NL-OMON52824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) - MK7902-012
Merck Sharp & Dohme (MSD)0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology
- •(fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not
- •2. Has HCC localized to the liver without portal vein thrombosis, and not
- •amenable to curative treatment such as resection, ablation, or liver
- •transplant. No extrahepatic HCC is permitted, confirmed by BICR.
- •3. Has at least one measurable HCC lesion based on RECIST 1.1, confirmed by
- •4. Has all lesions treatable with TACE in 1 or 2 (split-TACE) sessions.
- •5. Is amenable, without any contraindications, to the TACE procedure and
- •chemotherapy agent pre-specified at the study site.
- •6. Has a CP class A liver score within 7 days prior to first dose of study
- •intervention (see Appendix 10).
- •7. Has a predicted life expectancy of >3 months.
- •8. Has an ECOG PS of 0 to 1 within 7 days prior to first dose of study
- •intervention.
- •9. Is male or female >= 18 years of age at the time of signing the informed
- •10. Male participants are eligible to participate if they agree to the
- •following during the intervention period and for at least the time needed to
- •eliminate each study intervention after the last dose of study intervention.
- •The length of time required to continue contraception for each study
- •intervention is as follows:
- •- Lenvatinib 7 days
- •- TACE 95 days
- •Refrain from donating sperm
- •PLUS either:
- •- Be abstinent from heterosexual intercourse as their preferred and usual
- •lifestyle and agree to remain abstinent OR
- •- Must agree to use contraception unless confirmed to be azoospermic.
- •- Contraceptive use by men should be consistent with local regulations
- •regarding the methods of contraception for those participating in clinical
- •11. A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and at least one of the following conditions applies:
- •- Is not a WOCBP
- •- Is a WOCBP and using a contraceptive method that is highly effective (with a
- •failure rate of <1% per year), with low user dependency, or be abstinent from
- •heterosexual intercourse as their preferred and usual lifestyle (abstinent on a
- •long term and persistent basis), during the intervention period and for at
- •least the time needed to eliminate each study intervention after the last dose
- •of study intervention and agrees not to donate eggs (ova, oocytes) to others of
- •freeze/store for her own use for the purpose of reproduction during this
- •period. The length of time required to continue contraception for each study
- •intervention is as follows:
- •- Pembrolizumab 120 days
- •- Lenvatinib 30 days
- •- TACE 180 days
- •The investigator should evaluate the potential for contraceptive method
- •failure (ie, noncompliance, recently initiated) in relationship to the first
- •dose of study intervention.
- •- A WOCBP must have a negative highly sensitive pregnancy test within 24 hours
- •for urine or 72 hours for serum before the first dose of study intervention.
- •- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a
- 另有 5 项未显示
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. Is currently a candidate for liver transplantation.
- •3. Has had esophageal or gastric variceal bleeding within the last 6 months.
- •All participants will be screened for esophageal or gastric varices unless such
- •screening has been performed in the past 3 months before the first dose of
- •study intervention. If varices are present, they should be treated according to
- •institutional standards before starting study intervention; esophageal or
- •gastric varices that require interventional treatment within 28 days prior to
- •first dose of study intervention are excluded.
- •4. Has bleeding or thrombotic disorders or is using factor X inhibitors or
- •anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar
- •agents. Treatment with anti-platelet agents and low molecular weight heparin is
- •5. Has clinically apparent ascites on physical examination that is not
- •controlled with medication.
- •Note: Ascites detectable on imaging studies only are allowed.
- •6. Has any macrovascular tumor thrombosis in the portal veins, confirmed by
- •Note: microvascular tumor thrombosis detected on biopsy, but not radiographic
- •scan, is permitted.
- •7. 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.
- •8. Has medical contraindications that preclude all forms of contrast enhanced
- •imaging (CT or MRI).
- •9. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any
- •other condition that might affect the absorption of lenvatinib.
- •10. Has a preexisting Grade >=3 gastrointestinal or non-gastrointestinal fistula.
- •11. Has clinically significant hemoptysis from any source or tumor bleeding
- •within 2 weeks prior to the first dose of study intervention.
- •12. Has significant cardiovascular impairment within 12 months of the first
- •dose of study intervention such as history of congestive heart failure greater
- •than NYHA Class II (Appendix 12), unstable angina, myocardial infarction or
- •cerebrovascular accident stroke, or cardiac arrhythmia associated with
- •hemodynamic instability.
- •13. Has had major surgery to the liver within 4 weeks prior to the first dose
- •of study intervention.
- •Note: If participant underwent major surgery, they must have adequately
- •recovered from the toxicity and/or complications from the intervention prior to
- •starting study intervention.
- •14. Has had a minor surgery (ie, simple excision) within 7 days prior to the
- •first dose of study intervention (Cycle 1 Day 1).
- •15. Has serious nonhealing wound, ulcer, or bone fracture.
- •16. Has HAP score D.
- •17. Has received any systemic chemotherapy, including anti-VEGF therapy, or any
- •systemic investigational anticancer agents for HCC.
- •18. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2
- •agent or with an agent directed to another stimulatory or co-inhibitory T-cell
- •receptor (eg, CTLA-4, OX-40, or CD137).
- •19. Has received locoregional therapy to liver (such as TACE, transarterial
- 另有 1 项未显示
研究者
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