2024-516004-42-01已完成2 期
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
- 入组人数
- 143
- 试验地点
- 4
- 主要终点
- Objective response rate (ORR) in all MSI-High and non-MSI-High subjects as determined by Investigators
研究概览
简要总结
The purpose of this study is to examine if Nivolumab alone, Nivolumab in combination with Ipilimumab, Nivolumab in combination with anti-LAG3 agent (BMS-986016), or Nivolumab in combination with daratumumab will demonstrate a meaningful objective response rate in patients with recurrent and metastatic colon cancer who also have a specific biomarker in their tumors.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Men and women ≥ 18 years of age
- •ECOG performance status 0 to
- •Histologically confirmed colorectal cancer.
- •Measurable disease by CT or MRI.
- •Testing for MSI Status a. Subjects with microsatellite instability high (MSI-H) tumors will enroll in the MSI-H Cohort (mStage and cStage groups), the C3 Cohort, and the C5 Cohort. b. Subjects with phenotypes that are non-microsatellite instability high (non-MSI-H) will enroll in the non- MSI-H Safety Cohort and the C6, C4 Cohorts.
- •Adequate organ function as defined by study-specific laboratory tests
- •Must use acceptable form of birth control throughout the study. After the final dose of study drug, an acceptable form of birth control must be used for 23 weeks for women of childbearing potential (WOCBP) and 31 weeks for men who are sexually active with WOCBP.
- •Signed informed consent
- •Willing and able to comply with study procedures -Subjects 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-PD-1, anti-PD-L1, anti-PD-L2, anti-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
- •Subjects with active, known or suspected autoimmune disease.
- •Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
结局指标
主要结局
Objective response rate (ORR) in all MSI-High and non-MSI-High subjects as determined by Investigators
Objective response rate (ORR) in all MSI-High and non-MSI-High subjects as determined by Investigators
次要结局
- ORR in all MSI-H and non-MSI-H subjects based on IRRC
研究者
GSM-CT Representative
Scientific
Bristol Myers Squibb International Corporation
研究点 (4)
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