Status:
COMPLETED
Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies
Lead Sponsor:
Mirati Therapeutics Inc.
Conditions:
Clear-Cell Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04518046
Start Date
August 11 2020
End Date
June 30 2023
Last Update
June 5 2024
Active Locations (1)
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1
MD Anderson
Houston, Texas, United States, 77030