A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread
About the study
Who can take part
INCLUSION CRITERIA
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
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/exclusion criteria apply
Study Locations
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How to Apply
Study’s details
Contition
Renal Cell Carcinoma
Age (in years)
18+
Phase
Phase 1
Participants needed
30
Est. Completion Date
Feb 5, 2024
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT04540705
Study number
CA045011
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