EUCTR2018-000040-26-NO进行中（未招募）1 期
A Phase 3 Randomized Clinical Trial of Nivolumab alone, Nivolumab inCombination with Ipilimumab, or an Investigator's Choice Chemotherapy inParticipants with Microsatellite Instability High (MSI-H) or MismatchRepair Deficient (dMMR) Metastatic Colorectal Cancer - CheckMate 8HW: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 8HW
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 974
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Histologically confirmed recurrent or metastatic colorectal cancer
- •(CRC) irrespective of prior treatment history with chemotherapy and/or
- •targeted agents not
- •amenable to surgery (Applicable only during Part 1 enrollment of the
- •-Histologically confirmed recurrent or metastatic CRC with no prior
- •treatment history with chemotherapy and/or targeted agents for
- •metastatic disease and not
- •amenable to surgery (Applicable during Part 2 enrollment of the study)
- •- Known tumor MSI-H or dMMR status per local standard of practice
- •- Eastern cooperative oncology group (ECOG) performance status lower
- •than or equal to 1
- •- Other protocol-defined inclusion/exclusion criteria apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 682
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 292
排除标准
- •- Participants with an active, known or suspected autoimmune disease
- •- History of interstitial lung disease or pneumonitis
- •- Known history of positive test for human immunodeficiency virus (HIV)
- •or known acquired immunodeficiency syndrome (AIDS)
- •- Other protocol-defined inclusion/exclusion criteria apply
研究者
相似试验
进行中（未招募）
1 期
ivo versus Nivo/Ipi or versus other chemotherapies to treat colorectal cancerMicrosatellite Instability High (MSI-H) or Mismatch Repair DeficientMetastatic Colorectal Cancer (dMMR)MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-000040-26-BEBristol-Myers Squibb International Corporation974
招募中
3 期
A Phase 3 Randomized Clinical Trial of Nivolumab alone, Nivolumab in Combination with Ipilimumab, or an Investigator's Choice Chemotherapy in Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal CancerMetastatic Colorectal Cancer10017990NL-OMON56215Bristol-Myers Squibb28
进行中（未招募）
1 期
ivo versus Nivo/Ipi or versus other chemotherapies to treat colorectal cancerMicrosatellite Instability High (MSI-H) or Mismatch Repair DeficientMetastatic Colorectal Cancer (dMMR)MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864EUCTR2018-000040-26-ATBristol-Myers Squibb International Corporation974
进行中（未招募）
1 期
ivo versus Nivo/Ipi or versus other chemotherapies to treat colorectal cancerMicrosatellite Instability High (MSI-H) or Mismatch Repair DeficientMetastatic Colorectal Cancer (dMMR)MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864EUCTR2018-000040-26-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO974
进行中（未招募）
1 期
ivo versus Nivo/Ipi or versus other chemotherapies to treat colorectal cancerMicrosatellite Instability High (MSI-H) or Mismatch Repair DeficientMetastatic Colorectal Cancer (dMMR)MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-000040-26-NLBristol-Myers Squibb International Corporation974