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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02684006
Recruitment Status : Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Renal Cell Cancer Drug: Avelumab (MSB0010718C) Drug: Axitinib (AG-013736) Drug: Sunitinib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 888 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 23, 2016
Estimated Primary Completion Date : December 2, 2018
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Sutent




Primary Outcome Measures :
  1. Progression Free Survival (PFS) in PD-L1 positive patients [ Time Frame: From randomization up to 30 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.

  2. Overall Survival in PD-L1 positive patients [ Time Frame: Every 3 months up to 5 years ]
    OS is the time from date of randomization to date of death due to any cause.


Secondary Outcome Measures :
  1. Overall Survival (OS) in unselected patients [ Time Frame: Every 3 months up to 5 years ]
    OS is the time from date of randomization to date of death due to any cause.

  2. 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 30 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)

  3. Disease Control (DC) [ Time Frame: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 30 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.

  4. 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 30 months from randomization ]
    TRR is the time from randomization to first documentation of objective tumor response (CR or PR).

  5. 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 30 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

  6. 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 30 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.

  7. Trough plasma concentration (Ctrough) of avelumab [ Time Frame: Pre-dose ]
    Ctrough is defined as the concentration at the end of avelumab dosage interval

  8. Trough plasma concentration (Ctrough) of axitinib [ Time Frame: Pre-dose ]
    Ctrough is defined as the concentration at the end of axitinib dosage interval

  9. Maximum plasma concentration (Cmax) of axitinib [ Time Frame: 2 hours post-dose ]
    Cmax defined as the maximum plasma concentration of axitinib

  10. Anti-Drug Antibody (ADA) levels of avelumab/Neutralizing antibodies titers for MSB0010718C [ Time Frame: Pre-dose ]
    Immunogenicity assessment of avelumab

  11. 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

  12. Overall Survival (OS) in biomarker-positive and biomarker-negative subgroups [ Time Frame: Baseline ]
    OS in biomarker-negative and biomarker-positive subgroups.

  13. Change From Baseline in FACT-Kidney Symptom Index (FKSI)-19 [ Time Frame: Every 6 weeks up to 3 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.

  14. Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Health State Profile [ Time Frame: Every 6 weeks up to 3 years ]
    EQ-5D Health State Profile: participant rated questionnaire to assess health-related quality of life in terms of a single index value.

  15. 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.

  16. Objective Response (OR) in biomarker-positive and biomarker-negative subgroups [ Time Frame: Baseline ]
    OR in biomarker-negative and biomarker-positive subgroups

  17. Disease Control (DC) in biomarker-positive and biomarker-negative subgroups [ Time Frame: Baseline ]
    DC in biomarker-negative and biomarker-positive subgroups

  18. Time To Response (TTR) in biomarker-positive and biomarker-negative subgroups [ Time Frame: Baseline ]
    TTR in biomarker-negative and biomarker-positive subgroups.

  19. Duration of Response (DR) in biomarker-positive and biomarker-negative subgroups [ Time Frame: Baseline ]
    DR in biomarker-negative and biomarker-positive subgroups.

  20. Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Visual Analogic Scale [ Time Frame: Every 6 weeks up to 3 years ]
    EQ-5D Visual Analogic Scale:patients rated their overall health status from 0 (worst imaginable heath state) to 100 (best imaginable heath state).

  21. 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

  22. 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

  23. PFS on next-line therapy (PFS2) [ Time Frame: From randomization up to 5 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.

  24. Progression Free Survival (PFS) in unselected patients [ Time Frame: From randomization up to 30 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684006


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Locations
United States, Alabama
Southern Cancer Center
Daphne, Alabama, United States, 36526
Southern Cancer Center
Mobile, Alabama, United States, 36607
Southern Cancer Center
Mobile, Alabama, United States, 36608
United States, California
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States, 90211
City of Hope National Medical Center
Duarte, California, United States, 91010
City of Hope
Duarte, California, United States, 91010
Keck Hospital of USC
Los Angeles, California, United States, 90033
LAC + USC Medical Center
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
Cedars-Sinai
Los Angeles, California, United States, 90048
United States, Colorado
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
Anschutz Cancer Center Pavilion Pharmacy
Aurora, Colorado, United States, 80045
Genitourinary Oncology
Aurora, Colorado, United States, 80045
University of Colorado Cancer Center Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, United States, 80907
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Investigational Drug Service- Emory University
Atlanta, Georgia, United States, 30322
The Emory Clinic
Atlanta, Georgia, United States, 30322
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Louisiana
East Jefferson General - Inpatient Pharmacy
Metairie, Louisiana, United States, 70006
East Jefferson General Hospital
Metairie, Louisiana, United States, 70006
East Jefferson Hematology-Oncology Metairie Physician Service Inc.
Metairie, Louisiana, United States, 70006
United States, Maine
New England Cancer Specialists
Brunswick, Maine, United States, 04011
New England Cancer Specialists
Kennebunk, Maine, United States, 04043
New England Cancer Specialists
Scarborough, Maine, United States, 04074
United States, Maryland
Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital Clinical Trials Pharmacy
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
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
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Barnes-Jewish Hospital, Siteman Cancer Center - West County
Creve Coeur, Missouri, United States, 63141
Barnes-Jewish Hospital, Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
Washington University Infusion Center Pharmacy
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Barnes-Jewish Hospital, Siteman Cancer Center - South County
Saint Louis, Missouri, United States, 63129
Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters
Saint Peters, Missouri, United States, 63376
United States, Montana
St. Vincent Healthcare
Billings, Montana, United States, 59101
St. Vincent Frontier Cancer Center
Billings, Montana, United States, 59102
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
New York Oncology Hematology, PC
Albany, New York, United States, 12208
New York Oncology Hematology, P.C.
Clifton Park, New York, United States, 12065
Laura & Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
NYU Investigational Pharmacy
New York, New York, United States, 10016
NYU Langone Medical Center
New York, New York, United States, 10016
MSKCC-Monitoring Suite
New York, New York, United States, 10017
MSKCC Department of Laboratory Medicine-Main
New York, New York, United States, 10065
Sidney Kimmel-Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Stony Brook University
Stony Brook, New York, United States, 11794-7007
Stony Brook University Medical Center Cancer Center Division of Oncology / Hematology
Stony Brook, New York, United States, 11794
Stony Brook University
Stony Brook, New York, United States, 11794
United States, North Carolina
Novant Health Oncology Specialists
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 Winston Salem Health Care
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic Investigational Pharmacy
Cleveland, Ohio, United States, 44195
Cleveland Clinic
Cleveland, Ohio, United States, 44195
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
The Ohio State University - GU Clinic
Columbus, Ohio, United States, 43210
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Cancer Care Associates Medical Oncology
Allentown, Pennsylvania, United States, 18104
St.Luke's Hospital-Allentown Campus
Allentown, Pennsylvania, United States, 18104
Cancer Care Associate Medical Oncology
Bethlehem, Pennsylvania, United States, 18015
St.Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
St.Luke's Cancer Center Anderson
Easton, Pennsylvania, United States, 18045
St.Luke's Hospital-Anderson Campus
Easton, Pennsylvania, United States, 18045
Investigational Drug Service, University of Pennsylvania
Philadelphia PennsyIvania, Pennsylvania, United States, 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
St.Luke's Quakertown Hospital
Quakertown, Pennsylvania, United States, 18951
Memorial Hospital
York, Pennsylvania, United States, 17405
United States, Tennessee
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States, 37232
Vanderbilt University Oncology Pharmacy
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Investigational Product Center (IPC)
Fort Worth, Texas, United States, 76177
Investigational Products Center (IPC)
Fort Worth, Texas, United States, 76177
Investigational Products Center (lPC)
Fort Worth, Texas, United States, 76177
Texas Oncology- Memorial City
Houston, Texas, United States, 77024
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
United States, Washington
Rainier Hematology-Oncology, PC
Puyallup, Washington, United States, 98373
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States, 98109
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
Australia, New South Wales
Macquarie University Hospital Pharmacy
Macquarie University, New South Wales, Australia, 2109
Macquarie University
Macquarie University, New South Wales, Australia, 2109
Nuclear Medicine Department
Randwick, New South Wales, Australia, 2031
Pharmacy Department, Clinical Trials
Randwick, New South Wales, Australia, 2031
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Spectrum Medical Imaging
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Division of Cancer Services
Woolloongabba, Queensland, Australia, 4102
Main Pharmacy
Woolloongabba, Queensland, Australia, 4102
Metro South Health Queensland
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Lake Imaging
Ballarat, Victoria, Australia, 3350
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Eastern Health
Box Hill, Victoria, Australia, 3128
Monash Health Translational Precinct, Monash Medical Centre
Clayton, Victoria, Australia, 3168
Monash Health Translational Precinctd, Monash Medical Centre
Clayton, Victoria, Australia, 3168
Monash Cancer Centre
East Bentleigh, Victoria, Australia, 3165
Moorabbin Radiology
East Bentleigh, Victoria, Australia, 3165
Ballarat Day Procedure Centre
Wendouree, Victoria, Australia, 3355
Ballarat Oncology & Haematology Services
Wendouree, Victoria, Australia, 3355
Nova Pharmacy
Wendouree, Victoria, Australia, 3355
Slade Health
West Melbourne, Victoria, Australia, 3003
Australia, Western Australia
SKG Radiology
Murdoch, Western Australia, Australia, 6050
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
SKG Radiology
Murdoch, Western Australia, Australia, 6150
St John of God Murdoch Hospital
Murdoch, Western Australia, Australia, 6150
EPIC Pharmacy Murdoch
Perth, Western Australia, Australia, 6150
Austria
Krankenhaus der Barmherzigen Schwestern Wien
Wien, Austria, 1060
Allgemeines Krankenhaus Wien
Wien, Austria, 1090
Medizinische Universitaet Wien
Wien, Austria, 1090
Universitaetsklinik fur Radiologie und Nuklearmedizin
Wien, Austria, 1090
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
UZ Gent
Gent, Belgium, 9000
AZ Groeninge
Kortrijk, Belgium, 8500
CHU de Liège
Liège, Belgium, 4000
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health
Oshawa, Ontario, Canada, L1G 2B9
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Denmark
Herlev Hospital, Onkologisk Afdeling R
Herlev, Denmark, 2730
Odense Universitetshospital
Odense C, Denmark, 5000
France
Centre Eugene Marquis Service Pharmacie - Essais Cliniques
Rennes, Cedex, France, 35042
Centre FRANCOIS BACLESSE
CAEN cedex 05, France, 14076
Centre Francois Baclesse
Caen, Cedex 05, France, 14076
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, France, 72000
Clinique Victor Hugo
Le Mans, France, 72000
Centre Léon Bérard
Lyon cedex 8, France, 69008
Centre Léon Bérard
LYON cedex 8, France, 69373
Institut Paoli Calmettes
Marseille, France, 13009
Centre Eugene Marquis
Rennes cedex, France, 35042
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
Saint-Herblain Cedex, France, 44805
Institut de Cancerologie de Lorraine (ICL)
Vandoeuvre les Nancy, France, 54519
Institut de Cancerologie de Lorraine
Vandoeuvre les Nancy, France, 54519
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Universitaetsklinikum Tuebingen
Tuebingen, Baden-wuerttemberg, Germany, 072076
Universitaetsklinikum Tuebingen
Tuebingen, Baden-wuerttemberg, Germany, 72076
Universitaetsklinikum Jena
Jena, Thuringia, Germany, 07743
Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie
Jena, Thuringia, Germany, 07747
Universitaetsklinikum Jena
Jena, Thuringia, Germany, 07747
Hungary
Dél.pesti Centrumkórház-OHII Szent Lálszló Kórház telephely
Budapest, Hungary, 1097
Országos Onkológiai Intézet
Budapest, Hungary, 1122
Israel
The Chaim Sheba Medical Center
Tel-Hashomer, Ramat - GAN, Israel, 5265601
Assaf Harofe MC
Beer Yaakov, Israel, 70300
Rambam Health Care Campus
Haifa, Israel, 31096
Rambam Healthcare Campus
Haifa, Israel, 31096
Meir Medical Center
Kfar Saba, Israel, 44281
Rabin Medical Center
Petach Tikva, Israel, 49100
The Chaim Sheba Medical Center
Ramat - Gan, Israel, 5265601
Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Italy
Centro di Riferimento Oncologico - IRCCS
Aviano, (pn), Italy, 33081
S.O.C. di Farmacia
Aviano, (pn), Italy, 33081
Farmacia Studi Clinici
Rozzano, Milan, Italy, 20089
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
SC Farmacia
Milan, Italy, 20133
Istituto Europeo di Oncologia
Milan, Italy, 20141
Servizio di Farmacia
Milan, Italy, 20141
Azienda Ospedaliera San Camillo Forlanini
Rome, Italy, 00152
U.O.C. Farmacia
Rome, Italy, 00152
Japan
Nagoya University Hospital
Nagoya, Aichi, Japan, 466-8560
Hirosaki University School of Medicine & Hospital
Hirosaki, Aomori, Japan, 036-8563
Hokkaido University Hospital
Sapporo, Hokkaidô, Japan, 060-8648
Iwate Medical University
Morioka, Iwate, Japan, 020-8505
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Kindai University Hospital
Osakasayama, Osaka, Japan, 589-8511
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, Japan, 431-3192
Keio University Hospital
Shinjuku-ku, Tokyo, Japan, 160-8582
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 162-8666
Akita University Hospital
Akita, Japan, 010-8543
Chiba Cancer Center
Chiba, Japan, 260-8717
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Niigata University Medical & Dental Hospital
Niigata, Japan, 951-8520
Tokushima University Hospital
Tokushima, Japan, 770-8503
Yamagata University Hospital
Yamagata, Japan, 990-9585
Korea, Republic of
Clinical Trial Pharmacy, National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
National Cancer Center
Goyang-Si, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital, Clinical Pharmacy
Seongnam-si, Gyeonggido, Korea, Republic of, 13620
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, Korea, Republic of, 13620
Kyungpook National University Medical Center, Clinical Pharmacy
Daegu, Korea, Republic of, 41404
Kyungpook National University Medical Center
Daegu, Korea, Republic of, 41404
Chungnam National University Hospital, Clinical Pharmacy
Daejeon, Korea, Republic of, 35015
Chungnam National University Hospital
Daejeon, Korea, Republic of, 35015
Seoul National University Hospital, Clinical Pharmacy
Seoul, Korea, Republic of, 03080
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System, Clinical Pharmacy
Seoul, Korea, Republic of, 03722
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Clinical Trail Pharmcy
Seoul, Korea, Republic of, 05505
Samsung Medical Center Clinical Trial Pharmacy
Seoul, Korea, Republic of, 06351
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Mexico
Instituto Nacional de Cancerologia
Mexico, Ciudad DE Mexico, Mexico, 14080
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer
Monterrey, Nuevo LEON, Mexico, 64460
Oaxaca Site Management Organization S.C.
Oaxaca, Mexico, 68000
Netherlands
Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital
Amsterdam, Noord-holland, Netherlands, 1066 CX
Netherlands Cancer Institute / Apotheek MC Slotervaart
Amsterdam, Noord-holland, Netherlands, 1066 EC
VU University Medical Center (VUmc)
Amsterdam, Noord-holland, Netherlands, 1081 BT
VU University Medical Center (VUmc)
Amsterdam, Noord-holland, Netherlands, 1081 HZ
Sint Franciscus Gasthuis, Pharmacy
Rotterdam, Zuid-holland, Netherlands, 3045 PM
Sint Franciscus Gasthuis
Rotterdam, Zuid-holland, Netherlands, 3045 PM
Maxima Medisch Centrum
Eindhoven, Netherlands, 5631 BM
St Apotheek der Haarlemse Ziekenhuizen
Haarlem, Netherlands, 2035 RC
Spaarne Gasthuis
Hoofddorp, Netherlands, 2134 TM
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Maxima Medisch Centrum
Veldhoven, Netherlands, 5504 DB
Maxima Medisch Centrum
Veldhoven, Netherlands, 5504 DL
New Zealand
Auckland City Hospital
Grafton, Auckland, New Zealand, 1023
Tauranga Hospital, Bay of Plenty Clinical Trials Unit
Tauranga, BAY OF Plenty, New Zealand, 3143
Palmerston North Hospital
Palmerston North, Manawatu-wanganui, New Zealand, 4414
Tauranga Hospital
Tauranga Bay Of Plenty, Tauranga, New Zealand, 3112
Auckland City Hospital Pharmacy
Auckland, New Zealand, 1023
Baxter Healthcare New Zealand
Auckland, New Zealand, 1060
Christchurch Hospital
Christchurch, New Zealand, 8140
Waikato Hospital Pharmacy Services
Hamilton, New Zealand, 3240
Waikato Hospital
Hamilton, New Zealand, 3240
Broadway Radiology
Palmerston North, New Zealand, 4410
Romania
"Prof. Dr. Ion Chiricuta" Oncology Institute
Cluj-Napoca, Romania, 400015
S.C. Medisprof S.R.L.
Cluj-Napoca, Romania, 400058
"Sfantul Nectarie" Oncology Center
Craiova, Romania, 200347
Oncomed SRL
Timisoara, Romania, 300239
Russian Federation
FSBI "National Medical Radiology Research Center" of MoH of RF
Obninsk, Kaluga Region, Russian Federation, 249036
RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address)
Kursk, Kursk Region, Russian Federation, 305035
RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR
Kursk, Kursk Region, Russian Federation, 305524
FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF
Saint-Petersburg, Poselok Pesochniy, Russian Federation, 197758
Private medical institution "Euromedservice"
Pushkin, Saint-petersburg, Russian Federation, 196603
Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen
Moscow, Russian Federation, 125284
FBIH "Privolzhskiy Regional Medical Center" of FMBA
Nizhniy Novgorod, Russian Federation, 603001
SBIH of Nizhegorodskaya region "Clinical-Diagnostics center"
Nizhniy Novgorod, Russian Federation, 603006
FBIH "Privolzhskiy Regional Medical Center" of FMBA
Nizhniy Novgorod, Russian Federation, 603032
FBIH "Privolzhskiy Regional Medical Center" of FMBA
Nizhniy Novgorod, Russian Federation, 603109
SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary"
Nizhniy Novgorod, Russian Federation, 603126
NS HI "Road Clinical Hospital of JSC "Russian Railways""
Saint Petersburg, Russian Federation, 195271
SHI YR Regional Clinical Oncology Hospital
Yaroslavl, Russian Federation, 150040
Spain
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Sweden
Sahlgrenska University Hospital, Dept of Oncology
Gothenburg, Sweden, 413 45
United Kingdom
Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Mount Vernon Cancer Centre, East & North Herts NHS Trust
London, Middlesex, United Kingdom, HA6 2RN
Mount Vernon Cancer Centre, Pharmacy
Northwood, Middlesex, United Kingdom, HA6 2RN
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, London, United Kingdom, SM2 5PT
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Addenbrooke's Hospital, Central Pharmacy, Level 1
Cambridge, United Kingdom, CB2 0QQ
Beatson WOSCC
Glasgow, United Kingdom, G12 0YN
Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,
Glasgow, United Kingdom, G120YN
St Bartholomew's Hospital, Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Clinical Trials Pharmacy, The Christie
Manchester, United Kingdom, M20 4BX
Department of Medical Oncology, The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
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
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02684006     History of Changes
Other Study ID Numbers: B9991003
2015-002429-20 ( EudraCT Number )
JAVELIN RENAL 101 ( Other Identifier: Alias Study Number )
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

Keywords provided by Pfizer:
Cancer
renal cell cancer
kidney disease
kidney neoplasms
axitinib, sunitinib

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antibodies, Monoclonal
Axitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action