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

• Status: Recruiting
• Trial end date: 2026-01-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to first, in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination and then, in Part 2, to evaluate the effectiveness of nivolumab, bempegaldesleukin, and cabozantinib when compared with nivolumab and cabozantinib in participants with previously untreated kidney cancer that has advanced or has spread.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Nektar Therapeutics
• Treatments: Axitinib; Nivolumab

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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)

NOTE: Other protocol defined inclusion/exclusion criteria apply