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

Phase 3

Active, not recruiting

• Conditions: Cancer
• Interventions: Drug: Atezolizumab; Drug: Bevacizumab

• Registration Number: NCT03148418
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Study Start: 2017-09-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2030-03-06
• Study Completion: 2030-03-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 382

Inclusion Criteria

Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study (and survival follow up for pattients who roll over from IMpower133):

• Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study, with no access to commercially available comparator agent
• First dose of study treatment in the 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 parent-study closure as assessed by the investigator
• Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential

Specific criteria for patients from the IMpower133 parent study only who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq) outside this extension study and continue safety and survival follow-up only in the extension study:

• Discontinuation of atezolizumab-based therapy in the IMpower133 parent study and in survival follow- up at the time of IMpower133 parent study closure, or eligible for continuing or crossing over to atezolizumab-based therapy as per the IMpower133 parent protocol and have access to commercially available atezolizumab (Tecentriq) outside this extension study at the time of the IMpower133 parent-study closure

Exclusion Criteria

Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study:

• Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
• Study treatment is commercially marketed in the patient's country for the patient specific disease and is accessible to the patient
• Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period (± 7 days) allowed in the parent study
• Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in the 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 the extension study (if applicable)
• Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information
• Ongoing SAE(s) that has not resolved to baseline level or Grade less than or equal to (<=) 1 from the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study
• Any serious uncontrolled concomitant disease that would contraindicate the use of study treatment at the time of the extension study or that would place the participant at high risk for treatment-related complications
• Concurrent participation in any therapeutic clinical trial (other than the parent study)

Specific criteria for patients who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq) outside this extension study and continue safety and survival follow-up only in the extension study:

• Discontinuation of comparator in parent study and in survival follow-up at the time of parent study closure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined Agents with Atezolizumab	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.
Atezolizumab Monotherapy	Atezolizumab	Participants will continue to receive atezolizumab monotherapy in a Genentech or Roche-sponsored study (the parent study) in accordance with local prescribing information till the participant continues to derive clinical benefit or until death, withdrawal of study consent, unacceptable toxicity, pregnancy, participant non-compliance, or study termination by the Sponsor, whichever occurs first.
Combined Agents with Atezolizumab	Bevacizumab	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.
Comparator Treatment	Bevacizumab	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Serious Adverse Events (SAEs) by Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Day 1 up to 90 days after last dose of study treatment (last dose=till 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 by Severity Determined According to NCI CTCAE Version 4.0	Day 1 up to 90 days after last dose of study treatment (last dose=till 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)
Time from Randomization or Treatment Initiation to Death due to any Cause for IMpower133 Participants Only	Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years)

Trial Locations

Locations (171)

GH Paris Saint Joseph; 🇫🇷 Paris, France

Masarykuv onkologicky ustav; 🇨🇿 Brno, Czechia

Thomayerova nemocnice; 🇨🇿 Praha 4 - Krc, Czechia

Hopital Jean Minjoz; 🇫🇷 Besancon, France

Chu Grenoble - Hopital Albert Michallon; 🇫🇷 Grenoble, France

Hopital Tenon; 🇫🇷 Paris, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

CH de Saint Quentin; 🇫🇷 Saint Quentin, France

Centre Medico-Chirurgical Foch; 🇫🇷 Suresnes, France

CHU de Toulouse - Hôpital Larrey; 🇫🇷 Toulouse Cedex 9, France

Ospedale Santa Maria Della; 🇮🇹 Perugia, Umbria, Italy

Niigata Cancer Center Hospital; 🇯🇵 Niigata, Japan

Chonnam National University Hwasun Hospital; 🇰🇷 Jeollanam-do, Korea, Republic of

NKI/AvL; 🇳🇱 Amsterdam, Netherlands

Hospital de Santa Maria; 🇵🇹 Lisboa, Portugal

University Hospital Medical Center Bezanijska kosa; 🇷🇸 Belgrade, Serbia

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital NisA 9 de Octubre; 🇪🇸 Valencia, Spain

CHUV; 🇨🇭 Lausanne, Switzerland

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan

Texas Oncology - DFW; 🇺🇸 Dallas, Texas, United States

Royal Marsden Hospital - Surrey; 🇬🇧 Surrey, United Kingdom

HonorHealth Research Institute ? Bisgrove; 🇺🇸 Scottsdale, Arizona, United States

Angeles Clinic & Rsch Inst; 🇺🇸 Los Angeles, California, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente - San Diego (Zion Ave); 🇺🇸 San Marcos, California, United States

University Of Colorado; 🇺🇸 Aurora, Colorado, United States

Rocky Mountain Cancer Ctr - Denver (Williams); 🇺🇸 Denver, Colorado, United States

Smilow Cancer Hospital at Yale New Haven; 🇺🇸 New Haven, Connecticut, United States

Georgetown University Medical Center Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Florida Cancer Specialists - Fort Myers (Broadway); 🇺🇸 Fort Myers, Florida, United States

Hematology Oncology Associates of the Treasure Coast; 🇺🇸 Port Saint Lucie, Florida, United States

Florida Cancer Specialists.; 🇺🇸 Saint Petersburg, Florida, United States

H. Lee Moffitt Cancer Center and Research Inst.; 🇺🇸 Tampa, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital; 🇺🇸 Marietta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Tyler Cancer Center; 🇺🇸 Tyler, Texas, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University Of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Ingalls Memorial Hospital; 🇺🇸 Harvey, Illinois, United States

Illinois Cancer Care; 🇺🇸 Peoria, Illinois, United States

New England Cancer Specialists; 🇺🇸 Scarborough, Maine, United States

Johns Hopkins Univ Med Center; 🇺🇸 Baltimore, Maryland, United States

Maryland Oncology Hematology, P.A.; 🇺🇸 Columbia, Maryland, United States

Massachusetts General Hospital.; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Inst.; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Medical Center; 🇺🇸 Boston, Massachusetts, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

US oncology research at Minnesota Oncology; 🇺🇸 Saint Louis Park, Minnesota, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Comprehensive Cancer Centers of Nevada - Eastern Avenue; 🇺🇸 Las Vegas, Nevada, United States

Summit Medical Center; 🇺🇸 Florham Park, New Jersey, United States

New York Oncology Hematology, P.C.; 🇺🇸 Albany, New York, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Carolina BioOncology Institute, PLCC; 🇺🇸 Huntersville, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Oncology Associates of Oregon, P.C; 🇺🇸 Eugene, Oregon, United States

Northwest Cancer Specialists - Portland (N Broadway); 🇺🇸 Portland, Oregon, United States

Penn State Hershey Cancer Institute; 🇺🇸 Hershey, Pennsylvania, United States

Allegheny Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Sarah Cannon Res Inst; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt Univ Medical Ctr; 🇺🇸 Nashville, Tennessee, United States

Virginia Oncology Associates; 🇺🇸 Norfolk, Virginia, United States

Blue Ridge Cancer Care; 🇺🇸 Roanoke, Virginia, United States

University of Washington Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

Northwest Medical Specialties; 🇺🇸 Tacoma, Washington, United States

Fundación CENIT para la Investigación en Neurociencias; 🇦🇷 Buenos Aires, Argentina

Chris O'Brien Lifehouse; 🇦🇺 Camperdown, New South Wales, Australia

Princess AleXandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Klinik Penzing; 🇦🇹 Wien, Austria

Krankenhaus Nord - Klinik Floridsdorf; 🇦🇹 Wien, Austria

AZ Glorieux- vzw Werken Glorieux; 🇧🇪 Ronse, Belgium

Sint Augustinus Wilrijk; 🇧🇪 Wilrijk, Belgium

Hospital de Cancer de Barretos; 🇧🇷 Barretos, São Paulo, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP; 🇧🇷 Sao Paulo, São Paulo, Brazil

Fundacao Antonio Prudente; 🇧🇷 Sao Paulo, São Paulo, Brazil

Multiprofile Hospital for Active Treatment Serdika EOOD; 🇧🇬 Sofia, Bulgaria

Royal Victoria Hospital; 🇨🇦 Barrie, Ontario, Canada

William Osler Health Centre; 🇨🇦 Brampton, Ontario, Canada

Lakeridge Health Corporation-Oshawa; 🇨🇦 Oshawa, Ontario, Canada

Sunnybrook Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada

Cite de La Sante de Laval; 🇨🇦 Laval, Quebec, Canada

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Bradford Hill Centro de Investigaciones Clinicas; 🇨🇱 Recoleta, Chile

Centre Leon Berard; 🇫🇷 Lyon, France

Hopital Nord; 🇫🇷 Marseille, France

Centre René Gauducheau - cancer Nantes - Atlantique; 🇫🇷 Nantes, France

Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice; 🇫🇷 Nice, France

Hopital Saint Louis; 🇫🇷 Paris, France

Institut Gustave Roussy; 🇫🇷 VILLEJUIF Cedex, France

Klinikum d.Universität München Campus Großhadern; 🇩🇪 München, Germany

Semmelweis Egyetem X; 🇭🇺 Budapest, Hungary

Református Pulmonológiai Centrum; 🇭🇺 Törökbálint, Hungary

Belinson Medical Center; 🇮🇱 Petah Tikva, Israel

Azienda Osp Uni Seconda Università Degli Studi Di Napoli; 🇮🇹 Napoli, Campania, Italy

Azienda Ospedaliera A. Cardarelli; 🇮🇹 Napoli, Campania, Italy

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale; 🇮🇹 Napoli, Campania, Italy

A.O. Universitaria Policlinico Di Modena; 🇮🇹 Modena, Emilia-Romagna, Italy

Università Cattolica Del S Cuore; 🇮🇹 Roma, Lazio, Italy

IRCCS AOU San Martino - IST; 🇮🇹 Genova, Liguria, Italy

ASL 3 Genovese; 🇮🇹 Genova, Liguria, Italy

Irccs Istituto Nazionale Dei Tumori (Int); 🇮🇹 Milano, Lombardia, Italy

Irccs Istituto Europeo Di Oncologia (IEO); 🇮🇹 Milano, Lombardia, Italy

Asst Di Monza; 🇮🇹 Monza, Lombardia, Italy

A.O.U. Maggiore della Carità; 🇮🇹 Novara, Piemonte, Italy

Az. Osp. S. Luigi Gonzaga; 🇮🇹 Orbassano, Piemonte, Italy

Policlinico Vittorio Emanuele; 🇮🇹 Catania, Sicilia, Italy

Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato; 🇮🇹 Arezzo, Toscana, Italy

A.O. Universitaria Pisana-Ospedale Cisanello; 🇮🇹 Pisa, Toscana, Italy

Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica; 🇮🇹 Siena, Toscana, Italy

IOV - Istituto Oncologico Veneto - IRCCS; 🇮🇹 Padova, Veneto, Italy

Shikoku Cancer Center; 🇯🇵 Ehime, Japan

Iwate Medical University Hospital; 🇯🇵 Iwate, Japan

Sendai Kousei Hospital; 🇯🇵 Miyagi, Japan

Okayama University Hospital; 🇯🇵 Okayama, Japan

Toranomon Hospital; 🇯🇵 Tokyo, Japan

The Cancer Institute Hospital of JFCR, Respiratory Medicine; 🇯🇵 Tokyo, Japan

Wakayama Medical University Hospital; 🇯🇵 Wakayama, Japan

National Cancer Center; 🇰🇷 Gyeonggi-do, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Auckland city hospital; 🇳🇿 Auckland, New Zealand

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii; 🇵🇱 Gdansk, Poland

Oddzia? Onkologii Klinicznej i Chemioterapii Szpitala ELBL?SKA; 🇵🇱 Warszawa, Poland

Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; 🇵🇱 Warszawa, Poland

Centro Hospitalar do Porto ? Hospital de Santo António; 🇵🇹 Porto, Portugal

Institut Oncologic Ion Chiricuta; 🇷🇴 Cluj-napoca, Romania

ONCOMED - Medical Centre; 🇷🇴 Timisoara, Romania

Moscow City Oncology Hospital #62; 🇷🇺 Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation

Clinic for Pulmonology, Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

Institute of Oncology Ljubljana; 🇸🇮 Ljubljana, Slovenia

Hospital Universitario Reina Sofia; 🇪🇸 Córdoba, Cordoba, Spain

Hospital Son Llatzer; 🇪🇸 Palma de Mallorca, Islas Baleares, Spain

Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología; 🇪🇸 La Coruña, LA Coruna, Spain

Hospital Universitario Materno Infantil de Gran Canaria; 🇪🇸 Las Palmas de Gran Canaria, LAS Palmas, Spain

Clinica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Vall d'Hebron Institute of Oncology (VHIO), Barcelona; 🇪🇸 Barcelona, Spain

Hospital Clinic de Barcelona. Unidad de Nuevas Terapias; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Institut Catala d Oncologia Hospital Duran i Reynals; 🇪🇸 Barcelona, Spain

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Barcelona, Spain

Hospital San Pedro De Alcantara; 🇪🇸 Caceres, Spain

Complejo Hospitalario de Jaen; 🇪🇸 Jaen, Spain

Hospital Lucus Augusti; 🇪🇸 Lugo, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal; 🇪🇸 Madrid, Spain

Hospital Regional Universitario Carlos Haya; 🇪🇸 Malaga, Spain

Hospital Universitario Virgen del Rocio; 🇪🇸 Sevilla, Spain

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Taiwan Uni Hospital; 🇨🇳 Taipei, Taiwan

Chulalongkorn Hospital; 🇹🇭 Bangkok, Thailand

Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand

Faculty of Med. Siriraj Hosp.; 🇹🇭 Bangkok, Thailand

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi; 🇹🇷 Edirne, Turkey

Istanbul Uni Cerrahpasa Medical Faculty Hospital; 🇹🇷 Istanbul, Turkey

Hacettepe Uni Medical Faculty Hospital; 🇹🇷 S?hhiye, Ankara, Turkey

Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; 🇺🇦 Dnipropetrovsk, Ukraine

Barts & London School of Med; 🇬🇧 London, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom

St George's Hospital; 🇬🇧 London, United Kingdom

Royal Marsden Hospital - London; 🇬🇧 London, United Kingdom

Charing Cross Hospital; 🇬🇧 London, United Kingdom

Christie Hospital NHS Trust; 🇬🇧 Manchester, United Kingdom

Nottingham City Hospital; 🇬🇧 Nottingham, United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust; 🇬🇧 Wirral, United Kingdom