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
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- STATUS
- Recruiting
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 Carcinoma, Renal Cell Cancer, Renal Cell Cancer |
|---|---|
| Clinical Study Identifier | TX252463 |
| Last Modified on | 15 September 2020 |
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