A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)

PHASE3CompletedINTERVENTIONAL
Enrollment

886

Participants

Timeline

Start Date

March 23, 2016

Primary Completion Date

August 31, 2023

Study Completion Date

June 26, 2024

Conditions
Renal Cell Cancer
Interventions
DRUG

Avelumab (MSB0010718C)

IV treatment Avelumab administered at 10 mg/kg IV every two weeks

DRUG

Axitinib (AG-013736)

Oral treatment Axitinib given 5 mg PO BID

DRUG

Sunitinib

Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2

Trial Locations (270)

1023

Auckland City Hospital, Grafton

Auckland City Hospital Pharmacy, Auckland

1060

Krankenhaus der Barmherzigen Schwestern Wien, Vienna

Baxter Healthcare New Zealand, Auckland

1090

Medizinische Universitaet Wien, Vienna

1097

Dél.pesti Centrumkórház-OHII Szent Lálszló Kórház telephely, Budapest

1122

Országos Onkológiai Intézet, Budapest

1200

Cliniques Universitaires Saint-Luc, Brussels

2031

Nuclear Medicine Department, Randwick

Pharmacy Department, Clinical Trials, Randwick

Prince of Wales Hospital, Randwick

Spectrum Medical Imaging, Randwick

2109

Macquarie University Hospital Pharmacy, Macquarie University

Macquarie University, Macquarie University

2730

Herlev Hospital, Onkologisk Afdeling R, Herlev

3112

Tauranga Hospital, Tauranga Bay of Plenty

3128

Box Hill Hospital, Box Hill

Eastern Health, Box Hill

3143

Tauranga Hospital, Bay of Plenty Clinical Trials Unit, Tauranga

3149

Slade Health, Mount Waverley

3165

Monash Cancer Centre, East Bentleigh

Moorabbin Radiology, East Bentleigh

3168

Monash Health Translational Precinct, Monash Medical Centre, Clayton

Monash Medical Centre, Clayton

3240

Waikato Hospital Pharmacy Services, Hamilton

Waikato Hospital, Hamilton

3350

BHS Diagnostic Services, Ballarat

Lake Imaging, Ballarat

3355

Ballarat Day Procedure Centre, Wendouree

Ballarat Oncology & Haematology Services, Wendouree

Nova Pharmacy, Wendouree

4000

CHU de Liège, Liège

4102

Division of Cancer Services, Woolloongabba

4410

Broadway Radiology, Palmerston North

4414

Palmerston North Hospital, Palmerston North

5000

Odense Universitetshospital, Odense C

5840

Wairarapa District Health Board, Masterton

6050

SKG Radiology, Murdoch

6150

Fiona Stanley Hospital, Murdoch

SKG Radiology, Murdoch

St John of God Murdoch Hospital, Murdoch

EPIC Pharmacy Murdoch, Perth

8140

Christchurch Hospital, Christchurch

8500

AZ Groeninge, Kortrijk

9000

UZ Gent, Ghent

10016

Laura & Isaac Perlmutter Cancer Center at NYU Langone, New York

NYU Investigational Pharmacy, New York

NYU Langone Medical Center, New York

10017

MSKCC-Monitoring Suite, New York

10065

Evelyn H. Lauder Breast and Imaging Center, New York

Memorial Sloan Kettering Cancer Center, New York

Sidney Kimmel Center for Prostate and Urologic Cancers, New York

10408

Clinical Trial Pharmacy, National Cancer Center, Goyang-si

National Cancer Center, Goyang-si

11101

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy, Long Island City

11794

Stony Brook University-Cancer Center, Stony Brook

Stony Brook University, Stony Brook

12065

New York Oncology Hematology, P.C., Clifton Park

12206

New York Oncology Hematology, P.C., Albany

12208

New York Oncology Hematology, PC, Albany

13009

Institut Paoli Calmettes, Marseille

13620

Seoul National University Bundang Hospital, Clinical Pharmacy, Seongnam-si

Seoul National University Bundang Hospital, Seongnam-si

14076

Centre Francois Baclesse, Caen

14080

Instituto Nacional de Cancerologia, Mexico City

18015

Cancer Care Associate Medical Oncology, Bethlehem

St. Lukes University Health Network, Bethlehem

18045

St.Luke's Cancer Center Anderson, Easton

St.Luke's Hospital-Anderson Campus, Easton

18104

Cancer Care Associates Medical Oncology, Allentown

St.Luke's Hospital-Allentown Campus, Allentown

18951

St.Luke's Quakertown Hospital, Quakertown

19104

Hospital of the University of Pennsylvania, Philadelphia

Investigational Drug Service, University of Pennsylvania, Philadelphia

20007

Georgetown University Medical Center, Washington D.C.

20089

Farmacia Studi Clinici, Rozzano

Istituto Clinico Humanitas, Rozzano

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

SC Farmacia, Milan

20141

Istituto Europeo di Oncologia, Milan

Servizio di Farmacia, Milan

21231

Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital, Baltimore

21287

Johns Hopkins Hospital, Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

27103

Novant Health Oncology Specialists, Winston-Salem

28034

Hospital Universitario Ramon y Cajal, Madrid

30322

Emory University Hospital, Atlanta

Investigational Drug Service- Emory University, Atlanta

The Emory Clinic, Atlanta

Winship Cancer Institute, Emory University, Atlanta

31008

Clinica Universidad de Navarra, Pamplona

31096

Rambam Health Care Campus, Haifa

Rambam Healthcare Campus, Haifa

33081

Centro di Riferimento Oncologico - IRCCS, Aviano

33612

Moffitt Cancer Center and Research Institute, Tampa

35015

Chungnam National University Hospital, Clinical Pharmacy, Daejeon

Chungnam National University Hospital, Daejeon

35042

Centre Eugene Marquis Service Pharmacie - Essais Cliniques, Rennes

Centre Eugene Marquis, Rennes

36526

Southern Cancer Center, Daphne

36607

Southern Cancer Center, Mobile

36608

Southern Cancer Center, Mobile

37232

Henry-Joyce Cancer Clinic, Nashville

41013

Hospital Universitario Virgen del Rocio, Seville

41404

Kyungpook National University Medical Center, Clinical Pharmacy, Daegu

Kyungpook National University Medical Center, Daegu

43210

James Cancer Hospital and Solove Research Institute, Columbus

The Ohio State University - GU Clinic, Columbus

The Ohio State University, Columbus

44106

Cleveland Clinic Taussig Cancer Center, Cleveland

44195

Cleveland Clinic, Cleveland

44281

Meir Medical Center, Kfar Saba

44805

Institut de Cancérologie de l'Ouest - Centre René Gauducheau, Saint-Herblain

49100

Rabin Medical Center, Petah Tikva

54519

Institut de Cancerologie de Lorraine (ICL), Vandœuvre-lès-Nancy

Institut de Cancerologie de Lorraine, Vandœuvre-lès-Nancy

55905

Mayo Clinic, Rochester

59101

St. Vincent Healthcare, Billings

59102

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana, Billings

63110

Barnes-Jewish Hospital, Siteman Cancer Center, St Louis

Washington University Infusion Center Pharmacy, St Louis

Washington University School of Medicine, St Louis

63129

Barnes-Jewish Hospital, Siteman Cancer Center - South County, St Louis

63141

Barnes-Jewish Hospital, Siteman Cancer Center - West County, Creve Coeur

63376

Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters, City of Saint Peters

64460

Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer, Monterrey

68000

Oaxaca Site Management Organization S.C., Oaxaca City

69008

Centre Léon Bérard, Lyon

69373

Centre Léon Bérard, Lyon

70006

East Jefferson General Hospital, Metairie

East Jefferson Hematology-Oncology Metairie Physician Service Inc., Metairie

70300

Assaf Harofe MC, Beer Yaakov

Shamir Medical Center, Beer Yaakov

72000

Centre de Cancérologie de la Sarthe (CCS) - Clinique Victor Hugo, Le Mans

Clinique Victor Hugo Centre de Cancerologie de la Sarthe, Le Mans

72076

Universitaetsklinikum Tuebingen, Tübingen

75063

Comprehensive Cancer Centers of Nevada, Las Vegas

Investigational Product Center (IPC), Irving

Investigational Products Center (IPC), Irving

Investigational Products Center (lPC), Irving

US Oncology Investigational Products Center (IPC), Irving

75246

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

77024

Texas Oncology - Gulf Coast, Houston

77030

The University of Texas MD Anderson Cancer Center, Houston

79410

Joe Arrington Cancer Research and Treatment Center, Lubbock

80012

Rocky Mountain Cancer Centers, Aurora

80045

University of Colorado Cancer Center Anschutz Cancer Pavilion, Aurora

University of Colorado Hospital - Clinical Trials Office (CTO), Aurora

University of Colorado Hospital, Aurora

80907

Rocky Mountain Cancer Centers, Colorado Springs

89148

Comprehensive Cancer Centers of Nevada, Las Vegas

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90033

Keck Hospital of USC, Los Angeles

Los Angeles General Medical Center, Los Angeles

USC IDS Pharmacy, Los Angeles

USC/Norris Comprehensive Cancer Center, Los Angeles

90048

Cedars-Sinai Advanced Health Sciences Pavilion, Los Angeles

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles

Cedars-Sinai, Los Angeles

90211

Tower Hematology Oncology Medical Group, Beverly Hills

91010

City of Hope National Medical Center, Duarte

City of Hope, Duarte

94805

Institut Gustave Roussy, Villejuif

98109

Fred Hutchinson Cancer Center, Seattle

98195

University of Washington Medical Center, Seattle

98373

Rainier Hematology-Oncology, PC, Puyallup

98405

Northwest Medical Specialties, PLLC, Tacoma

105425

Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal, Moscow

125284

Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen, Moscow

150014

"LLC Clinical Diagnostic Center Medex-pert", Yaroslavl

150040

SHI YR Regional Clinical Oncology Hospital, Yaroslavl

194291

Clinical Hospital #122 n.a. L. G. Sokolov, Saint Petersburg

195271

"NS HI Road Clinical Hospital of JSC Russian Railways", Saint Petersburg

196247

"LLC Diagnostic center Energo", Saint Petersburg

196603

"Private Medical Institution Euromedservice", Pushkin

197758

Russian Research Center for Radiology and Surgical Technologies, Saint Petersburg

"FSBI Research Institute of Oncology n.a. N.N. Petrov MoH RF", Saint Petersburg

200347

"Sfantul Nectarie Oncology Center", Craiova

300239

Oncomed SRL, Timișoara

305035

"RBHI Kursk Regional Clinical Oncology Dispensary of HCKR (legal address)", Kursk

305524

"RBHI Kursk Regional Clinical Oncology Dispensary of HCKR", Kursk

400015

"Prof. Dr. Ion Chiricuta Oncology Institute", Cluj-Napoca

400641

S.C. Medisprof S.R.L., Cluj-Napoca

603001

"FBIH Privolzhskiy Regional Medical Center of FMBA", Nizhny Novgorod

603006

"SBIH of Nizhegorodskaya region Clinical-Diagnostics center", Nizhny Novgorod

603032

"FBIH Privolzhskiy Regional Medical Center of FMBA", Nizhny Novgorod

603109

"FBIH Privolzhskiy Regional Medical Center of FMBA", Nizhny Novgorod

603126

"SBIH of Nizhegorodskaya region Nizhniy Novgorod Regional Clinical Oncology Dispensary", Nizhny Novgorod

5265601

The Chaim Sheba Medical Center, Tel Litwinsky

The Chaim Sheba Medical Center, Ramat Gan

6423906

Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center, Tel Aviv

Tel Aviv Sourasky Medical Center, Tel Aviv

04043

New England Cancer Specialists, Kennebunk

04074

New England Cancer Specialists, Scarborough

04086

New England Cancer Specialists, Topsham

02114

Massachusetts General Hospital (MGH), Boston

Massachusetts General Hospital Clinical Trials Pharmacy, Boston

02115

Brigham & Women's Hospital, Boston

02215

Beth Israel Deaconess Medical Center (BIDMC), Boston

Beth Israel Deaconess Medical Center Pharmacy - BIDMC, Boston

Dana - Farber Cancer Institute, Boston

Dana-Farber Cancer Institute, Boston

01301

Baystate Franklin Medical Center, Greenfield

T2N 2T9

Foothills Medical Centre, Calgary

T2N 4N2

Alberta Health Services - Cancer Care, Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V1Y 5L3

British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior, Kelowna

V5Z 4E6

British Columbia Cancer Agency, Vancouver

V5Z IH7

BC Cancer GU Clinic - Fairmont Medical Building, Vancouver

N6A 4L6

London Regional Cancer Program, London Health Sciences Centre, London

N6A 5W9

London Regional Cancer Program, London Health Sciences Centre, London

L1G 2B9

R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health, Oshawa

M4N 3M5

Sunnybrook Research Institute, Toronto

H3T 1E2

Jewish General Hospital, Montreal

J1H 5N4

CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke, Sherbrooke

072076

Universitaetsklinikum Tuebingen, Tübingen

07743

Universitaetsklinikum Jena, Jena

07747

Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie, Jena

Universitaetsklinikum Jena, Jena

00152

Azienda Ospedaliera San Camillo Forlanini, Rome

466-8560

Nagoya University Hospital, Nagoya

036-8563

Hirosaki University School of Medicine & Hospital, Hirosaki

060-8648

Hokkaido University Hospital, Sapporo

028-3695

Iwate Medical University Hospital, Shiwa-gun

236-0004

Yokohama City University Hospital, Yokohama

589-8511

Kindai University Hospital, Sayama

565-0871

Osaka University Hospital, Suita

431-3192

Hamamatsu University School of Medicine, University Hospital, Hamamatsu

160-8582

Keio University Hospital, Shinjuku-ku

162-8666

Tokyo Women's Medical University Hospital, Shinjuku-ku

010-8543

Akita University Hospital, Akita

260-8717

Chiba Cancer Center, Chiba

812-8582

Kyushu University Hospital, Fukuoka

951-8520

Niigata University Medical & Dental Hospital, Niigata

770-8503

Tokushima University Hospital, Tokushima

990-9585

Yamagata University Hospital, Yamagata

1066 CX

Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Amsterdam

1066 EC

Netherlands Cancer Institute / Apotheek MC Slotervaart, Amsterdam

1081 BT

VU University Medical Center (VUmc), Amsterdam

1081 HZ

VU University Medical Center (VUmc), Amsterdam

3045 PM

Sint Franciscus Gasthuis, Pharmacy, Rotterdam

Sint Franciscus Gasthuis, Rotterdam

5631 BM

Maxima Medisch Centrum, Eindhoven

2035 RC

St Apotheek der Haarlemse Ziekenhuizen, Haarlem

2134 TM

Spaarne Gasthuis, Hoofddorp

6229 HX

Maastricht University Medical Center, Maastricht

5504 DB

Maxima Medisch Centrum, Veldhoven

5504 DL

Maxima Medisch Centrum, Veldhoven

03080

Seoul National University Hospital, Clinical Pharmacy, Seoul

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

Clinical Trial Pharmacy, Seoul

06351

Samsung Medical Center Clinical Trial Pharmacy, Seoul

Samsung Medical Center, Seoul

413 45

Sahlgrenska University Hospital, Dept of Oncology, Gothenburg

CB2 0QQ

Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital, Cambridge

Addenbrooke's Hospital, Central Pharmacy, Level 1, Cambridge

HA6 2RN

Mount Vernon Cancer Centre, East & North Herts NHS Trust, London

Mount Vernon Cancer Centre, Pharmacy, London

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

The Royal Marsden NHS Foundation Trust, Sutton

G12 0YN

Beatson WOSCC, Glasgow

G120YN

Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,, Glasgow

EC1A 7BE

St Bartholomew's Hospital, Barts Health NHS Trust, London

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

M20 4BX

Clinical Trials Pharmacy, The Christie, Manchester

Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester

NG5 1PB

Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus, Nottingham

Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02684006 - A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) | Biotech Hunter | Biotech Hunter