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Recruiting

A Study to Evaluate the Triplet Combination of Bempegaldesleukin (Bempeg/NKTR-214) Plus Nivolumab and Axitinib and the Doublet Combination of Nivolumab and Axitinib in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread - CA045-011

Updated: 3 September, 2020   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 5

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1: Nivolumab + bempeg + axitinib
Biological: Nivolumab Biological: Bempeg Drug: Axitinib
Experimental: Part 2 Arm A: Nivolumab + bempeg + axitinib
Biological: Nivolumab Biological: Bempeg Drug: Axitinib
Experimental: Part 2 Arm B: Nivolumab + axitinib
Drug: Axitinib Biological: Nivolumab

Key Eligibility 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) 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 - Inadequately treated adrenal insufficiency - History of deep vein thrombosis (DVT), pulmonary embolism (PE), or prior clinically significant venous or non-CVA/TIA arterial thromboembolic event (eg, internal jugular vein thrombosis) within the past 3 months prior to treatment assignment (Part 1) and randomization (Part 2) - Active, known or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com