A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]

Bladder Cancer Clinical Trial

Official title:

A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302807
• Other study ID #: GO29294
• Secondary ID: 2014-003231-19
• Status: Completed
• Phase: Phase 3
• Start date: January 13, 2015
• Est. completion date: November 8, 2018

Study information

• Verified date: July 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 931
• Est. completion date: November 8, 2018
• Est. primary completion date: March 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra).

• Representative tumor specimens as specified by the protocol

• Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Life expectancy greater than or equal to (>/=) 12 weeks

• Measurable disease, as defined by RECIST v1.1

• Adequate hematologic and end organ function

• For women of childbearing potential, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel.

• For men, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel, and agreement to refrain from donating sperm

Exclusion Criteria:

• Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment

• Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment

• Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments

• Leptomeningeal disease

• Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer

• Pregnant and lactating women

• Significant cardiovascular disease

• Severe infections within 4 weeks prior to randomization

• Major surgical procedure other than for diagnosis within 4 weeks prior to randomization

• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation

• History of autoimmune disease

• Prior allogeneic stem cell or solid organ transplant

• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan

• Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis

• Administration of a live, attenuated vaccine within 4 weeks prior to randomization

• Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including 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 antibodies

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
• Docetaxel
Docetaxel 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
• Paclitaxel
Paclitaxel 175 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
• Vinflunine
Vinflunine 320 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital; Oncology	Adelaide	South Australia
Australia	Monash Medical Centre; Oncology	Clayton	Victoria
Australia	Royal Brisbane and Women's Hospital; Medical Oncology	Herston	Queensland
Australia	Austin and Repatriation Medical Centre; Cancer Services	Melbourne	Victoria
Austria	Kaiser-Franz-Josef-Spital; Zent.Onkologie und Hamatologie	Wien
Austria	Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie	Wien
Belgium	ZNA Middelheim	Antwerpen
Belgium	Institut Jules Bordet	Bruxelles
Belgium	UZ Gent	Gent
Belgium	UZ Leuven Gasthuisberg	Leuven
Canada	Royal Victoria Hospital	Barrie	Ontario
Canada	Tom Baker Cancer Centre-Calgary	Calgary	Alberta
Canada	Bcca - Cancer Center Southern Interior	Kelowna	British Columbia
Canada	London Regional Cancer Centre	London	Ontario
Canada	McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology	Montreal	Quebec
Canada	Lakeridge Health Oshawa; Oncology	Oshawa	Ontario
Canada	The Ottawa Hospital Cancer Centre; Oncology	Ottawa	Ontario
Canada	Sault Area Hospitals	Sault Ste Marie	Ontario
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario
Canada	BCCA-Vancouver Cancer Centre	Vancouver	British Columbia
Canada	Bcca - Vancouver Island Cancer Centre; Oncology	Victoria	British Columbia
Czechia	Masarykuv onkologicky ustav	Brno
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	MULTISCAN, s.r.o., Radiologicke centrum Pardubice	Pardubice
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Denmark	Herlev Hospital; Onkologisk afdeling	Herlev
Denmark	Rigshospitalet; Onkologisk Klinik	København Ø
Finland	Docrates Cance Center	Helsinki
Finland	Turku University Central Hospital; Urology clinic	Turku
France	Ico - Paul Papin	Angers
France	Institut Sainte Catherine;Recherche Clinique	Avignon
France	Chr De Besancon - Hopital Jean Minjoz	Besancon
France	Hopital Saint Andre	Bordeaux
France	Institut Bergonie; Oncologie	Bordeaux
France	Centre Francois Baclesse; Recherche Clinique	Caen
France	CHU Henri Mondor; Service d'Oncologie Medicale	Creteil
France	Clinique Chenieux; Oncology	Limoges
France	Centre Leon Berard; Departement Oncologie Medicale	Lyon
France	Institut J Paolii Calmettes	Marseille
France	Institut régional du Cancer Montpellier	Montpellier
France	Centre D'Oncologie de Gentilly; Oncology	Nancy
France	Centre Antoine Lacassagne	Nice
France	CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge	Nimes
France	Hopital Cochin; Unite Fonctionnelle D Oncologie	Paris
France	Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale	Paris
France	Hopital Saint Louis; Oncologie Medicale	Paris
France	Institut Curie; Recherche Clinique	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	CHU de Rouen - Hôpital Charles Nicolle	Rouen
France	ICO - Site René Gauducheau	Saint Herblain
France	Hopital Hautepierre; Hematologie Oncologie	Strasbourg
France	Hopital Foch; Oncologie	Suresnes
France	Institut Claudius Regaud; Departement Oncologie Medicale	Toulouse
France	Institut Gustave Roussy; Departement Oncologie Medicale	Villejuif
Germany	Uniklinik RWTH Aachen; Klinik für Urologie	Aachen
Germany	Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie	Berlin
Germany	Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie	Dresden
Germany	Universitätsklinikum Düsseldorf; Urologische Klinik	Düsseldorf
Germany	Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V	Erlangen
Germany	Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie	Freiburg
Germany	Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie	Göttingen
Germany	Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II	Hamburg
Germany	Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg	Heidelberg
Germany	Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie	Homburg/Saar
Germany	Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie	Magdeburg
Germany	Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie	Mannheim
Germany	Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik	München
Germany	Universitätsklinikum Tübingen; Klinik für Urologie	Tübingen
Germany	Universitätsklinikum Ulm; Klinik für Urologie	Ulm
Greece	Alexandras General Hospital of Athens; Oncology Department	Athens
Greece	Univ General Hosp Heraklion; Medical Oncology	Heraklion
Greece	University Hospital of Patras Medical Oncology	Patras
Greece	Euromedical General Clinic of Thessaloniki; Oncology Department	Thessaloniki
Hungary	Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály	Budapest
Hungary	Semmelwies University of Medicine; Urology Dept.	Budapest
Hungary	Uzsoki Utcai Korhaz	Budapest
Hungary	Kecskemeti Onkoradilogai Centrum	Kecskemét
Hungary	Hetenyi Geza County Hospital; Onkologiai Kozpont	Szolnok
Italy	Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia	Arezzo	Toscana
Italy	Asst Papa Giovanni XXIII; Oncologia Medica	Bergamo	Lombardia
Italy	Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico	Candiolo	Piemonte
Italy	ASST DI CREMONA; Dip. Medicina - S.C. Oncologia	Cremona	Lombardia
Italy	Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1	Firenze	Toscana
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	Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico	Napoli	Campania
Italy	Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello	Palermo	Sicilia
Italy	Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica	Roma	Lazio
Italy	IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia	San Giovanni Rotondo	Puglia
Italy	A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia	Udine	Friuli-Venezia Giulia
Japan	Nagoya University Hospital; Urology	Aichi
Japan	Hirosaki University School of Medicine & Hospital; Urology	Aomori
Japan	Chiba Cancer Center; Urology	Chiba
Japan	National Cancer Center Hospital East; Breast and Medical Oncology	Chiba
Japan	National Hospital Organization Shikoku Cancer Center; Urology	Ehime
Japan	Harasanshin Hospital; Urology	Fukuoka
Japan	Kyushu University Hospital; Urology	Fukuoka
Japan	Gunma University Hospital; Urology	Gunma
Japan	Hiroshima City Hiroshima Citizens Hospital; Urology	Hiroshima
Japan	Hokkaido University Hospital; Urology	Hokkaido
Japan	Sapporo Medical University Hospital; Urology	Hokkaido
Japan	University of Tsukuba Hospital; Urology	Ibaraki
Japan	Iwate Medical University Hospital; Urology	Iwate
Japan	Yokohama City University Hospital; Urology	Kanagawa
Japan	Kumamoto University Hospital; Urology	Kumamoto
Japan	Niigata Cancer Center Hospital;Urology	Niigata
Japan	Kindai University Hospital; Urology	Osaka
Japan	Osaka International Cancer Institute; Urology	Osaka
Japan	Osaka University Hospital; Urology	Osaka
Japan	Shizuoka Cancer Center; Urology	Shizuoka
Japan	Tokushima University Hospital; Urology	Tokushima
Japan	National Cancer Center Hospital; Urology	Tokyo
Japan	Nippon Medical School Hospital; Urology	Tokyo
Japan	The Cancer Institute Hospital, JFCR; Urology	Tokyo
Japan	Toranomon Hospital; Medical Oncology	Tokyo
Korea, Republic of	Asan Medical Center - Oncology	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Netherlands	The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis	Amsterdam
Netherlands	Spaarne Ziekenhuis; Inwendige Geneeskunde	Hoofddorp
Netherlands	Maastricht University Medical Centre; Medical Oncology	Maastricht
Netherlands	St. Antonius Ziekenhuis Nieuwegein	Nieuwegein
Netherlands	Isala Klinieken	Zwolle
Norway	Sørlandet Sykehus Kristiansand	Kristiansand
Norway	Uni Hospital of Tromso; Dept. of Oncology	Tromsø
Norway	St. Olavs Hospital; Kreftavdelingen	Trondheim
Poland	Medical University of Bialystok; Oncology clinic	Bialystok
Poland	Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii	Gdansk
Poland	COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej	Lublin
Poland	Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu	Poznan
Poland	Centrum onkologii Instytutu im. Marii Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego	Warszawa
Poland	Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wroclawiu; Departament Of Urology	Wroclaw
Portugal	Hospital de Santa Maria; Servico de Oncologia Medica	Lisboa
Portugal	Hospital Beatriz Angelo; Departamento de Oncologia	Loures
Portugal	IPO do Porto; Servico de Oncologia Medica	Porto
Romania	Spitalul Judetean de Urgenta Dr Constantin Opris	Baia Mare
Romania	Institute Of Oncology Bucharest; Medical Oncology	Bucharest
Romania	Institut Oncologic Ion Chiricuta; Departament Radioterapie	Cluj-napoca
Romania	Oncology Center Sf. Nectarie	Craiova
Romania	Euroclinic Center of Oncology SRL	Iasi
Romania	Spital Clinic Judetean Mures; Oncologie	Targu Mures
Romania	ONCOMED - Medical Centre	Timisoara
Russian Federation	Altai Regional Oncological Center	Barnaul
Russian Federation	Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology	Moscow
Russian Federation	GBUZ Nizhegorodskay Region: Clinical Diagnostic Center	Nizhni Novgorod	Niznij Novgorod
Russian Federation	St. Petersburg Oncology Hospital	St Petersburg
Russian Federation	SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary	Stavropol
Serbia	Clinical Center of Serbia; Clinic of Urology	Belgrade
Serbia	Institute for Oncology and Radiology of Serbia; Medical Oncology	Belgrade
Serbia	Oncology Institute of Vojvodina	Sremska Kamenica
Slovenia	Institute of Oncology Ljubljana	Ljubljana
Spain	Hospital Clinic i Provincial; Servicio de Farmacia	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia	Barcelona
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Barcelona
Spain	Institut Catala d Oncologia Hospital Duran i Reynals	Barcelona
Spain	Hospital San Pedro De Alcantara; Servicio de Oncologia	Caceres
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 Clinico Universitario Virgen de la Victoria; Servicio de Oncologia	Malaga
Spain	Hospital de Navarra; Servicio de Oncologia	Navarra
Spain	Hospital Universitario Son Espases; Servicio de Oncologia	Palma De Mallorca	Islas Baleares
Spain	Clinica Universitaria de Navarra; Servicio de Oncologia	Pamplona	Navarra
Spain	Corporacio Sanitaria Parc Tauli; Servicio de Oncologia	Sabadell	Barcelona
Spain	Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia	Santiago de Compostela	LA Coruña
Spain	Hospital Universitario Virgen del Rocio; Servicio de Oncologia	Sevilla
Spain	Hospital Clínico Universitario de Valencia; Servicio de Oncología	Valencia
Spain	Hospital General Universitario de Valencia; Servicio de oncologia	Valencia
Sweden	Sahlgrenska Universitetssjukhuset; Jubileumskliniken	Göteborg
Sweden	Karolinska Hospital; Oncology - Radiumhemmet	Stockholm
Sweden	Norrlands Uni Hospital; Onkologi Avd.	Umea
Switzerland	Inselspital Bern; Universitätsklinik für medizinische Onkologie	Bern
Switzerland	Kantonsspital Graubünden;Onkologie und Hämatologie	Chur
Switzerland	HUG; Oncologie	Geneve
Switzerland	Kantonsspital St. Gallen; Onkologie/Hämatologie	St. Gallen
Switzerland	UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie	Zürich
Taiwan	China Medical University Hospital; Urology	Taichung
Taiwan	Taichung Veterans General Hospital; Division of Urology	Taichung
Taiwan	National Taiwan Uni Hospital; Dept of Oncology	Taipei
Taiwan	TAIPEI VETERANS GENERAL HOSPITAL, Urology	Taipei
Turkey	Uludag Uni Hospital; Oncology	Bursa
Turkey	Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department	Edirne
Turkey	Bezmialem Vakif Univ Medical	Istanbul
Turkey	Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology	Istanbul
Turkey	Istanbul VKV American Hospital; Medical Oncology	Istanbul
Turkey	Ege Uni Medical Faculty Hospital; Oncology Dept	Izmir
Turkey	Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department	Malatya
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye, Ankara
United Kingdom	University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital	Birmingham
United Kingdom	Bristol Haematology and Oncology Centre	Bristol
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Cheltenham General Hospital	Cheltenham
United Kingdom	University Hospital coventry; Oncology Department	Coventry
United Kingdom	Royal Devon & Exeter Hospital; Oncology Centre	Exeter
United Kingdom	Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust	Lancaster
United Kingdom	St James Institute of Oncology	Leeds
United Kingdom	Leicester Royal Infirmary; Dept. of Medical Oncology	Leicester
United Kingdom	Barts and The London	London
United Kingdom	Royal Free Hospital; Dept of Oncology	London
United Kingdom	Northern Centre for Cancer Care; Northern Centre for Cancer Care	Newcastle Upon Tyne
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Scunthorpe General Hospital; Dept of Oncology	Scunthorpe
United Kingdom	Southampton General Hospital; Medical Oncology	Southampton
United Kingdom	Royal Marsden Hospital; Dept of Medical Oncology	Sutton
United Kingdom	Royal Cornwall Hospital	Truro
United Kingdom	The Clatterbridge Cancer Centre NHS Foundation Trust	Wirral
United States	Emory University; Winship Cancer Institute	Atlanta	Georgia
United States	Duke Cancer Center	Durham	North Carolina
United States	Bon Secours - St. Francis Hospital	Greenville	South Carolina
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Vanderbilt-Ingram Cancer Ctr	Nashville	Tennessee
United States	Georgetown University Medical Center Lombardi Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovenia,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS was defined as time from randomization to death from any cause.	Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled
Secondary	Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1	PFS was defined as the time between the date of randomization and the date of first documented progression of disease (PD) or death, whichever occurred first. PD was determined on the basis of investigator assessment with use of RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters had to demonstrate an absolute increase of >/= 5 millimeters (mm).	Up to approximately 25 months after first participant enrolled
Secondary	Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1	DOR was defined as the time from first occurrence of a CR or PR, whichever came first, to first documented PD or death, whichever occurred first. Disease progression was determined on the basis of investigator assessment with use of RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.	Up to approximately 25 months after first participant enrolled
Secondary	Percentage of Participants With Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), 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 adverse events.	Up to approximately 46 months after first participant enrolled
Secondary	Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab	Participants were considered post-baseline ATA positive if they had post-baseline ATAs to Atezolizumab that were treatment-induced or treatment-enhanced. Participants had treatment-induced ATAs if they had a baseline-negative ATA result and developed ATAs at any time after initial drug administration. Participants had treatment-enhanced ATAs if they had a baseline-positive ATA result that showed an enhanced signal that was >/= 0.60 titer units at any time after initial drug initiation.	Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)
Secondary	Minimum Observed Serum Atezolizumab Concentration (Cmin)	Cmin was measured for all participants that received at least one dose of Atezolizumab.	Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)
Secondary	Percentage of Participants With Unconfirmed Objective Response Rate (ORR) as Determined by the Investigator With Use of Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)	ORR was defined as the percentage of participants, who had an objective response. Objective response was defined as either a complete response (CR) or partial response (PR) as determined by the investigator with use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). Objective response in this study did not need to be a confirmed response. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. ORR=CR+PR	Up to approximately 25 months after first participant enrolled
Secondary	Maximum Observed Serum Atezolizumab Concentration (Cmax)	Cmax was measured for all participants that received at least one dose of Atezolizumab.	30 minutes post dose on Day 1 of Cycles 1
Secondary	Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Global Health Status Scale	The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.	Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)
Secondary	Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Physical Functioning Scale	The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.	Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)
Secondary	Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Fatigue Symptom Scale	The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.	Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)