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

NCT ID: NCT03768063

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2028-07-05

Brief 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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

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).

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.

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

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).

Bevacizumab

Intervention Type: DRUG

Bevacizumab will be administered as directed per the parent study.

Alectinib

Intervention Type: DRUG

Alectinib will be administered as directed per the parent study.

Cobimetinib

Intervention Type: DRUG

Cobimetinib will be administered as directed per the parent study.

Vemurafenib

Intervention Type: DRUG

Vemurafenib will be administered as directed per the parent study.

FAP IL2V

Intervention Type: DRUG

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

Venetoclax

Intervention Type: DRUG

Venetoclax will be administered as directed per the parent study.

Enzalutamide

Intervention Type: DRUG

Enzalutamide will be administered as directed per the parent study.

Niraparib

Intervention Type: DRUG

Niraparib will be administered as directed per the parent study.

Cabozantinib

Intervention Type: DRUG

Cabozantinib will be administered as directed per the parent study.

Pemetrexed

Intervention Type: DRUG

Pemetrexed will be administered as directed per the parent study.

Paclitaxel

Intervention Type: DRUG

Paclitaxel will be administered as directed per the parent study.

Emactuzumab

Intervention Type: DRUG

Emactuzumab will be administered as directed per the parent study.

Rucaparib

Intervention Type: DRUG

Rucaparib will be administered as directed per the parent study.

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.

Group Type: ACTIVE_COMPARATOR

Cobimetinib

Intervention Type: DRUG

Cobimetinib will be administered as directed per the parent study.

Vemurafenib

Intervention Type: DRUG

Vemurafenib will be administered as directed per the parent study.

Venetoclax

Intervention Type: DRUG

Venetoclax will be administered as directed per the parent study.

Enzalutamide

Intervention Type: DRUG

Enzalutamide will be administered as directed per the parent study.

Pembrolizumab

Intervention Type: DRUG

Pembrolizumab will be administered as directed per the parent study.

Sunitinib

Intervention Type: DRUG

Sunitinib will be administered as directed per the parent study.

Niraparib

Intervention Type: DRUG

Niraparib will be administered as directed per the parent study.

Pemetrexed

Intervention Type: DRUG

Pemetrexed will be administered as directed per the parent study.

Paclitaxel

Intervention Type: DRUG

Paclitaxel will be administered as directed per the parent study.

Interventions

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).

Intervention Type: DRUG

Bevacizumab

Bevacizumab will be administered as directed per the parent study.

Intervention Type: DRUG

Alectinib

Alectinib will be administered as directed per the parent study.

Intervention Type: DRUG

Cobimetinib

Cobimetinib will be administered as directed per the parent study.

Intervention Type: DRUG

Vemurafenib

Vemurafenib will be administered as directed per the parent study.

Intervention Type: DRUG

FAP IL2V

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

Intervention Type: DRUG

Venetoclax

Venetoclax will be administered as directed per the parent study.

Intervention Type: DRUG

Enzalutamide

Enzalutamide will be administered as directed per the parent study.

Intervention Type: DRUG

Pembrolizumab

Pembrolizumab will be administered as directed per the parent study.

Intervention Type: DRUG

Sunitinib

Sunitinib will be administered as directed per the parent study.

Intervention Type: DRUG

Niraparib

Niraparib will be administered as directed per the parent study.

Intervention Type: DRUG

Cabozantinib

Cabozantinib will be administered as directed per the parent study.

Intervention Type: DRUG

Pemetrexed

Pemetrexed will be administered as directed per the parent study.

Intervention Type: DRUG

Paclitaxel

Paclitaxel will be administered as directed per the parent study.

Intervention Type: DRUG

Emactuzumab

Emactuzumab will be administered as directed per the parent study.

Intervention Type: DRUG

Rucaparib

Rucaparib will be administered as directed per the parent study.

Intervention Type: DRUG

Other Intervention Names

Tecentriq; Avastin; Alecensa; Cotellic; Zelboraf; simlukafusp alfa; Venclexta; Xtandi; Keytruda; Sutent; Zejula; Cometriq

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

University of Colorado Cancer Center

Aurora, Colorado, United States

Yale University School Of Medicine

Trumbull, Connecticut, United States

Advent Health Orlando

Maitland, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Carolina BioOncology Institute, PLCC

Huntersville, North Carolina, United States

St. Luke's Cancer Care Associates

Bethlehem, Pennsylvania, United States

University of Texas Health Sciences Center in San Antonio

San Antonio, Texas, United States

St Vincent'S Hospital

Darlinghurst, New South Wales, Australia

UZ Leuven

Leuven, Flemish Brabant, Belgium

Institut Jules Bordet

Brussels, , Belgium

UZ Brussel

Brussels, , Belgium

Hospital Araujo Jorge

Goiânia, Goiás, Brazil

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

Plovdiv, , Bulgaria

Pontificia Universidad Catolica de Chile

Santiago, , Chile

Masaryk?v onkologický ústav

Brno, , Czechia

Rigshospitalet

København Ø, , Denmark

CHU Angers

Angers, Pays de la Loire Region, France

Centre Antoine Lacassagne

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

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

Lille, , France

hopital de la Timone

Marseille, , France

Institut Gustave Roussy

Villejuif, Île-de-France Region, France

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Krankenhaus Barmherzige Bruder Regensburg

Regensburg, Bavaria, Germany

Universitätsklinikum Schleswig-Holstein;Campus Lübeck

Lübeck, Schleswig-Holstein, Germany

Kliniken Essen-Mitte

Essen, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Asklepios-Fachklinik Muenchen-Gauting

Gauting, , Germany

SRH Wald-Klinikum Gera

Gera, , Germany

HOPA MVZ GmbH

Hamburg, , Germany

Lungenfachklinik Immenhausen

Immenhausen, , Germany

Universitaetsklinikum Muenster

Münster, , Germany

Universitaets-Hautklinik Tuebingen

Tübingen, , Germany

Universitaettsklinikum Tübingen

Tübingen, , Germany

Universitätsklinik Tübingen

Tübingen, , Germany

Metropolitan Hospital

Piraeus, Attica, Greece

Laiko General Hospital Athen

Athens, , Greece

Anticancer Hospital Ag. Savas

Athens, , Greece

Grupo Angeles

Guatemala City, , Guatemala

Queen Mary Hospital

Hong Kong, , Hong Kong

Orszagos Onkologiai Intezet

Budapest, , Hungary

Szegedi Tudományegyetem

Szeged, , Hungary

Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Nagoya University Hospital

Aichi, , Japan

National Hospital Organization Shikoku Cancer Center

Ehime, , Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, , Japan

Kyushu University Hospital

Fukuoka, , Japan

Hokkaido University Hospital

Hokkaido, , Japan

University of Tsukuba Hospital

Ibaraki, , Japan

Kanazawa University Hospital

Ishikawa, , Japan

Sendai Kousei Hospital

Miyagi, , Japan

Niigata University Medical & Dental Hospital

Niigata, , Japan

Osaka Habikino Medical Center

Osaka, , Japan

NHO Kinki-Chuo Chest Medical Center

Sakaishi, , Japan

Phylasis Clinicas Research S de RL de CV

Toluca, , Mexico

Uniwersytecki Szpital Kliniczny w Poznaniu

Pozna?, Greater Poland Voivodeship, Poland

Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

Brzozów, , Poland

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

Otwock, , Poland

Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy

Otwock, , Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Późna, , Poland

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

Warsaw, , Poland

Dolnoslaskie Centrum Onkologii

Wroc?aw, , Poland

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca

Cluj-Napoca, , Romania

Centrul de Oncologie Sfantul Nectarie

Craiova, , Romania

Institutul Regional de Oncologie Iasi

Iași, , Romania

Centrul de Oncologie Oncohelp

Timișoara, , Romania

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, Arhangelsk, Russia

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

Moscow, Moscow Oblast, Russia

P.A. Herzen Oncological Inst.

Moscow, Moscow Oblast, Russia

University Hospital Bratislava

Bratislava, , Slovakia

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Asan Medical Center, Uni Ulsan Collegemedicine

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University College of Medicine, Liver Research Institute

Seoul, , South Korea

Hospital Universitario Quiron Dexeus

Barcelona, , Spain

Clinica Universidad de Navarra-Madrid

Madrid, , Spain

Hospital Universitario Madrid Sanchinarro

Madrid, , Spain

Faculty of Med. Siriraj Hosp.

Bangkok, , Thailand

Communal Non profit Enterprise Regional Center of Oncology

Kharkiv, Kharkiv Governorate, Ukraine

National Cancer Institute MOH of Ukraine

Kiev, , Ukraine

ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council

Kryvyi Rih, , Ukraine

Volyn Regional Oncology Dispensary

Lutsk, , Ukraine

Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

Sumy, , Ukraine

Countries

United States; Australia; Belgium; Brazil; Bulgaria; Chile; Czechia; Denmark; France; Germany; Greece; Guatemala; Hong Kong; Hungary; Italy; Japan; Mexico; Poland; Romania; Russia; Slovakia; South Korea; Spain; Thailand; Ukraine

Other Identifiers

2023-506184-34-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

BO40729

Identifier Type: -

Identifier Source: org_study_id