Renal Cell Carcinoma
Conditions
Keywords
NKTR-214, nivolumab, bempeg
Brief summary
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.
Interventions
BIOLOGICALNivolumab
Specified dose on specified days
DRUGAxitinib
Specified dose on specified days
DRUGCabozantinib
Specified dose on specified days
Sponsors
Nektar Therapeutics
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may also have sarcomatoid features * Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer (AJCC) Stage 4) RCC * No prior systemic therapy, including prior PD-L1 therapy, for RCC is allowed with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed. Therapy must have included an agent that targets vascular endothelial growth factor (VEGF) pathway or VEGF receptors and recurrence must have occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy * Life Expectancy ≥ 12 weeks * Karnofsky Performance Status (KPS) of at least 70% * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria * Males and females must agree to follow specific methods of contraception, if applicable
Exclusion criteria
* Active CNS brain metastases or leptomeningeal metastases * Active, known or suspected autoimmune disease * Inadequately treated adrenal insufficiency * History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA/TIA arterial thromboembolic event (eg, internal jugular vein thrombosis) within 3 months prior to treatment assignment (Part 1) and randomization (Part 2) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) by severity (Part 1) | Up to 2.5 years |
| Incidence of serious adverse events (SAEs) (Part 1) | Up to 2.5 years |
| Incidence of dose-limiting toxicities (DLTs) (Part 1) | Up to 2.5 years |
| Incidence of AEs leading to discontinuation (Part 1) | Up to 5 years |
| Incidence of immune-mediated adverse events (imAEs) (Part 1) | Up to 5 years |
| Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1) | Up to 2.5 years |
| Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1) | Up to 2.5 years |
| Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1) | Up to 2.5 years |
Countries
Argentina, Brazil, Canada, France, Germany, Mexico, Russia, United States
Outcome results
None listed