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

  • STATUS
    Recruiting
Updated on 15 September 2020
tyrosine
monoclonal antibodies
systemic therapy
carcinoma
VEGFR2
nivolumab
ipilimumab

Summary

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.

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.

Details
Condition Renal Cell Carcinoma, Renal Cell Cancer
Clinical Study IdentifierTX252463
Last Modified on15 September 2020

Eligibility

Yes No Not Sure

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
Clear my responses

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