Sitravatinib and Nivolumab in Urothelial Carcinoma Study



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:September 11, 2018
End Date:September 30, 2020
Contact:Mirati Therapeutics Study Locator Services
Email:Mirati516003@mirati.com
Phone:1-844-893-5530 (toll free)

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A Phase 2 Study of Sitravatinib in Combination With Nivolumab in Patients With Advanced or Metastatic Urothelial Carcinoma

The study will evaluate the clinical activity of nivolumab in combination with the
investigational agent sitravatinib in patients with advanced or metastatic urothelial
carcinoma.

Sitravatinib is an orally-available, potent small molecule inhibitor of a closely related
spectrum of receptor tyrosine kinases (RTKs) including MET, Axl, MERTK, VEGFR family, PDGFR
family, KIT, FLT3, Trk family, RET, DDR2 and selected Eph family members. Nivolumab is a
human IgG monoclonal antibody that binds to the programmed cell death-1(PD-1) receptor and
blocks its interaction with programmed cell death ligand-1 (PD-L1) and PD-L2, releasing PD-1
pathway-mediated inhibition of the immune response including anti-tumor immune response.
Combining an immunotherapeutic PD-L1 checkpoint inhibitor with an agent that has both immune
modulatory and antitumor properties could enhance the antitumor efficacy observed with either
agent alone. Sitravatinib selectively inhibits key molecular and cellular pathways strongly
implicated in checkpoint inhibitor resistance and therefore represents a rational strategy to
enhance or restore anti-tumor immunity when combined with nivolumab, a checkpoint inhibitor
therapy.

Inclusion Criteria:

- Diagnosis of urothelial carcinoma

- Most recent treatment must have included a checkpoint inhibitor

- Adequate bone marrow and organ function

Exclusion Criteria:

- Uncontrolled tumor in the brain

- Unacceptable toxicity with prior checkpoint inhibitor

- Impaired heart function
We found this trial at
17
sites
Saint Louis, Missouri 63110
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Albany, New York 12206
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Albany, NY
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Aurora, CO
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Austin, Texas 78731
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Austin, TX
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Detroit, Michigan 48201
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Detroit, MI
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Fairfax, Virginia 22031
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Fairfax, VA
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Houston, Texas 77024
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Lake Success, New York 11042
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Lake Success, NY
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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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Las Vegas, NV
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Omaha, NE
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Pittsburgh, Pennsylvania 15212
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Pittsburgh, PA
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Saint Petersburg, Florida 33705
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Saint Petersburg, FL
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Tyler, Texas 75702
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Tyler, TX
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West Palm Beach, Florida 33401
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West Palm Beach, FL
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