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

A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA

This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma

Study Overview

• Status: Completed
• Conditions: Renal Cell Cancer
• Intervention / Treatment: Drug: Avelumab (MSB0010718C); Drug: Axitinib (AG-013736); Drug: Sunitinib

• Study Type: Interventional
• Enrollment (Actual): 886
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Macquarie University, New South Wales, Australia, 2109
      • Macquarie University Hospital Pharmacy
    • Macquarie University, New South Wales, Australia, 2109
      • Macquarie University
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital
    • Randwick, New South Wales, Australia, 2031
      • Nuclear Medicine Department
    • Randwick, New South Wales, Australia, 2031
      • Pharmacy Department, Clinical Trials
    • Randwick, New South Wales, Australia, 2031
      • Spectrum Medical Imaging
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Division of Cancer Services
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • BHS Diagnostic Services
    • Ballarat, Victoria, Australia, 3350
      • Lake Imaging
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Box Hill, Victoria, Australia, 3128
      • Eastern Health
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • Clayton, Victoria, Australia, 3168
      • Monash Health Translational Precinct, Monash Medical Centre
    • East Bentleigh, Victoria, Australia, 3165
      • Monash Cancer Centre
    • East Bentleigh, Victoria, Australia, 3165
      • Moorabbin Radiology
    • Mount Waverley, Victoria, Australia, 3149
      • Slade Health
    • Wendouree, Victoria, Australia, 3355
      • Ballarat Day Procedure Centre
    • Wendouree, Victoria, Australia, 3355
      • Ballarat Oncology & Haematology Services
    • Wendouree, Victoria, Australia, 3355
      • Nova Pharmacy
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
    • Murdoch, Western Australia, Australia, 6050
      • SKG Radiology
    • Murdoch, Western Australia, Australia, 6150
      • SKG Radiology
    • Murdoch, Western Australia, Australia, 6150
      • St John of God Murdoch Hospital
    • Perth, Western Australia, Australia, 6150
      • EPIC Pharmacy Murdoch
• Austria
  • Wien, Austria, 1090
    • Medizinische Universitaet Wien
  • Wien, Austria, 1060
    • Krankenhaus der Barmherzigen Schwestern Wien
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-luc
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint-luc
  • Gent, Belgium, 9000
    • UZ Gent
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • Liège, Belgium, 4000
    • CHU de Liege
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
    • Calgary, Alberta, Canada, T2N 4N2
      • Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency
    • Vancouver, British Columbia, Canada, V5Z IH7
      • BC Cancer GU Clinic - Fairmont Medical Building
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Program, London Health Sciences Centre
    • London, Ontario, Canada, N6A 5W9
      • London Regional Cancer Program, London Health Sciences Centre
    • Oshawa, Ontario, Canada, L1G 2B9
      • R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke
• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital, Onkologisk Afdeling R
  • Odense C, Denmark, 5000
    • Odense Universitetshospital
• France
  • CAEN cedex 05, France, 14076
    • Centre Francois Baclesse
  • Caen, France, 14076
    • Centre Francois Baclesse
  • LYON cedex 8, France, 69373
    • Centre Léon Bérard
  • Le Mans, France, 72000
    • Centre de Cancérologie de la Sarthe (CCS) - Clinique Victor Hugo
  • Le Mans, France, 72000
    • Clinique Victor Hugo Centre de Cancerologie de la Sarthe
  • Lyon cedex 8, France, 69008
    • Centre Léon Bérard
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Rennes cedex, France, 35042
    • Centre Eugene Marquis
  • Saint-Herblain Cedex, France, 44805
    • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
  • Vandoeuvre les Nancy, France, 54519
    • Institut de Cancérologie de Lorraine (ICL)
  • Vandoeuvre les Nancy, France, 54519
    • Institut de Cancerologie de Lorraine
  • Villejuif, France, 94805
    • Institut Gustave Roussy
  • Cedex
    • Rennes, Cedex, France, 35042
      • Centre Eugene Marquis Service Pharmacie - Essais Cliniques
• Germany
  • Baden-wuerttemberg
    • Tuebingen, Baden-wuerttemberg, Germany, 072076
      • Universitaetsklinikum Tuebingen
    • Tuebingen, Baden-wuerttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen
  • Thuringia
    • Jena, Thuringia, Germany, 07743
      • Universitaetsklinikum Jena
    • Jena, Thuringia, Germany, 07747
      • Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie
    • Jena, Thuringia, Germany, 07747
      • Universitaetsklinikum Jena
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet
  • Budapest, Hungary, 1097
    • Dél.pesti Centrumkórház-OHII Szent Lálszló Kórház telephely
• Israel
  • Beer Yaakov, Israel, 70300
    • Assaf Harofe MC
  • Beer Yaakov, Israel, 70300
    • Shamir Medical Center
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Haifa, Israel, 31096
    • Rambam Healthcare Campus
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
  • Petach Tikva, Israel, 49100
    • Rabin Medical Center
  • Ramat - Gan, Israel, 5265601
    • The Chaim Sheba Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center
  • Tel Aviv, Israel, 6423906
    • Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center
  • Ramat - GAN
    • Tel-Hashomer, Ramat - GAN, Israel, 5265601
      • The Chaim Sheba Medical Center
• Italy
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia
  • Milan, Italy, 20133
    • SC Farmacia
  • Milan, Italy, 20141
    • Servizio di Farmacia
  • Rome, Italy, 00152
    • Azienda Ospedaliera San Camillo Forlanini
  • (pn)
    • Aviano, (pn), Italy, 33081
      • Centro di Riferimento Oncologico - IRCCS
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Istituto Clinico Humanitas
    • Rozzano, Milan, Italy, 20089
      • Farmacia Studi Clinici
• Japan
  • Akita, Japan, 010-8543
    • Akita University Hospital
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Niigata, Japan, 951-8520
    • Niigata University Medical & Dental Hospital
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Yamagata, Japan, 990-9585
    • Yamagata University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 466-8560
      • Nagoya University Hospital
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8563
      • Hirosaki University School of Medicine & Hospital
  • Hokkaidô
    • Sapporo, Hokkaidô, Japan, 060-8648
      • Hokkaido University Hospital
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
  • Osaka
    • Osakasayama, Osaka, Japan, 589-8511
      • Kindai University Hospital
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University School of Medicine, University Hospital
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Tokyo Women's Medical University Hospital
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Medical Center
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Medical Center, Clinical Pharmacy
  • Daejeon, Korea, Republic of, 35015
    • Chungnam national university hospital
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital, Clinical Pharmacy
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital, Clinical Pharmacy
  • Seoul, Korea, Republic of, 05505
    • Clinical trial Pharmacy
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center Clinical Trial Pharmacy
  • Gyeonggi-do
    • Goyang-Si, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Center
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • Clinical Trial Pharmacy, National Cancer Center
  • Gyeonggido
    • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital, Clinical Pharmacy
    • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
• Mexico
  • Oaxaca, Mexico, 68000
    • Oaxaca Site Management Organization S.C.
  • Ciudad DE Mexico
    • Mexico, Ciudad DE Mexico, Mexico, 14080
      • Instituto Nacional de Cancerologia
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64460
      • Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer
• Netherlands
  • Eindhoven, Netherlands, 5631 BM
    • Maxima Medisch Centrum
  • Haarlem, Netherlands, 2035 RC
    • St Apotheek der Haarlemse Ziekenhuizen
  • Hoofddorp, Netherlands, 2134 TM
    • Spaarne Gasthuis
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
  • Veldhoven, Netherlands, 5504 DB
    • Maxima Medisch Centrum
  • Veldhoven, Netherlands, 5504 DL
    • Maxima Medisch Centrum
  • Noord-holland
    • Amsterdam, Noord-holland, Netherlands, 1066 CX
      • Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital
    • Amsterdam, Noord-holland, Netherlands, 1066 EC
      • Netherlands Cancer Institute / Apotheek MC Slotervaart
    • Amsterdam, Noord-holland, Netherlands, 1081 BT
      • VU University Medical Center (VUMC)
    • Amsterdam, Noord-holland, Netherlands, 1081 HZ
      • VU University Medical Center (VUMC)
  • Zuid-holland
    • Rotterdam, Zuid-holland, Netherlands, 3045 PM
      • Sint Franciscus Gasthuis, Pharmacy
    • Rotterdam, Zuid-holland, Netherlands, 3045 PM
      • Sint Franciscus Gasthuis
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital Pharmacy
  • Auckland, New Zealand, 1060
    • Baxter Healthcare New Zealand
  • Christchurch, New Zealand, 8140
    • Christchurch Hospital
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • Hamilton, New Zealand, 3240
    • Waikato Hospital Pharmacy Services
  • Palmerston North, New Zealand, 4410
    • Broadway Radiology
  • Auckland
    • Grafton, Auckland, New Zealand, 1023
      • Auckland City Hospital
  • BAY OF Plenty
    • Tauranga, BAY OF Plenty, New Zealand, 3143
      • Tauranga Hospital, Bay of Plenty Clinical Trials Unit
  • Manawatu-wanganui
    • Palmerston North, Manawatu-wanganui, New Zealand, 4414
      • Palmerston North Hospital
  • Tauranga
    • Tauranga Bay Of Plenty, Tauranga, New Zealand, 3112
      • Tauranga Hospital
  • Wairarapa
    • Masterton, Wairarapa, New Zealand, 5840
      • Wairarapa District Health Board
• Romania
  • Cluj-Napoca, Romania, 400015
    • "Prof. Dr. Ion Chiricuta" Oncology Institute
  • Cluj-Napoca, Romania, 400641
    • S.C. Medisprof S.R.L.
  • Craiova, Romania, 200347
    • "Sfantul Nectarie" Oncology Center
  • Timisoara, Romania, 300239
    • Oncomed SRL
• Russian Federation
  • Moscow, Russian Federation, 105425
    • Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal
  • Moscow, Russian Federation, 125284
    • Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen
  • Nizhniy Novgorod, Russian Federation, 603001
    • FBIH "Privolzhskiy Regional Medical Center" of FMBA
  • Nizhniy Novgorod, Russian Federation, 603006
    • SBIH of Nizhegorodskaya region "Clinical-Diagnostics center"
  • Nizhniy Novgorod, Russian Federation, 603032
    • FBIH "Privolzhskiy Regional Medical Center" of FMBA
  • Nizhniy Novgorod, Russian Federation, 603109
    • FBIH "Privolzhskiy Regional Medical Center" of FMBA
  • Nizhniy Novgorod, Russian Federation, 603126
    • SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary"
  • Saint Petersburg, Russian Federation, 194291
    • Clinical Hospital #122 n.a. L. G. Sokolov
  • Saint Petersburg, Russian Federation, 195271
    • NS HI "Road Clinical Hospital of JSC "Russian Railways""
  • Saint Petersburg, Russian Federation, 196247
    • LLC "Diagnostic center "Energo"
  • Yaroslavl, Russian Federation, 150014
    • LLC "Clinical Diagnostic Center "Medex-pert"
  • Yaroslavl, Russian Federation, 150040
    • SHI YR Regional Clinical Oncology Hospital
  • Kursk Region
    • Kursk, Kursk Region, Russian Federation, 305035
      • RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address)
    • Kursk, Kursk Region, Russian Federation, 305524
      • RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR
  • Pesochny
    • Saint Petersburg, Pesochny, Russian Federation, 197758
      • Russian Research Center for Radiology and Surgical Technologies
  • Poselok Pesochniy
    • Saint-Petersburg, Poselok Pesochniy, Russian Federation, 197758
      • FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF
  • Saint-petersburg
    • Pushkin, Saint-petersburg, Russian Federation, 196603
      • Private Medical Institution "Euromedservice"
• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra
• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska University Hospital, Dept of Oncology
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's Hospital, Central Pharmacy, Level 1
  • Glasgow, United Kingdom, G12 0YN
    • Beatson WOSCC
  • Glasgow, United Kingdom, G120YN
    • Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, EC1A 7BE
    • St Bartholomew's Hospital, Barts Health NHS Trust
  • Manchester, United Kingdom, M20 4BX
    • Clinical Trials Pharmacy, The Christie
  • Manchester, United Kingdom, M20 4BX
    • Department of Medical Oncology, The Christie NHS Foundation Trust
  • Nottingham, United Kingdom, NG5 1PB
    • Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital
  • Middlesex
    • London, Middlesex, United Kingdom, HA6 2RN
      • Mount Vernon Cancer Centre, East & North Herts NHS Trust
    • London, Middlesex, United Kingdom, HA6 2RN
      • Mount Vernon Cancer Centre, Pharmacy
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Royal Marsden NHS Foundation Trust
  • Surrey, London
    • Sutton, Surrey, London, United Kingdom, SM2 5PT
      • The Royal Marsden NHS Foundation Trust
• United States
  • Alabama
    • Daphne, Alabama, United States, 36526
      • Southern Cancer Center
    • Mobile, Alabama, United States, 36607
      • Southern Cancer Center
    • Mobile, Alabama, United States, 36608
      • Southern Cancer Center
  • California
    • Beverly Hills, California, United States, 90211
      • Tower Hematology Oncology Medical Group
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • Duarte, California, United States, 91010
      • City of Hope
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai
    • Los Angeles, California, United States, 90033
      • USC/Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
    • Los Angeles, California, United States, 90033
      • USC IDS Pharmacy
    • Los Angeles, California, United States, 90033
      • Los Angeles General Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Advanced Health Sciences Pavilion
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center Anschutz Cancer Pavilion
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital - Clinical Trials Office (CTO)
    • Colorado Springs, Colorado, United States, 80907
      • Rocky Mountain Cancer Centers
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center and Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute, Emory University
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic
    • Atlanta, Georgia, United States, 30322
      • Investigational Drug Service- Emory University
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • East Jefferson General Hospital
    • Metairie, Louisiana, United States, 70006
      • East Jefferson Hematology-Oncology Metairie Physician Service Inc.
  • Maine
    • Kennebunk, Maine, United States, 04043
      • New England Cancer Specialists
    • Scarborough, Maine, United States, 04074
      • New England Cancer Specialists
    • Topsham, Maine, United States, 04086
      • New England Cancer Specialists
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
    • Baltimore, Maryland, United States, 21287
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Baltimore, Maryland, United States, 21231
      • Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital (MGH)
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Clinical Trials Pharmacy
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center (BIDMC)
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center Pharmacy - BIDMC
    • Boston, Massachusetts, United States, 02215
      • Dana - Farber Cancer Institute
    • Greenfield, Massachusetts, United States, 01301
      • Baystate Franklin Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Barnes-Jewish Hospital, Siteman Cancer Center - West County
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63110
      • Washington University Infusion Center Pharmacy
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital, Siteman Cancer Center
    • Saint Louis, Missouri, United States, 63129
      • Barnes-Jewish Hospital, Siteman Cancer Center - South County
    • Saint Peters, Missouri, United States, 63376
      • Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters
  • Montana
    • Billings, Montana, United States, 59101
      • St. Vincent Healthcare
    • Billings, Montana, United States, 59102
      • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Comprehensive Cancer Centers of Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
    • Las Vegas, Nevada, United States, 75063
      • Comprehensive Cancer Centers of Nevada
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology, P.C.
    • Albany, New York, United States, 12208
      • New York Oncology Hematology, PC
    • Clifton Park, New York, United States, 12065
      • New York Oncology Hematology, P.C.
    • Long Island City, New York, United States, 11101
      • Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10016
      • NYU Investigational Pharmacy
    • New York, New York, United States, 10016
      • Laura & Isaac Perlmutter Cancer Center At NYU Langone
    • New York, New York, United States, 10017
      • MSKCC-Monitoring Suite
    • New York, New York, United States, 10065
      • Sidney Kimmel Center for Prostate and Urologic Cancers
    • New York, New York, United States, 10065
      • Evelyn H. Lauder Breast and Imaging Center
    • Stony Brook, New York, United States, 11794
      • Stony Brook University
    • Stony Brook, New York, United States, 11794
      • Stony Brook University-Cancer Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Oncology Specialists
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic Taussig Cancer Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Columbus, Ohio, United States, 43210
      • James Cancer Hospital and Solove Research Institute
    • Columbus, Ohio, United States, 43210
      • The Ohio State University - GU Clinic
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Cancer Care Associates Medical Oncology
    • Allentown, Pennsylvania, United States, 18104
      • St.Luke's Hospital-Allentown Campus
    • Bethlehem, Pennsylvania, United States, 18015
      • Cancer Care Associate Medical Oncology
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Lukes University Health Network
    • Easton, Pennsylvania, United States, 18045
      • St.Luke's Cancer Center Anderson
    • Easton, Pennsylvania, United States, 18045
      • St.Luke's Hospital-Anderson Campus
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Investigational Drug Service, University of Pennsylvania
    • Quakertown, Pennsylvania, United States, 18951
      • St.Luke's Quakertown Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Henry-Joyce Cancer Clinic
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Charles A. Sammons Cancer Center
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77024
      • Texas Oncology - Gulf Coast
    • Irving, Texas, United States, 75063
      • Investigational Product Center (IPC)
    • Irving, Texas, United States, 75063
      • Investigational Products Center (IPC)
    • Irving, Texas, United States, 75063
      • Investigational Products Center (lPC)
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Products Center (IPC)
    • Lubbock, Texas, United States, 79410
      • Joe Arrington Cancer Research and Treatment Center
  • Washington
    • Puyallup, Washington, United States, 98373
      • Rainier Hematology-Oncology, PC
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center
    • Tacoma, Washington, United States, 98405
      • NorthWest Medical Specialties, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed advanced or metastatic RCC with clear cell component
• Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of randomization AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, 15 unstained slides (10 minimum) will be acceptable
• Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be provided as per documented regulations 15 unstained slides (10 minimum) will be acceptable
• At least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Adequate bone marrow function, renal and liver functions

Exclusion Criteria:

• Prior systemic therapy directed at advanced or metastatic RCC
• Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment.
• Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
• Prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors
• Newly diagnosed or active brain metastasis
• Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011)
• Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack
• Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism
• Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avelumab in combination with axitinib; Avelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID.	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; Other Names: Inlyta
Active Comparator: Sunitinib; Sunitinib given at 50 mg PO QD on schedule 4/2	Drug: Sunitinib; Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2; Other Names: Sutent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in PD-L1 Positive Participants	OS was defined as the time 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 the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants	PFS: time from the date of randomization to the date of the first documentation of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumours (RECIST version [v] 1.1) or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20 percent (%), increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute more than (>) of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression.	From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression	PFS: time from the date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression.	From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
OS in Participants Irrespective of PD-L1 Expression	OS 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 the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)
Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression	OR was defined as best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by BICR recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. 95% CI was based on Clopper-Pearson method.	From date of randomization until PD (maximum up to approximately 26 months)
Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression	OR was defined as best overall response of CR or PR according to RECIST v1.1 as assessed by investigator recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. 95% CI was based on Clopper-Pearson method.	From date of randomization until PD (maximum up to approximately 89 months)
Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression	DC was defined as a best overall response of CR, PR, non-CR/non-PD or stable disease (SD) according to RECIST v1.1 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. All lymph nodes must decrease to normal size (short axis<10mm). 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 (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds.	From date of randomization until PD (maximum up to approximately 26 months)
Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression	DC was defined as a best overall response of CR, PR, non-CR/non-PD or SD according to RECIST v1.1 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. All lymph nodes must decrease to normal size (short axis<10mm). 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 (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds.	From date of randomization until PD (maximum up to approximately 89 months)
Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression	TTR was defined as the time from randomization to the first documentation of objective tumor response according to RECIST v1.1 as assessed by BICR (CR or PR) which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.	From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)
TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression	TTR was defined as the time from randomization to the first documentation of objective tumor response according to RECIST v1.1 as assessed by investigator (CR or PR) which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.	From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 89 months)
Duration of Response (DR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression	BICR assessed DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of objective tumor progression assessed by BICR or death due to any cause whichever occurred first. As per RECIST v1.1. CR: complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. PD: at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression.	From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months)
DR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression	Investigator assessed DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of objective tumor progression (PD) assessed by investigator or death due to any cause whichever occurred first. As per RECIST v1.1. CR: complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. PD: at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression.	From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 89 months)
PFS as Assessed by Investigator in Participants Irrespective of PD-L1 Expression	Investigator assessed PFS: time from the date of randomization to the date of the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever occurred first. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression.	From date of randomization until PD, whichever occurred first (maximum up to approximately 89 months)
Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression	PFS2 is defined as the time (in months) from randomization to discontinuation of next-line treatment after first objective disease progression by investigator assessment, second objective disease progression by investigator assessment after initiation of next-line treatment, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression.	From date of randomization until PD or death, whichever occurred first (maximum up to approximately 89 months)
Trough Plasma Concentration (Ctrough) of Avelumab	Predose concentration during multiple dosing.	Pre dose (0 hour) on Day 1, 15 and 29 of Cycle 1, Day 1 and 29 of Cycles 2, 3, 4 and Day 1 of Cycle 6
Ctrough of Axitinib	Predose concentration during multiple dosing.	Pre dose (0 hour) on day 15 and 29 of cycle 1 (each cycle= 6 weeks)
Maximum Plasma Concentration (Cmax) of Axitinib		2 hours post-dose on Day 1, pre-dose and 2 hours post dose on Days 15 and 29 of Cycle 1
Number of Participants With Positive PD-L1 Biomarker Expression in Pre-treatment Tumor Tissue	Tumor biospecimens from pre-treatment tissue samples were analyzed by immunohistochemistry for PD-L1 biomarker expression. Number of participants with positive PD-L1 biomarker expression are reported in this outcome measure.	At screening
PFS in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups	PFS: time from the date of randomization to the date of the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever occurred first. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression.	From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups	OR was defined as best overall response of CR or PR according to RECIST v1.1 as assessed by BICR recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.	From date of randomization until PD (maximum up to approximately 26 months)
Percentage of Participants With DC in Biomarker-Positive Subgroup	DC was defined as a best overall response of CR, PR, or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression or death due to any cause, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. SD was defined as PR that the sum increases by less than 20% from the nadir, (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds.	From date of randomization until PD or death, whichever occurred first (maximum up to approximately 26 months)
TTR in Biomarker-Positive Subgroup	TTR was defined as the time from randomization to the first documentation of objective tumor response (CR or PR) according to RECIST v1.1 which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.	From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)
DR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups	DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause, whichever occurred first. As per RECIST version 1.1, CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30%< in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: defined as at least a 20% > in sum of diameters of target lesions, taking as reference the smallest sum on study (this included baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered progression.	From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months)
Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib		From start of treatment until 30 days after the end of avelumab treatment (maximum up to approximately 89 months)
Time to Symptom Deterioration (TTD) for Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS)	TTD was defined as the time from date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS. FKSI was used to assess symptoms and quality of life (QoL) for those diagnosed with advanced kidney cancer and it consisted of 19 questions. A 9-item subscale of the FKSI known as FKSI-Disease Related Symptoms subscale (FKSI-DRS). This subscale included 9 items: lack of energy, pain, losing weight, bone pain, fatigue, shortness of breath, coughing, bothered by fevers, and hematuria. Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher score indicated greater presence of symptoms.	Date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS (maximum up to approximately 26 months)
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score	EQ-5D-5L is a 5-item participant-completed questionnaire designed to assess health status in terms of a single utility score. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction. Published UK weights were used to create a single summary utility score. Utility scores range from -0.594 to 1, with higher scores representing better health status.	Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months)
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score	EQ-VAS records the participant's self-rated health status from 0 (worst imaginable health status) to 100 (best imaginable health status), where higher scores indicated better health status.	Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months)
Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (V) 4.03	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event was during the on-treatment period (time from the first dose of study treatment through 90 days after last dose of study treatment or start day of new anti-cancer drug therapy-1 day). As per NCI-CTCAE v4.03, grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death.	From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)
Number of Participants According to Grade Shift in Hematology Parameters	Following hematology parameters were assessed: hemoglobin decreased (anemia), hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell (WBC) decreased. Laboratory abnormalities were graded as per NCI- CTCAE v 4.03 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe, G4=life-threatening consequences and G5=death. Baseline was defined as last assessment prior to first dose of study treatment. Number of participants with a baseline grade of 0 to 4 which shifted to G3-4 post-baseline are reported in this outcome measure. Only non-zero categories for any reporting arm are reported.	From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)
Number of Participants According to Grade Shift in Chemistry Parameters	Following chemistry parameters were assessed: alanine aminotransferase(ALT) increased, alkaline phosphatase(ALP) increased, aspartate aminotransferase(AST) increased, blood bilirubin increased, cholesterol high, creatinine phosphokinase(CPK) increased, creatinine increased, gamma glutamyl transferase(GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesmia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased and serum amylase increased. Laboratory abnormality graded as per NCI CTCAE v4.03; G0=non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe, G4=life-threatening consequences and G5=death. Number of participants with a baseline grade of 0 to 4 which shifted to G3-4 post-baseline are reported. Only non-zero categories for any reporting arm are reported.	From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)
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	Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes.	Baseline (pre-dose on Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum up to approximately 89 months) (each cycle=42 days)
Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit	Pulse rate was measured with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes.	Baseline (pre-dose on Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum up to approximately 89 months) (each cycle=42 days)
Number of Participants Who Discontinued Treatment Due to Toxicity	Number of participants who discontinued treatment due to toxicity are reported in this outcome measure.	From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months)
Time to Treatment Discontinuation/Failure Due to Toxicity	Time to treatment discontinuation/ failure due to toxicity was defined as the time from first dose of study treatment to discontinuation of study treatment due to an adverse event or death due to study treatment toxicity.	From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• Rini BI, Moslehi JJ, Bonaca M, Schmidinger M, Albiges L, Choueiri TK, Motzer RJ, Atkins MB, Haanen J, Mariani M, Wang J, Hariharan S, Larkin J. Prospective Cardiovascular Surveillance of Immune Checkpoint Inhibitor-Based Combination Therapy in Patients With Advanced Renal Cell Cancer: Data From the Phase III JAVELIN Renal 101 Trial. J Clin Oncol. 2022 Jun 10;40(17):1929-1938. doi: 10.1200/JCO.21.01806. Epub 2022 Mar 3.
• Masters JC, Khandelwal A, di Pietro A, Dai H, Brar S. Model-informed drug development supporting the approval of the avelumab flat-dose regimen in patients with advanced renal cell carcinoma. CPT Pharmacometrics Syst Pharmacol. 2022 Apr;11(4):458-468. doi: 10.1002/psp4.12771. Epub 2022 Feb 27.
• Rini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5.
• Motzer RJ, Robbins PB, Powles T, Albiges L, Haanen JB, Larkin J, Mu XJ, Ching KA, Uemura M, Pal SK, Alekseev B, Gravis G, Campbell MT, Penkov K, Lee JL, Hariharan S, Wang X, Zhang W, Wang J, Chudnovsky A, di Pietro A, Donahue AC, Choueiri TK. Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN Renal 101 trial. Nat Med. 2020 Nov;26(11):1733-1741. doi: 10.1038/s41591-020-1044-8. Epub 2020 Sep 7.
• Choueiri TK, Motzer RJ, Rini BI, Haanen J, Campbell MT, Venugopal B, Kollmannsberger C, Gravis-Mescam G, Uemura M, Lee JL, Grimm MO, Gurney H, Schmidinger M, Larkin J, Atkins MB, Pal SK, Wang J, Mariani M, Krishnaswami S, Cislo P, Chudnovsky A, Fowst C, Huang B, di Pietro A, Albiges L. Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. Ann Oncol. 2020 Aug;31(8):1030-1039. doi: 10.1016/j.annonc.2020.04.010. Epub 2020 Apr 25.
• Motzer RJ, Penkov K, Haanen J, Rini B, Albiges L, Campbell MT, Venugopal B, Kollmannsberger C, Negrier S, Uemura M, Lee JL, Vasiliev A, Miller WH Jr, Gurney H, Schmidinger M, Larkin J, Atkins MB, Bedke J, Alekseev B, Wang J, Mariani M, Robbins PB, Chudnovsky A, Fowst C, Hariharan S, Huang B, di Pietro A, Choueiri TK. Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019 Mar 21;380(12):1103-1115. doi: 10.1056/NEJMoa1816047. Epub 2019 Feb 16.
• Choueiri TK, Larkin J, Pal S, Motzer RJ, Rini BI, Venugopal B, Alekseev B, Miyake H, Gravis G, Bilen MA, Hariharan S, Chudnovsky A, Ching KA, Mu XJ, Mariani M, Robbins PB, Huang B, di Pietro A, Albiges L. Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial. ESMO Open. 2021 Jun;6(3):100101. doi: 10.1016/j.esmoop.2021.100101. Epub 2021 Apr 23.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2016
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): June 26, 2024

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimated): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; kidney disease; renal cell cancer; kidney neoplasms; axitinib, sunitinib
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell; Antineoplastic Agents, Immunological; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Sunitinib; Avelumab; Axitinib
• Other Study ID Numbers: B9991003; 2015-002429-20 (EudraCT Number); JAVELIN RENAL 101 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.