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针对先前参加基因泰克和/或 F. Hoffman-La Roche 赞助研究的参与者的滚动研究 (UmbrellaMAX)

2026年11月3日 更新者：Hoffmann-La Roche

一项针对先前参加基因泰克和/或 F. Hoffmann-La Roche Ltd 赞助研究的患者的开放标签、多中心扩展研究

The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

200

阶段

  • 第三阶段

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。

学习联系方式

  • 姓名：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

研究联系人备份

  • 姓名：Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.
  • 电话号码：888-662-6728 (U.S. Only)
  • 邮箱：global-roche-genentech-trials@gene.com

学习地点

  • 中国
      • Beijing、中国、100142
        • 招聘中
        • Beijing Cancer Hospital
      • Changchun、中国、130021
        • 招聘中
        • the First Hospital of Jilin University
      • Chengdu、中国、610041
        • 招聘中
        • West China Hospital of Sichuan University
      • Guangzhou、中国、510515
        • 招聘中
        • Nanfang Hospital, Southern Medical University
      • Guangzhou、中国、510000
        • 招聘中
        • Cancer Center of Guangzhou Medical University
      • Hangzhou、中国、310022
        • 招聘中
        • Zhejiang Cancer Hospital
      • Hangzhou、中国、310014
        • 招聘中
        • Zhejiang People's Hospital
      • Hangzhou、中国、310016
        • 招聘中
        • Sir Run Run Shaw Hospital Zhejiang University
      • Harbin、中国、150081
        • 招聘中
        • Harbin Medical University Cancer Hospital
      • Hefei、中国、230601
        • 招聘中
        • The Second Affiliated Hospital of Anhui Medical University
      • Meizhou、中国、514031
        • 招聘中
        • Meizhou People's Hospital
      • Nanchang、中国、330052
        • 招聘中
        • The 1st Affiliated Hospital of Nanchang Unversity
      • Nanjing、中国、210029
        • 招聘中
        • Jiangsu Province Hospital of Chinese Medicine
      • Shanghai、中国、200030
        • 招聘中
        • Shanghai Chest Hospital
      • Shanghai、中国、200120
        • 招聘中
        • Fudan University Shanghai Cancer Center
      • Shanghai、中国、201104
        • 招聘中
        • Shanghai Geriatric Medical Center
      • Tianjin、中国、300060
        • 招聘中
        • Tianjin Cancer Hospital
      • Xi'an、中国、710061
        • 招聘中
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
      • Xi'an、中国、710126
        • 招聘中
        • Xi'an International Medical Center Hospital
      • Xiamen、中国、361003
        • 招聘中
        • The First Affiliated Hospital of Xiamen University
      • Xinxiang、中国
        • 招聘中
        • The First Affiliated Hospital of Xinxiang Medical University
      • Zhengzhou、中国、450008
        • 招聘中
        • Henan Cancer Hospital
    • Hubei
      • Wuhan、Hubei、中国、430048
        • 招聘中
        • Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
    • Shaanxi
      • XI 'an City, Shaanxi Province、Shaanxi、中国、710061
        • 招聘中
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200032
        • 招聘中
        • Fudan University Shanghai Cancer Center
  • 乌克兰
      • Kyiv、乌克兰、02000
        • 招聘中
        • Arensia Exploratory Medicine - Ukraine
  • 俄罗斯
    • Moscow Oblast
      • Moscow、Moscow Oblast、俄罗斯、117997
        • 主动，不招人
        • Russian Scientific Center of Roentgenoradiology
      • Moscow、Moscow Oblast、俄罗斯、125248
        • 招聘中
        • P.A. Herzen Oncological Inst.
      • Moscow、Moscow Oblast、俄罗斯、121205
        • 招聘中
        • Moscow City Oncology Hospital #62
      • Moskva、Moscow Oblast、俄罗斯、119991
        • 招聘中
        • I.M.Sechenov First Moscow State Medical University (1st MSMU)
  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M5G 1Z5
        • 招聘中
        • Princess Margaret Cancer Center
  • 台湾
      • Taichung、台湾、407
        • 招聘中
        • Taichung Veterans General Hospital
      • Tainan、台湾、70457
        • 招聘中
        • National Cheng Kung University Hospital
      • Taipei、台湾、110
        • 招聘中
        • National Taiwan University Hospital
      • Taoyuan、台湾、333
        • 主动，不招人
        • Chang Gung Memorial Hospital - Linkou
  • 哥斯达黎加
      • San José、哥斯达黎加、10103
        • 主动，不招人
        • Clinica CIMCA
      • San José、哥斯达黎加、10108
        • 主动，不招人
        • ICIMED Instituto de Investigación en Ciencias Médicas
  • 墨西哥
      • Durango、墨西哥、34000
        • 主动，不招人
        • Consultorio de Especialidad en Urologia Privado
    • Sinaloa
      • Culiacán、Sinaloa、墨西哥
        • 主动，不招人
        • Centro Medico Culiacan SA de CV
    • Yucatán
      • Mérida、Yucatán、墨西哥、97070
        • 完全的
        • Medical Care & Research
  • 希腊
      • Asvestochóri、希腊、570 10
        • 招聘中
        • General Hospital "G.Papanikolaou"
      • Cholargós、希腊、155 62
        • 招聘中
        • Metropolitan General Hospital
  • 日本
      • Chiba、日本、277-8577
        • 招聘中
        • National Cancer Center Hospital East
      • Chuo-ku, Fukuoka-shi、日本、810-8563
        • 招聘中
        • National Hospital Organization Kyushu Medical Center
      • Fukuoka、日本、812-8582
        • 招聘中
        • Kyushu University Hospital
      • Kanagawa、日本、232-0024
        • 主动，不招人
        • Yokohama City University Medical Center
      • Kanagawa、日本、241-8515
        • 完全的
        • Kanagawa Cancer Center
      • Kanagawa、日本、213-8587
        • 招聘中
        • Toranomon Branch Hospital
      • Kashiwa-shi、日本、277-8577
        • 招聘中
        • National Cancer Center Hospital East
      • Matsuyama、日本、791-0280
        • 招聘中
        • National Hospital Organization Shikoku Cancer Center
      • Numakunai、日本、028-3695
        • 招聘中
        • Iwate Medical University Hospital
      • Saitama、日本、362-0806
        • 招聘中
        • Saitama Cancer Center
      • Sakaishi、日本、591-8555
        • 招聘中
        • NHO Kinki-Chuo Chest Medical Center
  • 比利时
      • Charleroi、比利时、6060
        • 完全的
        • GHdC Site Les Viviers
      • Kortrijk、比利时、8500
        • 主动，不招人
        • AZ Groeninge
      • Leuven、比利时、3000
        • 主动，不招人
        • UZ Leuven Gasthuisberg
      • Leuven、比利时、3000
        • 完全的
        • UZ Leuven Gasthuisberg
  • 法国
      • Bordeaux、法国、33076
        • 招聘中
        • Institut Bergonie
      • Caen、法国、14076
        • 招聘中
        • Centre Francois Baclesse
      • Dijon、法国、21000
        • 招聘中
        • Institut de Cancérologie de Bourgogne
      • Lyon、法国、69373
        • 招聘中
        • Centre Leon Berard
      • Marseille、法国、13005
        • 招聘中
        • Hopital de la Timone
      • Montpellier、法国、34298
        • 招聘中
        • Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
      • Nantes、法国、44093
        • 招聘中
        • CHU de Nantes - Hotel Dieu
      • Nîmes、法国、30029
        • 完全的
        • Institut de cancerologie du Gard
      • Paris、法国、75005
        • 招聘中
        • Institut Curie
      • Paris、法国、75970
        • 招聘中
        • Hopital Tenon
      • Saint-Herblain、法国、44805
        • 招聘中
        • ICO - Site René Gauducheau
      • Toulouse、法国、31059
        • 招聘中
        • Institut Claudius Regaud
      • Vandœuvre-lès-Nancy、法国、54511
        • 招聘中
        • Hopitaux de Brabois - Gastro-Entereologie
      • Villejuif、法国、94800
        • 招聘中
        • Gustave Roussy
    • Bouches-du-Rhône
      • Marseille、Bouches-du-Rhône、法国、13005
        • 招聘中
        • AP-HM- Hôpital de La Timone
  • 波兰
      • Gda?sk、波兰、80-214
        • 招聘中
        • Uniwersyteckie Centrum Kliniczne
      • Koszalin、波兰、75-581
        • 招聘中
        • Szpital Wojewódzki im. Miko?aja Kopernika
      • Warsaw、波兰、02-781
        • 招聘中
        • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
  • 泰国
      • Bangkok、泰国、10700
        • 招聘中
        • Siriraj Hospital
      • Bangkok、泰国、10330
        • 主动，不招人
        • Chulalongkorn Hospital
      • Chiang Mai、泰国、50200
        • 主动，不招人
        • Maharaj Nakorn Chiangmai Hospital
  • 英国
      • Leicester、英国、LE1 5WW
        • 招聘中
        • Leicester Royal Infirmary
      • Surrey、英国、SM2 5PT
        • 完全的
        • Royal Marsden Hospital - Surrey
  • 韩国
      • Goyang-si、韩国、10408
        • 招聘中
        • National Cancer Center
      • Gyeonggi-do、韩国、13496
        • 招聘中
        • CHA Bundang Medical Center
      • Seongnam-si、韩国、463-707
        • 完全的
        • Seoul National University Bundang Hospital
      • Seoul、韩国、06351
        • 招聘中
        • Samsung Medical Center
      • Seoul、韩国、05505
        • 主动，不招人
        • Asan Medical Center

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

  • 孩子
  • 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:

  • Eligible for continuing Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol OR
  • Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
  • First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
  • Continue to benefit from the Roche IMP-based therapy or comparator at the time of roll-over from the parent study as assessed by the investigator
  • Ability to comply with the extension study protocol, per Investigator's judgement

Exclusion Criteria:

  • Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
  • Study treatment or comparator agent is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant
  • Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study
  • Permanent discontinuation of all study treatment(s) or comparator agent(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
  • Ongoing SAE(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study. Potential participants with an ongoing SAE that has not resolved to baseline level or Grade 1 may be enrolled at the investigator's discretion, provided the event is deemed clinically stable and the investigator documents that the potential clinical benefit outweighs the risk to the potential participant.
  • Concurrent participation in any therapeutic clinical trial (other than the parent study)

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：非随机化
  • 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：Roche IMP(s) Monotherapy

Participants will continue to receive Roche IMP(s) monotherapy as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first.
药品：Ipatasertib

Ipatasertib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

其他名称：
  • RO5532961
药品：Atezolizumab

Atezolizumab will be administered as a monotherapy and in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants' discontinuation from the parent study.

其他名称：
  • RO5541267
药品：Bevacizumab

Bevacizumab will be administered as a monotherapy or in combination with atezolizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

其他名称：
  • RO4876646
药品：Entrectinib

Entrectinib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

其他名称：
  • RO7102122
药品：Inavolisib

Inavolisib will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

其他名称：
  • RO7113755
药品：Divarasib

Divarasib will be administered as a monotherapy or in combination with atezolizumab or bevacizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

其他名称：
  • RO7435846
药品：Giredestrant

Giredestrant will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

其他名称：
  • RO7197597
实验性的：Roche Combined Agents

Participants will continue to receive Roche IMP(s) in combination with other agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first.
药品：Atezolizumab

Atezolizumab will be administered as a monotherapy and in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants' discontinuation from the parent study.

其他名称：
  • RO5541267
药品：Bevacizumab

Bevacizumab will be administered as a monotherapy or in combination with atezolizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

其他名称：
  • RO4876646
药品：Inavolisib

Inavolisib will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

其他名称：
  • RO7113755
药品：Divarasib

Divarasib will be administered as a monotherapy or in combination with atezolizumab or bevacizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

其他名称：
  • RO7435846
药品：Tiragolumab

Tiragolumab in combination with atezolizumab will be administered at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

其他名称：
  • RO7092284
药品：Tiragolumab and Atezolizumab

Tiragolumab and Atezolizumab in fixed dose combination administered intravenously (IV) at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

其他名称：
  • RO7538483
药品：Giredestrant

Giredestrant will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

其他名称：
  • RO7197597

研究衡量的是什么？

主要结果指标

结果测量
大体时间
继续使用基于罗氏 IMP 的治疗和/或比较剂的参与者人数
大体时间：最长约 10 年
最长约 10 年
根据美国国家癌症研究所不良事件通用术语标准 (NCI CTCAE) 5.0 版评估患有选定不良事件的参与者的数量和严重程度
大体时间：最长约10年
最长约10年

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

Hoffmann-La Roche

调查人员

  • 研究主任：Clinical Trials、Hoffmann-La Roche

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)

2023年6月1日

初级完成 (估计的)

2033年3月1日

研究完成 (估计的)

2033年3月1日

研究注册日期

首次提交

2023年5月1日

首先提交符合 QC 标准的

2023年5月16日

首次发布 (实际的)

2023年5月17日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月3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

  • BX44273
  • 2022-003414-36 (EudraCT编号)
  • 2023 (美国 NIH 拨款/合同)
  • 2023-504263-16-00 (克蒂斯)

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

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

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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