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CancerPhase 3IMbrella BNCT03768063

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

A Phase 3 study testing Atezolizumab, Bevacizumab and Alectinib in people with Cancer, run by Hoffmann-La Roche at 80 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Atezolizumab, Bevacizumab and Alectinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
80 sitesin 24 countries
Study dates
28 Feb 2019to 5 Jul 2028
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible for continuing atezolizumab-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
  • Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. 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 atezolizumab-based study treatment or from the comparator at the time of roll-over from the parent study as assessed by the investigator
  • Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
  • For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

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 patient's country for the patient-specific disease and is accessible to the patient
  • Treatment with any anti-cancer treatment during the time between last treatment in the parent study and the first dose of study treatment in this extension study
  • Permanent discontinuation of atezolizumab 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). Exception: Participants who permanently discontinued atezolizumab from parent studies that permit participants to continue treatment with the combination agent(s) alone after permanently discontinuing atezolizumab are eligible to enroll in this study.
  • Ongoing serious adverse event(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
  • Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
  • Concurrent participation in any therapeutic clinical trial (other than the parent study)
  • Pregnant or lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment specified in the designated referenced safety information (RSI)

Trial locations and contacts

80 sites in 24 countries.

80 sites in 24 countries

Germany12 sites

  • Kliniken Essen-Mitte

    Essen, 45136

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Asklepios-Fachklinik Muenchen-Gauting

    Gauting, 82131

  • SRH Wald-Klinikum Gera

    Gera, 07548

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Universitätsklinikum Schleswig-Holstein;Campus Lübeck

    Lübeck, Schleswig-Holstein, 23538

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Krankenhaus Barmherzige Bruder Regensburg

    Regensburg, Bavaria, 93049

  • Universitaets-Hautklinik Tuebingen

    Tübingen, 72076

  • Universitaettsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinik Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Japan11 sites

  • Nagoya University Hospital

    Aichi, 466-8560

  • National Hospital Organization Shikoku Cancer Center

    Ehime, 791-0280

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • University of Tsukuba Hospital

    Ibaraki, 305-8576

  • Kanazawa University Hospital

    Ishikawa, 920-8641

  • Sendai Kousei Hospital

    Miyagi, 981-0914

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Osaka Habikino Medical Center

    Osaka, 583-8588

  • NHO Kinki-Chuo Chest Medical Center

    Sakaishi, 591-8555

Other trials in Japan

United States7 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • St. Luke's Cancer Care Associates

    Bethlehem, Pennsylvania, 18015

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Carolina BioOncology Institute, PLCC

    Huntersville, North Carolina, 28078

  • University of Texas Health Sciences Center in San Antonio

    San Antonio, Texas, 78229

  • Yale University School Of Medicine

    Trumbull, Connecticut, 06611

Other trials in United States

Poland7 sites

  • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

    Brzozów, 36-200

  • Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

    Otwock, 05-400

  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy

    Otwock, 05-400

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Pozna?, Greater Poland Voivodeship, 60-569

  • Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

    Warsaw, 02-781

  • Dolnoslaskie Centrum Onkologii

    Wroc?aw, 53-412

Other trials in Poland

France5 sites

  • CHU Angers

    Angers, Pays de la Loire Region, 49933

  • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

    Lille, 59037

  • hopital de la Timone

    Marseille, 13005

  • Centre Antoine Lacassagne

    Nice, Provence-Alpes-Côte d'Azur Region, 06189

  • Institut Gustave Roussy

    Villejuif, Île-de-France Region, 94805

Other trials in France

South Korea5 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center, Uni Ulsan Collegemedicine

    Seoul, 138-736

  • Samsung Medical Center

    Seoul, 6351

  • Seoul National University College of Medicine, Liver Research Institute

    Seoul

Other trials in South Korea

Ukraine5 sites

  • Communal Non profit Enterprise Regional Center of Oncology

    Kharkiv, Kharkiv Governorate, 61070

  • National Cancer Institute MOH of Ukraine

    Kiev, 36022

  • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council

    Kryvyi Rih, 50048

  • Volyn Regional Oncology Dispensary

    Lutsk, 43018

  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

    Sumy, 40022

Other trials in Ukraine

Romania4 sites

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca

    Cluj-Napoca, 400015

  • Centrul de Oncologie Sfantul Nectarie

    Craiova, 200347

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Centrul de Oncologie Oncohelp

    Timișoara, 300239

Other trials in Romania

Belgium3 sites

  • Institut Jules Bordet

    Brussels, 1000

  • UZ Brussel

    Brussels, 1090

  • UZ Leuven

    Leuven, Flemish Brabant, 3000

Other trials in Belgium

Greece3 sites

  • Laiko General Hospital Athen

    Athens, 115 27

  • Anticancer Hospital Ag. Savas

    Athens, 11522

  • Metropolitan Hospital

    Piraeus, Attica, 18547

Other trials in Greece

Russia3 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, Arhangelsk, 163045

  • Russian Oncology Research Center n.a. N.N. Blokhin

    Moscow, Moscow Oblast, 115478

  • P.A. Herzen Oncological Inst.

    Moscow, Moscow Oblast, 125248

Other trials in Russia

Spain3 sites

  • Hospital Universitario Quiron Dexeus

    Barcelona, 08028

  • Clinica Universidad de Navarra-Madrid

    Madrid, 28027

  • Hospital Universitario Madrid Sanchinarro

    Madrid, 28050

Other trials in Spain

Australia1 site

  • St Vincent'S Hospital

    Darlinghurst, New South Wales, 2010

Other trials in Australia

Brazil1 site

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul

Other trials in Brazil

Bulgaria1 site

  • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

    Plovdiv, 4004

Other trials in Bulgaria

Chile1 site

  • Pontificia Universidad Catolica de Chile

    Santiago, 8330032

Other trials in Chile

Czechia1 site

  • Masaryk?v onkologický ústav

    Brno, 656 53

Other trials in Czechia

Denmark1 site

  • Rigshospitalet

    København Ø, 2100

Other trials in Denmark

Guatemala1 site

  • Grupo Angeles

    Guatemala City, 01015

Other trials in Guatemala

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Hungary1 site

  • Szegedi Tudományegyetem

    Szeged

Other trials in Hungary

Italy1 site

  • Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

Other trials in Italy

Mexico1 site

  • Phylasis Clinicas Research S de RL de CV

    Toluca, 50090

Other trials in Mexico

Thailand1 site

  • Faculty of Med. Siriraj Hosp.

    Bangkok, 10700

Other trials in Thailand

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 Atezolizumab Study (IMbrella B)

This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.

Conditions
Cancer
Being tested
Atezolizumab, Bevacizumab, Alectinib, Cobimetinib, Vemurafenib
Medical subject headings
Neoplasms

What participants receive

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

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W).

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab will be administered as directed per the parent study.

  • AlectinibDrug

    Also called Alecensa

    Alectinib will be administered as directed per the parent study.

  • CobimetinibDrug

    Also called Cotellic

    Cobimetinib will be administered as directed per the parent study.

  • VemurafenibDrug

    Also called Zelboraf

    Vemurafenib will be administered as directed per the parent study.

  • FAP IL2VDrug

    Also called simlukafusp alfa

    FAP IL2V will be administered as directed per the parent study.

  • VenetoclaxDrug

    Also called Venclexta

    Venetoclax will be administered as directed per the parent study.

  • EnzalutamideDrug

    Also called Xtandi

    Enzalutamide will be administered as directed per the parent study.

  • PembrolizumabDrug

    Also called Keytruda

    Pembrolizumab will be administered as directed per the parent study.

  • SunitinibDrug

    Also called Sutent

    Sunitinib will be administered as directed per the parent study.

  • NiraparibDrug

    Also called Zejula

    Niraparib will be administered as directed per the parent study.

  • CabozantinibDrug

    Also called Cometriq

    Cabozantinib will be administered as directed per the parent study.

  • PemetrexedDrug

    Pemetrexed will be administered as directed per the parent study.

  • PaclitaxelDrug

    Paclitaxel will be administered as directed per the parent study.

  • EmactuzumabDrug

    Emactuzumab will be administered as directed per the parent study.

  • RucaparibDrug

    Rucaparib will be administered as directed per the parent study.

Study groups in NCT03768063
Study groupRoleWhat they receive
Atezolizumab MonotherapyExperimentalParticipants will receive atezolizumab by intravenous infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Receives: Drug: Atezolizumab
Combined Agents with AtezolizumabExperimentalParticipants will receive treatment of atezolizumab with combined agent(s) as directed per the parent study. Participants will receive agent(s) in combination with atezolizumab at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Alectinib; Drug: Cobimetinib; Drug: Vemurafenib; Drug: FAP IL2V; Drug: Venetoclax; Drug: Enzalutamide; Drug: Niraparib; Drug: Cabozantinib; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Emactuzumab; Drug: Rucaparib
Comparator TreatmentActive comparatorParticipants will receive comparator treatment administration as directed per the parent study. Participants will receive comparator treatment at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
Receives: Drug: Cobimetinib; Drug: Vemurafenib; Drug: Venetoclax; Drug: Enzalutamide; Drug: Pembrolizumab; Drug: Sunitinib; Drug: Niraparib; Drug: Pemetrexed; Drug: Paclitaxel

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 Atezolizumab-Based Therapy and/or Comparator Agent(s)

    Measured: Day 1 up to maximum 10 years

Secondary outcomes (5)

  1. Percentage of Participants With Serious Adverse Events (SAEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    Measured: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)

  2. Percentage of Participants With Adverse Events of Special Interest Determined According to NCI CTCAE Version 5.0

    Measured: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)

  3. Treatment Duration

    Measured: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)

  4. Total Dose Received

    Measured: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)

  5. Number of Treatment Cycles

    Measured: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 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 posted7 Dec 2018
  2. Study start28 Feb 2019
  3. Primary completion5 Jul 2028 (estimated)
  4. Study completion5 Jul 2028 (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
Not applicable
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03768063
Sponsor's protocol ID
BO40729
Other IDs
2023-506184-34-00, 2023
Acronym
IMbrella B
Status last verified
Oct 2026
First submitted
30 Nov 2018
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
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 Atezolizumab, Bevacizumab and Alectinib in people with Cancer, run by Hoffmann-La Roche at 80 sites in 24 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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 22 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 80 sites in Germany, Japan, United States, Poland, France and 19 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s) (time frame: Day 1 up to maximum 10 years). 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 NCT03768063.

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 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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