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

December 21, 2023 updated by: Pfizer

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

888

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Liège
  • 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 - Kelowna
      • 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 François Baclesse
      • Caen, Cedex 05, France, 14076
        • Centre François Baclesse
      • LYON cedex 8, France, 69373
        • Centre Leon Bérard
      • Le Mans, France, 72000
        • Clinique Victor Hugo - Centre Jean Bernard
      • Le Mans, France, 72000
        • Clinique Victor Hugo
      • Le Mans, France, 72000
        • Centre de cancerologie de la Sarthe
      • 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 Leon Bérard
      • Marseille, France, 13009
        • Institut Paoli Calmettes
      • Rennes cedex, France, 35042
        • Centre Eugène Marquis
      • Saint-Herblain Cedex, France, 44805
        • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
      • Vandoeuvre les Nancy, France, 54519
        • Institut de Cancerologie de Lorraine (ICL)
      • Vandoeuvre les Nancy, France, 54519
        • Institut de Cancérologie 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
        • Országos Onkológiai Intézet
      • 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- Whanganui
      • Palmerston North, Manawatu- Whanganui, New Zealand, 4414
        • Palmerston North Hospital
    • 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, 90033
        • LAC + USC Medical Center
      • 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, 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
        • Anschutz Cancer Center Pavilion Pharmacy
      • 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
        • John 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
      • Baltimore, Maryland, United States, 21231
        • The Sidney Kimmel Comprehensive Cancer Center
      • Brandywine, Maryland, United States, 20613
        • MedStar Health Cardiology Associates, LLC.
      • Chester, Maryland, United States, 21619
        • Cardiology Associates, P.C.
    • 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, 59102
        • St. Vincent Frontier Cancer Center
      • Billings, Montana, United States, 59101
        • St. Vincent Healthcare
    • 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, 11794-7007
        • Stony Brook University
      • Stony Brook, New York, United States, 11794-7263
        • Stony Brook University-Cancer Center
    • North Carolina
      • Kernersville, North Carolina, United States, 27284
        • Novant Health Oncology Specialists
      • Lexington, North Carolina, United States, 27295
        • Novant Health Oncology Specialists
      • Mount Airy, North Carolina, United States, 27030
        • Novant Health Oncology Specialists
      • North Wilkesboro, North Carolina, United States, 28659
        • Novant Health Oncology Specialists
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Oncology Specialists
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Clinical Research Onocolgy
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Winston Salem Health Care
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Investigational Pharmacy
      • 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.Luke's University Health Network
      • 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
      • York, Pennsylvania, United States, 17405
        • Memorial Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Henry-Joyce Cancer Clinic
      • Nashville, Tennessee, United States, 37232-6307
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Oncology Pharmacy
      • Nashville, Tennessee, United States, 37232
        • Oncology IDS Pharmacy
    • 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- Memorial City
      • 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, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance / University of Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 providedas per documented regulations 15 unstained slides (10 minimum) will be acceptable
  • At least one measureable 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 dignosed 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Progression Free Survival (PFS) in PD-L1 positive patients
Time Frame: From randomization up to 40 months.
Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by BICR (by RECIST version 1.1) or death due to any cause.
From randomization up to 40 months.
Overall Survival in PD-L1 positive patients
Time Frame: Every 3 months up to 8 years
OS is the time from date of randomization to date of death due to any cause.
Every 3 months up to 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in unselected patients
Time Frame: Every 3 months up to 8 years
OS is the time from date of randomization to date of death due to any cause.
Every 3 months up to 8 years
Number of participants with Objective Response (OR)
Time Frame: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Number of participants with objective response (ie, confirmed complete or partial response according to RECIST Version 1.1 recorded from randomization until disease progression assessed by BICR or death due to any cause)
Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Disease Control (DC)
Time Frame: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
DC is defined as complete response (CR), partial response (PR), or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression assessed by BICR or death due to any cause.
Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Time to Tumor Response (TTR)
Time Frame: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
TRR is the time from randomization to first documentation of objective tumor response (CR or PR).
Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Duration of response (DR)
Time Frame: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
DR is the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression assessed by BICR or death due to any cause
Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Progression Free Survival (PFS) by Investigator assessment
Time Frame: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by the Investigator (by RECIST version 1.1) or death due to any cause.
Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Trough plasma concentration (Ctrough) of avelumab
Time Frame: Pre-dose
Ctrough is defined as the concentration at the end of avelumab dosage interval
Pre-dose
Trough plasma concentration (Ctrough) of axitinib
Time Frame: Pre-dose
Ctrough is defined as the concentration at the end of axitinib dosage interval
Pre-dose
Maximum plasma concentration (Cmax) of axitinib
Time Frame: 2 hours post-dose
Cmax defined as the maximum plasma concentration of axitinib
2 hours post-dose
Anti-Drug Antibody (ADA) levels of avelumab/Neutralizing antibodies titers for MSB0010718C
Time Frame: Pre-dose
Immunogenicity assessment of avelumab
Pre-dose
Tumor tissue biomarker status
Time Frame: Baseline
Biomarker status defined as positive or negative based on a pre-specified scoring algorithm involving, for example, PD-L1 expression and/or quantitation of tumor infiltrating CD8+T lymphocytes as assessed by IHC
Baseline
Overall Survival (OS) in biomarker-positive and biomarker-negative subgroups
Time Frame: Baseline
OS in biomarker-negative and biomarker-positive subgroups.
Baseline
Change From Baseline in FACT-Kidney Symptom Index (FKSI)-19
Time Frame: Every 6 weeks up to 8 years
The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains- Disease Related Symptoms (physical and emotional), Treatment related side effects and Functional and Well-Being . A negative change from Baseline represents a worsening of condition.
Every 6 weeks up to 8 years
Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Health State Profile
Time Frame: Every 6 weeks up to 8 years
EQ-5D Health State Profile: participant rated questionnaire to assess health-related quality of life in terms of a single index value.
Every 6 weeks up to 8 years
Progression Free Survival (PFS) in biomarker-positive and biomarker-negative subgroups
Time Frame: Baseline
PFS as measure of clinical outcome in biomarker-negative and biomarker-positive subgroups.
Baseline
Objective Response (OR) in biomarker-positive and biomarker-negative subgroups
Time Frame: Baseline
OR in biomarker-negative and biomarker-positive subgroups
Baseline
Disease Control (DC) in biomarker-positive and biomarker-negative subgroups
Time Frame: Baseline
DC in biomarker-negative and biomarker-positive subgroups
Baseline
Time To Response (TTR) in biomarker-positive and biomarker-negative subgroups
Time Frame: Baseline
TTR in biomarker-negative and biomarker-positive subgroups.
Baseline
Duration of Response (DR) in biomarker-positive and biomarker-negative subgroups
Time Frame: Baseline
DR in biomarker-negative and biomarker-positive subgroups.
Baseline
Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Visual Analogic Scale
Time Frame: Every 6 weeks up to 8 years
EQ-5D Visual Analogic Scale:patients rated their overall health status from 0 (worst imaginable heath state) to 100 (best imaginable heath state).
Every 6 weeks up to 8 years
Time to treatment discontinuation/failure due to toxicity (TTF)
Time Frame: From Cycle 1 Day 1, every 6 weeks up to the End of Treatment
TTF is defined as the time from Cycle 1 Day 1 to the date of the first documentation of discontinuation due to an adverse event or death due to study treatment toxicity
From Cycle 1 Day 1, every 6 weeks up to the End of Treatment
Treatment discontinuation/failure due to toxicity
Time Frame: From Cycle 1 Day 1, every 6 weeks up to the End of Treatment
Treatment discontinuation is the percentage of patients who discontinue the treatment due to an adverse event or death due to study treatment toxicity
From Cycle 1 Day 1, every 6 weeks up to the End of Treatment
PFS on next-line therapy (PFS2)
Time Frame: From randomization up to 8 years.
PFS2 is defined as the time from randomization to discontinuation of next line treatment, second objective disease progression, or death from any cause, whichever occurs first.
From randomization up to 8 years.
Progression Free Survival (PFS) in unselected patients
Time Frame: From randomization up to 40 months.
Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by BICR (by RECIST version 1.1) or death due to any cause.
From randomization up to 40 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2016

Primary Completion (Actual)

August 31, 2023

Study Completion (Estimated)

May 21, 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)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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