Clinical Trials /

Study of Sitravatinib and Nivolumab in Urothelial Carcinoma

NCT03606174

Description:

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

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Sitravatinib and Nivolumab in Urothelial Carcinoma Study
  • Official Title: A Phase 2 Study of Sitravatinib in Combination With Nivolumab in Patients With Advanced or Metastatic Urothelial Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: 516-003
  • NCT ID: NCT03606174

Conditions

  • Urothelial Carcinoma
  • Urothelial Carcinoma Bladder
  • Urothelial Carcinoma Ureter
  • Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Urothelial Carcinoma Urethra

Interventions

DrugSynonymsArms
SitravatinibMGCD516Sitravatinib and Nivolumab
NivolumabOpdivoSitravatinib and Nivolumab

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.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Sitravatinib and NivolumabExperimentalSitravatinib oral capsule administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks
  • Sitravatinib
  • Nivolumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients experiencing tumor size reduction
Time Frame:up to 3 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of patients experiencing adverse events
Time Frame:up to 12 months
Safety Issue:
Description:
Measure:Blood plasma concentration of the investigational agent
Time Frame:up to 20 weeks
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Mirati Therapeutics Inc.

Trial Keywords

  • MGCD516
  • Antineoplastic Agents
  • Immunologic Factors
  • Nivolumab
  • Tyrosine Kinase Inhibitor
  • VEGFR
  • TAM RTKs
  • PD-1
  • PD-L1

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