Saint Louis, Missouri 63110


Purpose:

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


Study summary:

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.


Criteria:

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


NCT ID:

NCT03606174


Primary Contact:

Study Director
Isan Chen, MD
Mirati Therapeutics Inc.

Mirati Therapeutics Study Locator Services
Phone: 1-844-893-5530 (toll free)
Email: miratistudylocator@emergingmed.com


Backup Contact:

N/A


Location Contact:

Saint Louis, Missouri 63110
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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