- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04540705
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)
A Phase 1 Study to Compare Bempegaldesleukin Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, 1419
- Local Institution - 0026
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San Juan, Argentina, 5400
- Local Institution - 0024
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Buenos Aires
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Mar del Plata, Buenos Aires, Argentina, 7600
- Local Institution - 0025
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Córdoba
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Río Cuarto, Córdoba, Argentina, X5800ALB
- Local Institution - 0075
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30130-090
- Local Institution - 0030
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Parana
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Curitiba, Parana, Brazil, 80730-150
- Local Institution - 0035
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RIO Grande DO SUL
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Porto Alegre, RIO Grande DO SUL, Brazil, 91350-200
- Local Institution - 0028
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Santa Cruz do Sul, RIO Grande DO SUL, Brazil, 96830-180
- Local Institution - 0036
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SAO Paulo
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Barretos, SAO Paulo, Brazil, 14784400
- Local Institution - 0032
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Sao Jose do Rio Preto, SAO Paulo, Brazil, 15090-000
- Local Institution - 0029
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Local Institution - 0056
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- Local Institution - 0015
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Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Local Institution - 0022
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Ontario
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Toronto, Ontario, Canada, M5G 1Z5
- Local Institution - 0008
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Marseille, France, 13273
- Local Institution - 0079
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Essen, Germany, 45147
- Local Institution - 0042
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Hannover, Germany, 30625
- Local Institution - 0045
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Jena, Germany, 07747
- Local Institution - 0040
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Munich, Germany, 81675
- Local Institution - 0044
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Nürnberg, Germany, 90419
- Local Institution - 0041
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Würzburg, Germany, 97080
- Local Institution - 0046
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Queretaro, Mexico, 76000
- Local Institution - 0055
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Distrito Federal
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Mexico City, Distrito Federal, Mexico, 14080
- Local Institution - 0048
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Jalisco
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Zapopan, Jalisco, Mexico, 45070
- Local Institution - 0050
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Nuevo LEON
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Monterrey, Nuevo LEON, Mexico, 66460
- Local Institution - 0049
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Moscow, Russian Federation, 115478
- Local Institution - 0059
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Moscow, Russian Federation, 121205
- Local Institution - 0052
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Moscow, Russian Federation, 121359
- Local Institution - 0087
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Novosibirsk, Russian Federation, 630099
- Local Institution - 0051
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Omsk, Russian Federation, 644013
- Local Institution - 0085
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Saint Petersburg, Russian Federation, 197758
- Local Institution - 0058
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Arkansas
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Springdale, Arkansas, United States, 72762
- Local Institution - 0005
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Kentucky
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Louisville, Kentucky, United States, 40202
- Local Institution
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Missouri
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Saint Louis, Missouri, United States, 63110
- Local Institution - 0001
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New York
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New York, New York, United States, 10065
- Local Institution - 0009
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Oregon
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Portland, Oregon, United States, 97213
- Local Institution
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Tennessee
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Nashville, Tennessee, United States, 37232
- Local Institution
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Texas
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Houston, Texas, United States, 77030-3721
- Local Institution - 0014
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Washington
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Seattle, Washington, United States, 98109
- Local Institution - 0007
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Part 1A (Part 1): Nivolumab + Axitinib
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Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
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Experimental: Part 1B (Part 1): Nivolumab + Cabozantinib
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Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of adverse events (AEs) by severity (Part 1)
Time Frame: Up to 2.5 years
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Up to 2.5 years
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Incidence of serious adverse events (SAEs) (Part 1)
Time Frame: Up to 2.5 years
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Up to 2.5 years
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Incidence of dose-limiting toxicities (DLTs) (Part 1)
Time Frame: Up to 2.5 years
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Up to 2.5 years
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Incidence of AEs leading to discontinuation (Part 1)
Time Frame: Up to 5 years
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Up to 5 years
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Incidence of immune-mediated adverse events (imAEs) (Part 1)
Time Frame: Up to 5 years
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Up to 5 years
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Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)
Time Frame: Up to 2.5 years
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Up to 2.5 years
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Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)
Time Frame: Up to 2.5 years
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Up to 2.5 years
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Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)
Time Frame: Up to 2.5 years
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Up to 2.5 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Protein Kinase Inhibitors
- Immune Checkpoint Inhibitors
- Nivolumab
- Axitinib
Other Study ID Numbers
- CA045-011
- 2018-003200-39 (EudraCT Number)
- 18-214-15 (Other Identifier: Nektar Therapeutics)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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