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



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:March 23, 2016
End Date:June 26, 2021

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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


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)
We found this trial at
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Billings, Montana 59102
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Albany, New York 12206
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Allentown, Pennsylvania 18104
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Allentown, Pennsylvania 18104
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Atlanta, Georgia 30322
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Aurora, Colorado 80012
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13001 E. 17th Pl.
Aurora, Colorado 80045
303-724-5000
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Baltimore, Maryland 21231
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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Bethlehem, Pennsylvania 18015
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Bethlehem, Pennsylvania 18015
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Beverly Hills, California 90211
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Billings, Montana 59101
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Boston, Massachusetts 02114
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Boston, Massachusetts 02215
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Brandywine, Maryland 20613
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Brunswick, Maine 04011
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Chester, Maryland 21619
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Cleveland, Ohio 44195
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Clifton Park, New York 12065
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Colorado Springs, Colorado 80907
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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Daphne, Alabama 36526
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Duarte, California 91010
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
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Easton, Pennsylvania 18045
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Fort Worth, Texas 76177
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Greenfield, Massachusetts 01301
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Houston, Texas 77024
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
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Kennebunk, Maine 04043
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Kernersville, North Carolina 27284
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Lexington, North Carolina 27295
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Los Angeles, California 90048
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Los Angeles, California 90089
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Macquarie University, New South Wales 2113
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Metairie, Louisiana 70006
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Mobile, Alabama 36608
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Mount Airy, North Carolina 27030
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Nashville, Tennessee 37232
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New York, New York 10016
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New York, New York 10016
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New York, New York 10017
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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353 East 68th Street
New York, New York 10065
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North Wilkesboro, North Carolina 28659
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Puyallup, Washington 98373
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Quakertown, Pennsylvania 18951
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Rochester, Minnesota 55905
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Saint Louis, Missouri 63110
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Scarborough, Maine 04074
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Stony Brook, New York 11794
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Tacoma, Washington 98405
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
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Winston-Salem, North Carolina 27103
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Winston-Salem, North Carolina 27103
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York, Pennsylvania 17403
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