A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA
3 other identifiers
interventional
886
20 countries
246
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2016
Longer than P75 for phase_3
246 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2016
CompletedFirst Posted
Study publicly available on registry
February 17, 2016
CompletedStudy Start
First participant enrolled
March 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2024
CompletedResults Posted
Study results publicly available
October 29, 2024
CompletedJuly 30, 2025
July 1, 2025
7.4 years
January 25, 2016
August 27, 2024
July 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants
PFS: time from the date of randomization to the date of the first documentation of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumours (RECIST version \[v\] 1.1) or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20 percent (%), increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute more than (\>) of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression.
From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
Overall Survival (OS) in PD-L1 Positive Participants
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)
Secondary Outcomes (32)
PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression
From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
OS in Participants Irrespective of PD-L1 Expression
From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)
Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression
From date of randomization until PD (maximum up to approximately 26 months)
Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression
From date of randomization until PD (maximum up to approximately 89 months)
Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression
From date of randomization until PD (maximum up to approximately 26 months)
- +27 more secondary outcomes
Study Arms (2)
Avelumab in combination with axitinib
EXPERIMENTALAvelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID.
Sunitinib
ACTIVE COMPARATORSunitinib given at 50 mg PO QD on schedule 4/2
Interventions
IV treatment Avelumab administered at 10 mg/kg IV every two weeks
Oral treatment Axitinib given 5 mg PO BID
Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed advanced or metastatic RCC with clear cell component
- Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of randomization AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, 15 unstained slides (10 minimum) will be acceptable
- Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be provided as per documented regulations 15 unstained slides (10 minimum) will be acceptable
- At least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow function, renal and liver functions
You may not qualify if:
- Prior systemic therapy directed at advanced or metastatic RCC
- Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment.
- Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
- Prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors
- Newly diagnosed or active brain metastasis
- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011)
- Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack
- Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism
- Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (270)
Southern Cancer Center
Daphne, Alabama, 36526, United States
Southern Cancer Center
Mobile, Alabama, 36607, United States
Southern Cancer Center
Mobile, Alabama, 36608, United States
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
City of Hope
Duarte, California, 91010, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC IDS Pharmacy
Los Angeles, California, 90033, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars-Sinai Advanced Health Sciences Pavilion
Los Angeles, California, 90048, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048, United States
Cedars-Sinai
Los Angeles, California, 90048, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
University of Colorado Cancer Center Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Clinical Trials Office (CTO)
Aurora, Colorado, 80045, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80907, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Investigational Drug Service- Emory University
Atlanta, Georgia, 30322, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
East Jefferson Hematology-Oncology Metairie Physician Service Inc.
Metairie, Louisiana, 70006, United States
New England Cancer Specialists
Kennebunk, Maine, 04043, United States
New England Cancer Specialists
Scarborough, Maine, 04074, United States
New England Cancer Specialists
Topsham, Maine, 04086, United States
Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, 21231, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114, United States
Massachusetts General Hospital Clinical Trials Pharmacy
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215, United States
Beth Israel Deaconess Medical Center Pharmacy - BIDMC
Boston, Massachusetts, 02215, United States
Dana - Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Baystate Franklin Medical Center
Greenfield, Massachusetts, 01301, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, 63376, United States
Barnes-Jewish Hospital, Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141, United States
Barnes-Jewish Hospital, Siteman Cancer Center
St Louis, Missouri, 63110, United States
Washington University Infusion Center Pharmacy
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Barnes-Jewish Hospital, Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
St. Vincent Healthcare
Billings, Montana, 59101, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, Montana, 59102, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 75063, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
New York Oncology Hematology, PC
Albany, New York, 12208, United States
New York Oncology Hematology, P.C.
Clifton Park, New York, 12065, United States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, 11101, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
NYU Investigational Pharmacy
New York, New York, 10016, United States
NYU Langone Medical Center
New York, New York, 10016, United States
MSKCC-Monitoring Suite
New York, New York, 10017, United States
Evelyn H. Lauder Breast and Imaging Center
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Sidney Kimmel Center for Prostate and Urologic Cancers
New York, New York, 10065, United States
Stony Brook University-Cancer Center
Stony Brook, New York, 11794, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210, United States
The Ohio State University - GU Clinic
Columbus, Ohio, 43210, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Cancer Care Associates Medical Oncology
Allentown, Pennsylvania, 18104, United States
St.Luke's Hospital-Allentown Campus
Allentown, Pennsylvania, 18104, United States
Cancer Care Associate Medical Oncology
Bethlehem, Pennsylvania, 18015, United States
St. Lukes University Health Network
Bethlehem, Pennsylvania, 18015, United States
St.Luke's Cancer Center Anderson
Easton, Pennsylvania, 18045, United States
St.Luke's Hospital-Anderson Campus
Easton, Pennsylvania, 18045, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Investigational Drug Service, University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
St.Luke's Quakertown Hospital
Quakertown, Pennsylvania, 18951, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology - Gulf Coast
Houston, Texas, 77024, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Investigational Product Center (IPC)
Irving, Texas, 75063, United States
Investigational Products Center (IPC)
Irving, Texas, 75063, United States
Investigational Products Center (lPC)
Irving, Texas, 75063, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
Rainier Hematology-Oncology, PC
Puyallup, Washington, 98373, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
Macquarie University Hospital Pharmacy
Macquarie University, New South Wales, 2109, Australia
Macquarie University
Macquarie University, New South Wales, 2109, Australia
Nuclear Medicine Department
Randwick, New South Wales, 2031, Australia
Pharmacy Department, Clinical Trials
Randwick, New South Wales, 2031, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Spectrum Medical Imaging
Randwick, New South Wales, 2031, Australia
Division of Cancer Services
Woolloongabba, Queensland, 4102, Australia
BHS Diagnostic Services
Ballarat, Victoria, 3350, Australia
Lake Imaging
Ballarat, Victoria, 3350, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Eastern Health
Box Hill, Victoria, 3128, Australia
Monash Health Translational Precinct, Monash Medical Centre
Clayton, Victoria, 3168, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Monash Cancer Centre
East Bentleigh, Victoria, 3165, Australia
Moorabbin Radiology
East Bentleigh, Victoria, 3165, Australia
Slade Health
Mount Waverley, Victoria, 3149, Australia
Ballarat Day Procedure Centre
Wendouree, Victoria, 3355, Australia
Ballarat Oncology & Haematology Services
Wendouree, Victoria, 3355, Australia
Nova Pharmacy
Wendouree, Victoria, 3355, Australia
SKG Radiology
Murdoch, Western Australia, 6050, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
SKG Radiology
Murdoch, Western Australia, 6150, Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, 6150, Australia
EPIC Pharmacy Murdoch
Perth, Western Australia, 6150, Australia
Krankenhaus der Barmherzigen Schwestern Wien
Vienna, 1060, Austria
Medizinische Universitaet Wien
Vienna, 1090, Austria
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
UZ Gent
Ghent, 9000, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
CHU de Liège
Liège, 4000, Belgium
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
BC Cancer GU Clinic - Fairmont Medical Building
Vancouver, British Columbia, V5Z IH7, Canada
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Herlev Hospital, Onkologisk Afdeling R
Herlev, 2730, Denmark
Odense Universitetshospital
Odense C, 5000, Denmark
Centre Eugene Marquis Service Pharmacie - Essais Cliniques
Rennes, Cedex, 35042, France
Centre Francois Baclesse
Caen, 14076, France
Centre de Cancérologie de la Sarthe (CCS) - Clinique Victor Hugo
Le Mans, 72000, France
Clinique Victor Hugo Centre de Cancerologie de la Sarthe
Le Mans, 72000, France
Centre LĂ©on BĂ©rard
Lyon, 69008, France
Centre LĂ©on BĂ©rard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13009, France
Centre Eugene Marquis
Rennes, 35042, France
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
Saint-Herblain, 44805, France
Institut de Cancerologie de Lorraine (ICL)
VandÅ“uvre-lès-Nancy, 54519, France
Institut de Cancerologie de Lorraine
VandÅ“uvre-lès-Nancy, 54519, France
Institut Gustave Roussy
Villejuif, 94805, France
Universitaetsklinikum Tuebingen
TĂ¼bingen, Baden-Wurttemberg, 072076, Germany
Universitaetsklinikum Tuebingen
TĂ¼bingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Jena
Jena, Thuringia, 07743, Germany
Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie
Jena, Thuringia, 07747, Germany
Universitaetsklinikum Jena
Jena, Thuringia, 07747, Germany
DĂ©l.pesti CentrumkĂ³rhĂ¡z-OHII Szent LĂ¡lszlĂ³ KĂ³rhĂ¡z telephely
Budapest, 1097, Hungary
OrszĂ¡gos OnkolĂ³giai IntĂ©zet
Budapest, 1122, Hungary
The Chaim Sheba Medical Center
Tel Litwinsky, Ramat - GAN, 5265601, Israel
Assaf Harofe MC
Beer Yaakov, 70300, Israel
Shamir Medical Center
Beer Yaakov, 70300, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Rambam Healthcare Campus
Haifa, 31096, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Centro di Riferimento Oncologico - IRCCS
Aviano, (PN), 33081, Italy
Farmacia Studi Clinici
Rozzano, Milan, 20089, Italy
Istituto Clinico Humanitas
Rozzano, Milan, 20089, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
SC Farmacia
Milan, 20133, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Servizio di Farmacia
Milan, 20141, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, 00152, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Hirosaki University School of Medicine & Hospital
Hirosaki, Aomori, 036-8563, Japan
Hokkaido University Hospital
Sapporo, HokkaidĂ´, 060-8648, Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate, 028-3695, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
Kindai University Hospital
Sayama, Osaka, 589-8511, Japan
Osaka University Hospital
Suita, Osaka, 565-0871, Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666, Japan
Akita University Hospital
Akita, 010-8543, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Instituto Nacional de Cancerologia
Mexico City, Mexico City, 14080, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer
Monterrey, Nuevo LeĂ³n, 64460, Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, 68000, Mexico
Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital
Amsterdam, North Holland, 1066 CX, Netherlands
Netherlands Cancer Institute / Apotheek MC Slotervaart
Amsterdam, North Holland, 1066 EC, Netherlands
VU University Medical Center (VUmc)
Amsterdam, North Holland, 1081 BT, Netherlands
VU University Medical Center (VUmc)
Amsterdam, North Holland, 1081 HZ, Netherlands
Sint Franciscus Gasthuis, Pharmacy
Rotterdam, South Holland, 3045 PM, Netherlands
Sint Franciscus Gasthuis
Rotterdam, South Holland, 3045 PM, Netherlands
Maxima Medisch Centrum
Eindhoven, 5631 BM, Netherlands
St Apotheek der Haarlemse Ziekenhuizen
Haarlem, 2035 RC, Netherlands
Spaarne Gasthuis
Hoofddorp, 2134 TM, Netherlands
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
Maxima Medisch Centrum
Veldhoven, 5504 DB, Netherlands
Maxima Medisch Centrum
Veldhoven, 5504 DL, Netherlands
Auckland City Hospital
Grafton, Auckland, 1023, New Zealand
Tauranga Hospital, Bay of Plenty Clinical Trials Unit
Tauranga, Bay of Plenty, 3143, New Zealand
Palmerston North Hospital
Palmerston North, Manawatu-Wanganui, 4414, New Zealand
Tauranga Hospital
Tauranga Bay of Plenty, Tauranga, 3112, New Zealand
Wairarapa District Health Board
Masterton, Wairarapa, 5840, New Zealand
Auckland City Hospital Pharmacy
Auckland, 1023, New Zealand
Baxter Healthcare New Zealand
Auckland, 1060, New Zealand
Christchurch Hospital
Christchurch, 8140, New Zealand
Waikato Hospital Pharmacy Services
Hamilton, 3240, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Broadway Radiology
Palmerston North, 4410, New Zealand
"Prof. Dr. Ion Chiricuta" Oncology Institute
Cluj-Napoca, 400015, Romania
S.C. Medisprof S.R.L.
Cluj-Napoca, 400641, Romania
"Sfantul Nectarie" Oncology Center
Craiova, 200347, Romania
Oncomed SRL
Timișoara, 300239, Romania
RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address)
Kursk, Kursk Oblast, 305035, Russia
RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR
Kursk, Kursk Oblast, 305524, Russia
Russian Research Center for Radiology and Surgical Technologies
Saint Petersburg, Pesochny, 197758, Russia
FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF
Saint Petersburg, Poselok Pesochniy, 197758, Russia
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, 196603, Russia
Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal
Moscow, 105425, Russia
Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen
Moscow, 125284, Russia
FBIH "Privolzhskiy Regional Medical Center" of FMBA
Nizhny Novgorod, 603001, Russia
SBIH of Nizhegorodskaya region "Clinical-Diagnostics center"
Nizhny Novgorod, 603006, Russia
FBIH "Privolzhskiy Regional Medical Center" of FMBA
Nizhny Novgorod, 603032, Russia
FBIH "Privolzhskiy Regional Medical Center" of FMBA
Nizhny Novgorod, 603109, Russia
SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary"
Nizhny Novgorod, 603126, Russia
Clinical Hospital #122 n.a. L. G. Sokolov
Saint Petersburg, 194291, Russia
NS HI "Road Clinical Hospital of JSC "Russian Railways""
Saint Petersburg, 195271, Russia
LLC "Diagnostic center "Energo"
Saint Petersburg, 196247, Russia
LLC "Clinical Diagnostic Center "Medex-pert"
Yaroslavl, 150014, Russia
SHI YR Regional Clinical Oncology Hospital
Yaroslavl, 150040, Russia
Clinical Trial Pharmacy, National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital, Clinical Pharmacy
Seongnam-si, Gyeonggido, 13620, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13620, South Korea
Kyungpook National University Medical Center, Clinical Pharmacy
Daegu, 41404, South Korea
Kyungpook National University Medical Center
Daegu, 41404, South Korea
Chungnam National University Hospital, Clinical Pharmacy
Daejeon, 35015, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Seoul National University Hospital, Clinical Pharmacy
Seoul, 03080, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Clinical Trial Pharmacy
Seoul, 05505, South Korea
Samsung Medical Center Clinical Trial Pharmacy
Seoul, 06351, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Sahlgrenska University Hospital, Dept of Oncology
Gothenburg, 413 45, Sweden
Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Mount Vernon Cancer Centre, East & North Herts NHS Trust
London, Middlesex, HA6 2RN, United Kingdom
Mount Vernon Cancer Centre, Pharmacy
London, Middlesex, HA6 2RN, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, London, SM2 5PT, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
Addenbrooke's Hospital, Central Pharmacy, Level 1
Cambridge, CB2 0QQ, United Kingdom
Beatson WOSCC
Glasgow, G12 0YN, United Kingdom
Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,
Glasgow, G120YN, United Kingdom
St Bartholomew's Hospital, Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
Clinical Trials Pharmacy, The Christie
Manchester, M20 4BX, United Kingdom
Department of Medical Oncology, The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus
Nottingham, NG5 1PB, United Kingdom
Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy
Nottingham, NG5 1PB, United Kingdom
Related Publications (12)
Tucker M, Chen YW, Voss MH, McGregor BA, Bilen MA, Grimm MO, Nathan P, Kollmannsberger C, Tomita Y, Huang B, Amezquita R, Mariani M, di Pietro A, Rini B. Association between neutrophil-to-eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma: post hoc analyses from the JAVELIN Renal 101 trial. BMJ Oncol. 2024 Jun 12;3(1):e000181. doi: 10.1136/bmjonc-2023-000181. eCollection 2024.
PMID: 39886142DERIVEDGrimm MO, Oya M, Choueiri TK, Motzer RJ, Schmidinger M, Quinn DI, Gravis-Mescam G, Verzoni E, Van den Eertwegh AJM, di Pietro A, Mariani M, Wang J, Thomaidou D, Albiges L. Impact of Prior Cytoreductive Nephrectomy on Efficacy in Patients with Synchronous Metastatic Renal Cell Carcinoma Treated with Avelumab plus Axitinib or Sunitinib: Post Hoc Analysis from the JAVELIN Renal 101 Phase 3 Trial. Eur Urol. 2024 Jan;85(1):8-12. doi: 10.1016/j.eururo.2023.09.016. Epub 2023 Oct 16.
PMID: 37852850DERIVEDRini BI, Atkins MB, Choueiri TK, Teresi RE, Rosbrook B, Thakur M, Hutson TE. Plain language summary looking at how long side effects last after treatment with axitinib is stopped in people with advanced renal cell carcinoma. Future Oncol. 2023 Dec;19(40):2623-2629. doi: 10.2217/fon-2023-0233. Epub 2023 Aug 1.
PMID: 37526095DERIVEDAldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
PMID: 37146227DERIVEDHaanen JBAG, Larkin J, Choueiri TK, Albiges L, Rini BI, Atkins MB, Schmidinger M, Penkov K, Michelon E, Wang J, Mariani M, di Pietro A, Motzer RJ. Extended follow-up from JAVELIN Renal 101: subgroup analysis of avelumab plus axitinib versus sunitinib by the International Metastatic Renal Cell Carcinoma Database Consortium risk group in patients with advanced renal cell carcinoma. ESMO Open. 2023 Jun;8(3):101210. doi: 10.1016/j.esmoop.2023.101210. Epub 2023 Apr 25.
PMID: 37104931DERIVEDRini BI, Moslehi JJ, Bonaca M, Schmidinger M, Albiges L, Choueiri TK, Motzer RJ, Atkins MB, Haanen J, Mariani M, Wang J, Hariharan S, Larkin J. Prospective Cardiovascular Surveillance of Immune Checkpoint Inhibitor-Based Combination Therapy in Patients With Advanced Renal Cell Cancer: Data From the Phase III JAVELIN Renal 101 Trial. J Clin Oncol. 2022 Jun 10;40(17):1929-1938. doi: 10.1200/JCO.21.01806. Epub 2022 Mar 3.
PMID: 35239416DERIVEDMasters JC, Khandelwal A, di Pietro A, Dai H, Brar S. Model-informed drug development supporting the approval of the avelumab flat-dose regimen in patients with advanced renal cell carcinoma. CPT Pharmacometrics Syst Pharmacol. 2022 Apr;11(4):458-468. doi: 10.1002/psp4.12771. Epub 2022 Feb 27.
PMID: 35166465DERIVEDRini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5.
PMID: 33947608DERIVEDChoueiri TK, Larkin J, Pal S, Motzer RJ, Rini BI, Venugopal B, Alekseev B, Miyake H, Gravis G, Bilen MA, Hariharan S, Chudnovsky A, Ching KA, Mu XJ, Mariani M, Robbins PB, Huang B, di Pietro A, Albiges L. Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial. ESMO Open. 2021 Jun;6(3):100101. doi: 10.1016/j.esmoop.2021.100101. Epub 2021 Apr 23.
PMID: 33901870DERIVEDMotzer RJ, Robbins PB, Powles T, Albiges L, Haanen JB, Larkin J, Mu XJ, Ching KA, Uemura M, Pal SK, Alekseev B, Gravis G, Campbell MT, Penkov K, Lee JL, Hariharan S, Wang X, Zhang W, Wang J, Chudnovsky A, di Pietro A, Donahue AC, Choueiri TK. Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN Renal 101 trial. Nat Med. 2020 Nov;26(11):1733-1741. doi: 10.1038/s41591-020-1044-8. Epub 2020 Sep 7.
PMID: 32895571DERIVEDChoueiri TK, Motzer RJ, Rini BI, Haanen J, Campbell MT, Venugopal B, Kollmannsberger C, Gravis-Mescam G, Uemura M, Lee JL, Grimm MO, Gurney H, Schmidinger M, Larkin J, Atkins MB, Pal SK, Wang J, Mariani M, Krishnaswami S, Cislo P, Chudnovsky A, Fowst C, Huang B, di Pietro A, Albiges L. Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. Ann Oncol. 2020 Aug;31(8):1030-1039. doi: 10.1016/j.annonc.2020.04.010. Epub 2020 Apr 25.
PMID: 32339648DERIVEDMotzer RJ, Penkov K, Haanen J, Rini B, Albiges L, Campbell MT, Venugopal B, Kollmannsberger C, Negrier S, Uemura M, Lee JL, Vasiliev A, Miller WH Jr, Gurney H, Schmidinger M, Larkin J, Atkins MB, Bedke J, Alekseev B, Wang J, Mariani M, Robbins PB, Chudnovsky A, Fowst C, Hariharan S, Huang B, di Pietro A, Choueiri TK. Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019 Mar 21;380(12):1103-1115. doi: 10.1056/NEJMoa1816047. Epub 2019 Feb 16.
PMID: 30779531DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2016
First Posted
February 17, 2016
Study Start
March 23, 2016
Primary Completion
August 31, 2023
Study Completion
June 26, 2024
Last Updated
July 30, 2025
Results First Posted
October 29, 2024
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
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.