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子研究 01A：基于 MK-5684 的治疗组合或单独使用 MK-5684 对转移性去势抵抗性前列腺癌 (mCRPC) 参与者的安全性和有效性 (MK-5684-01A)

2026年11月6日 更新者：Merck Sharp & Dohme LLC

MK-5684-01A 子研究：MK-5684-U01 主方案的 1/2 期伞子研究，用于评估基于 MK-5684 的治疗组合或单独使用 MK-5684 在转移性去势抵抗性前列腺癌参与者中的安全性和有效性(mCRPC)

Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01).

The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (估计的)

220

阶段

  • 阶段2
  • 阶段1

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

  • 丹麦
    • Capital Region
      • Copenhagen、Capital Region、丹麦、2730
        • Herlev and Gentofte Hospital ( Site 0501)
    • North Denmark
      • Aalborg、North Denmark、丹麦、9000
        • Aalborg Universitetshospital, Syd ( Site 0503)
  • 以色列
      • Haifa、以色列、3109601
        • Rambam Health Care Campus-Oncology Division ( Site 1002)
      • Petah Tikva、以色列、4941492
        • Rabin Medical Center ( Site 1001)
      • Ramat Gan、以色列、5265601
        • Sheba Medical Center ( Site 1000)
  • 加拿大
    • Quebec
      • Montreal、Quebec、加拿大、H2X 3E4
        • Centre Hospitalier de l'Université de Montréal ( Site 0200)
      • Montreal、Quebec、加拿大、H3T 1E2
        • Jewish General Hospital ( Site 0206)
      • Québec、Quebec、加拿大、G1J 1Z4
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207)
  • 台湾
      • Taichung、台湾、404332
        • China Medical University Hospital ( Site 1703)
      • Taipei、台湾、112
        • Taipei Veterans General Hospital ( Site 1701)
      • Taoyuan、台湾、333
        • Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1702)
    • Kaohsiung
      • Kaohsiung Niao Sung Dist、Kaohsiung、台湾、83301
        • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1704)
  • 哥伦比亚
    • Bogota D.C.
      • Bogotá、Bogota D.C.、哥伦比亚、110131
        • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406)
      • Bogotá、Bogota D.C.、哥伦比亚、111321
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402)
    • Cesar Department
      • Valledupar、Cesar Department、哥伦比亚、200001
        • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0400)
    • Departamento de Córdoba
      • Montería、Departamento de Córdoba、哥伦比亚、230002
        • IMAT S.A.S ( Site 0404)
    • Valle del Cauca Department
      • Cali、Valle del Cauca Department、哥伦比亚、760032
        • Fundación Valle del Lili-Oncology CIC ( Site 0403)
  • 土耳其（türkiye）
      • Adana、土耳其（türkiye）、01250
        • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1802)
      • Ankara、土耳其（türkiye）、06230
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1800)
      • Ankara、土耳其（türkiye）、06800
        • Ankara Bilkent Şehir Hastanesi ( Site 1801)
      • Istanbul、土耳其（türkiye）、34668
        • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1804)
      • Istanbul、土耳其（türkiye）、34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1803)
  • 德国
      • Berlin、德国、10117
        • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800)
      • Hamburg、德国、20246
        • Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0804)
    • Baden-Wurttemberg
      • Heidelberg、Baden-Wurttemberg、德国、69120
        • Universitaetsklinikum Heidelberg ( Site 0805)
      • Tübingen、Baden-Wurttemberg、德国、72076
        • Universitaetsklinikum Tuebingen-Urologie ( Site 0801)
    • Bavaria
      • Munich、Bavaria、德国、81675
        • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0802)
  • 意大利
      • Verona、意大利、37134
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedal-Centro Ricerche Cliniche di Verona ( Site 1100)
    • Lazio
      • Rome、Lazio、意大利、00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1102)
    • Lombardy
      • Milan、Lombardy、意大利、20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1103)
    • Milano
      • Rozzano、Milano、意大利、20089
        • Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1101)
  • 新西兰
      • Auckland、新西兰、1023
        • Auckland City Hospital ( Site 1333)
  • 日本
      • Fukuoka、日本、812-8582
        • Kyushu University Hospital ( Site 1204)
    • Chiba
      • Sakura、Chiba、日本、285-8741
        • Toho University Sakura Medical Center ( Site 1201)
    • Kanagawa
      • Yokohama、Kanagawa、日本、232-0024
        • Yokohama City University Medical Center ( Site 1203)
    • Tokyo
      • Mitato、Tokyo、日本、105-8471
        • The Jikei University Hospital ( Site 1202)
  • 智利
    • Biobio
      • Temuco、Biobio、智利、4810218
        • CIDO SpA-Oncology ( Site 0302)
    • Maule Region
      • Talca、Maule Region、智利、3465584
        • Clinica Universidad Catolica del Maule-Oncology ( Site 0304)
    • Region M. de Santiago
      • Santiago、Region M. de Santiago、智利、7500921
        • Fundación Arturo López Pérez ( Site 0301)
      • Santiago、Region M. de Santiago、智利、832000
        • Pontificia Universidad Catolica de Chile ( Site 0303)
      • Santiago、Region M. de Santiago、智利、8420383
        • Bradfordhill ( Site 0300)
  • 法国
      • Paris、法国、75015
        • Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0702)
    • Aquitaine
      • Bordeaux、Aquitaine、法国、33076
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0703)
    • Bas-Rhin
      • Strasbourg、Bas-Rhin、法国、67200
        • Hopitaux Universitaires de Strasbourg ( Site 0700)
    • Île-de-France Region
      • Villejuif、Île-de-France Region、法国、94805
        • Gustave Roussy ( Site 0701)
  • 波兰
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz、Kuyavian-Pomeranian Voivodeship、波兰、85-796
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1402)
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰、02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1400)
    • Pomeranian Voivodeship
      • Gdansk、Pomeranian Voivodeship、波兰、80-952
        • Uniwersyteckie Centrum Kliniczne ( Site 1405)
  • 澳大利亚
    • New South Wales
      • Macquarie University、New South Wales、澳大利亚、2109
        • Macquarie University-MQ Health Clinical Trials Unit ( Site 0108)
    • Queensland
      • Greenslopes、Queensland、澳大利亚、4120
        • Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107)
    • Victoria
      • Melbourne、Victoria、澳大利亚、3000
        • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110)
  • 爱尔兰
      • Cork、爱尔兰、T12 DC4A
        • Cork University Hospital ( Site 0902)
      • Dublin、爱尔兰、D24 NR0A
        • Tallaght University Hospital ( Site 0900)
    • Dublin
      • Dublin、Dublin、爱尔兰、D04 T6F4
        • St. Vincent's University Hospital ( Site 0901)
  • 美国
    • California
      • La Jolla、California、美国、92037
        • UCSD Moores Cancer Center ( Site 0039)
      • Los Angeles、California、美国、90404
        • UCLA Hematology/Oncology - Santa Monica ( Site 0044)
    • Florida
      • Miami、Florida、美国、33136
        • University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051)
    • Maryland
      • Baltimore、Maryland、美国、21201
        • University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049)
    • New Jersey
      • New Brunswick、New Jersey、美国、08903-2681
        • Rutgers Cancer Institute of New Jersey ( Site 0033)
    • Ohio
      • Cleveland、Ohio、美国、44106
        • University Hospitals Cleveland Medical Center ( Site 0043)
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020)
  • 芬兰
    • Pohjanmaa
      • Vaasa、Pohjanmaa、芬兰、65130
        • Vaasan Keskussairaala ( Site 0603)
    • Uusimaa
      • Helsinki、Uusimaa、芬兰、00029
        • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0604)
      • Helsinki、Uusimaa、芬兰、00180
        • Docrates Syöpäsairaala ( Site 0602)
  • 英国
      • Birmingham、英国、B15 2TH
        • Queen Elizabeth Hospital Birmingham ( Site 1903)
    • Cambridgeshire
      • Cambridge、Cambridgeshire、英国、CB2 2QQ
        • Addenbrooke's Hospital ( Site 1902)
    • Glasgow City
      • Glasgow、Glasgow City、英国、G12 0YN
        • The Beatson West of Scotland Cancer Centre ( Site 1904)
    • Lancashire
      • Preston、Lancashire、英国、PR2 9HT
        • Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)
    • London, City of
      • London、London, City of、英国、NW1 2PG
        • University College London Hospital ( Site 1905)
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1602)
      • Madrid、西班牙、28007
        • Hospital General Universitario Gregorio Marañón ( Site 1601)
      • Madrid、西班牙、28040
        • Hospital Clinico San Carlos-Oncology Department ( Site 1604)
    • Barcelona
      • L'Hospitalet de Llobregat、Barcelona、西班牙、08908
        • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 1603)
    • Madrid, Comunidad de
      • Madrid、Madrid, Comunidad de、西班牙、28034
        • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1600)
  • 韩国
      • Seoul、韩国、03722
        • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1502)
      • Seoul、韩国、06351
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 1501)
    • Seoul
      • Songpagu、Seoul、韩国、05505
        • Asan Medical Center-Oncology ( Site 1500)

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology.
  • Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening.
  • Evidence of disease progression from either, >4 weeks from last flutamide treatment, or >6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy.
  • Current evidence of metastatic disease.
  • Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment.
  • Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for >4 weeks before randomization.
  • Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to <Grade 1 or baseline.
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load.
  • Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • History of pituitary dysfunction.
  • Poorly controlled diabetes mellitus.
  • Active or unstable cardio/cerebro-vascular disease, including thromboembolic events and history of stroke or transient ischemic attack within 6 months before the first dose of study intervention, history of myocardial infarction within 6 months before the first dose of study intervention, New York Heart Association Class III or IV cardiac disease or congestive heart failure, coronary heart disease that is symptomatic, or unstable angina
  • History or family history of long corrected QT interval (QTc) syndrome.
  • Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML.
  • History or current condition of adrenal insufficiency.
  • History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and/or complications.
  • Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention.
  • Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization).
  • Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
  • Received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities, requiring corticosteroids.
  • Received a live or live-attenuated vaccine within 30 days before the first does of study intervention. Administration of killed vaccines is allowed.
  • Diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy, or any other form of immunosuppressive therapy, within 7 days prior to the first dose of study intervention.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • Active infection requiring systemic therapy.
  • Concurrent active HBV or HCV infections.

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：随机化
  • 介入模型：并行分配
  • 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：Arm A1: Opevesostat

Participants receive 5 mg of opevesostat twice daily (BID) via oral tablet plus dexamethasone 1.5 mg by oral tablets once daily (QD) and 0.1 mg fludrocortisone acetate by oral tablet QD until progression or discontinuation.
药品：Opevesostat

Oral Tablet

其他名称：
  • MK-5684
药品：Fludrocortisone acetate

Oral Tablet

药品：Dexamethasone

Oral Tablet
实验性的：Arm A2: Olaparib + Opevesostat

Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 300 mg of olaparib BID via oral tablet until progressive disease or discontinuation.
药品：Opevesostat

Oral Tablet

其他名称：
  • MK-5684
药品：Fludrocortisone acetate

Oral Tablet

药品：Dexamethasone

Oral Tablet

药品：Olaparib

Oral Tablet

其他名称：
  • 林帕扎®
实验性的：Arm A3: Docetaxel + Opevesostat

Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 75 mg/m^2 of docetaxel once every 3 weeks (Q3W) via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation.
药品：Docetaxel

IV Infusion

其他名称：
  • 泰索帝®
药品：Opevesostat

Oral Tablet

其他名称：
  • MK-5684
药品：Fludrocortisone acetate

Oral Tablet

药品：Dexamethasone

Oral Tablet

药品：Prednisone

Oral Tablet
实验性的：Arm A4: Cabazitaxel + Opevesostat

Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 20 mg/m^2 of cabazitaxel Q3W via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation.
药品：Opevesostat

Oral Tablet

其他名称：
  • MK-5684
药品：Fludrocortisone acetate

Oral Tablet

药品：Dexamethasone

Oral Tablet

药品：Prednisone

Oral Tablet

药品：Cabazitaxel

IV Infusion

其他名称：
  • 杰夫塔纳®

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 who experience one or more dose-limiting toxicities (DLTs)
大体时间：Up to approximately 28 days

The following events, if considered drug related by the investigator, will be considered a DLT: Grade 4 nonhematologic toxicity (not laboratory value); Grade 4 hematologic toxicity lasting >7 days, except thrombocytopenia (Grade 4 thrombocytopenia of any duration, Grade 3 thrombocytopenia associated with clinically significant bleeding); Any nonhematologic adverse event (AE) >Grade 3 in severity should be considered a DLT (with exceptions); Any Grade 3 or Grade 4 nonhematologic laboratory value (if certain criteria are met); Febrile neutropenia Grade 3 or Grade 4; Prolonged delay (>2 weeks) in initiating treatment after the first 28 days due to study intervention-related toxicity; Missing >25% of study intervention doses as a result of drug-related AE(s) during the first 28 days; Grade 5 toxicity.
Up to approximately 28 days
Number of participants who experience one or more adverse events (AEs)
大体时间：Up to approximately 46 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 46 months
Number of participants who discontinue study intervention due to an AE
大体时间：Up to approximately 46 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 46 months
Prostate-specific antigen (PSA) response rate
大体时间：Up to approximately 46 months

The Prostate-specific Antigen (PSA) response rate is the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level will be confirmed by an additional PSA evaluation performed ≥3 weeks from the original response per Prostate Cancer Working Group (PCWG) criteria.
Up to approximately 46 months

次要结果测量

结果测量
措施说明
大体时间
Objective response rate (ORR)
大体时间：Up to approximately 46 months

The ORR is defined as the percentage of participants with complete response (CR: disappearance of all target lesions per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1); and no evidence of disease (NED) on base scan per Prostate Cancer Working Group (PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG). ORR will be assessed by Blinded Independent Central Review (BICR).
Up to approximately 46 months
Radiographic progression-free survival (rPFS)
大体时间：Up to approximately 46 months

rPFS is defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per modified RECIST 1.1 is ≥20% increase in the sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria is the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for ≥6 weeks. rPFS will be assessed by BICR.
Up to approximately 46 months
Overall survival (OS)
大体时间：Up to approximately 46 months

OS is defined as the time from randomization to death due to any cause.
Up to approximately 46 months
Duration of response (DOR)
大体时间：Up to approximately 46 months

DOR is defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of a least 5 mm. PD per PCWG is the appearance of >2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for >6 weeks. DOR will be assessed by BICR.
Up to approximately 46 months
Time to first subsequent anticancer therapy (TFST)
大体时间：Up to approximately 46 months

TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.
Up to approximately 46 months
Time to pain progression (TTPP)
大体时间：Up to approximately 46 months

TTPP is defined as the time from randomization to pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 "worst pain in 24 hours" and by opiate analgesic use.
Up to approximately 46 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

合作者

Orion Corporation, Orion Pharma

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)

2024年5月20日

初级完成 (估计的)

2029年1月15日

研究完成 (估计的)

2029年1月15日

研究注册日期

首次提交

2024年4月3日

首先提交符合 QC 标准的

2024年4月3日

首次发布 (实际的)

2024年4月9日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 5684-01A
  • MK-5684-01A (其他标识符：MSD)
  • U1111-1292-6912 (注册表标识符：UTN)
  • jRCT2031240224 (注册表标识符：Japan Registry of Clinical Trials (jRCT))
  • 2023-506288-33-00 (注册表标识符：EU CT)
  • 2023 (美国 NIH 拨款/合同)

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

https://trialstransparency.msdclinicaltrials.com/pdf/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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