Sitravatinib and Nivolumab in Urothelial Carcinoma Study

  • Interventional
  • Recruiting
  • NCT03606174
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03606174

IRB#IRB18-1239

Lead SponsorMirati Therapeutics Inc.

Lead PhysicianRandy Sweis

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting