A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Axitinib versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426) - Pembrolizumab plus axitinib vs. sunitinib monotherapy in advanced/metastatic renal cell carcinoma

Merck Sharp & Dohme LLC0 个研究点目标入组 840 人开始时间: 2016年8月8日最近更新: 2024年2月26日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Merck Sharp & Dohme LLC
入组人数: 840

研究概览入排标准研究者记录与标识符相似试验

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

•- Be > or = 18 years of age on day of signing informed consent
•- Have histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features
•- Have locally advanced/metastatic disease, ie, newly diagnosed Stage IV RCC per American Joint Committee on Cancer or have recurrent disease.
•- Have measurable disease per RECIST 1.1 as assessed by the investigator /site radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
•- Have received no prior systemic therapy for advanced RCC
•- Provide tumor tissue for biomarker analysis
•- Demonstrate adequate organ function
•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 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 440

排除标准

•- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
•- Has had major surgery within 4 weeks, received radiation therapy within 2 weeks prior to randomization, or has not recovered (i.e., = Grade 1 or at baseline) from AEs due to prior treatment.
•- Has had prior treatment with any anti-PD-1, or PD-L1, or PD-L2 agent or an antibody targeting any other immune-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against IDO, PD-L1, IL-2R, and GITR
•- Has received prior systemic anti-cancer therapy for RCC (e.g., VEGF/VEGFR, chemotherapy or mTOR-targeting agents).
•- Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding physiologic corticosteroid dose or any other form of immunosuppressive therapy within 7 days prior to randomization
•- Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) OR with a documented history of clinically severe
•autoimmune disease
•- Has a known additional malignancy that has progressed or has required active treatment in the last 3 years
•- Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable
•- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
•- Has a clinically significant gastrointestinal (GI) abnormality including: a) Malabsorption, total gastric resection, or any other condition that might affect the absorption of orally taken medication. b) Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy c) Intraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other GI condition associated with increased risk
•of perforation
•- Has QT interval corrected for heart rate (QTc) > or = 480 msec
•- Has a history of any of the following cardiovascular conditions within 12 months of randomization: Myocardial infarction, Unstable angina pectoris, Cardiac angioplasty or stenting, Coronary/peripheral artery bypass graft, Class III or IV congestive heart failure per New York Heart Association, Cerebrovascular accident or transient ischemic attack
•- Has a history of deep vein thrombosis or pulmonary embolism within 6 months of screening
•- Has poorly controlled hypertension defined as systolic blood pressure (SBP) > or = 150 mm Hg and/or diastolic blood pressure (DBP) > or = 90 mm Hg
•- Has evidence of inadequate wound healing
•- Has active bleeding disorder or other history of significant bleeding episodes within 30 days of randomization
•- Has hemoptysis within 6 weeks prior to randomization
•- Has current use (within 7 days of randomization) or anticipated need for treatment with drugs or foods that are known strong cytochrome P450 (CYP3A4/5) inhibitors
•- Has current use (within 7 days of randomization) or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John’s wort; or drugs that are known with proarrhythmic potential
•- Has had a prior solid organ transplant

研究者

发起方

Merck Sharp & Dohme LLC

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