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

Korábbi kezelés

• 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

Más betegség

• Active, known or suspected autoimmune disease
• Inadequately treated adrenal insufficiency

Egyéb

• Active CNS brain metastases or leptomeningeal metastases

• 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:
  • 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