A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 213
- 主要终点
- PFS by IRRC based on RECIST v1.1
研究概览
简要总结
A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)
详细描述
This trial will be performed as a phase 3, randomized, active-controlled, double-blind, multiregional study comparing Ivonescimab in combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in combination with mFOLFOX6 in patients with metastatic colorectal cancer who have not previously received systemic therapy for metastatic disease. Approximately 600 patients will be randomly assigned to the 2 treatment groups in a 1:1 ratio. Each enrolled subject will receive an intravenous infusion of the Ivonescimab/Bevacizumab Plus mFOLFOX6 (Q2W, up to 8 cycles) in treatment periods per the randomization schedule. Afterward, Ivonescimab/ Bevacizumab Plus 5-Fluorouracil and Leucovorin will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) for up to 2 years.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •ECOG performance status score of 0 or 1
- •Expected life expectancy ≥ 6 months
- •Patients with histologically or cytologically confirmed metastatic CRC
- •No prior systemic therapy for metastatic CRC
- •At least 1 measurable noncerebral lesion
排除标准
- •Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease
- •Known BRAF V600E mutant status
- •Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction
- •Ascites requiring paracentesis within last 30 days
- •Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer
- •Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
- •Resectable disease
研究组 & 干预措施
Arm A: Ivonescimab in combination with mFOLFOX6
Subjects will receive Ivonescimab Plus mFOLFOX6 via intravenous infusion (IV) Q2W, up to 8 cycles. Afterward, Ivonescimab plus Leucovorin and 5-FU will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) up to 2 years.
干预措施: Drug: Ivonescimab Injection (Drug)
Arm B: Bevacizumab in combination with mFOLFOX6
Subjects will receive bevacizumab Plus mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) via intravenous infusion (IV) Q2W, up to 8 cycles in treatment periods per the randomization schedule. Afterward, bevacizumab Plus 5-FU and Leucovorin will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) up to 2 years.
干预措施: Drug: Bevacizumab Injection (Drug)
结局指标
主要结局
PFS by IRRC based on RECIST v1.1
时间窗: Up to approximately 2.5 years
Progression-free survival (PFS) assessed by IRRC per RECIST v1.1
次要结局
- Overall Survival (OS) in the population(Up to approximately 4 years)
- ORR(Up to approximately 2.5 years)
- Adverse Events (AE)(Up to approximately 4 years)
- DoR(up to approximately 2.5 years)