A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and Non-MSI-H Colon Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 385
- 试验地点
- 32
- 主要终点
- Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
研究概览
简要总结
The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Histologically confirmed recurrent or metastatic colorectal cancer
- •Measurable disease per RECIST v1.1
- •Microsatellite instability expression detected by an accredited laboratory
- •Participants enrolled into the C3 Cohort must have not had treatment for their metastatic disease
排除标准
- •Active brain metastases or leptomeningeal metastases are not allowed
- •Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- •Prior malignancy active within the previous 3 years except for locally curable cancers
- •Participants with active, known or suspected autoimmune disease
- •Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Nivolumab Monotherapy
干预措施: Nivolumab (Drug)
Nivolumab + Ipilimumab
干预措施: Ipilimumab (Drug)
Nivolumab + Ipilimumab
干预措施: Nivolumab (Drug)
Nivolumab + Ipilimumab Cohort C3
干预措施: Ipilimumab (Drug)
Nivolumab + Ipilimumab Cohort C3
干预措施: Nivolumab (Drug)
Nivolumab + Ipilimumab + Cobimetinib Cohort C4
干预措施: Ipilimumab (Drug)
Nivolumab + Ipilimumab + Cobimetinib Cohort C4
干预措施: Nivolumab (Drug)
Nivolumab + Ipilimumab + Cobimetinib Cohort C4
干预措施: Cobimetinib (Drug)
Nivolumab + BMS-986016 Cohort C5
干预措施: Nivolumab (Drug)
Nivolumab + BMS-986016 Cohort C5
干预措施: BMS-986016 (Drug)
Nivolumab + Daratumumab Cohort C6
干预措施: Nivolumab (Drug)
Nivolumab + Daratumumab Cohort C6
干预措施: Daratumumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
时间窗: From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months)
Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \\\[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\\\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Independent Review Committee (IRC)(From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months))