Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies
NCT04518046 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2024-06-05
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.
Conditions
- Clear-Cell Renal Cell Carcinoma
Interventions
- DRUG
-
Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
- DRUG
-
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
- DRUG
-
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Sponsors & Collaborators
-
Mirati Therapeutics Inc.
lead INDUSTRY
Principal Investigators
-
Curtis Chin, MD · Mirati Therapeutics Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-11
- Primary Completion
- 2023-06-30
- Completion
- 2023-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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