A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study (UmbrellaMAX)

September 1, 2026 updated by: Hoffmann-La Roche

An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Study Locations

  • Belgium
      • Charleroi, Belgium, 6060
        • Completed
        • GHdC Site Les Viviers
      • Kortrijk, Belgium, 8500
        • Active, not recruiting
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • Completed
        • UZ Leuven Gasthuisberg
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Recruiting
        • Princess Margaret Cancer Center
  • China
      • Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
      • Changchun, China, 130021
        • Recruiting
        • The First hospital of Jilin University
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
      • Guangzhou, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
      • Guangzhou, China, 510000
        • Recruiting
        • Cancer Center of Guangzhou Medical University
      • Hangzhou, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
      • Hangzhou, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital Zhejiang University
      • Harbin, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
      • Hefei, China, 230601
        • Recruiting
        • The Second Affiliated Hospital of Anhui Medical University
      • Meizhou, China, 514031
        • Recruiting
        • Meizhou People's Hospital
      • Nanchang, China, 330052
        • Recruiting
        • The 1st Affiliated Hospital of Nanchang Unversity
      • Nanjing, China, 210029
        • Recruiting
        • Jiangsu Province Hospital of Chinese Medicine
      • Shanghai, China, 200120
        • Recruiting
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 201104
        • Recruiting
        • Shanghai Geriatric Medical Center
      • Tianjin, China, 300060
        • Recruiting
        • Tianjin Cancer Hospital
      • Xiamen, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
      • Xinxiang, China
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical University
      • Zhengzhou, China, 450008
        • Recruiting
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430048
        • Recruiting
        • Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
    • Shaanxi
      • XI 'an City, Shaanxi Province, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
  • Costa Rica
      • San José, Costa Rica, 10103
        • Active, not recruiting
        • Clinica CIMCA
      • San José, Costa Rica, 10108
        • Active, not recruiting
        • ICIMED Instituto de Investigación en Ciencias Médicas
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Institut Bergonie
      • Caen, France, 14076
        • Recruiting
        • Centre Francois Baclesse
      • Dijon, France, 21000
        • Recruiting
        • Institut de Cancérologie de Bourgogne
      • Lyon, France, 69373
        • Recruiting
        • Centre Leon Berard
      • Marseille, France, 13005
        • Recruiting
        • Hopital de la Timone
      • Montpellier, France, 34298
        • Recruiting
        • Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
      • Nîmes, France, 30029
        • Completed
        • Institut de cancerologie du Gard
      • Paris, France, 75005
        • Recruiting
        • Institut Curie
      • Paris, France, 75970
        • Recruiting
        • Hôpital Tenon
      • Saint-Herblain, France, 44805
        • Recruiting
        • ICO - Site René Gauducheau
      • Toulouse, France, 31059
        • Recruiting
        • Institut Claudius Regaud
      • Villejuif, France, 94800
        • Recruiting
        • Gustave Roussy
  • Greece
      • Asvestochóri, Greece, 570 10
        • Recruiting
        • General Hospital "G.Papanikolaou"
      • Cholargós, Greece, 155 62
        • Recruiting
        • Metropolitan General Hospital
  • Japan
      • Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
      • Kanagawa, Japan, 232-0024
        • Active, not recruiting
        • Yokohama City University Medical Center
      • Kanagawa, Japan, 241-8515
        • Completed
        • Kanagawa Cancer Center
      • Kanagawa, Japan, 213-8587
        • Recruiting
        • Toranomon Branch Hospital
      • Kashiwa-shi, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
      • Saitama, Japan, 362-0806
        • Recruiting
        • Saitama Cancer Center
      • Sakaishi, Japan, 591-8555
        • Recruiting
        • NHO Kinki-Chuo Chest Medical Center
  • Mexico
      • Durango, Mexico, 34000
        • Active, not recruiting
        • Consultorio de Especialidad en Urologia Privado
    • Sinaloa
      • Culiacán, Sinaloa, Mexico
        • Active, not recruiting
        • Centro Medico Culiacan SA de CV
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Completed
        • Medical Care & Research
  • Poland
      • Gda?sk, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
      • Koszalin, Poland, 75-581
        • Recruiting
        • Szpital Wojewódzki im. Miko?aja Kopernika
      • Warsaw, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
  • Russia
    • Moscow Oblast
      • Moscovskaya Oblast, Moscow Oblast, Russia, 143423
        • Recruiting
        • Moscow City Oncology Hospital #62
      • Moscow, Moscow Oblast, Russia, 117997
        • Active, not recruiting
        • Russian Scientific Center of Roentgenoradiology
      • Moscow, Moscow Oblast, Russia, 125248
        • Recruiting
        • P.A. Herzen Oncological Inst.
  • South Korea
      • Goyang-si, South Korea, 10408
        • Recruiting
        • National Cancer Center
      • Gyeonggi-do, South Korea, 13496
        • Recruiting
        • CHA Bundang Medical Center
      • Seongnam-si, South Korea, 463-707
        • Completed
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 05505
        • Active, not recruiting
        • Asan Medical Center
  • Taiwan
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 70457
        • Recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 110
        • Recruiting
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Active, not recruiting
        • Chang Gung Memorial Hospital - Linkou
  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
      • Bangkok, Thailand, 10330
        • Active, not recruiting
        • Chulalongkorn Hospital
      • Chiang Mai, Thailand, 50200
        • Active, not recruiting
        • Maharaj Nakorn Chiangmai Hospital
  • Ukraine
      • Kyiv, Ukraine, 02000
        • Recruiting
        • Arensia Exploratory Medicine - Ukraine
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • Leicester Royal Infirmary
      • Surrey, United Kingdom, SM2 5PT
        • Completed
        • Royal Marsden Hospital - Surrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • Concurrent participation in any therapeutic clinical trial (other than the parent study)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: 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.
Other Names:
  • RO5532961
Drug: 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.
Other Names:
  • RO5541267
Drug: 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.
Other Names:
  • RO4876646
Drug: 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.
Other Names:
  • RO7102122
Drug: 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.
Other Names:
  • RO7113755
Drug: 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.
Other Names:
  • RO7435846
Experimental: 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.
Drug: 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.
Other Names:
  • RO7092284
Drug: 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.
Other Names:
  • RO5541267
Drug: 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.
Other Names:
  • RO4876646
Drug: 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.
Other Names:
  • RO7113755
Drug: 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.
Other Names:
  • RO7538483
Drug: 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.
Other Names:
  • RO7435846

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)
Time Frame: Up to approximately 10 years
Up to approximately 10 years
Number and Severity of Participants With Selected Adverse Events Assessed as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0
Time Frame: Up to approximately 10 years
Up to approximately 10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number and Severity of Participants With Selected Adverse Events Assessed as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0
Time Frame: Up to approximately 10 years
Up to approximately 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2033

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BX44273
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2022-003414-36 (EudraCT Number)
  • 2023-504263-16-00 (Ctis: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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