EUCTR2015-004567-36-IT进行中（未招募）1 期
A Phase III Study of Pembrolizumab (MK-3475) vs. Best Supportive Care as Second-Line Therapy in Subjects with Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-240) - Phase III Study of MK 3475 + Best Supportive Care in Subjects with Advanced Hepatocellular Carcinoma
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 408 人开始时间: 2021年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 408
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. Be willing and able to provide written informed consent for the trial.
- •The subject may also provide consent for Future Biomedical Research (FBR). However, the subject may participate in the main trial without
- •participating in FBR.
- •2. Be 18 years of age on day of signing informed consent.
- •3. Have a HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes
- •are not eligible). Radiologic confirmation diagnosis is provided by the study site. Definition of radiological confirmation: Clinical findings
- •consistent with the diagnosis of liver cirrhosis and a liver mass measuring at least 2 cm with characteristic vascularization (intense enhancement seen in the hepatic arterial-dominant phase and contrast washout in the late portal venous phase) seen in either triphasic computed tomography (CT) scan or magnetic resonance imaging (MRI).
- •4. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to
- •locoregional therapy, and not amenable to a curative treatment approach (see Section 12.8).
- •5. Have a Child-Pugh class A liver score within 7 days of first dose of study drug.
- •6. Have a predicted life expectancy of >3 months.
- •7. Have at least one measurable lesion based on RECIST 1.1 as confirmed by the blinded central imaging vendor.
- •8. Have a performance status of 0 or 1 using the ECOG Performance Scale within 7 days of first dose of study drug.
- •9. Have documented objective radiographic progression during or after treatment with sorafenib or intolerance to sorafenib. Sorafenib intolerance definition: Any Grade =2 drug-related AE which, 1) despite supportive therapy, recurred after sorafenib treatment interruption of at least 7 days and dose reduction resulting in the subject requesting, or the physician recommending discontinuation due to toxicity; OR 2) required discontinuation of sorafenib due to toxicity, recommended by the physician with no rechallenge.
- •10. Subjects with chronic infection by HCV who are treated (successfully or treatment failure) or untreated are allowed on study. In addition,
- •subjects with successful HCV treatment are allowed as long as there are =4 weeks between achieving
- •sustained viral response (SVR12) and start of study drug. Successful HCV treatment definition: SVR12.
- •11. Has been treated with anti-Hepatitis B therapy.
- •Controlled (treated) hepatitis B subjects will be allowed if they meet the following criteria:
- •Antiviral therapy for HBV must be given for at least 12 weeks and HBV viral load must be less than 100 IU/mL prior to first dose of study drug.
- •Subjects on active HBV therapy with viral loads under 100 IU/ml should stay on the same therapy throughout study treatment.
- •Subjects who are anti-HBc (+), negative for HBsAg, and negative or positive for anti- HBs, and who have an HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis.
- •12. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose
- •of study medication (Cycle 1, Day 1). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •13. Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of contraception as outlined in Section 5.7.2 – Contraception for the course of the study, starting with the first dose of study medicatio
排除标准
- •1. Is currently participating, or has participated, in a study of an investigational agent and received study therapy, herbal/complementary oral or IV medicine, or used an investigation device within 4 weeks of the first dose of treatment.
- •Subjects must also have recovered from associated therapy (i.e., to Grade =1 or baseline) and from AEs due to any prior therapy.
- •2. Has received sorafenib within 14 days of first dose of study medication.
- •3. Has had esophageal or gastric variceal bleeding within the last 6 months. All subjects will be screened for esophageal varices, unless such
- •screening has been performed in the past 12 months before first dose of treatment. If varices are present, they should be treated according to institutional standards before starting study
- •4. Has clinically apparent ascites on physical examination.
- •5. Portal vein invasion at the main portal (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging.
- •6. Has had clinically diagnosed hepatic encephalopathy in the last 6 months. Subjects on rifaximin or lactulose to control their hepatic
- •encephalopathy are not allowed.
- •7. Had a solid organ or hematologic transplant.
- •8. Had prior systemic therapy for HCC in the advanced (incurable) setting other than sorafenib, prior to start study drug.
- •9. Has a known severe hypersensitivity (= Grade 3) to pembrolizumab, its active substance and/or any of its excipients. (Refer to the respective Investigator's Brochure for a list of excipients.)
- •10. Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy
- •(e.g., thyroxine, insulin, or physiologic corticosteroid
- •replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •11. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days
- •prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor
- •12. Has received locoregional therapy to liver ranscatheter chemoembolization [TACE], transcatheter embolization [TAE], hepatic
- •arterial infusion [HAI], radiation, radioembolization, or ablation) within 4 weeks prior to the first dose of
- •study drug. Subject is not eligible if aforementioned treatments were administered between last dose of sorafenib and first dose of study medication.
- •13. Has had major surgery to liver or other site within 4 weeks prior to the first dose of study drug.
- •14. Has had a minor surgery (i.e., simple excision, tooth extraction) =7days prior to the first dose of study treatment (Cycle 1, Day 1).
- •15. Has not recovered adequately (i.e., Grade =1 or baseline) from the toxicity and/or complications from any intervention prior to starting therapy.
- •16. Has a diagnosed additional malignancy within 3 years prior to first dose of study with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or
- •curatively resected in situ cancers.
- •17. Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis as assessed by local
- •site investigator.
- •18. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- •19. Has an active infection requiring systemic therapy.
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