Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies
NCT ID: NCT04518046
Last Updated: 2024-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2020-08-11
2023-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1: Dose Escalation
Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment.
Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
Nivolumab
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Ipilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Phase 1b Dose Escalation Cohort A
Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment
Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
Nivolumab
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Ipilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Phase 1b Dose Escalation Cohort B
Patients with favorable-risk RCC with clear cell component for first-line treatment.
Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
Nivolumab
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Ipilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Interventions
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Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
Nivolumab
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Ipilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior treatment with systemic therapy (for initial cohorts under consideration)
* Adequate bone marrow and organ function
Exclusion Criteria
* Brain metastases (for initial cohorts under consideration)
* Carcinomatous meningitis
* Immunocompromising conditions
* Impaired heart function
* Active or prior documented autoimmune disease
18 Years
ALL
No
Sponsors
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Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Curtis Chin, MD
Role: STUDY_DIRECTOR
Mirati Therapeutics Inc.
Locations
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MD Anderson
Houston, Texas, United States
Countries
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References
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Msaouel P, Yu K, Yuan Y, Chen J, Yan X, Karki M, Duan F, Sheth RA, Rao P, Sircar K, Shah AY, Zurita AJ, Genovese G, Li M, Yeh CC, Dang M, Han G, Chu Y, Hallin M, Olson P, Yang R, Slavin D, Der-Torossian H, Chin CD, Tannir NM, Wang L, Gao J. Sitravatinib in combination with nivolumab plus ipilimumab in patients with advanced clear cell renal cell carcinoma: a phase 1 trial. Nat Commun. 2025 Jan 10;16(1):578. doi: 10.1038/s41467-024-55642-8.
Other Identifiers
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516-008
Identifier Type: -
Identifier Source: org_study_id
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