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

April 27, 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 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • 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 Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital
  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium, 1090
        • UZ Brussel
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • UZ Leuven
  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Hospital das Clinicas - UFRGS
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
  • Chile
      • Santiago, Chile, 8330032
        • Pontificia Universidad Catolica de Chile
  • Czechia
      • Brno, Czechia, 656 53
        • Masaryk?v onkologický ústav
  • Denmark
      • København Ø, Denmark, 2100
        • Rigshospitalet
  • France
      • Lille, France, 59037
        • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
      • Marseille, France, 13005
        • Hopital de la Timone
    • Pays de la Loire Region
      • Angers, Pays de la Loire Region, France, 49933
        • CHU Angers
    • Provence-Alpes-Côte d'Azur Region
      • Nice, Provence-Alpes-Côte d'Azur Region, France, 06189
        • Centre Antoine Lacassagne
    • Île-de-France Region
      • Villejuif, Île-de-France Region, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Essen, Germany, 45136
        • Kliniken Essen-Mitte
      • Freiburg im Breisgau, Germany, 79106
        • Universitatsklinikum Freiburg
      • Gauting, Germany, 82131
        • Asklepios-Fachklinik Muenchen-Gauting
      • Gera, Germany, 07548
        • SRH Wald-Klinikum Gera
      • Hamburg, Germany, 22767
        • HOPA MVZ GmbH
      • Immenhausen, Germany, 34376
        • Lungenfachklinik Immenhausen
      • Münster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Tübingen, Germany, 72076
        • Universitaettsklinikum Tübingen
      • Tübingen, Germany, 72076
        • Universitätsklinik Tübingen
      • Tübingen, Germany, 72076
        • Universitaets-Hautklinik Tuebingen
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitatsklinikum Ulm
    • Bavaria
      • Regensburg, Bavaria, Germany, 93049
        • Krankenhaus Barmherzige Brüder Regensburg
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein;Campus Lübeck
  • Greece
      • Athens, Greece, 115 27
        • Laiko General Hospital Athen
      • Athens, Greece, 11522
        • Anticancer Hospital Ag. Savas
    • Attica
      • Piraeus, Attica, Greece, 18547
        • Metropolitan Hospital
  • Guatemala
      • Guatemala City, Guatemala, 01015
        • Grupo Angeles
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • Hungary
      • Szeged, Hungary
        • Szegedi Tudomanyegyetem
  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Istituto Nazionale dei Tumori
  • Japan
      • Aichi, Japan, 466-8560
        • Nagoya University Hospital
      • Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
      • Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
      • Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital
      • Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital
      • Miyagi, Japan, 981-0914
        • Sendai Kousei Hospital
      • Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital
      • Osaka, Japan, 583-8588
        • Osaka Habikino Medical Center
      • Sakaishi, Japan, 591-8555
        • NHO Kinki-Chuo Chest Medical Center
  • Mexico
      • Toluca, Mexico, 50090
        • Phylasis Clinicas Research S de RL de CV
  • Poland
      • Brzozów, Poland, 36-200
        • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
      • Otwock, Poland, 05-400
        • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
      • Otwock, Poland, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
      • Warsaw, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
      • Wroc?aw, Poland, 53-412
        • Dolnoslaskie Centrum Onkologii
    • Greater Poland Voivodeship
      • Pozna?, Greater Poland Voivodeship, Poland, 60-569
        • Uniwersytecki Szpital Kliniczny w Poznaniu
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Centrum Onkologii Im. Prof. F. Lukaszczyka W Bydgoszczy
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
      • Craiova, Romania, 200347
        • Centrul de Oncologie Sfantul Nectarie
      • Iași, Romania, 700483
        • Institutul Regional de Oncologie Iasi
      • Timișoara, Romania, 300239
        • Centrul de Oncologie Oncohelp
  • Russia
    • Arhangelsk
      • Arkhangelsk, Arhangelsk, Russia, 163045
        • Arkhangelsk Regional Clinical Oncology Dispensary
    • Moscow Oblast
      • Moscow, Moscow Oblast, Russia, 115478
        • Russian Oncology Research Center n.a. N.N. Blokhin
      • Moscow, Moscow Oblast, Russia, 125248
        • P.A. Herzen Oncological Inst.
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Severance Hospital
      • Seoul, South Korea, 6351
        • Samsung Medical Center
      • Seoul, South Korea
        • Seoul National University College of Medicine, Liver Research Institute
      • Seoul, South Korea, 138-736
        • Asan Medical Center, Uni Ulsan Collegemedicine
  • Spain
      • Barcelona, Spain, 08028
        • Hospital Universitario Quiron Dexeus
      • Madrid, Spain, 28050
        • Hospital Universitario Madrid Sanchinarro
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra-Madrid
  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Med. Siriraj Hosp.
  • Ukraine
      • Kiev, Ukraine, 36022
        • National Cancer Institute MOH of Ukraine
      • Kryvyi Rih, Ukraine, 50048
        • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
      • Lutsk, Ukraine, 43018
        • Volyn Regional Oncology Dispensary
      • Sumy, Ukraine, 40022
        • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
    • Kharkiv Governorate
      • Kharkiv, Kharkiv Governorate, Ukraine, 61070
        • Communal Non profit Enterprise Regional Center of Oncology
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • Yale University School Of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Carolina BioOncology Institute, PLCC
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Cancer Care Associates
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Sciences Center in San Antonio

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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 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)

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: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atezolizumab Monotherapy
Participants 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.
Drug: Atezolizumab
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).
Other Names:
  • Tecentriq
Experimental: Combined Agents with Atezolizumab
Participants 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.
Drug: Bevacizumab
Bevacizumab will be administered as directed per the parent study.
Other Names:
  • Avastin
Drug: Pemetrexed
Pemetrexed will be administered as directed per the parent study.
Drug: Paclitaxel
Paclitaxel will be administered as directed per the parent study.
Drug: Enzalutamide
Enzalutamide will be administered as directed per the parent study.
Other Names:
  • Xtandi
Drug: Atezolizumab
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).
Other Names:
  • Tecentriq
Drug: Alectinib
Alectinib will be administered as directed per the parent study.
Other Names:
  • Alecensa
Drug: Cobimetinib
Cobimetinib will be administered as directed per the parent study.
Other Names:
  • Cotellic
Drug: Vemurafenib
Vemurafenib will be administered as directed per the parent study.
Other Names:
  • Zelboraf
Drug: FAP IL2V
FAP IL2V will be administered as directed per the parent study.
Other Names:
  • simlukafusp alfa
Drug: Venetoclax
Venetoclax will be administered as directed per the parent study.
Other Names:
  • Venclexta
Drug: Niraparib
Niraparib will be administered as directed per the parent study.
Other Names:
  • Zejula
Drug: Cabozantinib
Cabozantinib will be administered as directed per the parent study.
Other Names:
  • Cometriq
Drug: Emactuzumab
Emactuzumab will be administered as directed per the parent study.
Drug: Rucaparib
Rucaparib will be administered as directed per the parent study.
Active Comparator: Comparator Treatment
Participants 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.
Drug: Pemetrexed
Pemetrexed will be administered as directed per the parent study.
Drug: Paclitaxel
Paclitaxel will be administered as directed per the parent study.
Drug: Enzalutamide
Enzalutamide will be administered as directed per the parent study.
Other Names:
  • Xtandi
Drug: Cobimetinib
Cobimetinib will be administered as directed per the parent study.
Other Names:
  • Cotellic
Drug: Vemurafenib
Vemurafenib will be administered as directed per the parent study.
Other Names:
  • Zelboraf
Drug: Venetoclax
Venetoclax will be administered as directed per the parent study.
Other Names:
  • Venclexta
Drug: Niraparib
Niraparib will be administered as directed per the parent study.
Other Names:
  • Zejula
Drug: Pembrolizumab
Pembrolizumab will be administered as directed per the parent study.
Other Names:
  • Keytruda
Drug: Sunitinib
Sunitinib will be administered as directed per the parent study.
Other Names:
  • Sutent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
Time Frame: Day 1 up to maximum 10 years
Day 1 up to maximum 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Serious Adverse Events (SAEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time Frame: 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)
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)
Percentage of Participants With Adverse Events of Special Interest Determined According to NCI CTCAE Version 5.0
Time Frame: 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)
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)
Treatment Duration
Time Frame: 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)
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)
Total Dose Received
Time Frame: 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)
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)
Number of Treatment Cycles
Time Frame: 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)
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)

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

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)

February 28, 2019

Primary Completion (Estimated)

July 5, 2028

Study Completion (Estimated)

July 5, 2028

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO40729
  • 2023-506184-34-00 (Registry Identifier: CTIS (EU))

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

Yes

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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