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

NCT03768063 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: BO407292023-506184-34-00
• Study Type: interventional
• Target: 1,000
• Locations: 24 countries
• Sites: 81

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

Outcome Measures

Primary Outcomes (1)

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

  Day 1 up to maximum 10 years

Secondary Outcomes (5)

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

  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

  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

  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

  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

  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)

Study Arms (3)

Atezolizumab Monotherapy

EXPERIMENTAL

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

Combined Agents with Atezolizumab

EXPERIMENTAL

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

Comparator Treatment

ACTIVE COMPARATOR

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

Atezolizumab 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).

Also known as: Tecentriq

Atezolizumab Monotherapy; Combined Agents with Atezolizumab

Bevacizumab DRUG

Bevacizumab will be administered as directed per the parent study.

Also known as: Avastin

Combined Agents with Atezolizumab

Alectinib DRUG

Alectinib will be administered as directed per the parent study.

Also known as: Alecensa

Combined Agents with Atezolizumab

Cobimetinib DRUG

Cobimetinib will be administered as directed per the parent study.

Also known as: Cotellic

Combined Agents with Atezolizumab; Comparator Treatment

Vemurafenib DRUG

Vemurafenib will be administered as directed per the parent study.

Also known as: Zelboraf

Combined Agents with Atezolizumab; Comparator Treatment

FAP IL2V DRUG

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

Also known as: simlukafusp alfa

Combined Agents with Atezolizumab

Venetoclax DRUG

Venetoclax will be administered as directed per the parent study.

Also known as: Venclexta

Combined Agents with Atezolizumab; Comparator Treatment

Enzalutamide DRUG

Enzalutamide will be administered as directed per the parent study.

Also known as: Xtandi

Combined Agents with Atezolizumab; Comparator Treatment

Pembrolizumab DRUG

Pembrolizumab will be administered as directed per the parent study.

Also known as: Keytruda

Comparator Treatment

Sunitinib DRUG

Sunitinib will be administered as directed per the parent study.

Also known as: Sutent

Comparator Treatment

Niraparib DRUG

Niraparib will be administered as directed per the parent study.

Also known as: Zejula

Combined Agents with Atezolizumab; Comparator Treatment

Cabozantinib DRUG

Cabozantinib will be administered as directed per the parent study.

Also known as: Cometriq

Combined Agents with Atezolizumab

Pemetrexed DRUG

Pemetrexed will be administered as directed per the parent study.

Combined Agents with Atezolizumab; Comparator Treatment

Paclitaxel DRUG

Paclitaxel will be administered as directed per the parent study.

Combined Agents with Atezolizumab; Comparator Treatment

Emactuzumab DRUG

Emactuzumab will be administered as directed per the parent study.

Combined Agents with Atezolizumab

Rucaparib DRUG

Rucaparib will be administered as directed per the parent study.

Combined Agents with Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (81)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Yale University School Of Medicine

Trumbull, Connecticut, 06611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Carolina BioOncology Institute, PLCC

Huntersville, North Carolina, 28078, United States

Location

St. Luke's Cancer Care Associates

Bethlehem, Pennsylvania, 18015, United States

Location

University of Texas Health Sciences Center in San Antonio

San Antonio, Texas, 78229, United States

Location

St Vincent'S Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

UZ Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Location

Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

Plovdiv, 4004, Bulgaria

Location

Pontificia Universidad Catolica de Chile

Santiago, 8330032, Chile

Location

Masaryk?v onkologický ústav

Brno, 656 53, Czechia

Location

Rigshospitalet

København Ø, 2100, Denmark

Location

CHU Angers

Angers, Pays de la Loire Region, 49933, France

Location

Centre Antoine Lacassagne

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

Location

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

Lille, 59037, France

Location

hopital de la Timone

Marseille, 13005, France

Location

Institut Gustave Roussy

Villejuif, Île-de-France Region, 94805, France

Location

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Krankenhaus Barmherzige Bruder Regensburg

Regensburg, Bavaria, 93049, Germany

Location

Universitätsklinikum Schleswig-Holstein;Campus Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Kliniken Essen-Mitte

Essen, 45136, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Asklepios-Fachklinik Muenchen-Gauting

Gauting, 82131, Germany

Location

SRH Wald-Klinikum Gera

Gera, 07548, Germany

Location

HOPA MVZ GmbH

Hamburg, 22767, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Universitaets-Hautklinik Tuebingen

Tübingen, 72076, Germany

Location

Universitaettsklinikum Tübingen

Tübingen, 72076, Germany

Location

Universitätsklinik Tübingen

Tübingen, 72076, Germany

Location

Metropolitan Hospital

Piraeus, Attica, 18547, Greece

Location

Laiko General Hospital Athen

Athens, 115 27, Greece

Location

Anticancer Hospital Ag. Savas

Athens, 11522, Greece

Location

Grupo Angeles

Guatemala City, 01015, Guatemala

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Szegedi Tudományegyetem

Szeged, Hungary

Location

Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

Location

Nagoya University Hospital

Aichi, 466-8560, Japan

Location

National Hospital Organization Shikoku Cancer Center

Ehime, 791-0280, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, 810-8563, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Hokkaido University Hospital

Hokkaido, 060-8648, Japan

Location

University of Tsukuba Hospital

Ibaraki, 305-8576, Japan

Location

Kanazawa University Hospital

Ishikawa, 920-8641, Japan

Location

Sendai Kousei Hospital

Miyagi, 981-0914, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, 951-8520, Japan

Location

Osaka Habikino Medical Center

Osaka, 583-8588, Japan

Location

NHO Kinki-Chuo Chest Medical Center

Sakaishi, 591-8555, Japan

Location

Phylasis Clinicas Research S de RL de CV

Toluca, 50090, Mexico

Location

Uniwersytecki Szpital Kliniczny w Poznaniu

Pozna?, Greater Poland Voivodeship, 60-569, Poland

Location

Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

Brzozów, 36-200, Poland

Location

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

Otwock, 05-400, Poland

Location

Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy

Otwock, 05-400, Poland

Location

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

Warsaw, 02-781, Poland

Location

Dolnoslaskie Centrum Onkologii

Wroc?aw, 53-412, Poland

Location

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca

Cluj-Napoca, 400015, Romania

Location

Centrul de Oncologie Sfantul Nectarie

Craiova, 200347, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

Centrul de Oncologie Oncohelp

Timișoara, 300239, Romania

Location

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, Arhangelsk, 163045, Russia

Location

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

Moscow, Moscow Oblast, 115478, Russia

Location

P.A. Herzen Oncological Inst.

Moscow, Moscow Oblast, 125248, Russia

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center, Uni Ulsan Collegemedicine

Seoul, 138-736, South Korea

Location

Samsung Medical Center

Seoul, 6351, South Korea

Location

Seoul National University College of Medicine, Liver Research Institute

Seoul, South Korea

Location

Hospital Universitario Quiron Dexeus

Barcelona, 08028, Spain

Location

Clinica Universidad de Navarra-Madrid

Madrid, 28027, Spain

Location

Hospital Universitario Madrid Sanchinarro

Madrid, 28050, Spain

Location

Faculty of Med. Siriraj Hosp.

Bangkok, 10700, Thailand

Location

Communal Non profit Enterprise Regional Center of Oncology

Kharkiv, Kharkiv Governorate, 61070, Ukraine

Location

National Cancer Institute MOH of Ukraine

Kiev, 36022, Ukraine

Location

ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council

Kryvyi Rih, 50048, Ukraine

Location

Volyn Regional Oncology Dispensary

Lutsk, 43018, Ukraine

Location

Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

Sumy, 40022, Ukraine

Location

MeSH Terms

Conditions

Neoplasms

Interventions

atezolizumab; Bevacizumab; alectinib; cobimetinib; Vemurafenib; venetoclax; enzalutamide; pembrolizumab; Sunitinib; niraparib; cabozantinib; Pemetrexed; Paclitaxel; emactuzumab; rucaparib

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 7, 2018
• Study Start: February 28, 2019
• Primary Completion (Estimated): July 5, 2028
• Study Completion (Estimated): July 5, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); JP (11); RU (3); HK (1); PL (7); UA (5); KR (5); GU (1); ME (1); DK (1); BR (1); DE (13); HU (1); GR (3); BE (3); CZ (1); RO (4); ES (3); CL (1); BU (1); TH (1); US (7); IT (1); FR (5)