A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 286
- 主要终点
- Progression-Free Survival (PFS)
概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.
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
- •Stage IV colorectal adenocarcinoma not amenable to curative resection.
- •No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment.
- •Measurable disease per RECIST v1.
- •ECOG performance status of 0 or
- •Adequate organ function determined by laboratory results.
排除标准
- •MSI-H/dMMR per historical data in the medical record.
- •BRAF V600E mutation per historical data in the medical record.
- •Untreated and/or progressing CNS metastases.
- •History of other malignancy within 2 years.
- •Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years.
- •Active autoimmune disease that has required systemic treatment in the past 2 years.
- •Significant concurrent and/or uncontrolled medical condition.
- •History of organ transplant, including allogeneic stem cell transplantation.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
INCA33890
INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
干预措施: FOLFOX (Drug)
Placebo
Placebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
干预措施: Placebo (Drug)
Placebo
Placebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
干预措施: FOLFOX (Drug)
INCA33890
INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
干预措施: Bevacizumab (Drug)
Placebo
Placebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
干预措施: Bevacizumab (Drug)
INCA33890
INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
干预措施: INCA33890 (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 3 years
Defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or death due to any cause.
次要结局
- Overall Survival (OS)(Up to 4 years)
- Objective response(Up to 3 years)
- Duration of Response (DOR)(Up to 3 years)
- TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatmen(Up to 4 years)
- Treatment Emergent Adverse Events (TEAEs)(Up to 4 years)
- Change from baseline in EQ-5D-5L score at protocol-defined visits(Up to 4 years)
- Change from baseline in Functional Assessment of Cancer Therapy Colorectal Symptom Index (FCSI)-9 score at protocol-defined visits(Up to 4 years)
- Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at protocol-defined visits(Up to 4 years)