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
NCT ID: NCT04540705
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2020-09-11
2024-01-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1A (Part 1): Nivolumab + Axitinib
Nivolumab
Specified dose on specified days
Axitinib
Specified dose on specified days
Part 1B (Part 1): Nivolumab + Cabozantinib
Nivolumab
Specified dose on specified days
Cabozantinib
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Axitinib
Specified dose on specified days
Cabozantinib
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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, 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)
18 Years
ALL
No
Sponsors
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Nektar Therapeutics
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Local Institution - 0040
Jena, , Germany
Local Institution - 0044
Munich, , Germany
Local Institution - 0041
Nuremberg, , Germany
Local Institution - 0046
Würzburg, , Germany
Local Institution - 0050
Zapopan, Jalisco, Mexico
Local Institution - 0048
Mexico City, Mexico City, Mexico
Local Institution - 0049
Monterrey, Nuevo León, Mexico
Local Institution - 0055
Querétaro, , Mexico
Local Institution - 0059
Moscow, , Russia
Local Institution - 0052
Moscow, , Russia
Local Institution - 0087
Moscow, , Russia
Local Institution - 0051
Novosibirsk, , Russia
Local Institution - 0085
Omsk, , Russia
Local Institution - 0058
Saint Petersburg, , Russia
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2018-003200-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18-214-15
Identifier Type: OTHER
Identifier Source: secondary_id
CA045-011
Identifier Type: -
Identifier Source: org_study_id
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