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复合制剂 Pembrolizumab/Quavonlimab (MK-1308A) 与 Lenvatinib (E7080/MK-7902) 联合治疗晚期肝细胞癌 (MK-1308A-004) 的安全性和有效性

2026年6月28日 更新者：Merck Sharp & Dohme LLC

一项评估 MK-1308A（复合配方 MK-1308/MK-3475）与乐伐替尼（E7080/MK-7902）联合用于晚期肝细胞癌参与者一线治疗的安全性和有效性的 2 期多中心临床研究

本研究的目的是评估固定剂量联合配制的 pembrolizumab/quavonlimab (MK-1308A) 加乐伐替尼在一线 (1L) 肝细胞癌 (HCC) 治疗中的安全性和有效性。 不进行假设检验。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

116

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Anhui
      • Hefei、Anhui、中国、230071
        • Anhui Provincial Hospital ( Site 0113)
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
        • Beijing Cancer hospital-Department of Hepato-Pancreato-Biliary Surgery II ( Site 0107)
    • Fujian
      • Fuzhou、Fujian、中国
        • Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 0105)
    • Guangdong
      • Guangzhou、Guangdong、中国、510515
        • Southern Medical University Nanfang Hospital-Liver Cancer Department ( Site 0106)
    • Hubei
      • Wuhan、Hubei、中国、430022
        • Wuhan Union Hospital Cancer Center ( Site 0108)
    • Hunan
      • Changsha、Hunan、中国、410013
        • Hunan Cancer Hospital-intervention department ( Site 0109)
    • Shaanxi
      • Xi'an、Shaanxi、中国、710061
        • The First Affiliated Hospital of Xian Jiaotong University ward1 depattment of medical oncology ( Sit
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200032
        • Zhongshan Hospital,Fudan University ( Site 0103)
      • Shanghai、Shanghai Municipality、中国、200040
        • Huashan Hospital Affiliated Fudan University-Surgery Department ( Site 0118)
  • 台湾
      • Tainan、台湾、704
        • NATIONAL CHENG-KUNG UNI. HOSP.-Clinical Trial Research Team of Liver Diseases ( Site 0354)
      • Taipei、台湾、10002
        • National Taiwan University Hospital-Oncology ( Site 0351)
      • Taipei、台湾、112201
        • Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (
  • 意大利
      • Milan、意大利、20132
        • Ospedale San Raffaele-Oncologia Medica ( Site 0227)
      • Naples、意大利、80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0230)
    • Milano
      • Rozzano、Milano、意大利、20089
        • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0231)
  • 日本
      • Hiroshima、日本、734-8551
        • Hiroshima University Hospital ( Site 0156)
    • Chiba
      • Kashiwa、Chiba、日本、2778577
        • National Cancer Center Hospital East ( Site 0153)
    • Kanagawa
      • Kawasaki、Kanagawa、日本、213-8587
        • Toranomon Hospital Kajigaya ( Site 0154)
    • Osaka
      • Sayama、Osaka、日本、589-8511
        • Kindai University Hospital- Osakasayama Campus-Department of Gastroenterology and Hepatology ( Site
  • 波兰
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰、02-034
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site
    • Podkarpackie Voivodeship
      • Przemyśl、Podkarpackie Voivodeship、波兰、37-700
        • Wojewódzki Szpital im. Św. Ojca Pio w Przemyślu ( Site 0249)
    • Pomeranian Voivodeship
      • Gdansk、Pomeranian Voivodeship、波兰、80-952
        • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0247)
    • West Pomeranian Voivodeship
      • Koszalin、West Pomeranian Voivodeship、波兰、75-581
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0246)
  • 瑞士
      • Bern、瑞士、3010
        • Inselspital Bern-Universitätsklinik für Viszerale Chirurgie und Medizin ( Site 0331)
    • Canton of Geneva
      • Geneva、Canton of Geneva、瑞士、1211
        • Hôpitaux Universitaires de Genève (HUG) ( Site 0335)
    • Canton of St. Gallen
      • Sankt Gallen、Canton of St. Gallen、瑞士、9007
        • Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 0334)
    • Canton of Vaud
      • Lausanne、Canton of Vaud、瑞士、1011
        • CHUV (centre hospitalier universitaire vaudois) ( Site 0333)
    • Canton of Zurich
      • Zurich、Canton of Zurich、瑞士、8091
        • UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 0332)
  • 美国
    • California
      • Duarte、California、美国、91010
        • City of Hope Comprehensive Cancer Center ( Site 0002)
    • Maryland
      • Baltimore、Maryland、美国、21287
        • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 0013)
    • New York
      • New York、New York、美国、10029
        • Icahn School of Medicine at Mount Sinai ( Site 0009)
    • Oregon
      • Portland、Oregon、美国、97239
        • Oregon Health and Science University ( Site 0006)
    • South Carolina
      • Charleston、South Carolina、美国、29414
        • Charleston Oncology ( Site 0003)
    • Virginia
      • Roanoke、Virginia、美国、24014
        • Blue Ridge Cancer Care ( Site 0008)
    • Washington
      • Seattle、Washington、美国、98101
        • Virginia Mason Medical Center ( Site 0004)
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 0310)
    • Principality of Asturias
      • Oviedo、Principality of Asturias、西班牙、33011
        • Hospital Universitario Central de Asturias-Hepatology ( Site 0309)
  • 韩国
      • Seoul、韩国、05505
        • Asan Medical Center ( Site 0289)
    • Kyonggi-do
      • Seongnam、Kyonggi-do、韩国、13620
        • Seoul National University Bundang Hospital-Medical Oncology ( Site 0290)
      • Seoul、Kyonggi-do、韩国、06351
        • Samsung Medical Center ( Site 0288)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 具有经放射学、组织学或细胞学证实的 HCC 诊断（纤维板层和混合肝细胞/胆管癌亚型不符合条件）
  • 患有巴塞罗那临床肝癌 (BCLC) C 期疾病，或 BCLC B 期疾病，不适于局部治疗或局部治疗难治，且不适用于治愈性治疗方法
  • 在第一次研究干预前 7 天内有 Child-Pugh A 级肝脏评分。
  • 预计预期寿命 > 3 个月
  • 根据 RECIST 1.1，至少有 1 个可测量的 HCC 病灶，由 BICR 确认
  • 在首次研究干预之前的 7 天内，东部肿瘤合作组表现评分 (ECOG PS) 为 0 至 1。
  • 只要符合以下标准，乙型肝炎受控的参与者就有资格：乙型肝炎病毒 (HBV) 的抗病毒治疗必须至少持续 4 周，并且 HBV 病毒载量在首次给药前必须低于 500 IU/mL研究药物
  • 使用或不使用抗高血压药物可充分控制血压
  • 具有足够的器官功能。

排除标准：

  • 在过去 6 个月内有过食管或胃静脉曲张破裂出血。
  • 有出血或血栓性疾病或使用因子 X 抑制剂或抗凝剂需要治疗性国际标准化比率 (INR) 监测，例如华法林或类似药物
  • 体检时有临床明显的腹水
  • 根据影像学检查有 HCC 下腔静脉或心脏受累
  • 在过去 6 个月内曾被临床诊断为肝性脑病且对治疗无反应
  • 有排除所有形式对比增强成像（计算机断层扫描 [CT] 或磁共振成像 [MRI]）的医学禁忌症
  • 有胃肠道吸收不良、胃肠道吻合或任何其他可能影响乐伐替尼吸收的情况
  • 已有 ≥ 3 级胃肠道或非胃肠道瘘管
  • 在研究药物首次给药前 3 周内有临床活动性咯血（至少 0.5 茶匙的鲜红色血液）
  • 在首次接受研究干预后 12 个月内出现有临床意义的心血管损害，包括纽约心脏协会 (NYHA) III 级或 IV 级充血性心力衰竭、不稳定型心绞痛、心肌梗塞、脑血管意外或与血流动力学不稳定相关的心律失常
  • 在第一次研究干预前的 4 周内接受过肝脏大手术
  • 在第一次研究干预（第 1 周期第 1 天）之前的 7 天内进行过小手术（即简单切除）
  • 有严重的不愈合伤口、溃疡或骨折
  • 接受过任何全身化疗，包括抗血管内皮生长因子 (VEGF) 治疗，或任何用于治疗 HCC 的全身研究性抗癌药物
  • 既往接受过抗 PD-1、抗 PD-L1 或抗 PD-L2 药物或针对另一种刺激性或共抑制性 T 细胞受体的药物的治疗
  • 在首次研究干预前 4 周内接受过肝脏局部治疗
  • 在研究干预开始后的 2 周内曾接受过非肝脏区域的放疗
  • 在研究药物首次给药前 30 天内接受过活疫苗或减毒活疫苗
  • 目前正在或已经参与研究药物的研究，或在首次研究干预前 4 周内使用过研究设备
  • 在首次研究干预前 7 天内被诊断为免疫缺陷或正在接受慢性全身性类固醇治疗或任何其他形式的免疫抑制治疗
  • 在过去 3 年内有已知的其他恶性肿瘤正在进展或需要积极治疗
  • 根据当地现场调查员的评估，具有中枢神经系统 (CNS) 转移和/或癌性脑膜炎的已知病史或任何证据
  • 对研究干预和/或其任何赋形剂有严重的超敏反应（≥3 级）
  • 在过去 2 年内患有需要全身治疗的活动性自身免疫性疾病
  • 有（非感染性）肺炎/间质性肺病病史需要类固醇或目前有肺炎/间质性肺病
  • 有需要全身治疗的活动性感染，HBV 或丙型肝炎病毒 (HCV) 除外
  • 已知有人类免疫缺陷病毒 (HIV) 感染史
  • 在研究开始时具有双重活动性 HBV 感染（HBsAg (+) 和/或可检测到的 HBV DNA）和 HCV 感染（抗 HCV 抗体 [Ab] 阳性和可检测到的 HCV RNA）
  • 有任何病症、治疗或实验室异常的历史或当前证据，这些异常、治疗或实验室异常可能会混淆研究结果，干扰参与者在整个研究期间的参与，或不符合参与者的最大利益参与，在治疗研究者看来
  • 患有已知的精神疾病或药物滥用疾病，会干扰参与者配合研究要求的能力
  • 进行过同种异体组织/实体器官移植

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Pembrolizumab/Quavonlimab + Lenvatinib
参与者每 6 周 (Q6W) 通过静脉内 (IV) 输注 pembrolizumab/quavonlimab，持续长达 2 年，加上口服乐伐替尼（根据筛选时的实际体重），直至疾病进展或出现不可接受的毒性，持续长达 5 年。 如果由于无法耐受的毒性而停用 pembrolizumab/quavonlimab，可以考虑重新开始 pembrolizumab 治疗。
生物：派姆单抗/Quavonlimab
Pembrolizumab/Quavonlimab (400 mg/25 mg) 通过静脉输注 Q6W 给药。
其他名称：
  • MK-1308A
药品：乐伐替尼
Lenvatinib 12 mg（体重 [BW] ≥60 kg）或 8 mg（BW
其他名称：
  • MK-7902
生物：派姆单抗
如果对 pembrolizumab/quavonlimab 产生无法耐受的毒性，则每 6 周通过 IV 输注给予 Pembrolizumab (400 mg)。
其他名称：
  • MK-3475
  • 可瑞达®

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase
大体时间：3 weeks
DLTs were defined as follows unless determined to be unrelated to study intervention: any Grade 4 nonhematologic toxicity (not laboratory); any Grade 4 hematologic toxicity lasting >7 days (Grade 4 lymphopenia lasting ≥21 days); Grade 3 platelet count decreased if associated with clinically significant hemorrhage; any Grade 3 nonhematologic toxicity (not laboratory) lasting >3 days despite optimal supportive care; any clinically significant Grade 3 or Grade 4 nonhematologic laboratory abnormality if: medical intervention is required to treat participant, or abnormality leads to hospitalization, or abnormality persists for >1 week (or bilirubin if persists >4 weeks); aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) >10.0 times upper limit of normal (ULN) or >10.0 times baseline if baseline >ULN; any febrile neutropenia Grade 3 or Grade 4; a treatment-related adverse event (AE) causing discontinuation of study intervention during the DLT window; any Grade 5 toxicity.
3 weeks
Number of Participants With ≥1 Adverse Event (AE)
大体时间：Up to approximately 44 months
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with an AE was reported.
Up to approximately 44 months
Number of Participants With ≥1 Serious Adverse Event (SAE)
大体时间：Up to approximately 44 months
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. The number of participants with an SAE was reported.
Up to approximately 44 months
Number of Participants With ≥1 Immune-related AE (irAE)
大体时间：Up to approximately 44 months
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs associated with pembrolizumab/quavonlimab exposure may represent an immune-related response. A list of irAEs was pre-specified for the compound of pembrolizumab/quavonlimab. The number of participants with an irAE was reported.
Up to approximately 44 months
Number of Participants With ≥1 Hepatic AE
大体时间：Up to approximately 44 months
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Hepatic events of clinical interest (ECIs) included any of the following events if the event is considered not due to disease progression as judged by the investigator: among participants with Baseline ALT <2 × ULN: ALT ≥5 × ULN; among participants with Baseline ALT ≥2 × ULN: ALT >3 × the Baseline level; ALT >500 U/L regardless of baseline level; total bilirubin >3.0 mg/dL; hepatic decompensation diagnosed clinically (regardless of laboratory values) including new onset clinically detectable ascites requiring intervention for >3 days, hepatic encephalopathy, or gastrointestinal bleeding suggestive of portal hypertension. The number of participants with a hepatic AE was reported.
Up to approximately 44 months
Number of Participants Discontinuing Study Treatment Due to an AE
大体时间：Up to approximately 40 months
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinued study treatment due to an AE was reported.
Up to approximately 40 months
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
大体时间：Up to approximately 51 months
ORR was defined as the percentage of participants who achieve a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ, and assessed by BICR. The percentage of participants who experienced CR or PR per RECIST 1.1 as assessed BICR was presented.
Up to approximately 51 months

次要结果测量

结果测量
措施说明
大体时间
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
大体时间：Up to approximately 51 months
For participants who demonstrated confirmed CR or PR per RECIST 1.1 assessed by BICR, DOR was defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.
Up to approximately 51 months
Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR
大体时间：Up to approximately 51 months
DCR was defined as the percentage of participants who have achieved CR (disappearance of all target lesions), PR (at least a 30% decrease in the SOD of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) after ≥6 weeks (the start of the window for the first scheduled scan) per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per RECIST 1.1 assessed by BICR was presented.
Up to approximately 51 months
Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR
大体时间：Up to approximately 51 months
PFS was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 as assessed by BICR was reported.
Up to approximately 51 months
Time-To-Progression (TTP) Per RECIST 1.1 as Assessed by BICR
大体时间：Up to approximately 51 months
TTP was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. TTP per RECIST 1.1 as assessed by BICR was presented.
Up to approximately 51 months
Overall Survival (OS)
大体时间：Up to approximately 51 months
OS was defined as the time from the first dose of study intervention to death due to any cause.
Up to approximately 51 months
ORR Per Modified RECIST (mRECIST) as Assessed by BICR
大体时间：Up to approximately 51 months
ORR was defined as the percentage of participants who achieve a confirmed CR (disappearance of any intratumoral arterial enhancement in all target lesions) or a PR (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. The percentage of participants who experienced CR or PR per mRECIST as assessed BICR was presented.
Up to approximately 51 months
DOR Per mRECIST as Assessed by BICR
大体时间：Up to approximately 51 months
For participants who demonstrate confirmed CR or PR per mRECIST assessed by BICR, DOR is defined as the time from the first documented evidence of CR (disappearance of any intratumoral arterial enhancement in all target lesions) or PR (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) until PD or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The DOR as assessed using mRECIST for all participants who experienced a confirmed CR or PR was presented.
Up to approximately 51 months
DCR Per mRECIST as Assessed by BICR
大体时间：Up to approximately 51 months
DCR was defined as the percentage of participants who have achieved CR (disappearance of any intratumoral arterial enhancement in all target lesions), PR (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions), or SD (any cases that do not qualify for either PR or PD) after ≥6 weeks (the start of the window for the first scheduled scan) per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per mRECIST assessed by BICR was presented.
Up to approximately 51 months
PFS Per mRECIST as Assessed by BICR
大体时间：Up to approximately 51 months
PFS was defined as the time from the first dose of study intervention to the first documented PD per mRECIST by BICR or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. PFS per mRECIST as assessed by BICR was reported.
Up to approximately 51 months
TTP Per mRECIST as Assessed by BICR
大体时间：Up to approximately 51 months
TTP was defined as the time from the first dose of study intervention to the first documented PD per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. TTP per mRECIST as assessed by BICR was presented.
Up to approximately 51 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Merck Sharp & Dohme LLC

调查人员

  • 研究主任：Medical Director、Merck Sharp & Dohme LLC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月16日

初级完成 (实际的)

2025年7月29日

研究完成 (实际的)

2025年7月29日

研究注册日期

首次提交

2021年2月2日

首先提交符合 QC 标准的

2021年2月2日

首次发布 (实际的)

2021年2月5日

研究记录更新

最后更新发布 (实际的)

2026年6月30日

上次提交的符合 QC 标准的更新

2026年6月28日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 1308A-004
  • MK-1308A-004 (其他标识符：MSD)
  • jRCT2061210033 (其他标识符：jRCT (Japan Registry of Clinical Trials))
  • 2020-004490-52 (EudraCT编号)
  • 2023-505698-34-00 (注册表标识符：EU CT)
  • U1111-1292-3158 (注册表标识符：UTN)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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