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

Completed · Phase 1

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT04540705

Run by

Bristol-Myers Squibb

People needed

30

Starts

2020-09-11

Expected to finish

2024-01-18

Last updated by the study team

2024-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0005 — Springdale, Arkansas, United States
• Local Institution — Louisville, Kentucky, United States
• Local Institution - 0001 — St Louis, Missouri, United States
• Local Institution - 0009 — New York, New York, United States
• Local Institution — Portland, Oregon, United States
• Local Institution — Nashville, Tennessee, United States
• Local Institution - 0014 — Houston, Texas, United States
• Local Institution - 0007 — Seattle, Washington, United States
• Local Institution - 0025 — Mar del Plata, Buenos Aires, Argentina
• Local Institution - 0075 — Río Cuarto, Córdoba Province, Argentina
• Local Institution - 0026 — Buenos Aires, Argentina
• Local Institution - 0024 — San Juan, Argentina
• Local Institution - 0030 — Belo Horizonte, Minas Gerais, Brazil
• Local Institution - 0035 — Curitiba, Paraná, Brazil
• Local Institution - 0028 — Porto Alegre, Rio Grande do Sul, Brazil
• Local Institution - 0036 — Santa Cruz do Sul, Rio Grande do Sul, Brazil
• Local Institution - 0032 — Barretos, São Paulo, Brazil
• Local Institution - 0029 — São José do Rio Preto, São Paulo, Brazil
• Local Institution - 0056 — Edmonton, Alberta, Canada
• Local Institution - 0015 — Vancouver, British Columbia, Canada
• Local Institution - 0022 — St. John's, Newfoundland and Labrador, Canada
• Local Institution - 0008 — Toronto, Ontario, Canada
• Local Institution - 0079 — Marseille, France
• Local Institution - 0042 — Essen, Germany
• Local Institution - 0045 — Hanover, Germany

Full record on ClinicalTrials.gov

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