An Open-Label Exploratory Phase 2/3 Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 49
- 主要终点
- Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
研究概览
简要总结
This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (mCRC).
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 confirmed metastatic colorectal cancer, not amenable to curative resection
- •No prior chemotherapy for metastatic colorectal cancer
- •ECOG Performance Status of 0-1
- •Ability to provide adequate tissue sample
排除标准
- •Patients with clinically relevant medical history, including autoimmune disease, cardiovascular disease, hepatic disease or bleeding disorders
- •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm B
SOC
干预措施: Leucovorin (Drug)
Arm B
SOC
干预措施: Fluorouracil (Drug)
Arm A
Nivo + SOC
干预措施: Nivolumab (Biological)
Arm A
Nivo + SOC
干预措施: Oxaliplatin (Drug)
Arm A
Nivo + SOC
干预措施: Leucovorin (Drug)
Arm A
Nivo + SOC
干预措施: Fluorouracil (Drug)
Arm A
Nivo + SOC
干预措施: Bevacizumab (Drug)
Arm B
SOC
干预措施: Oxaliplatin (Drug)
Arm B
SOC
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
时间窗: From randomization to up to the date of the first documented progression (up to 16 months)
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression per BICR and who did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression per BICR will be censored at the date of the last tumor assessment on or prior to initiation of the subsequent anticancer therapy, if any. Participants who die without a reported prior progression per BICR will be considered to have progressed on the date of death. Participants who did not have any baseline or post baseline tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date.
次要结局
- Time to Objective Response Per Blinded Independent Central Review (BICR)(From the randomization date up to the date of the first confirmed CR or PR (up to approximately 44 months))
- Overall Survival (OS)(From the date of randomization up to the date of death (up to 44 months))
- Objective Response Rate (ORR) Per Investigator Assessment(From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months))
- Duration of Response (DoR) Per Blinded Independent Central Review (BICR)(From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months))
- Time to Objective Response Per Investigator Assessment(From the randomization date up to the date of the first confirmed CR or PR (up to 44 months))
- Number of Participants With Adverse Events (AEs)(From first dose to 30 days post last dose (up to 45 months))
- Number of Participants With Laboratory Abnormalities in Specific Liver Tests(From first dose up to 30 days post last dose (up to 45 months))
- Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests(From first dose up to 30 days post last dose (up to 45 months))
- Disease Control Rate (DCR) Per Blinded Independent Central Review (BICR)(From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months))
- Disease Control Rate (DCR) Per Investigator(From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months))
- Progression Free Survival (PFS) Per Investigator Assessment(From randomization up to the date of the first documented progression (up to approximately 44 months))
- Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)(From the date of randomization up to the date of objectively documented progression or the date of subsequent anticancer therapy, whichever occurs first (up to approximately 44 months))
- Duration of Response (DoR) Per Investigator Assessment(From randomization up to the date of the first documented progression (per RECIST 1.1) or death due to any cause, whichever occurs first (up to 44 months))
- Number of Participants With Serious Adverse Events (SAEs)(From first dose to 30 days post last dose (up to 45 months))
- Number of Participants Experiencing Death(From first dose up to 6 weeks post last dose (up to 46 months))