EUCTR2017-001830-24-ES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 that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results.
- •b) Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate/cervix/breast.
- •c) Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not
- •expected to recur in the absence of an external trigger are permitted to enroll.
- •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, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents.
- •f) All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE [current version]) or baseline before administration of study drug.
- •g) Toxicities from the prior anti-cancer treatment have not been resolved to Grade 1 (NCI CTCAE current version) at the time of study entry
- •h) Current use of a prohibited medication. Treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to first dose of study treatment
- •i) Prior treatment with any MEK inhibitor
- •j) History of interstitial lung disease or pneumonitis.
- •k) Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, significant bowel resection that would preclude adequate absorption of oral medication.
- •l) Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.
- •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, or hemorrhage or bleeding event = NCI-CTCAE Grade 3 within 4 weeks prior to the start of study medication
- •iv) Prior or current gastrointestinal perforation or fistula
- •v) Arterial or venous thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis, or pulmonary embolism within 6 months before the start of study medication
- •vi) Non-healing wound, non-healing ulcer, or non-healing bone fracture
- •vii) Active infection (ie, body temperature = 38°C due to infection)
- •3) Physical and Laboratory Test Findings
- •a) WBC < 2000/µL
- •b) Neutrophils < 1500/µL
- •c) Platelets < 100×103/µL
- •d) Hemoglobin < 9.0 g/dL
- •e) PT/INR and PTT > 1.5 ×ULN
- •f) Serum creatinine > 1.5 ×ULN, unless creatinine clearance > 50 mL/min (measured or calcula
研究者
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