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CancerPhase 3UmbrellaMAXNCT05862285

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

A Phase 3 study testing Ipatasertib, Tiragolumab and Atezolizumab in people with Cancer, run by Hoffmann-La Roche at 77 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Cancer
What is being tested?
Ipatasertib, Tiragolumab and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
77 sitesin 15 countries
Study dates
1 Jun 2023to 1 Mar 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

77 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

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

77 sites in 15 countries

China23 sites, 23 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Recruiting

  • the First Hospital of Jilin University

    Changchun, 130021

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, 610041

    Recruiting

  • Cancer Center of Guangzhou Medical University

    Guangzhou, 510000

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515

    Recruiting

  • Zhejiang People's Hospital

    Hangzhou, 310014

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

    Recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, 230601

    Recruiting

  • Meizhou People's Hospital

    Meizhou, 514031

    Recruiting

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330052

    Recruiting

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, 210029

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

    Recruiting

  • Shanghai Geriatric Medical Center

    Shanghai, 201104

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, 300060

    Recruiting

  • Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology

    Wuhan, Hubei, 430048

    Recruiting

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    XI 'an City, Shaanxi Province, Shaanxi, 710061

    Recruiting

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, 450008

    Recruiting

Other trials in China

France14 sites, 13 recruiting

  • Institut Bergonie

    Bordeaux, 33076

    Recruiting

  • Centre Francois Baclesse

    Caen, 14076

    Recruiting

  • Institut de Cancérologie de Bourgogne

    Dijon, 21000

    Recruiting

  • Centre Leon Berard

    Lyon, 69373

    Recruiting

  • AP-HM- Hôpital de La Timone

    Marseille, Bouches-du-Rhône, 13005

    Recruiting

  • Hopital de la Timone

    Marseille, 13005

    Recruiting

  • Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

    Montpellier, 34298

    Recruiting

  • CHU de Nantes - Hotel Dieu

    Nantes, 44093

    Recruiting

  • Institut de cancerologie du Gard

    Nîmes, 30029

    Completed

  • Institut Curie

    Paris, 75005

    Recruiting

  • Hopital Tenon

    Paris, 75970

    Recruiting

  • ICO - Site René Gauducheau

    Saint-Herblain, 44805

    Recruiting

  • Institut Claudius Regaud

    Toulouse, 31059

    Recruiting

  • Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Japan8 sites, 6 recruiting

  • National Cancer Center Hospital East

    Chiba, 277-8577

    Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582

    Recruiting

  • Toranomon Branch Hospital

    Kanagawa, 213-8587

    Recruiting

  • Yokohama City University Medical Center

    Kanagawa, 232-0024

    Active, not recruiting

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

    Completed

  • National Cancer Center Hospital East

    Kashiwa-shi, 277-8577

    Recruiting

  • Saitama Cancer Center

    Saitama, 362-0806

    Recruiting

  • NHO Kinki-Chuo Chest Medical Center

    Sakaishi, 591-8555

    Recruiting

Other trials in Japan

South Korea5 sites, 3 recruiting

  • National Cancer Center

    Goyang-si, 10408

    Recruiting

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

    Completed

  • Asan Medical Center

    Seoul, 05505

    Active, not recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

Other trials in South Korea

Taiwan4 sites, 3 recruiting

  • Taichung Veterans General Hospital

    Taichung, 407

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 70457

    Recruiting

  • National Taiwan University Hospital

    Taipei, 110

    Recruiting

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan, 333

    Active, not recruiting

Other trials in Taiwan

Belgium3 sites

  • GHdC Site Les Viviers

    Charleroi, 6060

    Completed

  • AZ Groeninge

    Kortrijk, 8500

    Active, not recruiting

  • UZ Leuven Gasthuisberg

    Leuven, 3000

    Completed

Other trials in Belgium

Mexico3 sites

  • Centro Medico Culiacan SA de CV

    Culiacán, Sinaloa

    Active, not recruiting

  • Consultorio de Especialidad en Urologia Privado

    Durango, 34000

    Active, not recruiting

  • Medical Care & Research

    Mérida, Yucatán, 97070

    Completed

Other trials in Mexico

Poland3 sites, 3 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214

    Recruiting

  • Szpital Wojewódzki im. Miko?aja Kopernika

    Koszalin, 75-581

    Recruiting

  • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie

    Warsaw, 02-781

    Recruiting

Other trials in Poland

Russia3 sites, 2 recruiting

  • Russian Scientific Center of Roentgenoradiology

    Moscow, Moscow Oblast, 117997

    Active, not recruiting

  • Moscow City Oncology Hospital #62

    Moscow, Moscow Oblast, 121205

    Recruiting

  • P.A. Herzen Oncological Inst.

    Moscow, Moscow Oblast, 125248

    Recruiting

Other trials in Russia

Thailand3 sites, 1 recruiting

  • Chulalongkorn Hospital

    Bangkok, 10330

    Active, not recruiting

  • Siriraj Hospital

    Bangkok, 10700

    Recruiting

  • Maharaj Nakorn Chiangmai Hospital

    Chiang Mai, 50200

    Active, not recruiting

Other trials in Thailand

Costa Rica2 sites

  • Clinica CIMCA

    San José, 10103

    Active, not recruiting

  • ICIMED Instituto de Investigación en Ciencias Médicas

    San José, 10108

    Active, not recruiting

Other trials in Costa Rica

Greece2 sites, 2 recruiting

  • General Hospital "G.Papanikolaou"

    Asvestochóri, 570 10

    Recruiting

  • Metropolitan General Hospital

    Cholargós, 155 62

    Recruiting

Other trials in Greece

United Kingdom2 sites, 1 recruiting

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

    Recruiting

  • Royal Marsden Hospital - Surrey

    Surrey, SM2 5PT

    Completed

Other trials in United Kingdom

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5

    Recruiting

Other trials in Canada

Ukraine1 site, 1 recruiting

  • Arensia Exploratory Medicine - Ukraine

    Kyiv, 02000

    Recruiting

Other trials in Ukraine

About this study

Official title: 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.

Conditions
Cancer
Being tested
Ipatasertib, Tiragolumab, Atezolizumab, Tiragolumab and Atezolizumab, Bevacizumab
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IpatasertibDrug

    Also called RO5532961

    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.

  • TiragolumabDrug

    Also called RO7092284

    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.

  • AtezolizumabDrug

    Also called RO5541267

    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.

  • Tiragolumab and AtezolizumabDrug

    Also called RO7538483

    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.

  • BevacizumabDrug

    Also called RO4876646

    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.

  • EntrectinibDrug

    Also called RO7102122

    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.

  • InavolisibDrug

    Also called RO7113755

    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.

  • DivarasibDrug

    Also called RO7435846

    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.

Study groups in NCT05862285
Study groupRoleWhat they receive
Roche IMP(s) MonotherapyExperimentalParticipants 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.
Receives: Drug: Ipatasertib; Drug: Atezolizumab; Drug: Bevacizumab; Drug: Entrectinib; Drug: Inavolisib; Drug: Divarasib
Roche Combined AgentsExperimentalParticipants 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.
Receives: Drug: Tiragolumab; Drug: Atezolizumab; Drug: Tiragolumab and Atezolizumab; Drug: Bevacizumab; Drug: Inavolisib; Drug: Divarasib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)

    Measured: Up to approximately 10 years

  2. 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

    Measured: Up to approximately 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2023
  2. Study start1 Jun 2023
  3. Primary completion1 Mar 2033 (estimated)
  4. Study completion1 Mar 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05862285
Sponsor's protocol ID
BX44273
Other IDs
2022-003414-36, 2023-504263-16-00, 2023
Acronym
UmbrellaMAX
Status last verified
Oct 2026
First submitted
1 May 2023
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ipatasertib, Tiragolumab and Atezolizumab in people with Cancer, run by Hoffmann-La Roche at 77 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in China, France, Japan, South Korea, Taiwan and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s) (time frame: Up to approximately 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05862285.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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