Spots Global Cancer Trial Database for A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
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Trial Identification
Brief Title: A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Official Title: 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
Study ID: NCT02684006
Conditions
Study Description
Brief Summary: 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
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Southern Cancer Center, Daphne, Alabama, United States
Southern Cancer Center, Mobile, Alabama, United States
Southern Cancer Center, Mobile, Alabama, United States
Tower Hematology Oncology Medical Group, Beverly Hills, California, United States
City of Hope National Medical Center, Duarte, California, United States
City of Hope, Duarte, California, United States
Keck Hospital of USC, Los Angeles, California, United States
LAC + USC Medical Center, Los Angeles, California, United States
USC IDS Pharmacy, Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Cedars-Sinai Advanced Health Sciences Pavilion, Los Angeles, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
Cedars-Sinai, Los Angeles, California, United States
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
Anschutz Cancer Center Pavilion Pharmacy, Aurora, Colorado, United States
University of Colorado Cancer Center Anschutz Cancer Pavilion, Aurora, Colorado, United States
University of Colorado Hospital - Clinical Trials Office (CTO), Aurora, Colorado, United States
University of Colorado Hospital, Aurora, Colorado, United States
Rocky Mountain Cancer Centers, Colorado Springs, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Emory University Hospital, Atlanta, Georgia, United States
Investigational Drug Service- Emory University, Atlanta, Georgia, United States
The Emory Clinic, Atlanta, Georgia, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
East Jefferson General Hospital, Metairie, Louisiana, United States
East Jefferson Hematology-Oncology Metairie Physician Service Inc., Metairie, Louisiana, United States
New England Cancer Specialists, Kennebunk, Maine, United States
New England Cancer Specialists, Scarborough, Maine, United States
New England Cancer Specialists, Topsham, Maine, United States
Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital, Baltimore, Maryland, United States
The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
John Hopkins Hospital, Baltimore, Maryland, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
MedStar Health Cardiology Associates, LLC., Brandywine, Maryland, United States
Cardiology Associates, P.C., Chester, Maryland, United States
Massachusetts General Hospital (MGH), Boston, Massachusetts, United States
Massachusetts General Hospital Clinical Trials Pharmacy, Boston, Massachusetts, United States
Brigham & Women's Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC), Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center Pharmacy - BIDMC, Boston, Massachusetts, United States
Dana - Farber Cancer Institute, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Baystate Franklin Medical Center, Greenfield, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Barnes-Jewish Hospital, Siteman Cancer Center - West County, Creve Coeur, Missouri, United States
Barnes-Jewish Hospital, Siteman Cancer Center, Saint Louis, Missouri, United States
Washington University Infusion Center Pharmacy, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Barnes-Jewish Hospital, Siteman Cancer Center - South County, Saint Louis, Missouri, United States
Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters, Saint Peters, Missouri, United States
St. Vincent HealthCare, Billings, Montana, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
New York Oncology Hematology, P.C., Albany, New York, United States
New York Oncology Hematology, PC, Albany, New York, United States
New York Oncology Hematology, P.C., Clifton Park, New York, United States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy, Long Island City, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
NYU Investigational Pharmacy, New York, New York, United States
NYU Langone Medical Center, New York, New York, United States
MSKCC-Monitoring Suite, New York, New York, United States
Evelyn H. Lauder Breast and Imaging Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Sidney Kimmel Center for Prostate and Urologic Cancers, New York, New York, United States
Stony Brook University, Stony Brook, New York, United States
Stony Brook University-Cancer Center, Stony Brook, New York, United States
Stony Brook University, Stony Brook, New York, United States
Novant Health Oncology Specialists, Kernersville, North Carolina, United States
Novant Health Oncology Specialists, Lexington, North Carolina, United States
Novant Health Oncology Specialists, Mount Airy, North Carolina, United States
Novant Health Oncology Specialists, North Wilkesboro, North Carolina, United States
Novant Health Clinical Research Onocolgy, Winston-Salem, North Carolina, United States
Novant Health Oncology Specialists, Winston-Salem, North Carolina, United States
Novant Health Winston Salem Health Care, Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Investigational Pharmacy, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States
The Ohio State University - GU Clinic, Columbus, Ohio, United States
The Ohio State University, Columbus, Ohio, United States
Cancer Care Associates Medical Oncology, Allentown, Pennsylvania, United States
St.Luke's Hospital-Allentown Campus, Allentown, Pennsylvania, United States
Cancer Care Associate Medical Oncology, Bethlehem, Pennsylvania, United States
St. Lukes University Health Network, Bethlehem, Pennsylvania, United States
St.Luke's University Health Network, Bethlehem, Pennsylvania, United States
St.Luke's Cancer Center Anderson, Easton, Pennsylvania, United States
St.Luke's Hospital-Anderson Campus, Easton, Pennsylvania, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Investigational Drug Service, University of Pennsylvania, Philadelphia, Pennsylvania, United States
St.Luke's Quakertown Hospital, Quakertown, Pennsylvania, United States
Memorial Hospital, York, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Henry-Joyce Cancer Clinic, Nashville, Tennessee, United States
Oncology IDS Pharmacy, Nashville, Tennessee, United States
Vanderbilt University Oncology Pharmacy, Nashville, Tennessee, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - Gulf Coast, Houston, Texas, United States
Texas Oncology- Memorial City, Houston, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Investigational Product Center (IPC), Irving, Texas, United States
Investigational Products Center (IPC), Irving, Texas, United States
Investigational Products Center (lPC), Irving, Texas, United States
US Oncology Investigational Products Center (IPC), Irving, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Rainier Hematology-Oncology, PC, Puyallup, Washington, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Seattle Cancer Care Alliance / University of Washington, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
Macquarie University Hospital Pharmacy, Macquarie University, New South Wales, Australia
Macquarie University, Macquarie University, New South Wales, Australia
Nuclear Medicine Department, Randwick, New South Wales, Australia
Pharmacy Department, Clinical Trials, Randwick, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Spectrum Medical Imaging, Randwick, New South Wales, Australia
Division of Cancer Services, Woolloongabba, Queensland, Australia
BHS Diagnostic Services, Ballarat, Victoria, Australia
Lake Imaging, Ballarat, Victoria, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
Eastern Health, Box Hill, Victoria, Australia
Monash Health Translational Precinct, Monash Medical Centre, Clayton, Victoria, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Monash Cancer Centre, East Bentleigh, Victoria, Australia
Moorabbin Radiology, East Bentleigh, Victoria, Australia
Slade Health, Mount Waverley, Victoria, Australia
Ballarat Day Procedure Centre, Wendouree, Victoria, Australia
Ballarat Oncology & Haematology Services, Wendouree, Victoria, Australia
Nova Pharmacy, Wendouree, Victoria, Australia
SKG Radiology, Murdoch, Western Australia, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
SKG Radiology, Murdoch, Western Australia, Australia
St John of God Murdoch Hospital, Murdoch, Western Australia, Australia
EPIC Pharmacy Murdoch, Perth, Western Australia, Australia
Krankenhaus der Barmherzigen Schwestern Wien, Wien, , Austria
Medizinische Universitaet Wien, Wien, , Austria
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
UZ Gent, Gent, , Belgium
AZ Groeninge, Kortrijk, , Belgium
CHU de Liège, Liège, , Belgium
Foothills Medical Centre, Calgary, Alberta, Canada
Alberta Health Services - Cancer Care, Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency - Kelowna, Kelowna, British Columbia, Canada
British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior, Kelowna, British Columbia, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
BC Cancer GU Clinic - Fairmont Medical Building, Vancouver, British Columbia, Canada
London Regional Cancer Program, London Health Sciences Centre, London, Ontario, Canada
London Regional Cancer Program, London Health Sciences Centre, London, Ontario, Canada
R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health, Oshawa, Ontario, Canada
Sunnybrook Research Institute, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Herlev Hospital, Onkologisk Afdeling R, Herlev, , Denmark
Odense Universitetshospital, Odense C, , Denmark
Centre Eugene Marquis Service Pharmacie - Essais Cliniques, Rennes, Cedex, France
Centre FRANCOIS BACLESSE, CAEN cedex 05, , France
Centre Francois Baclesse, Caen, Cedex 05, , France
Centre de cancerologie de la Sarthe, Le Mans, , France
Centre de Cancérologie de la Sarthe (CCS) - Clinique Victor Hugo, Le Mans, , France
Clinique Victor Hugo - Centre Jean Bernard, Le Mans, , France
Clinique Victor Hugo Centre de Cancerologie de la Sarthe, Le Mans, , France
Clinique Victor Hugo, Le Mans, , France
Centre Léon Bérard, Lyon cedex 8, , France
Centre Léon Bérard, LYON cedex 8, , France
Institut Paoli Calmettes, Marseille, , France
Centre Eugene Marquis, Rennes cedex, , France
Institut de Cancérologie de l'Ouest - Centre René Gauducheau, Saint-Herblain Cedex, , France
Institut de Cancerologie de Lorraine (ICL), Vandoeuvre les Nancy, , France
Institut de Cancerologie de Lorraine, Vandoeuvre les Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Universitaetsklinikum Tuebingen, Tuebingen, Baden-wuerttemberg, Germany
Universitaetsklinikum Tuebingen, Tuebingen, Baden-wuerttemberg, Germany
Universitaetsklinikum Jena, Jena, Thuringia, Germany
Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie, Jena, Thuringia, Germany
Universitaetsklinikum Jena, Jena, Thuringia, Germany
Dél.pesti Centrumkórház-OHII Szent Lálszló Kórház telephely, Budapest, , Hungary
Országos Onkológiai Intézet, Budapest, , Hungary
The Chaim Sheba Medical Center, Tel-Hashomer, Ramat - GAN, Israel
Assaf Harofe MC, Beer Yaakov, , Israel
Shamir Medical Center, Beer Yaakov, , Israel
Rambam Health Care Campus, Haifa, , Israel
Rambam Healthcare Campus, Haifa, , Israel
Meir Medical Center, Kfar Saba, , Israel
Rabin Medical Center, Petach Tikva, , Israel
The Chaim Sheba Medical Center, Ramat - Gan, , Israel
Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Centro di Riferimento Oncologico - IRCCS, Aviano, (pn), Italy
Farmacia Studi Clinici, Rozzano, Milan, Italy
Istituto Clinico Humanitas, Rozzano, Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, , Italy
SC Farmacia, Milan, , Italy
Istituto Europeo di Oncologia, Milan, , Italy
Servizio di Farmacia, Milan, , Italy
Azienda Ospedaliera San Camillo Forlanini, Rome, , Italy
Nagoya University Hospital, Nagoya, Aichi, Japan
Hirosaki University School of Medicine & Hospital, Hirosaki, Aomori, Japan
Hokkaido University Hospital, Sapporo, Hokkaidô, Japan
Iwate Medical University Hospital, Shiwa-gun, Iwate, Japan
Yokohama City University Hospital, Yokohama, Kanagawa, Japan
Kindai University Hospital, Osakasayama, Osaka, Japan
Osaka University Hospital, Suita, Osaka, Japan
Hamamatsu University School of Medicine, University Hospital, Hamamatsu, Shizuoka, Japan
Keio University Hospital, Shinjuku-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital, Shinjuku-ku, Tokyo, Japan
Akita University Hospital, Akita, , Japan
Chiba Cancer Center, Chiba, , Japan
Kyushu University Hospital, Fukuoka, , Japan
Niigata University Medical & Dental Hospital, Niigata, , Japan
Tokushima University Hospital, Tokushima, , Japan
Yamagata University Hospital, Yamagata, , Japan
Clinical Trial Pharmacy, National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
National Cancer Center, Goyang-Si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Clinical Pharmacy, Seongnam-si, Gyeonggido, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggido, Korea, Republic of
Kyungpook National University Medical Center, Clinical Pharmacy, Daegu, , Korea, Republic of
Kyungpook National University Medical Center, Daegu, , Korea, Republic of
Chungnam National University Hospital, Clinical Pharmacy, Daejeon, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Seoul National University Hospital, Clinical Pharmacy, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Clinical Trial Pharmacy, Seoul, , Korea, Republic of
Samsung Medical Center Clinical Trial Pharmacy, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Instituto Nacional de Cancerologia, Mexico, Ciudad DE Mexico, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer, Monterrey, Nuevo LEON, Mexico
Oaxaca Site Management Organization S.C., Oaxaca, , Mexico
Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Amsterdam, Noord-holland, Netherlands
Netherlands Cancer Institute / Apotheek MC Slotervaart, Amsterdam, Noord-holland, Netherlands
VU University Medical Center (VUmc), Amsterdam, Noord-holland, Netherlands
VU University Medical Center (VUmc), Amsterdam, Noord-holland, Netherlands
Sint Franciscus Gasthuis, Pharmacy, Rotterdam, Zuid-holland, Netherlands
Sint Franciscus Gasthuis, Rotterdam, Zuid-holland, Netherlands
Maxima Medisch Centrum, Eindhoven, , Netherlands
St Apotheek der Haarlemse Ziekenhuizen, Haarlem, , Netherlands
Spaarne Gasthuis, Hoofddorp, , Netherlands
Maastricht University Medical Center, Maastricht, , Netherlands
Maxima Medisch Centrum, Veldhoven, , Netherlands
Maxima Medisch Centrum, Veldhoven, , Netherlands
Auckland City Hospital, Grafton, Auckland, New Zealand
Tauranga Hospital, Bay of Plenty Clinical Trials Unit, Tauranga, BAY OF Plenty, New Zealand
Palmerston North Hospital, Palmerston North, Manawatu- Whanganui, New Zealand
Palmerston North Hospital, Palmerston North, Manawatu-wanganui, New Zealand
Tauranga Hospital, Tauranga Bay Of Plenty, Tauranga, New Zealand
Wairarapa District Health Board, Masterton, Wairarapa, New Zealand
Auckland City Hospital Pharmacy, Auckland, , New Zealand
Baxter Healthcare New Zealand, Auckland, , New Zealand
Christchurch Hospital, Christchurch, , New Zealand
Waikato Hospital Pharmacy Services, Hamilton, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Broadway Radiology, Palmerston North, , New Zealand
"Prof. Dr. Ion Chiricuta" Oncology Institute, Cluj-Napoca, , Romania
S.C. Medisprof S.R.L., Cluj-Napoca, , Romania
"Sfantul Nectarie" Oncology Center, Craiova, , Romania
Oncomed SRL, Timisoara, , Romania
RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address), Kursk, Kursk Region, Russian Federation
RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR, Kursk, Kursk Region, Russian Federation
Russian Research Center for Radiology and Surgical Technologies, Saint Petersburg, Pesochny, Russian Federation
FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF, Saint-Petersburg, Poselok Pesochniy, Russian Federation
Private medical institution "Euromedservice", Pushkin, Saint-petersburg, Russian Federation
Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal, Moscow, , Russian Federation
Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen, Moscow, , Russian Federation
FBIH "Privolzhskiy Regional Medical Center" of FMBA, Nizhniy Novgorod, , Russian Federation
SBIH of Nizhegorodskaya region "Clinical-Diagnostics center", Nizhniy Novgorod, , Russian Federation
FBIH "Privolzhskiy Regional Medical Center" of FMBA, Nizhniy Novgorod, , Russian Federation
FBIH "Privolzhskiy Regional Medical Center" of FMBA, Nizhniy Novgorod, , Russian Federation
SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary", Nizhniy Novgorod, , Russian Federation
Clinical Hospital #122 n.a. L. G. Sokolov, Saint Petersburg, , Russian Federation
NS HI "Road Clinical Hospital of JSC "Russian Railways"", Saint Petersburg, , Russian Federation
LLC "Diagnostic center "Energo", Saint Petersburg, , Russian Federation
LLC "Clinical Diagnostic Center "Medex-pert", Yaroslavl, , Russian Federation
SHI YR Regional Clinical Oncology Hospital, Yaroslavl, , Russian Federation
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Sahlgrenska University Hospital, Dept of Oncology, Gothenburg, , Sweden
Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, Cambridgeshire, United Kingdom
Mount Vernon Cancer Centre, East & North Herts NHS Trust, London, Middlesex, United Kingdom
Mount Vernon Cancer Centre, Pharmacy, London, Middlesex, United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, London, United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
Addenbrooke's Hospital, Central Pharmacy, Level 1, Cambridge, , United Kingdom
Beatson WOSCC, Glasgow, , United Kingdom
Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,, Glasgow, , United Kingdom
St Bartholomew's Hospital, Barts Health NHS Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
Clinical Trials Pharmacy, The Christie, Manchester, , United Kingdom
Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, , United Kingdom
Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus, Nottingham, , United Kingdom
Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy, Nottingham, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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