For Healthcare Professionals

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

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may also have sarcomatoid features
  2. 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

  1. Life Expectancy ≥ 12 weeks
  2. Karnofsky Performance Status (KPS) of at least 70%
  3. Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria
  4. Males and females must agree to follow specific methods of contraception, if applicable


Exclusion Criteria:

  1. Active CNS brain metastases or leptomeningeal metastases
  2. Active, known or suspected autoimmune disease
  3. Inadequately treated adrenal insufficiency
  4. 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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Renal Cell Carcinoma

Age (in years)



Phase 1

Participants needed


Est. Completion Date

Feb 5, 2024

Treatment type



Bristol-Myers Squibb identifier


Study number


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