EUCTR2019-003444-72-ES进行中（未招募）1 期
An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants with Advanced Renal Cell Carcinoma That Has Progressed After Prior PD- 1/L1 and VEGF-Targeted Therapies
Merck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc0 个研究点目标入组 736 人开始时间: 2020年3月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 736
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
- •1. Has unresectable, locally advanced or metastatic clear cell RCC
- •2. Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- •3. Has received systemic treatment for locally advanced or metastatic RCC with a PD-1/L1 checkpoint inhibitor (at least 2 doses of a PD-1/L1 checkpoint inhibitor) and a VEGF-targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies) as monotherapy, or in combination
- •4. Has received no more than 3 prior systemic regimens for locally advanced or metastatic RCC
- •5. For the most recently received regimen, has demonstrated disease progression as defined by RECIST 1.1
- •6. Is male or female, who is at least 18 years of age at the time of signing the informed consent
- •7. Has a KPS score of at least 70% assessed within 7 days prior to the first dose of study intervention
- •8. A male participant must agree to use contraception during the treatment period and for at least 95 days, corresponding to time needed to eliminate any study intervention(s) and refrain from donating sperm during this period
- •9. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- •a. Not a WOCBP
- •b. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 95 days after the last dose of study intervention, corresponding to time needed to eliminate any study intervention(s)
- •10. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for FBR. However, the participant may participate in the main study without participating in FBR
- •11. Has adequate organ function; all screening laboratory tests should be performed within 10 days prior to the first dose of study intervention
- •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 74
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 662
排除标准
- •1. A WOCBP who has a positive urine pregnancy test within 3 days prior to randomization or treatment allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •2. Has hypoxia as defined by a pulse oximeter reading <92% at rest or requires intermittent or chronic supplemental oxygen
- •3. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- •4. Has known CNS metastases and/or carcinomatous meningitis
- •5. Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted
- •6. Has poorly controlled hypertension defined as SBP =150 mm Hg and/or DBP =90 mm Hg
- •7. Has moderate to severe hepatic impairment (Child-Pugh B or C)
- •8. Received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention
- •9. Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study
- •10. Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, malabsorption)
- •11. Has known hypersensitivity or allergy to the active pharmaceutical ingredient or any component of the study intervention (MK-6482 or everolimus) formulations
- •12. Has received prior treatment with MK-6482 or another HIF-2a inhibitor
- •13. Has received prior treatment with everolimus or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus) in the advanced disease setting
- •14. Has received any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization
- •15. Has received any type of systemic anticancer antibody (including investigational antibody) within 4 weeks before randomization
- •16. Has received prior radiotherapy within 2 weeks prior to first dose of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is required for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease
- •17. Has had major surgery within 3 weeks prior to first dose of study intervention
- •18. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed
- •19. Is currently receiving either strong (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of CYP3A4 that cannot be discontinued for the duration of the study
- •20. Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John’s Wort) or moderate (eg, bosentan, efavirenz, modafinil) ind
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