A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152)

Carcinoma, Hepatocellular Clinical Trial

— SKYSCRAPER-14  

Official title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904886
• Other study ID #: CO44668
• Secondary ID: 2023-503422-39-0
• Status: Recruiting
• Phase: Phase 3
• Start date: September 14, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: CO44668 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants
• Disease that is not amenable to curative surgical and/or locoregional therapies
• No prior systemic treatment for locally advanced or metastatic and/or unresectable HCC
• Measurable disease according to RECIST v1.1
• ECOG Performance Status of 0 or 1 within 7 days prior to randomization
• Child-Pugh Class A within 7 days prior to randomization
• Adequate hematologic and end-organ function
• Female participants of childbearing potential must be willing to avoid pregnancy within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
• Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab/placebo to avoid exposing the embryo.

Exclusion Criteria:

• Pregnancy or breastfeeding within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies
• Treatment with investigational therapy within 28 days prior to initiation of study treatment
• Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure
• Treatment with systemic immunostimulatory agents
• Treatment with systemic immunosuppressive medication
• Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
• A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
• Mixed histology or other subtypes/variants of HCC, including, but not limited to, known liver adenocarcinoma, fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
• Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
• Acute Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Atezolizumab
Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
• Bevacizumab
Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
• Tiragolumab
Tiragolumab will be administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle.

Other:
• Placebo
Placebo matching tiragolumab will be administered by IV infusion on Day 1 of each 21-day cycle.

Locations

Country	Name	City	State
Belgium	Imeldaziekenhuis	Bonheiden
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	Hospital Erasme	Bruxelles
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	AZ Delta (Campus Rumbeke)	Roeselare
Brazil	Hospital de Cancer de Barretos	Barretos	SP
Brazil	Oncoclínicas do Brasil - BELO HORIZONTE	Belo Horizonte	MG
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS
Brazil	Hospital de Amor Amazônia	Porto Velho	RO
Brazil	Hospital do Cancer de Pernambuco - HCP	Recife	PE
Brazil	Clinicas Oncologicas Integradas - COI	Rio De Janeiro	RJ
Brazil	Hospital A. C. Camargo; Oncologia	Sao Paulo	SP
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
Brazil	CEDOES - Diagnóstico e Pesquisa	Vitoria	ES
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	William Osler Health Centre	Etobicoke	Ontario
Canada	Juravinski Hospital	Hamilton	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Centre - Glen Site	Montreal	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
China	Baoji Central Hospital	Baoji City
China	Beijing Cancer Hospital	Beijing
China	Beijing Youan Hospital, Capital Medical University; Center for Infectious Diseases	Beijing City
China	The First Hospital of Jilin University	Changchun City
China	Peoples Hospital of Hunan Province	Changsha
China	Hunan Cancer Hospital	Changsha CITY
China	West China Hospital - Sichuan University	Chengdu City
China	Mengchao Hepatobiliary Hospital Of Fujian Medical University	Fuzhou City
China	The First Affliated Hospital Of Fujian Medical University; Intervention Department	Fuzhou City
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	Sun yat-sen University Cancer Center; Department of Liver Surgery	Guangzhou
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou City
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou
China	Zhejiang Provincial People?s Hospital	Hangzhou
China	Harbin Medical University Cancer Hospital	Harbin
China	Anhui Provincial Hospital	Hefei
China	The Second Affiliated Hospital of Anhui Medical University	Hefei
China	Shandong Cancer Hospital	Jinan
China	Lishui Central Hospital	Lishui City
China	The First Affiliate Hospital of Guangxi Medical University	Nanning
China	Guangxi Cancer Hospital of Guangxi Medical University	Nanning City
China	Renji Hospital Shanghai Jiaotong University School of Medicine	Shanghai City
China	Zhongshan Hospital Fudan Unvierstiy	Shanghai City
China	Shengjing Hospital of China Medical University	ShenYang
China	Tianjin Cancer Hospital	Tianjin
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an
China	Xi'an Inernational Medical Center Hospital	Xi'an
Côte D'Ivoire	Centre National d'Oncologie Médicale et de Radiothérapie Alassane Ouattara (CNRAO)	Abidjan
Côte D'Ivoire	Polyclinique Internationale Sainte Anne- Marie (PISAM)	Abidjan
France	CHU CAEN - Hôpital de la Côte de Nacre; Service Hepatogastroenterologie	Caen Cedex
France	Hôpital Albert Michallon	La Tronche
France	CHRU de Lille - Hopital Claude Huriez	Lille
France	Hopital Dupuytren; Hepatologie Gastro Enterologie	Limoges
France	Fondation Hopital Saint Joseph; Gastro-Enterologie	Marseille
France	CH Saint Eloi	Montpellier
France	Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie	Nantes
France	APHP - Hopital Saint Antoine	Paris
France	Hopital Robert Debre; Gastro Enterologie	Reims
France	Centre Hospitalier Valence	Valence
France	Hopitaux de Brabois - Gastro-Entereologie	Vandoeuvre-les-nancy
France	Hopital Paul Brousse; Centre Hepatologie Biliaire	Villejuif
Germany	Klinikum Esslingen; Allg. Innere Med., Onkologie, Hämatologie, Gastroenterologie und Infektiologie	Esslingen
Germany	Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG	Göttingen
Germany	Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Medizinische Klinik I	Lübeck
Germany	Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie	Mageburg
Germany	Uniklinik Mainz; I. Medizinische Klinik	Mainz
Germany	Universität Tübingen; Med. Klinik; Innere Medizin I	Tübingen
Germany	Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I	Ulm
Hong Kong	Queen Mary Hospital; Dept. Of Haematology & Oncology	Hong Kong
Hong Kong	Prince of Wales Hosp; Dept. Of Clinical Onc	Shatin
Italy	A.O. S. Orsola Malpighi; Ambulatorio Epatocarcinoma (Bolondi)	Bologna	Emilia-Romagna
Italy	Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical	Genova	Liguria
Italy	Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica	Napoli	Campania
Italy	A.O.U. Policlinico Paolo Giaccone; Gastroenterologia ed Epatologia	Palermo	Sicilia
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Lazio
Italy	IRCCS Istituto Clinico Humanitas; Oncologia	Rozzano (MI)	Lombardia
Italy	Az. Osp. G. Panico; U.O. Oncologia	Tricase (LE)	Puglia
Italy	A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U.	Verona	Veneto
Japan	Fujita Health University Hospital	Aichi
Japan	Chiba University Hospital	Chiba
Japan	National Cancer Center Hospital East	Chiba
Japan	Ehime Prefectural Central Hospital	Ehime
Japan	Kurume University Hospital	Fukuoka
Japan	Hiroshima University Hospital	Hiroshima
Japan	Hokkaido University Hospital	Hokkaido
Japan	Sapporo Kosei Genaral Hospital	Hokkaido
Japan	Japanese Red Cross Society Himeji Hospital	Hyogo
Japan	Kanazawa University Hospital	Ishikawa
Japan	Iwate Medical University Hospital	Iwate
Japan	Kanagawa Cancer Center	Kanagawa
Japan	Kitasato University Hospital	Kanagawa
Japan	Toranomon Branch Hospital	Kanagawa
Japan	Kyoto University Hospital	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto
Japan	Kindai University Hospital	Osaka
Japan	Osaka University Hospital	Osaka
Japan	Jichi Medical University Hospital	Tochigi
Japan	Japanese Red Cross Musashino Hospital	Tokyo
Japan	Toranomon Hospital	Tokyo
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	CHA Bundang Medical Center	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Ulsan University Hosiptal	Ulsan
Mexico	OncoMed; Supportive Care	Ciudad de México	Mexico CITY (federal District)
Mexico	Centro Medico Nacional Siglo Xxi - Imss; Hospital de Oncologia	Mexico City	Mexico CITY (federal District)
Mexico	Instituto Nacional de Ciencias Médicas Y de Nutricion Salvador Zubirán	Mexico DF	Mexico CITY (federal District)
Mexico	Centro de Investigacion Clinica de Oaxaca	Oaxaca de Juárez	Oaxaca
Mexico	Oncare	San Pedro Garza García	Nuevo LEON
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital; Gastroenterology Dept	Christchurch
New Zealand	Wellington Hospital	Wellington
Nigeria	Jos University Teaching Hospital; Internal medicine and Gastroenterology	JOS
Nigeria	Lagos University Teaching Hospital Lagos (LUTH), Lagos State	Lagos
Poland	Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii; Oddzia? Onkologii Klinicznej	Gdansk
Poland	Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii	Kraków
Poland	ID Clinic	Myslowice
Poland	NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii	Warszawa
Puerto Rico	PanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center	San Juan
Singapore	Curie Oncology	Singapore
Singapore	National Cancer Centre; Medical Oncology	Singapore
Singapore	National University Hospital; National University Cancer Institute, Singapore (NCIS)	Singapore
Singapore	Tan Tock Seng Hospital; Oncology	Singapore
South Africa	Limpopo Cancer Research Institute	Polokwane
Spain	Hospital Clinic i Provincial; Servicio de Hepatología	Barcelona
Spain	Hospital Duran i Reynals; Oncologia	Barcelona
Spain	Hospital Universitari Vall d'Hebron; Servicio de Hepatologia	Barcelona
Spain	Hospital Universitario de Burgos; Oncología	Burgos
Spain	Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia	Jaen
Spain	Clinica Universitaria de Navarra de Madrid; Servicio de Hepatologia; Servicio de Hepatologia	Madrid
Spain	Hospital Clinico San Carlos; Servicio de Oncologia	Madrid
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Aparato Digestivo	Madrid
Spain	Hospital Universitario Puerta de Hierro; Servicio de Gastroenterologia	Madrid
Spain	Hospital de Navarra; Servicio de Oncologia	Navarra
Spain	Hospital Universitario Central de Asturias; Servicio de Hepatología	Oviedo	Asturias
Spain	Clinica Universitaria de Navarra; Servicio de Hepatologia	Pamplona/iruña	Navarra
Spain	Hospital Clinico de Valencia; Servicio de Hepatologia	Valencia
Taiwan	China Medical University Hospital; Surgery	Taichung
Taiwan	Chi-Mei Medical Centre; Hematology & Oncology	Tainan
Taiwan	National Cheng Kung University Hospital; Oncology	Tainan
Taiwan	National Taiwan Uni Hospital; Dept of Oncology	Taipei
Taiwan	Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology	Taoyuan
Thailand	Chulalongkorn Hospital; Medical Oncology	Bangkok
Thailand	Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital; Department of Medicine	ChiangMai
Thailand	Khon Kaen Uni ; Faculty of Medicine, Division of Gastroenterology	Khon Kaen
Turkey	Adana Baskent University Medical Faculty; Oncology	Adana
Turkey	Ankara Bilkent City Hospital	Ankara
Turkey	Gazi Uni Medical Faculty Hospital; Oncology Dept	Ankara
Turkey	Dicle University Faculty of Medicine	Diyarbakir
Turkey	Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi	Edirne
Turkey	?zmir Medical Point; Oncology	Kar?iyaka
United Kingdom	Western General Hospital; Dept of Oncology	Edinburgh
United Kingdom	Hammersmith Hospital; Clinical trials unit	London
United Kingdom	Royal Free Hospital; Dept of Oncology	London
United States	UCLA MEDICAL CENTER; Alhambra	Alhambra	California
United States	Virginia Cancer Specialists - Arlington	Arlington	Virginia
United States	Texas Oncology - Austin	Austin	Texas
United States	Mercy Medical Center	Baltimore	Maryland
United States	Hematology Oncology Clinic	Baton Rouge	Louisiana
United States	James J Peters VA Hospital / Mental Illness Research Education and Clinic Center	Bronx	New York
United States	Montefiore Medical Center	Bronx	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Illinois	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Univ Hospitals of Cleveland	Cleveland	Ohio
United States	UCSF Fresno at Community Cancer Institute	Clovis	California
United States	North Texas VA Medical Center	Dallas	Texas
United States	Texas Oncology - DFW	Dallas	Texas
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics	Duarte	California
United States	Swedish Cancer Institute - Edmonds Campus	Edmonds	Washington
United States	Florida Cancer Specialists - Fort Myers (Broadway)	Fort Myers	Florida
United States	Cancer & Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	Hartford Healthcare Cancer Institute at Hartford Hospital	Hartford	Connecticut
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	Kelsey Seybold Clnic	Houston	Texas
United States	Swedish Cancer Institute - Issaquah	Issaquah	Washington
United States	G.V. (Sonny) Montgomery VA Medical Center	Jackson	Michigan
United States	Mayo Clinic Cancer Center	Jacksonville	Florida
United States	University of California San Diego Moores Cancer Center	La Jolla	California
United States	Kaiser Permanente - Los Angeles (N. Vermont)	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Norton Cancer Institute - Audubon	Louisville	Kentucky
United States	Univ of Wisconsin-Madison	Madison	Wisconsin
United States	William S Middleton Memorial Veterans Hospital (CARES); Research ATTN: Pharmacy 119	Madison	Wisconsin
United States	Miami VA Healthcare System	Miami	Florida
United States	Ochsner Cancer Inst.	New Orleans	Louisiana
United States	Columbia University	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	NYU Langone	New York	New York
United States	USC Norris Cancer Center; Oncology/Hematology - Newport Beach Treatment Center	Newport Beach	California
United States	Capt. James A. Lovell Federal Health Care Center	North Chicago	Illinois
United States	Kaiser Permanente - Oakland	Oakland	California
United States	OU Health Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	AdventHealth Cancer Institute	Orlando	Florida
United States	Stanford Cancer Center	Palo Alto	California
United States	Va Palo Alto Health Care System	Palo Alto	California
United States	Thomas Jefferson Uni	Philadelphia	Pennsylvania
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	Renown Regional Medical Center	Reno	Nevada
United States	Virginia Commonwealth Uni Health Center	Richmond	Virginia
United States	Mayo Clinic Rochester; Medical Oncology	Rochester	Minnesota
United States	Kaiser Permanente - Roseville	Roseville	California
United States	Washington Uni School of Medicine	Saint Louis	Missouri
United States	Florida Cancer Specialist, North Region	Saint Petersburg	Florida
United States	Kaiser Permanente - San Francisco (2238 Geary)	San Francisco	California
United States	Kaiser Permanente - Santa Clara; Oncology Clinical trials	Santa Clara	California
United States	UCLA Cancer Center	Santa Monica	California
United States	Swedish Cancer Inst.	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Texas Oncology - Northeast Texas	Tyler	Texas
United States	Kaiser Permanente; Oncology Clinical Trials	Vallejo	California
United States	Kaiser Permanente - Walnut Creek	Walnut Creek	California
United States	MedStar Washington Hosp Center	Washington	District of Columbia
United States	Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins	Willow Grove	Pennsylvania
United States	Minnesota Oncology Hematology Woodbury	Woodbury	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Chugai Pharmaceutical

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  China,  Côte D'Ivoire,  France,  Germany,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Mexico,  New Zealand,  Nigeria,  Poland,  Puerto Rico,  Singapore,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator-Assessed Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1		From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Primary	Overall Survival (OS)		From randomization to death from any cause (up to approximately 36 months)
Secondary	Investigator-Assessed Confirmed Objective Response Rate (ORR) According to RECIST v1.1		From randomization up to approximately 36 months
Secondary	Investigator-Assessed Duration of Objective Response (DOR) According to RECIST v1.1		From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary	Investigator-Assessed PFS Rate According to RECIST v1.1 at 6 and 12 Months		Month 6, Month 12
Secondary	OS Rate at 1 and 2 Years		Year 1, Year 2
Secondary	Investigator-Assessed PFS According to Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST)		From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary	Investigator-Assessed Confirmed ORR According to HCC mRECIST		From randomization up to approximately 36 months
Secondary	Investigator-Assessed DOR According to HCC mRECIST		From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary	Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer 30 (QLQ-C30) Subscales	The following subscales of the EORTC QLQ-C30 will be used for the assessment: global health status/quality-of-life (GHS/QoL), physical functioning and role functioning. GHS and QoL are scored on a 7-point scale: 1=Very poor to 7=Excellent. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with a higher score indicating a worse outcome. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. A higher score indicates a better outcome.	From randomization up to approximately 36 months
Secondary	Change from Baseline in GHS/QoL, Physical Functioning, and Role Functioning Assessed Using the EORTC QLQ-C30	GHS and QoL are scored on a 7-point scale: 1=Very poor to 7=Excellent. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with a higher score indicating a worse outcome. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. A higher score indicates a better outcome.	From baseline up to approximately 36 months
Secondary	Percentage of Participants With Adverse Events		Up to approximately 36 months
Secondary	Serum Concentrations of Atezolizumab		Prior to the first infusion and 30 minutes after atezolizumab infusion on Day 1 of Cycle 1 (cycle = 21 days), prior to infusion on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 36 months)
Secondary	Serum Concentrations of Tiragolumab		Prior to the first infusion and 30 minutes after tiragolumab infusion on Day 1 of Cycle 1 (cycle = 21 days), prior to infusion on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 36 months)
Secondary	Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab		Prior to the first infusion on Day 1 of Cycles (cycle = 21 days) 1, 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 36 months)
Secondary	Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab		Prior to the first infusion on Day 1 of Cycles (cycle = 21 days) 1, 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 36 months)