A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

Urothelial Cancer Clinical Trial

Official title:

A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603432
• Other study ID #: B9991001
• Secondary ID: 2015-003262-86JA
• Status: Completed
• Phase: Phase 3
• Start date: April 25, 2016
• Est. completion date: March 28, 2023

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: March 28, 2023
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed, unresectable locally advanced or metastatic transitional cell carcinoma of the urothelium

• Stage IV disease at the start of first-line chemotherapy

• Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy

• Prior first-line chemotherapy must have consisted of at least 4 cycles and no more than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin

• No evidence of progressive disease following completion of first-line chemotherapy (i.e., ongoing CR, PR, or SD per RECIST v1.1 guidelines )

Exclusion Criteria:

• Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization

• Prior immunotherapy with IL-2, IFN-a, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

• Persisting toxicity related to prior therapy (Grade >1 NCI CTCAE v4.0); however, alopecia, sensory neuropathy (Grade 2 or less), or other (Grade 2 or less) adverse events not constituting a safety risk based on the investigator's judgement are acceptable.

• Patients with known symptomatic central nervous system (CNS) metastases requiring steroids

• Diagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.

Related Conditions & MeSH terms

• Urothelial Cancer

Intervention

Biological:
• Avelumab
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles

Other:
• Best Supportive Care
BSC will be administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. BSC does not include any active anti-tumor therapy, however local radiotherapy of isolated lesions with palliative intent is acceptable.

Biological:
• Following the planned interim analysis for this study: Avelumab
1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles

Locations

Country	Name	City	State
Argentina	Fundación CENIT para la Investigación en Neurociencias	Caba
Argentina	Centro Oncologico Riojano Integral (Cori)	La Rioja
Argentina	GP Diagnostico SRL	La Rioja
Argentina	Hospital Regional Dr. Enrique Vera Barros	La Rioja
Argentina	Instituto del Diagnostico	La Rioja
Argentina	Centro de Investigacion Pergamino S.A.	Pergamino	Buenos Aires
Australia	Icon Cancer Care Wesley	Auchenflower	Queensland
Australia	River City Pharmacy	Auchenflower	Queensland
Australia	Ballarat Oncology & Haematology Services	Ballarat	Victoria
Australia	BHS Diagnostic Services	Ballarat	Victoria
Australia	Lake Imaging	Ballarat	Victoria
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	SA Pharmacy, Level 3 Pharmacy	Bedford Park	South Australia
Australia	Oncology Pharmacy	Birtinya	Queensland
Australia	Sunshine Coast University Hospital	Birtinya	Queensland
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Box Hill Hospital - Pharmacy Department, Bulding B, Loading Dock (access via Thames St)	Box Hill	Victoria
Australia	Eastern Health Clinical School	Box Hill	Victoria
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	Icon Cancer Care Chermside	Chermside	Queensland
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Concord Hospital	Concord	New South Wales
Australia	The Townsville Hospital	Douglas	Queensland
Australia	Dubbo Base Hospital	Dubbo	New South Wales
Australia	Monash Medical Centre	East Bentleigh	Victoria
Australia	Moorabbin Radiology	East Bentleigh	Victoria
Australia	Slade Health	Geebung	Queensland
Australia	Ramsay Pharmacy	Kogarah	New South Wales
Australia	St George Private Hospital	Kogarah	New South Wales
Australia	Adelaide Cancer Centre	Kurralta Park	South Australia
Australia	Ashford Cancer Centre Research	Kurralta park	South Australia
Australia	Cancer Care SA Pty Ltd	Kurralta Park	South Australia
Australia	Icon Cancer Care SA trading as Icon Pharmacy Adelaide	Kurralta Park	South Australia
Australia	Epic Pharmacy	Lismore	New South Wales
Australia	North Coast Radiology St Vincents	Lismore	New South Wales
Australia	Northern Rivers Pathology Service	Lismore	New South Wales
Australia	St Vincent's Pathology Lismore	Lismore	New South Wales
Australia	Macquarie Medical Imaging	Macquarie University	New South Wales
Australia	Macquarie University	Macquarie University	New South Wales
Australia	Macquarie University Hospital Pharmacy	Macquarie University	New South Wales
Australia	Slade Health	Mount Waverley
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	St John of God Murdoch Hospital	Murdoch	Western Australia
Australia	The Murwillumbah Hospital	Murwillubah	New South Wales
Australia	Macquarie Heart	New South Wales
Australia	Icon Cancer Care	South Brisbane	Queensland
Australia	Icon Cancer Care South Brisbane	South Brisbane	Queensland
Australia	Integrated Clinical Oncology Network (ICON) Corporate Office	South Brisbane	Queensland
Australia	Icon Cancer Care Southport	Southport	Queensland
Australia	The Tweed Hospital	Tweed Heads	New South Wales
Australia	The Tweed Hospital Pharmacy Department	Tweed Heads	New South Wales
Australia	Ballarat Day Procedure Centre	Wendouree	Victoria
Australia	Ballarat Oncology & Haematology Services	Wendouree	Victoria
Australia	Nova Pharmacy	Wendouree	Victoria
Australia	The Queen Elizabeth Hospital	Woodville South	South Australia
Belgium	AZ Klina	Brasschaat
Belgium	AZ Klina - Apotheek	Brasschaat
Belgium	Hôpital Erasme	Brussels
Belgium	Hôpital Erasme	Bruxelles
Belgium	UZ Gent	Gent
Belgium	UZ Gent	Ghent
Belgium	AZ Groeninge	Kortrijk
Belgium	CHU de Liège	Liège
Belgium	GZA Sint-Augustinus	Wilrijk
Brazil	Fundação FPio XII Barretos	Barretos	SP
Brazil	Fundação Pio XII Barretos	Barretos	SP
Brazil	Associacao Hospital de Caridade Ijui	Ijui	RS
Brazil	ONCOSITE - Centro de Pesquisa Clinica em Oncologia	Ijui	RIO Grande DO SUL
Brazil	Associação Educadora São Carlos - AESC / Hospital Mãe de Deus	Porto Alegre	RS
Brazil	Associação Educadora São Carlos - AESC / Hospital Mãe de Deus	Porto Alegre	RS
Brazil	Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Ambulatório Quimioterapia	Porto Alegre	RS
Brazil	Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Centro de Abastecimento Farmaceut	Porto Alegre	RS
Brazil	Associação Educadora São Carlos - AESC / Hospital Mãe de Deus - Farmácia Oncológica	Porto Alegre	RS
Brazil	Hospital Mãe de Deus/Aesc	Porto Alegre	RIO Grande DO SUL
Brazil	Uniao Brasileira de Educacao e Assistencia / Hospital Sao Lucas da PUCRS	Porto Alegre	RS
Brazil	Instituto Nacional de Câncer - INCA	Rio de Janeiro	RJ
Brazil	CENOB Centro de Oncologia da Bahia S/S Ltda. / Oncovida	Salvador	BA
Brazil	Hospital da Bahia	Salvador	BA
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto	Sao Jose do Rio Preto	SP
Brazil	Centro Integrado de Pesquisa Clinica - CIP	São José do Rio Preto	SP
Brazil	Fundacao Faculdade de Medicina / Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
Brazil	Hospital Alemao Oswaldo Cruz	Sao Paulo	SP
Brazil	Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP	Sao Paulo	SP
Brazil	Hospital Israelita Albert Einstein - SP	São Paulo	SP
Brazil	Sociedade Beneficente de Senhoras Hospital Sírio Libanês	São Paulo	SP
Brazil	Sociedade Beneficente de Senhoras Hospital Sírio Libanês	São Paulo	SP
Brazil	Sociedade Beneficente de Senhoras Hospital Sírio Libanês/ Instituo Sirio Libanes de Ensino e Pesqu	São Paulo
Canada	William Osler Health System	Brampton	Ontario
Canada	CHUM - Centre Hospitalier de l'Universite de Montreal	Montréal	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno	Ceska Republika
Czechia	Fakultni nemocnice u sv.Anny v Brne	Brno
Czechia	Nemocnice Horovice	Horovice
Czechia	Nemocnice Horovice, NH Hospital a.s.	Horovice
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Aalborg Universitetshospital Syd	Aalborg
Denmark	Sygehusapoteket Aalborg	Aalborg
Denmark	Aarhus Universitetshospital	Aarhus C
Denmark	Aarhus Universitetshospital	Aarhus N
Denmark	CT-Klinikken A/S	Aarhus N
Denmark	Rigshospitalet, Onkologisk Klinik, afsnit 5073	Copenhagen OE
Denmark	Herlev Hospital	Herlev
Denmark	Herlev og Gentofte Hospital	Herlev
Denmark	Klinik for Klinisk Fysiologi,Nuklearmedicin og PET	København Ø
Denmark	Rigshospitalet	København Ø
Denmark	Odense Universitetshospital	Odense
Denmark	Odense Universitetshospital	Odense C
France	Institut de cancérologie de l'Ouest - Site Paul Papin	Angers
France	Institut de cancérologie de l'Ouest - Site Paul Papin	Angers Cedex 02
France	Centre d'Oncologie et de Radiothérapie du Pays-Basque	Bayonne
France	Clinique CAPIO Belharra	Bayonne
France	CHU Besançon	Besançon
France	CHU Besançon - Pharmacie Unite Essais cliniques	Besançon
France	Hôpital Jean Minjoz	BESANCON cedex
France	Hôpital Henri Mondor	CRÉTEIL Cedex
France	Hôpital Privé Toulon-Hyères - Clinique Sainte Marguerite	Hyères
France	Clinique Victor Hugo	Le Mans
France	Centre Oscar Lambret	Lille
France	Centre Oscar Lambret	Lille cedex
France	Centre Leon Berard	Lyon cedex 8
France	Centre Léon Berard	LYON cedex 8
France	Hopital de La Timone	Marseille
France	Hopital de La Timone	Marseille
France	Institut Paoli Calmettes	Marseille
France	Hopital La Conception	Marseille cedex 5
France	Institut Paoli Calmettes	Marseille Cedex 9
France	CHU Nimes - Hopital Caremeau	Nimes
France	CHU Nimes	Nimes Cedex 9
France	CHU Nimes - Institut de Cancerologie du Gard	Nimes Cedex 9
France	Groupe hospitalier Pitie Saleptriere	Paris	Cedex 13
France	Groupe Hospitalier Pitié Salpêtrière	Paris
France	Groupe Hospitalier Pitié Salpêtrière	PARIS cedex 13
France	Centre Eugene Marquis	Rennes Cedex
France	CHU de Rouen	Rouen
France	CHU de Rouen - Hôpital Charles Nicolle	Rouen
France	Centre Henri Becquerel	Rouen Cedex 1
France	Institut de Cancérologie de l'Ouest - Centre René Gauducheau	Saint Herblain Cedex
France	Centre de Radiothérapie - Clinique Sainte Anne	Strasbourg
France	Clinique Sainte Anne	Strasbourg
France	Hopital Foch	Suresnes
France	Hopital Foch -Pharmacie	Suresnes
France	Institut Gustave Roussy	Villejuif
France	Institut Gustave Roussy	Villejuif cedex
Greece	Alexandra General Hospital, Oncology Department	Athens
Greece	Metropolitan General Hospital	Athens	PC
Greece	Sotiria General Chest Disease Hospital	Athens
Greece	Medical Center of Athens	Marousi	Athens
Greece	University General Hospital of Patras, Division of Oncology	Patra
Greece	EUROMEDICA General Clinic of Thessaloniki	Thessaloniki
Hong Kong	Department of Clinical Oncology	Hong Kong
Hungary	Kaposvári Egyetem Egészségügyi Centrum	Kaposvár
Hungary	Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvár
India	CIMS Cancer, Care Institute of Medical Sciences, CIMS Hospital	Ahmedabad	Gujarat
India	Rajiv Gandhi Cancer Institute And Research Centre	Delhi
India	Apollo Hospitals	Hyderabad	Telangana
India	Medica Superspecialty hospital	Kolkata	WEST Bengal
India	Dr Ram Manohar Lohia (RML) Hospital & PGI MER	New Delhi	Delhi
India	Sahyadri Super Speciality Hospital	Pune	Maharashtra
Israel	Assaf Harofe MC	Beer Yaakov
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah University Hospital	Kiryat Hadassah	Jerusalem
Israel	The Chaim Sheba Medical Center	Ramat - Gan
Israel	The Chaim Sheba Medical Center	Tel-Hashomer	Ramat - GAN
Italy	Farmacia Ospedaliera	Arezzo
Italy	Presidio Ospedaliero San Donato	Arezzo
Italy	Centro di Riferimento Oncologico - IRCCS	Aviano (PN)
Italy	S.O.C. di Farmacia	Aviano (PN)
Italy	Azienda Ospedaliero-Universitaria Policlinico S.Orsola Malpighi	Bologna
Italy	U.O. Farmacia Clinica - IDS	Bologna
Italy	Farmacia Ospedaliera	Candiolo	(torino)
Italy	Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo	Candiolo	Torino
Italy	AUSL della Romagna - RAVENNA, Presidio Ospedaliero di Faenza	Faenza	Ravenna
Italy	U.O. Anatomia Patologica	Forli	Forli-cesena
Italy	U.O. Radiologia	Forli	Forli-cesena
Italy	U.O.S. Medicina Nucleare	Forli	Forli-cesena
Italy	IRCCS Ospedale Policlinico San Martino	Genova	Liguria
Italy	U.O.C. Farmacia	Genova	Genoa
Italy	Presidio Ospedaliero di Lugo	Lugo	Ravenna
Italy	Farmacia Oncologica	Meldola	Forli-cesena
Italy	IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"	Meldola	Forli-cesena
Italy	Fondazione IRCCS Istituto Nazionale Dei Tumori	Milan
Italy	Instituto Europeo di Oncologia	Milan
Italy	SC Farmacia	Milan
Italy	Servizio di Farmacia	Milan
Italy	Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"	Naples
Italy	UOSC Farmacia	Naples
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori, IRCCS Fondazione Giovanni Pascale	Napoli
Italy	S.C. Farmacia Ospedaliera	Napoli
Italy	A.O.U. Pisana Ospedale S. Chiara	Pisa
Italy	Presidio Ospedaliero di Ravenna	Ravenna
Italy	Servizio Farmacia Ospedaliera - Farmacia Oncologica	Ravenna
Italy	Azienda Ospedaliera San Camillo Forlanini_Oncologia Medica	Rome
Italy	U.O.C. Farmacia	Rome
Italy	Farmacia Studi Clinici	Rozzano	Milan
Italy	Istituto Clinico Humanitas	Rozzano	Milan
Italy	Azienda Ospedaliera S. Maria di Terni	Terni
Italy	S.C. Farmacia Interna	Terni
Italy	AOU Ospedali Riuniti di Ancona	Torrette	Ancona
Japan	Chiba Cancer Center	Chiba
Japan	Kyushu University Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Hamamatsu University School of Medicine, University Hospital	Hamamatsu	Shizuoka
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Hirosaki University School of Medicine & Hospital	Hirosaki	Aomori
Japan	Hiroshima City Hiroshima Citizens Hospital	Hiroshima
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	Kagoshima University Hospital	Kagoshima
Japan	Kobe City Medical Center General Hospital	Kobe-city	Hyogo
Japan	Dokkyo Medical University Saitama Medical Center	Koshigaya	Saitama
Japan	The Cancer Institute Hospital of JFCR	Koto-Ku	Tokyo
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Niigata University Medical & Dental Hospital	Niigata
Japan	Osaka City University Hospital	Osaka
Japan	Kindai University Hospital	Osakasayama	Osaka
Japan	Gunma Prefectural Cancer Center	Ota	Gunma
Japan	National Hospital Organization Sagamihara National Hospital	Sagamihara	Kanagawa
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	National Hospital Organization hokkaido Cancer Center	Sapporo,	Hokkaido
Japan	Keio University Hospital	Shinjuku-Ku	Tokyo
Japan	Iwate Medical University Hospital	Shiwa-gun	Iwate
Japan	Tokushima University Hospital	Tokushima
Japan	Tsukuba Medical Center Hospital	Tsukuba	Ibaraki
Japan	Yamaguchi University Hospital	Ube	Yamaguchi
Japan	Yamagata University Hospital	Yamagata
Japan	Kanagawa cancer center	Yokohama	Kanagawa
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chungnam National University Hospital, Clinical Pharmacy	Daejeon
Korea, Republic of	National Cancer Center - Clinical Trial Pharmacy	Goyang-si	Gyeonggi-do
Korea, Republic of	National Cancer Center Urology center for Prostate Cancer	Goyang-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggido
Korea, Republic of	Seoul National University Bundang Hospital, Clinical Pharmacy	Seongnam-si	Gyeonggido
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Asan Medical Center - Clinical Trial Pharmacy	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Samsung Medical Center Clinical Trial Pharmacy	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Mexico	Phylasis Clinicas Research S. de R.L. de C.V.	Cuautitlan Izcalli	Estado DE Mexico
Mexico	Centro de Investigación Clínica de Leon S.C.	Leon	Guanajuato
Mexico	Hospital Médica Campestre (Administradora Hospitalaria S.A de C.V.)	León	Guanajuato
Mexico	Instituto Nacional de Cancerologia	Mexico	Ciudad DE Mexico
Netherlands	Rijnstate Arnhem	Arnhem
Netherlands	Ziekenhuis Rijnstate	Arnhem
Netherlands	St Apotheek der Haarlemse Ziekenhuizen	Haarlem
Netherlands	Spaarne Gasthuis	Hoofddorp
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	Radboudumc	Nijmegen
New Zealand	Slade Health Inward Goods	Auckalnd
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Auckland City Hospital	Grafton	Auckland
New Zealand	Auckland City Hospital Pharmacy	Grafton	Auckland
New Zealand	Waikato Hospital	Hamilton
Norway	Akershus University Hospital	Lorenskog
Norway	Sykehusapoteket HF 23 Lørenskog	Lorenskog
Norway	Bildediagnostisk avdeling	Nordbyhagen
Norway	Sykehusapoteket HF 23 Lørenskog	Nordbyhagen
Norway	Sykehusapoteket Lorenskog	Nordbyhagen
Norway	Stavanger University Hospital	Stavanger
Poland	Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli	Lublin
Poland	Lecznice CITOMED Sp. z o.o.	Torun
Poland	Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu	Torun
Poland	Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny	Torun
Poland	Wojewodzki Szpital Zespolony im. L. Rydygiera, Szpital Specjalistyczny dla Dzieci I Doroslych	Torun
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warsaw	Masovian
Poland	Centralny Szpital Kliniczny MSWiA	Warszawa	Masovian
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warszawa	Masovian
Portugal	Hospital Da Luz Coimbra, SA	Coimbra
Portugal	Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE	Coimbra
Portugal	Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos	Lisboa
Portugal	Hospital CUF Descobertas, SA	Lisboa
Portugal	Centro Hospitalar de São João, EPE	Porto
Portugal	Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A.	Porto
Portugal	Instituto Português de Oncologia do Porto Francisco Gentil, EPE	Porto
Portugal	Dr. Campos Costa - Consultório de Tomografia Computorizada, S.A.- Matosinhos	Senhora da Hora
Portugal	Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE	Vila Real
Russian Federation	Moscow Research Oncology Institute named after P. A. Gertsen	Moscow
Russian Federation	Principal Military Clinical Hospital n.a. N.N. Burdenko	Moscow
Russian Federation	Federal State Budgetary Institution "National medical research radiology center" MoH RF	Obninsk	Kaluzhskaya Region
Russian Federation	BHI of Omsk region "Clinical oncological dispensary"	Omsk
Russian Federation	Private Medical Institution "Evromedservice"	Pushkin	Saint Petersburg
Russian Federation	"Ramsay Diagnostics Rus", LLC	St. Petersburg
Russian Federation	FGBIH "Clinical Hospital #122 n.a. L.G. Sokolov of Federal Medico-biological agency"	St. Petersburg
Russian Federation	FSBEI HE "First St. Petersburg State Medical University n. a. academician l.P Pavlov" MoH RF	St. Petersburg
Russian Federation	FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov"	St. Petersburg
Russian Federation	FSBEI HE "First St. Petersburg State Medical University n.a. academician I.P Pavlov" MoH RF	St. Petersburg
Russian Federation	FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov	St. Petersburg
Russian Federation	Hospital Orkli, LLC	St. Petersburg
Russian Federation	Mart, Llc	St. Petersburg
Russian Federation	Non-State Healthcare Institution "Railway Clinical Hospital JSC RZhD"	St. Petersburg
Russian Federation	State Budgetary Healthcare Insti. Republican Clinical Oncology Dispensary of the MoH of Bashk. Rep.	Ufa	Bashkortostan Republic
Russian Federation	SHI YR "Regional Clinical Oncology Hospital"	Yaroslavl
Serbia	Institute for Oncology and Radiology of Serbia	Belgrade
Serbia	Clinical Centre Nis, Clinic of Oncology	Nis
Serbia	Oncology Institute of Vojvodina	Sremska Kamenica
Spain	Hospital Vithas Internacional Medimar	Alicante
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	CETIR Grup Medic	Barcelona
Spain	Cetir, Centre Mèdic, S.L	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de La Santa Creu i Sant Pau	Barcelona
Spain	Hospital de La Santa Creu i Sant pau_Oncology department	Barcelona
Spain	Hospital de Vall d'Hebron	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Quiron	Barcelona
Spain	Hospital Quirón de Barcelona	Barcelona
Spain	Hospital Quiron of Barcelona	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Laboratorio Dr. F. Echevarne Analisis, S.A	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Universitario Reina Sofía	Cordoba
Spain	Hospital General Universitario de Elche	Elche	Comunidad Valenciana
Spain	Hospital Comarcal General de Elda de Virgen de la Salud	Elda	Alicante
Spain	H. univ Girona Dr. Josep Trueta - lnstitut Catala d'Oncologia	Gerona
Spain	Institut Catala d'Oncologia	Gerona
Spain	Institut Diagnostic de la lmatge	Gerona
Spain	Institut Catalá d'Oncología	L´Hospitalet de Llobregat	Barcelona
Spain	Institut Catalá d'Oncología - Hospital Duran i Reynals	l´Hospitalet de LLobregat	Barcelona
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Fundacion Maria Rafols para la investigacion del Diagnostico de la imagen	Madrid
Spain	Gabinete Radiologico Doctor Pita	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Ruber Internacional	Madrid
Spain	Hospital Ruber International	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario HM Sanchinarro - CIOCC	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Althaia. Xarxa Assistencial Universitaria de Manresa	Manresa	Barcelona
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona
Spain	Hospital Universitario Infanta Sofia	San Sebastian de los Reyes	Madrid
Spain	Hospital Universitario Infanta Sofia	San Sebastián de los Reyes	Madrid
Spain	C.H. Univ. Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital Clinico Universitario de Valencia	Valencia	Comunidad Valenciana
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Instituto Valenciano de Oncología	Valencia
Spain	C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro	Vigo	Galicia
Spain	C. H. Universitario de Vigo- Hospital Álvaro Cunqueiro	Vigo	Galicia
Spain	C.H. Universitario de Vigo- Hospital Meixoeiro	Vigo	Galicia
Sweden	APL	Stockholm
Sweden	Karolinska University Hospital	Stockholm
Taiwan	China Medical University Hospital	Taichung
Taiwan	Clinical Trial Pharmacy, China Medical University Hospital	Taichung
Taiwan	Department of Pharmacy, National Cheng Kung University Hospital	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Investigational Drug services, National Taiwan University Hospital	Taipei
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan
Taiwan	Chemotherapy pharmacy, Chang Gung Memorial Hospital, Linkou	Taoyuan
United Kingdom	Royal United Hospitals Bath NHS Foundation Trust	Bath
United Kingdom	Guy's & St. Thomas' NHS Foundation Trust	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital	London
United Kingdom	St Bartholomew 's Hospital, Barts Health NHS Trust	London
United Kingdom	St. Bartholomew's Hospital, Barts Health NHS Trust	London
United Kingdom	Churchill Hospital, Oxford University Hospitals NHS Trust	Oxford
United States	Anschutz Cancer Center Pavilion Pharmacy	Aurora	Colorado
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	University of Colorado Denver, CTO (CTRC)	Aurora	Colorado
United States	University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)	Aurora	Colorado
United States	University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)	Aurora	Colorado
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Cleveland Clinic Taussing Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussing Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussing Cancer Center	Cleveland	Ohio
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	Inova Schar Cancer Institute Infusion Pharmacy	Fairfax	Virginia
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Smilow Cancer Hospital at Yale New Haven	New Haven	Connecticut
United States	Smilow Cancer Hospital at Yale-New Haven	New Haven	Connecticut
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  Denmark,  France,  Greece,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Russian Federation,  Serbia,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.	From randomization to discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
Secondary	Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)	BICR assessed PFS: Duration from randomization until disease progression (PD) or death. PD as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was defined for target disease as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 millimeters. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. PFS data was censored on date of last adequate tumor assessment for participants with no event (PD or death), who started new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments.	From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
Secondary	Progression-Free Survival (PFS) as Assessed by Investigator	Investigator assessed PFS: Duration from randomization to first documentation of PD or death, whichever occurred first. PD as per RECIST version 1.1 was defined for target disease as at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier. PFS data was censored on date of last adequate tumor assessment for participants with no event (PD or death), who started a new anti-cancer therapy prior to an event or with an event after 2 or more missing tumor assessments.	From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
Secondary	Percentage of Participants With Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)	BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.	From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months)
Secondary	Percentage of Participants With Objective Response as Assessed by Investigator	Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. A CR also required normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.	From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months)
Secondary	Time to Tumor Response (TTR) as Assessed by Blinded Independent Central Review (BICR)	TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR), which was confirmed subsequently. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.	From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months)
Secondary	Time to Tumor Response (TTR) as Assessed by Investigator	TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. A CR also required normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.	From the date of randomization to the first documentation of objective response (CR or PR) (for a maximum duration of 41 months)
Secondary	Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR)	BICR assessed DOR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR: complete disappearance of all target and non-target lesions, with exception of nodal disease sustained for 4 weeks. Any pathological lymph nodes reduced in short axis to <10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD for target disease: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study and relative increase of 20%, sum also demonstrated absolute increase of at least 5 mm. PD for non-target disease: unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD.	First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (for a maximum duration of 41 months)
Secondary	Duration of Response (DOR) as Assessed by Investigator	Investigator assessed DOR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR: complete disappearance of all target and non-target lesions, with exception of nodal disease sustained for 4 weeks. Additionally, normalization of tumor marker levels and any pathological lymph nodes reduced in short axis to <10 mm. PR: at least 30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD for target disease: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study and relative increase of 20%, sum also demonstrated absolute increase of at least 5 mm. PD for non-target disease: unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy. Appearance of any new unequivocal malignant lesion was also considered PD.	First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (for a maximum duration of 41 months)
Secondary	Percentage of Participants With Disease Control (DC) as Assessed by Blinded Independent Central Review (BICR)	Disease Control (DC) was defined as a best overall response of CR, PR, non-CR/non-PD or stable disease (SD) as assessed by BICR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds.	From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months)
Secondary	Percentage of Participants With Disease Control (DC) as Assessed by Investigator	DC was defined as a best overall response of CR, PR, non-CR/non-PD or SD as assessed by Investigator. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. Additionally, normalization of tumor marker levels and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds.	From randomization to PD, death or start of new anti-cancer therapy (for a maximum duration of 41 months)
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent AEs are events between first dose of study drug and up to 90 days after last dose of study drug or end of treatment (EOT) visit, that were absent before treatment or that worsened relative to pretreatment state.	For "Avelumab + Best Supportive Care (BSC)'' group: Day1 up to 90 days after last dose of study drug; for BSC group: Day1 up to 90 days after EOT visit (for a maximum duration of up to approximately 70 months for both groups)
Secondary	Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3 (G3), Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03	Hematology (Anemia G3: hemoglobin<8.0 grams per deciliter [g/dL],<4.9 millimoles (mmol)/liter (L),<80 g/L, transfusion indicated, Grade 4 [G4]: life-threatening consequences, urgent intervention indicated, Grade 5 [G5]: death; platelet count decreased-G3:<50.0 to 25.0*10^9/L, G4: <25.0*10^9/L; lymphocyte count decreased-G3:<0.5-0.2*10^9/L, G4:<0.2*10^9/L; neutrophil count decreased-G3:<1.0 to 0.5*10^9 /L, G4:<0.5*10^9/L). Chemistry (creatinine increased-G3:>3.0 to 6.0*upper limit of normal [ULN], G4:>6.0*ULN; serum amylase increased, lipase increased-G3:>2.0- 5.0*ULN, G4:>5.0*ULN. Aspartate aminotransferase [AST], alanine aminotransferase [ALT]-G3:>5.0 to 20.0*ULN, G4:>20.0*ULN]. Blood bilirubin increased-[G3:>3.0 to 10.0*ULN, G4:>10.0*ULN], Creatine phosphokinase [CPK] increased- [G3:>5.0 to 10.0*ULN, G4:>10.0*ULN], Hyperglycemia-[G3:>250 to 500 mg/dL; >13.9 to 27.8 mmol/L hospitalization indicated, G4:>500 mg/DL; >27.8 mmol/L life-threatening consequences]).	For "Avelumab + Best Supportive Care (BSC)'' group: Day1 up to 90 days after last dose of study drug; for BSC group: Day1 up to 90 days after EOT visit (for a maximum duration of up to approximately 70 months for both groups)
Secondary	Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit	Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP).	Baseline (Day [D] 1 of Cycle [C] 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7 , EOT visit (for a maximum duration of 41 months) (each cycle=28 days)
Secondary	Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit	Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.	Baseline (Day [D] 1 of Cycle [C] 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7 , EOT visit (for a maximum duration of 41 months) (each cycle=28 days)
Secondary	Maximum Plasma Concentration (Cmax) of Avelumab	The Lower Limit of Quantitation (LLQ) of avelumab was 0.20 micrograms (mcg)/milliliter (mL). Data for this outcome measure was not collected for reporting group "Best Supportive Care", since avelumab was not administered in this arm.	End of avelumab infusion on Day 1 of Cycle 1, 2, 3, 5, 7, 9, 11, 13 and Day 15 of Cycle 1, 2, 3 (each cycle=28 days)
Secondary	Predose Plasma Concentration (Ctrough) of Avelumab	The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not collected for reporting group "Best Supportive Care", since avelumab was not administered in this arm.	Pre-dose (0 hour) on Day 1 of Cycle 1, 2, 3, 5, 7, 9, 11, 13 and Day 15 of Cycle 1, 2, 3 (each cycle=28 days)
Secondary	Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status	ADA against avelumab in serum samples was determined and reported separately for ADA never positive and ADA ever positive participants. Participants were considered ADA ever-positive if they had at least one positive ADA result at any time point during study and were otherwise considered negative. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Best Supportive Care", since avelumab was not administered in this arm.	From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
Secondary	Number of ADA Ever Positive Participants For Each Serum of ADA Titers for Avelumab	Serum samples were assayed for ADA using a validated analytical method. Number of ADA ever positive participants for each serum of ADA titer (60, 180, 540, 1620, 4860, 14580, and 131220) are reported.	From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
Secondary	Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never Positive and Ever Positive Status	nAb against avelumab in serum samples was determined and reported separately for nAb never positive and nAb ever positive participants. Participants were considered nAb ever-positive if they had at least one positive nAb result at any time point during study and were otherwise considered negative.	From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
Secondary	Number of Participants With Programmed Death Receptor-1 Ligand 1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)	PD-L1 assessment was performed using immunohistochemistry on pre-treatment tumor tissue samples. Participants were classified as having PD-L1 -positive status if at least one of the following three criteria were met: at least 25% of tumor cells stained for PD-L1, at least 25% of immune cells stained for PD-L1 if more than 1% of the tumor area contained immune cells, or 100% of immune cells stained for PD-L1 if no more than 1% of the tumor area contained immune cells.	Up to 41 months at the time of the analysis
Secondary	Number of Participants With Cluster of Differentiation 8 (CD8) T Lymphocytes (Cytotoxic T Lymphocytes)	Number of Participants With CD8 T Lymphocytes (Cytotoxic T lymphocytes) were presented in this outcome.	Up to approximately 60 months
Secondary	Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Score at Day 1 of Cycle 6	NCCN-FACT FBlSI-18 is an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms- physical subscale with 9 items, disease related symptoms- emotional subscale with 2 items, treatment side effects subscale with 5 items and general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging from 0=not at all to 4=very much. Items that were negatively framed, and the scores were reversed for analysis so that higher scores= good quality of life. Overall score: total of 18 items, ranging from 0=severely symptomatic to 72=asymptomatic. Higher scores= better functioning or lower symptom burden.	Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
Secondary	Time to Deterioration (TTD) Based on National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores	NCCN-FACT FBlSI-18: an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms-physical subscale with 9 items, disease related symptoms-emotional subscale with 2 items, treatment side effects subscale with 5 items, general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging: 0=not at all to 4=very much. For items negatively framed, scores were reversed for analysis so that higher scores= good quality of life. DRS-P score: total 9 items, ranging from 0=severely symptomatic to 36= asymptomatic. Higher scores=better functioning or lower symptom burden. TTD: time from randomization to first time participant's score showed 3 point or greater decrease from baseline in FBlSI-DRS-P subscale for 2 consecutive assessments.	From randomization up to the 90-Day Follow-up Visit (maximum duration of up to 41 months)
Secondary	Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score at Cycle 6	The EQ-5D-5L was a 6-item participant-completed questionnaire designed to assess health status in terms of a single utility score. There were 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participant rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). Published UK weights was used to create a single summary utility score. Utility scores range from -0.594 to 1, with low scores representing lower health status.	Baseline, Day 1 of Cycle 6 (1 cycle=28 days)
Secondary	Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) - Visual Analog Scale (VAS) Score at Cycle 6	The EQ-5D-5L was a 6-item participant-completed questionnaire designed to assess health status in terms of a single utility score. There were 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participant rated their overall health status from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.	Baseline, Day 1 of Cycle 6 (1 cycle=28 days)

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