EUCTR2017-001830-24-IT进行中（未招募）1 期
A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers - CheckMate 9N9: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9N9
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
- 405
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18, signed written informed consent
- •Histological or cytological confirmed diagnosis of previously treated mCRC with adenocarcinoma histology and in Stage IV per AJCC
- •Confirmed microsatellite status: only participants with pMMR/MSS mCRC are eligible
- •Verified KRAS, NRAS (extended RAS) and BRAF mutation status: BRAF V600 mutant are not eligible
- •Measurable disease per RECIST 1.1
- •Provide Tumor Tissue sample at screening.
- •ECOG Performance Status of 0-1
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 107
排除标准
- •1) Target Disease Exceptions
- •a) Participants with BRAF V600 mutant colorectal cancer are NOT eligible for this study in Part 1, 1A, and 1B only.
- •2) Medical History and Concurrent Diseases
- •a) Any serious or uncontrolled medical disorder.
- •b) Prior malignancy active within the previous 3 years
- •c) Participants with an active, known or suspected autoimmune disease.
- •d) Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
- •e) 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.
- •f) All toxicities attributed to prior anti-cancer therapy
- •g) Toxicities from the prior anti-cancer treatment have not been resolved to Grade 1
- •h) Current use of a prohibited medication.
- •i) Prior treatment with any MEK inhibitor
- •j) History of interstitial lung disease or pneumonitis.
- •k) Inability to take oral medication
- •l) Psychological, familial, or sociological condition potentially hampering compliance with the study protocol.
- •m) Additional criteria for Part 2 only:
- •i) Prior treatment with regorafenib or TAS-102
- •ii) Severe hepatic impairment (Child-Pugh C)
- •iii) Any evidence of active bleeding
- •iv) Prior or current gastrointestinal perforation or fistula
- •v) Arterial or venous thrombotic or embolic events within 6 months before the start of study medication
- •vi) Non-healing wound, non-healing ulcer, or non-healing bone fracture
- •vii) Active infection
- •3) Physical and Laboratory Test Findings
- •4) Allergies/Adverse Drug Reaction
- •5) Other Exclusion Criteria
研究者
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