CClinicalTrials.gg
Active, not recruitingNCT03768063IMbrella BUpdated Jul 24, 2026

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

A Phase 3 interventional study of Atezolizumab and Bevacizumab in Cancer, sponsored by Hoffmann-La Roche. Active, not recruiting at 80 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cancer

Browse trials for

03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • 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

  • 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: 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

  • 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: Cobimetinib · Drug: Vemurafenib · Drug: Venetoclax · Drug: Enzalutamide · Drug: Pembrolizumab · Drug: Sunitinib · Drug: Niraparib · Drug: Pemetrexed · Drug: Paclitaxel

Interventions

  • DrugAtezolizumab

    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).

    Also known as: Tecentriq

  • DrugBevacizumab

    Bevacizumab will be administered as directed per the parent study.

    Also known as: Avastin

  • DrugAlectinib

    Alectinib will be administered as directed per the parent study.

    Also known as: Alecensa

  • DrugCobimetinib

    Cobimetinib will be administered as directed per the parent study.

    Also known as: Cotellic

  • DrugVemurafenib

    Vemurafenib will be administered as directed per the parent study.

    Also known as: Zelboraf

  • DrugFAP IL2V

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

    Also known as: simlukafusp alfa

  • DrugVenetoclax

    Venetoclax will be administered as directed per the parent study.

    Also known as: Venclexta

  • DrugEnzalutamide

    Enzalutamide will be administered as directed per the parent study.

    Also known as: Xtandi

  • DrugPembrolizumab

    Pembrolizumab will be administered as directed per the parent study.

    Also known as: Keytruda

  • DrugSunitinib

    Sunitinib will be administered as directed per the parent study.

    Also known as: Sutent

  • DrugNiraparib

    Niraparib will be administered as directed per the parent study.

    Also known as: Zejula

  • DrugCabozantinib

    Cabozantinib will be administered as directed per the parent study.

    Also known as: Cometriq

  • DrugPemetrexed

    Pemetrexed will be administered as directed per the parent study.

  • DrugPaclitaxel

    Paclitaxel will be administered as directed per the parent study.

  • DrugEmactuzumab

    Emactuzumab will be administered as directed per the parent study.

  • DrugRucaparib

    Rucaparib will be administered as directed per the parent study.

06

What researchers measure

Primary outcomes

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

    Time frame: Day 1 up to maximum 10 years

Secondary outcomes

  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

    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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

07

Study locations

80 sites
  • University of Colorado Cancer Center
    Aurora, Colorado 80045, United States
  • Yale University School Of Medicine
    Trumbull, Connecticut 06611, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Carolina BioOncology Institute, PLCC
    Huntersville, North Carolina 28078, United States
  • St. Luke's Cancer Care Associates
    Bethlehem, Pennsylvania 18015, United States
  • University of Texas Health Sciences Center in San Antonio
    San Antonio, Texas 78229, United States
  • St Vincent'S Hospital
    Darlinghurst, New South Wales 2010, Australia
  • UZ Leuven
    Leuven, Flemish Brabant 3000, Belgium
  • Institut Jules Bordet
    Brussels, 1000, Belgium
  • UZ Brussel
    Brussels, 1090, Belgium
  • Hospital das Clinicas - UFRGS
    Porto Alegre, Rio Grande do Sul, Brazil
  • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
    Plovdiv, 4004, Bulgaria
  • Pontificia Universidad Catolica de Chile
    Santiago, 8330032, Chile
  • Masaryk?v onkologický ústav
    Brno, 656 53, Czechia
  • Rigshospitalet
    København Ø, 2100, Denmark
  • CHU Angers
    Angers, Pays de la Loire Region 49933, France
  • Centre Antoine Lacassagne
    Nice, Provence-Alpes-Côte d'Azur Region 06189, France
  • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
    Lille, 59037, France
  • hopital de la Timone
    Marseille, 13005, France
  • Institut Gustave Roussy
    Villejuif, Île-de-France Region 94805, France
  • Universitätsklinikum Ulm
    Ulm, Baden-Wurttemberg 89081, Germany
  • Krankenhaus Barmherzige Bruder Regensburg
    Regensburg, Bavaria 93049, Germany
  • Universitätsklinikum Schleswig-Holstein;Campus Lübeck
    Lübeck, Schleswig-Holstein 23538, Germany
  • Kliniken Essen-Mitte
    Essen, 45136, Germany
  • Universitätsklinikum Freiburg
    Freiburg im Breisgau, 79106, Germany
  • Asklepios-Fachklinik Muenchen-Gauting
    Gauting, 82131, Germany
  • SRH Wald-Klinikum Gera
    Gera, 07548, Germany
  • Lungenfachklinik Immenhausen
    Immenhausen, 34376, Germany
  • Universitaetsklinikum Muenster
    Münster, 48149, Germany
  • Universitaets-Hautklinik Tuebingen
    Tübingen, 72076, Germany
  • Universitaettsklinikum Tübingen
    Tübingen, 72076, Germany
  • Universitätsklinik Tübingen
    Tübingen, 72076, Germany
  • Metropolitan Hospital
    Piraeus, Attica 18547, Greece
  • Laiko General Hospital Athen
    Athens, 115 27, Greece
  • Anticancer Hospital Ag. Savas
    Athens, 11522, Greece
  • Grupo Angeles
    Guatemala City, 01015, Guatemala
  • Queen Mary Hospital
    Hong Kong, Hong Kong
  • Szegedi Tudományegyetem
    Szeged, Hungary
  • Istituto Nazionale dei Tumori
    Milan, Lombardy 20133, Italy
  • Nagoya University Hospital
    Aichi, 466-8560, Japan
  • National Hospital Organization Shikoku Cancer Center
    Ehime, 791-0280, Japan
  • National Hospital Organization Kyushu Medical Center
    Fukuoka, 810-8563, Japan
  • Kyushu University Hospital
    Fukuoka, 812-8582, Japan
  • Hokkaido University Hospital
    Hokkaido, 060-8648, Japan
  • University of Tsukuba Hospital
    Ibaraki, 305-8576, Japan
  • Kanazawa University Hospital
    Ishikawa, 920-8641, Japan
  • Sendai Kousei Hospital
    Miyagi, 981-0914, Japan
  • Niigata University Medical & Dental Hospital
    Niigata, 951-8520, Japan
  • Osaka Habikino Medical Center
    Osaka, 583-8588, Japan
  • NHO Kinki-Chuo Chest Medical Center
    Sakaishi, 591-8555, Japan
  • Phylasis Clinicas Research S de RL de CV
    Toluca, 50090, Mexico
  • Uniwersytecki Szpital Kliniczny w Poznaniu
    Pozna?, Greater Poland Voivodeship 60-569, Poland
  • Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
  • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
    Brzozów, 36-200, Poland
  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
    Otwock, 05-400, Poland
  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
    Otwock, 05-400, Poland
  • Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
    Warsaw, 02-781, Poland
  • Dolnoslaskie Centrum Onkologii
    Wroc?aw, 53-412, Poland
  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
    Cluj-Napoca, 400015, Romania
  • Centrul de Oncologie Sfantul Nectarie
    Craiova, 200347, Romania
  • Institutul Regional de Oncologie Iasi
    Iași, 700483, Romania
  • Centrul de Oncologie Oncohelp
    Timișoara, 300239, Romania
  • Arkhangelsk Regional Clinical Oncology Dispensary
    Arkhangelsk, Arhangelsk 163045, Russia
  • Russian Oncology Research Center n.a. N.N. Blokhin
    Moscow, Moscow Oblast 115478, Russia
  • P.A. Herzen Oncological Inst.
    Moscow, Moscow Oblast 125248, Russia
  • Seoul National University Hospital
    Seoul, 03080, South Korea
  • Severance Hospital
    Seoul, 03722, South Korea
  • Asan Medical Center, Uni Ulsan Collegemedicine
    Seoul, 138-736, South Korea
  • Samsung Medical Center
    Seoul, 6351, South Korea
  • Seoul National University College of Medicine, Liver Research Institute
    Seoul, South Korea
  • Hospital Universitario Quiron Dexeus
    Barcelona, 08028, Spain
  • Clinica Universidad de Navarra-Madrid
    Madrid, 28027, Spain
  • Hospital Universitario Madrid Sanchinarro
    Madrid, 28050, Spain
  • Faculty of Med. Siriraj Hosp.
    Bangkok, 10700, Thailand
  • Communal Non profit Enterprise Regional Center of Oncology
    Kharkiv, Kharkiv Governorate 61070, Ukraine
  • National Cancer Institute MOH of Ukraine
    Kiev, 36022, Ukraine
  • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
    Kryvyi Rih, 50048, Ukraine
  • Volyn Regional Oncology Dispensary
    Lutsk, 43018, Ukraine
  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
    Sumy, 40022, Ukraine
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03768063
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Dec 7, 2018
Start date
Feb 28, 2019
Primary completion
Jul 5, 2028 (estimated)
Completion
Jul 5, 2028 (estimated)
Last update
Jul 24, 2026

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion