A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy

Renal Cell Carcinoma Clinical Trial

— IMmotion010  

Official title:

A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03024996
• Other study ID #: WO39210
• Secondary ID: 2016-001881-27
• Status: Terminated
• Phase: Phase 3
• Start date: January 3, 2017
• Est. completion date: December 8, 2022

Study information

• Verified date: July 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 778
• Est. completion date: December 8, 2022
• Est. primary completion date: May 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ECOG performance status of less than or equal to (</=) 1

• Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology that has not been previously treated in the adjuvant or neoadjuvant setting and classified as being at high risk of RCC recurrence

• Radical or partial nephrectomy with lymphadenectomy in select participants

• Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization. Confirmation of disease-free status will be assessed by an independent central radiologic review of imaging data.

• Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to randomization. Applicable only to metastasectomy participants

• Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery

Exclusion Criteria:

• Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau

• Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment

• Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days or five half-lives of the investigational agent, whichever is longer, prior to enrollment

• Malignancies other than RCC within 5 years prior to Cycle 1, Day 1

• History of autoimmune disease

• Participants with prior allogeneic stem cell or solid organ transplantation

• History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan

• Positive test for HIV

• Participants with active hepatitis B or hepatitis C

• Active tuberculosis

• Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia

• Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis

• Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1

• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications

• Prior treatment with cluster of differentiation (CD)137 agonists, anti-cytotoxic T-lymphocyte-associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibody or pathway-targeting agents

• Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization

• Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to randomization or anticipated need for systemic immunosuppressive medications during the study

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Atezolizumab
Atezolizumab 1200 mg IV infusion q3w

Other:
• Placebo
Placebo matching to atezolizumab q3w

Locations

Country	Name	City	State
Argentina	Hospital Britanico; Oncologia	Buenos Aires
Argentina	Hospital Aleman	Caba
Argentina	Centro Oncologico Riojano Integral (CORI)	La Rioja
Australia	Austin Hospital; Medical Oncology	Heidelberg	Victoria
Australia	Royal Brisbane & Women's Hosp; Cancer Care Serv	Herston	Queensland
Australia	Ashford Cancer Center Research	Kurralta Park	South Australia
Australia	Calvary Mater Newcastle; Medical Oncology	Waratah	New South Wales
Austria	Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie	Linz
Austria	Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU	Salzburg
Austria	Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome	Wien
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	UZ Leuven Gasthuisberg	Leuven
Brazil	Hospital Erasto Gaertner	Curitiba	PR
Brazil	Hospital das Clinicas - UFRGS	Porto Alegre	RS
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Hospital Alemao Oswaldo Cruz	Sao Paulo	SP
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
Canada	Tom Baker Cancer Centre-Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre; Oncology	Halifax	Nova Scotia
Canada	BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)	Kelowna	British Columbia
Canada	McGill University Health Centre - Glen Site	Montreal	Quebec
Canada	The Ottawa Hospital Cancer Centre; Oncology	Ottawa	Ontario
Canada	Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont	Sherbrooke	Quebec
Canada	North York General Hospital; Inpatient Pharmacy	Toronto	Ontario
Canada	Princess Margaret Cancer Center	Toronto	Ontario
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario
Chile	Bradford Hill Centro de Investigaciones Clinicas	Recoleta
Chile	Sociedad de Investigaciones Medicas Ltda (SIM)	Temuco
Chile	ONCOCENTRO APYS; Oncología	Vina Del Mar
China	Jiangsu Cancer Hospital	Nanjing City
China	Fudan University Shanghai Cancer Center; Medical Oncology	Shanghai City
Czechia	Masarykuv onkologicky ustav	Brno
Czechia	Fakultni nemocnice Olomouc; Onkologicka klinika	Olomouc
Czechia	General University Hospital; CLINIC OF ONCOLOGY	Praha 2
Czechia	Thomayerova nemocnice	Praha 4 - Krc
Denmark	Aarhus Universitetshospital; Kræftafdelingen	Aarhus N
Denmark	Herlev Hospital; Afdeling for Kræftbehandling	Herlev
France	CHU d'Angers	Angers
France	CHU Henri Mondor; Service d'Oncologie Medicale	Creteil
France	CHU de Nantes - Hotel Dieu	Nantes
France	Institut Mutualiste Montsouris; Oncologie	Paris
France	CHU Pontchaillou	Rennes
France	CHU de Rouen - Hôpital Charles Nicolle	Rouen
France	Nouvel Hopital Civil - CHU Strasbourg; Urologie	Strasbourg
France	Institut Gustave Roussy	Villejuif
Germany	Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie	Dresden
Germany	Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie	Hannover
Germany	Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen	Heidelberg
Germany	Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie	Homburg/Saar
Germany	Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik	München
Germany	Universitätsklinikum Tübingen; Klinik für Urologie	Tübingen
Ireland	Cork Uni Hospital; Oncology Dept	Cork
Ireland	Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit	Dublin
Israel	Soroka Medical Center; Oncology Dept	Beer Sheva
Israel	Rambam Health Care Campus; Oncology	Haifa
Israel	Hadassah Ein Karem Hospital; Oncology Dept	Jerusalem
Israel	Meir Medical Center; Oncology	Kfar-Saba
Israel	Belinson Medical Center, Division of Oncology	Petach Tikva
Israel	Chaim Sheba medical center, Oncology division	Ramat Gan
Israel	Sourasky Medical Center; Oncology Department	Tel-Aviv
Italy	Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia	Arezzo	Toscana
Italy	Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica	Bologna	Emilia-Romagna
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2	Milano	Lombardia
Italy	A.O. Universitaria Policlinico Di Modena; Oncologia	Modena	Emilia-Romagna
Italy	IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima	Padova	Veneto
Italy	Fondazione IRCCS Policlinico San Matteo, Oncologia	Pavia	Lombardia
Japan	Nagoya University Hospital	Aichi
Japan	Hirosaki University Hospital	Aomori
Japan	Kyushu University Hospital	Fukuoka
Japan	Kobe University Hospital	Hyogo
Japan	University of Tsukuba Hospital	Ibaraki
Japan	Mie University Hospital	Mie
Japan	Niigata University Medical & Dental Hospital	Niigata
Japan	Okayama University Hospital	Okayama
Japan	Jichi Medical University Hospital	Tochigi
Japan	Tokushima University Hospital	Tokushima
Japan	Keio University Hospital	Tokyo
Japan	Nippon Medical School Hospital	Tokyo
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Japan	Tokyo Medical and Dental University Hospital	Tokyo
Japan	Tokyo Women?s Medical University Adachi Medical Center	Tokyo
Japan	Toranomon Hospital	Tokyo
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Netherlands	Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis	Amsterdam
Netherlands	VU Medisch Centrum; VU University Medical Center	Amsterdam
Netherlands	UMC Radboud Nijmegen	Nijmegen
Netherlands	Sint Franciscus Gasthuis; Inwendige Geneeskunde	Rotterdam
Netherlands	St. Antonius locatie Leidsche Rijn	Utrecht
Poland	Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej	Kraków
Poland	Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii	Kraków
Poland	Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli	Lublin
Poland	Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii	Pozna?
Poland	Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.	Warszawa
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw
Russian Federation	Altai Region Oncology Dispensory; Oncology	Barnaul	Altaj
Russian Federation	City Clinical Oncology Hospital	Moscow	Moskovskaja Oblast
Russian Federation	P.A. Herzen Oncological Inst. ; Oncology	Moscow	Moskovskaja Oblast
Russian Federation	Privolzhsk Regional Medical Center	Nizhny Novgorod	Niznij Novgorod
Russian Federation	City Clinical Oncology Dispensary	Saint-Petersburg	Sankt Petersburg
Russian Federation	Sverdlovsk Regional Clinical Hospital 1	Yekaterinburg	Sverdlovsk
Serbia	Clinic for Urology, Clinical Center of Serbia; Clinic for Urology	Belgrade
Serbia	Clinic for Urology; Military Medical Academy	Belgrade
Serbia	Oncology Institute of Vojvodina	Sremska Kamenica
Spain	Hospital Clínic i Provincial; Servicio de Oncología	Barcelona
Spain	Institut Catala d Oncologia Hospital Duran i Reynals	Barcelona
Spain	Hospital Universitario Reina Sofia; Servicio de Oncologia	Córdoba	Cordoba
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid
Spain	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Clínico San Carlos; Servicio de Oncologia	Madrid
Spain	Hospital Univ. Central de Asturias; Servicio de Oncologia	Oviedo	Asturias
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Sant Andreu de La Barca	Barcelona
Spain	Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia	Santiago de Compostela	LA Coruña
Taiwan	China Medical University Hospital; Urology	Taichung
Taiwan	Taichung Veterans General Hospital; Division of Urology	Taichung
Taiwan	National Taiwan University Hospital, Department of Urology	Taipei
Taiwan	TAIPEI VETERANS GENERAL HOSPITAL, Urology	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou, Urinary Oncology	Taoyuan
Thailand	Division of Urological surgery; Department of surgery, Chulalongkorn University	Bangkok
Thailand	Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit	Chiangmai
Turkey	Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology	Adana
Turkey	Ankara Uni School of Medicine; Medical Oncology	Ankara
Turkey	Gazi University Medical Faculty; Department of ?nternal Medicine	Ankara
Turkey	Trakya University Medical Faculty	Edirne
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye/Ankara
Ukraine	CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR	Dnipropetrovsk
Ukraine	Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4	Kharkiv	Kharkiv Governorate
Ukraine	Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction	Lviv
Ukraine	Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary	Sumy
Ukraine	Zaporizhzhia Regional Clinic	Zaporizhzhia
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Royal Free Hospital	London
United Kingdom	Christie Hospital	Manchester
United Kingdom	Freeman Hospital	Newcastle upon Tyne
United Kingdom	Weston Park Hospital	Sheffield
United Kingdom	Singleton Hospital; Pharmacy Department	Swansea
United States	New York Oncology Hematology at Albany Medical Center	Albany	New York
United States	Emory Uni - Winship Cancer Center; Hematology/Oncology	Atlanta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Erlanger Health Systems	Chattanooga	Tennessee
United States	The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology	Chicago	Illinois
United States	Cleveland Clinic Foundation; Hematology and Oncology	Cleveland	Ohio
United States	Fairview Hospital; Cleveland Clinic Cancer Center	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	City of Hope National Medical Center	Duarte	California
United States	Florida Cancer Specialists-Broadway, Fort Myers	Fort Myers	Florida
United States	University of Florida	Gainesville	Florida
United States	MD Anderson Cancer Center	Houston	Texas
United States	Urology Associates of Kingsport, P.C.	Kingsport	Tennessee
United States	City of Hope, Antelope Valley	Lancaster	California
United States	UCLA Urology; Urology	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Hillcrest Hospital; Hirsch Cancer Center	Mayfield Heights	Ohio
United States	Loyola University Medical Center, Cardinal Bernardin Cancer Center	Maywood	Illinois
United States	Univ of Miami, School of Med; Hem/Onc	Miami	Florida
United States	West Virginia University Hospitals Inc	Morgantown	West Virginia
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center; Vanderbilt University	Nashville	Tennessee
United States	Yale School of Medicine	New Haven	Connecticut
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Tulane Uni Health Sciences Center	New Orleans	Louisiana
United States	Bellevue Hospital	New York	New York
United States	Laura and ISAAC Perlmutter Cancer Center at NYU Langone.	New York	New York
United States	Mount SInai Medical Center	New York	New York
United States	University of Oklahoma; Stephenson Oklahoma Canc Ctr	Oklahoma City	Oklahoma
United States	University of California Irvine Medical Center	Orange	California
United States	Fox Chase Cancer Center; Hematology/Oncology	Philadelphia	Pennsylvania
United States	Oregon Health & Science Uni	Portland	Oregon
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	University of Rochester Medical Center; Urology	Rochester	New York
United States	University of Utah; Huntsman Cancer Hospital	Salt Lake City	Utah
United States	Mayo Clinic- Scottsdale	Scottsdale	Arizona
United States	Sanford Cancer Cnt Onco Clinic	Sioux Falls	South Dakota
United States	City of Hope-South Pasadena	South Pasadena	California
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Moffitt Cancer Center	Tampa	Florida
United States	Chesapeake Urology Research Associates	Towson	Maryland
United States	City of Hope; Upland	Upland	California
United States	Garden State Urology	Whippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Czechia,  Denmark,  France,  Germany,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Serbia,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator-assessed Disease-Free Survival (DFS)	Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.	From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)
Secondary	Overall Survival (OS)	OS was defined as the time from randomization to death from any cause.	From baseline up to death due to any cause (up to approximately 64 months)
Secondary	Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3	Investigator assessed DFS for participants with PD-L1 expression of IC1/2/3 vs IC0, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. PD-L1 IC0 was defined as <1% and IC1/2/3 was defined as >=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC.	From baseline until first occurrence of DFS event (up to approximately 64 months)
Secondary	Independent Review Facility (IRF)-Assessed DFS	IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first.	From baseline until first documented recurrence event (up to approximately 64 months)
Secondary	IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3	IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. PD-L1 IC0 was defined as <1% and IC1/2/3 was defined as >=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay.	From baseline until first occurrence of DFS event (up to approximately 64 months)
Secondary	IRF-assessed Event-free Survival (EFS)	IRF-assessed EFS was defined as the time from randomization to death from any cause, or the first documented recurrence in participants without baseline disease by IRF or the first documented disease progression in participants identified as having baseline disease by IRF, whichever occurred first. Disease progression was defined as either unequivocal progression of baseline disease or new unequivocal lesions.	From baseline until first documented recurrence event (up to approximately 64 months)
Secondary	Disease-Specific Survival	Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).	From baseline up to death due to RCC (up to approximately 64 months)
Secondary	Distant Metastasis-Free Survival	Distant metastasis-free survival, defined as the time from randomization to death from any cause or the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator, whichever occurred first.	From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)
Secondary	Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3	IRF-assessed DFS was defined as the percentage of participants being alive and free of recurrence assessed by IRF at Year 1, 2, and 3 after randomization.	Up to 3 years
Secondary	Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3	Investigator-assessed DFS rate was defined as the percentage of participants being alive and free of recurrence assessed by investigator at Year 1, 2, and 3 after randomization.	Up to 3 years
Secondary	Percentage of Participants With Adverse Events	An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.	From baseline up to death due to any cause (up to approximately 71 months)
Secondary	Maximum Serum Concentration (Cmax) of Atezolizumab		Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
Secondary	Minimum Serum Concentration (Cmin) of Atezolizumab		Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
Secondary	Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab		Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)