EUCTR2019-002345-37-IT进行中（未招募）1 期
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with TransarterialChemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012) -
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 950 人开始时间: 2021年6月15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
- 950
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
- •1Has diagn ofHCC confirmed by radiol,histol,cytol(fibrolamellar and mixed hepatocel/cholangiocarcin subtypes arent eligible) Has radiol diagn ofHCC as per AASLDguidel,which requires:
- •-liver cirr and liver mass conf byBICR that shows arterial phase hyperenhancem on triphasic CTorMRI AND:
- •Is=20mm with either non-periph portal washout or enhancing capsule OR
- •Is10-19mm with non-periph port venous washoutANDenhancing caps
- •2HasHCC localiz to liver without port vein thromb,and not amenable to curat treatm such as resect, ablat,or liver transplant.No extrahep HCC is permit,conf byBICR
- •3Has at least 1measurable HCClesion based onRECIST 1.1 conf byBICR
- •4all les treatable withTACE in1or2sessions
- •5Is amenable,without contraindic,toTACEproced and chemother agent prespecified at study site
- •6Has CPclassA liver score within 7days prior first dose of study interv
- •7 predicted life expect of >3months
- •8 ECOG PS of 0to1 within 7days prior first dose of st interv
- •9Is male or fem=18years at time of signing inf consent
- •10Male particip are elig to part if they agree to the foll during interv period and for at least 180days postTACE or 30days after last dose of lenva/oral placebo, whichever occurs last:
- •-Be abstinent from heterosex intercourse as their preferred and usual lifestyle(abst on a long term and persistent basis) and agree to remain abst OR
- •-use contracept unless conf to be azoospermic(vasectomized or second to medical cause)
- •-Contracept use by men should be consistent with local regulat regarding the meth of contracept for those particip in clinical studies
- •-M particip must agree to refrain from donating sperm for 180days afterTACE
- •11female part is eligible to part if she isn’t pregnant or breastfeeding and at least1 of follow condit applies:
- •-Isnt a WOCBP OR
- •-Is WOCBP and using a contracept meth highly effect(with failure rate of <1%per year),with low user dependency,or be abst from heterosex interc as their pref and usual lifestyle(abst on a long term and persist basis), dur the interv period and for at least 180days postTACE,120days post pembro/IV placebo or 30days post lenva/oral plac,whichever occurs last. Investig should evaluate the pot for contracept meth failure(noncompl, recently initiated)in relationship to first dose of study interv
- •-WOCBP must have neg highly sensit pregnancy test(urine or serum as req by local regulations) within 24h before first dose of st interv
- •-If urine test cant be conf as neg(eg ambiguous result),serum pregn test is required. In such cases particip must be excluded from particip if serum pregn result is pos
- •Invest is respons for review of medical history,menstrual hist and recent sex activity to decrease risk for inclus of woman with early undetected pregn
- •Contracept use by women should be consistent with local regul regarding the meth of contraception for those particip in clinical stud
- •12Particip(or legally acceptable representat if appl) provides written inf consent/assent for study
- •13Part with past or ongoing HCVinfection will be eligible for study. Treated particip must have compl their treatm at least 1month prior to starting st interv
- •14Part with controlledHBV will be eligible as long as they meet following criteria:
- •-Antiviral ther forHBV must be given for at least4weeks and HBVviral load must be<500IU/mL prior to first dose of study interv.Particip on active HBV ther with viral loads<500IU/mL should stay on same ther throughout stu interv
- •-Part who are pos forHBc, negatfor HBsAg, and neg or pos forHBs, an
排除标准
- •1.Has HCC lesion(s) measuring =10 cm in any dimension, has more than 10 lesions on radiographic evaluation or has HCC lesions occupying = 50% of the liver volume, confirmed by BICR.
- •2.Has had esophageal or gastric variceal bleeding within the last 6 months.
- •3.Has bleeding or thrombotic disorders or is using factor X inhibitors or anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Treatment with antiplatelet agents and low molecular weight heparin is permitted.
- •4.Has clinically apparent ascites on physical examination that is not controlled with medication. Ascites detectable on imaging studies only is allowed.
- •5.Has any macrovascular tumor thrombosis in the portal veins, confirmed by BICR. Microvascular tumor thrombosis detected on biopsy, but not radiographic scan, is permitted.
- •6.Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy. Participants on rifaximin or lactulose during screening to control their hepatic encephalopathy are excluded.
- •7.Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for HCC.
- •8. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PDL2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
研究者
相似试验
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for Incurable/Non-metastatic Hepatocellular CarcinomaIncurable/Non-metastatic Hepatocellular CarcinomaMedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002345-37-DEMerck Sharp & Dohme LLC450
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for Incurable/Non-metastatic Hepatocellular CarcinomaIncurable/Non-metastatic Hepatocellular CarcinomaMedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002345-37-NOMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc950
招募中
1 期
Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for Incurable/Non-metastatic Hepatocellular CarcinomaIncurable/Non-metastatic Hepatocellular CarcinomaMedDRA version: 20.0Level: PTClassification code: 10073071Term: Hepatocellular carcinoma Class: 100000004864CTIS2022-502116-36-00Merck Sharp & Dohme LLC549
已完成
3 期
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)liver cancerNL-OMON52824Merck Sharp & Dohme (MSD)12
进行中（未招募）
1 期
Phase 3 Study of Pembrolizumab and Lenvatinib in Combination with TACE for Incurable/Non-metastatic Hepatocellular CarcinomaIncurable/Non-metastatic Hepatocellular CarcinomaMedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002345-37-DKMerck Sharp & Dohme LLC450