic setting
- •ECOG Performance status 0-1
- •Adequate organ function
排除标准
- •Prior treatment with any KRAS inhibitor
- •Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug
- •Known active CNS metastases
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
INCB161734 plus chemotherapy
INCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
干预措施: Investigator's choice of chemotherapy (Drug)
Placebo plus chemotherapy
Placebo at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
干预措施: Placebo (Drug)
Placebo plus chemotherapy
Placebo at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
干预措施: Investigator's choice of chemotherapy (Drug)
INCB161734 plus chemotherapy
INCB161734 at the protocol-defined dose with investigator's choice of chemotherapy (mFOLFIRINOX or GemNabP) in accordance with the protocol-defined requirements.
干预措施: INCB161734 (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 3 years
Defined as the time from the date of randomization to the date of death due to any cause.
Progression-free survival (PFS) by BICR
时间窗: Up to approximately 2 years
Defined as the time from the date of randomization to the date of the first documented progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause.
Objective Response by BICR
时间窗: Up to approximately 2 years
Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1.
次要结局
- Disease control by BICR(Up to approximately 2 years)
- Duration of Response (DOR) by BICR(Up to approximately 2 years)
- Progression-Free Survival (PFS) by investigator assessment(Up to approximately 2 years)
- Objective response by investigator assessment(Up to approximately 2 years)
- DOR by investigator assessment(Up to approximately 2 years)
- Disease control by investigator assessment(Up to approximately 2 years)
- Treatment Emergent Adverse Events (TEAEs)(Up to approximately 2 years and 30 days)
- TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment(Up to approximately 2 years and 30 days)
- Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit(Up to approximately 2 years)
- Change from baseline in EORTC QLQ-PAN26 score at each postbaseline visit(Up to approximately 2 years)
- Change from baseline in EQ-5D-5L score at each postbaseline visit(Up to approximately 2 years)