Clinical Trials /

Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies

NCT04518046

Description:

Study 516-008 is an open-label Phase 1 dose escalation/Phase 1b dose expansion study evaluating the safety and tolerability, clinical activity, and PK of sitravatinib in combination with nivolumab and ipilimumab for the treatment of ccRCC and potentially other solid tumor types.

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

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04518046

Trial Eligibility

Document

Title

  • Brief Title: Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies
  • Official Title: A Phase 1/1b Study of Sitravatinib in Combination With Nivolumab and Ipilimumab in Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies

Clinical Trial IDs

  • ORG STUDY ID: 516-008
  • NCT ID: NCT04518046

Conditions

  • Clear-Cell Renal Cell Carcinoma

Interventions

DrugSynonymsArms
SitravatinibMGCD516Phase 1: Dose Escalation
NivolumabOPDIVOPhase 1: Dose Escalation
IpilimumabYERVOYPhase 1: Dose Escalation

Purpose

Study 516-008 is an open-label Phase 1 dose escalation/Phase 1b dose expansion study evaluating the safety and tolerability, clinical activity, and PK of sitravatinib in combination with nivolumab and ipilimumab for the treatment of ccRCC and potentially other solid tumor types.

Detailed Description

      Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits
      several closely related RTKs including the TAM family (Tyro3/Axl/MERTK), VEGFR2, KIT, and
      MET.

      NIVO/IPI are monoclonal antibodies (mAbs) that inhibit the immune checkpoint proteins
      programmed death receptor-1 (PD-1) and cytotoxic T- lymphocyte antigen-4 (CTLA-4),
      respectively.

      The current study is designed to evaluate the triple combination of sitravatinib plus
      NIVO/IPI in patients with solid tumor malignancies that have shown favorable responses to
      NIVO/IPI combinations in previous clinical trials. Combining sitravatinib and NIVO/IPI is
      predicted to have complementary effects in triggering a tumor-directed immune response.

Trial Arms

NameTypeDescriptionInterventions
Phase 1: Dose EscalationExperimentalPatients with poor- or intermediate-risk RCC with clear cell component for first-line treatment.
  • Sitravatinib
  • Nivolumab
  • Ipilimumab
Phase 1b Dose Escalation Cohort AExperimentalPatients with poor- or intermediate-risk RCC with clear cell component for first-line treatment
  • Sitravatinib
  • Nivolumab
  • Ipilimumab
Phase 1b Dose Escalation Cohort BExperimentalPatients with favorable-risk RCC with clear cell component for first-line treatment.
  • Sitravatinib
  • Nivolumab
  • Ipilimumab

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of Clear-Cell Renal Cell Carcinoma (for initial cohorts under
             consideration)

          -  No prior treatment with systemic therapy (for initial cohorts under consideration)

          -  Adequate bone marrow and organ function

        Exclusion Criteria:

          -  Known or suspected presence of other cancer

          -  Brain metastases (for initial cohorts under consideration)

          -  Carcinomatous meningitis

          -  Immunocompromising conditions

          -  Impaired heart function

          -  Active or prior documented autoimmune disease
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Frequency of patients experiencing treatment-emergent AEs
Time Frame:Through study completion, an average of 12 months
Safety Issue:
Description:Characterization of AEs by incidence, severity, timing, seriousness & relationship to study treatment

Secondary Outcome Measures

Measure:Objective Response Rate (ORR) in accordance with RECIST v1.1
Time Frame:Through duration of study, average of 10 months
Safety Issue:
Description:Frequency of patients experiencing an objective response
Measure:Duration of Response (DOR)
Time Frame:Through duration of study, average of 10 months
Safety Issue:
Description:Time in months from date of the first documentation of objective tumor response (CR or PR) to the first documentation of objective PD or to death due to any cause in the absence of documented PD
Measure:Progression-free Survival (PFS)
Time Frame:Through duration of study, average of 10 months
Safety Issue:
Description:Time from date of first study treatment to first PD or death due to any cause in the absence of documented PD

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Mirati Therapeutics Inc.

Last Updated

December 22, 2020