The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Incidence of adverse events (AEs) by severity (Part 1)
Time frame: Up to 2.5 years
Incidence of serious adverse events (SAEs) (Part 1)
Time frame: Up to 2.5 years
Incidence of dose-limiting toxicities (DLTs) (Part 1)
Time frame: Up to 2.5 years
Incidence of AEs leading to discontinuation (Part 1)
Time frame: Up to 5 years
Incidence of immune-mediated adverse events (imAEs) (Part 1)
Time frame: Up to 5 years
Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)
Time frame: Up to 2.5 years
Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)
Time frame: Up to 2.5 years
Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)
Time frame: Up to 2.5 years
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Springdale, Arkansas, United States
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Louisville, Kentucky, United States
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St Louis, Missouri, United States
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New York, New York, United States
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Portland, Oregon, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Mar del Plata, Buenos Aires, Argentina
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Río Cuarto, Córdoba Province, Argentina
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