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 (PIVOT IO 011)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Renal Cell Carcinoma

Treatments: Drug: Cabozantinib; Drug: Axitinib; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04540705

18-214-15 (Other Identifier)

2018-003200-39 (EudraCT Number)

CA045-011

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Part 1A (Part 1): Nivolumab + Axitinib

Experimental group

Treatment:

Drug: Axitinib

Biological: Nivolumab

Part 1B (Part 1): Nivolumab + Cabozantinib

Experimental group

Treatment:

Biological: Nivolumab

Drug: Cabozantinib