Clinical Trials /

Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma

NCT03680521

Description:

The study will evaluate the clinical activity of nivolumab in combination with the investigational agent sitravatinib in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the pre-surgical setting.

Related Conditions:
  • Clear Cell Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma
  • Official Title: A Phase 2 Study of Sitravatinib in Combination With Nivolumab in Patients Undergoing Nephrectomy for Locally-Advanced Clear Cell Renal Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: 516-002
  • NCT ID: NCT03680521

Conditions

  • Clear Cell Renal Cell Carcinoma

Interventions

DrugSynonymsArms
SitravatinibSitravatinib and nivolumab
NivolumabSitravatinib and nivolumab

Purpose

The study will evaluate the clinical activity of nivolumab in combination with the investigational agent sitravatinib in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the pre-surgical setting.

Detailed Description

      Sitravatinib is a receptor tyrosine kinase inhibitor (TKI) that targets multiple closely
      related receptor tyrosine kinase pathways including VEGFR, PDGF receptor (PDGFR), c-KIT, MET,
      and the TAM family of receptors (TYRO3, AXL, and MER). Nivolumab is a monoclonal antibody
      directed against PD-1 and blocks the interaction between PD-1 and its ligands, thereby
      releasing PD-1-mediated inhibition of T-cell proliferation (including cytotoxic CD8+ T-cells)
      and cytokine production. Together, sitravatinib and nivolumab may cooperate to elicit greater
      anti-tumor activity than either agent alone, as sitravatinib is predicted to enhance several
      steps in the cancer immunity cycle that may augment the efficacy of nivolumab.
    

Trial Arms

NameTypeDescriptionInterventions
Sitravatinib and nivolumabExperimentalSitravatinib oral capsule administered daily 2 weeks alone then in combination with nivolumab administered as 240 mg IV every 2 weeks. Total treatment duration: 6-8 weeks.
  • Sitravatinib
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          1. Imaging results consistent with locally-advanced RCC

          2. Candidate for partial or complete nephrectomy as part of treatment plan.

          3. Measurable disease as per RECIST version 1.1.

          4. ECOG performance status 0 or 1.

          5. Adequate bone marrow and organ function.

        Exclusion Criteria:

          1. Prior systemic anti-tumor treatment for RCC.

          2. Patients who are receiving any other investigational agents.

          3. Clinical status indicating that immediate surgery (within 6 weeks) is warranted
             regardless of whether neoadjuvant therapy is to be administered, as assessed by the
             treating surgeon.

          4. Inability to undergo baseline tumor biopsy.

          5. Active or prior documented autoimmune or immunocompromising conditions.

          6. Uncontrolled hypertension.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of patients achieving a point in time objective response (either complete or partial response [CR or PR]) prior to surgery.
Time Frame:6-8 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of patients experiencing adverse events (number and percent of patients reporting AEs)
Time Frame:12 weeks
Safety Issue:
Description:

Details

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

Trial Keywords

  • ccRCC
  • MGCD516
  • Antineoplastic Agents
  • Immunologic factors
  • nivolumab
  • Tyrosine Kinase Inhibitor
  • VEGFR
  • TAM RTKs
  • PD-1
  • PD-L1

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