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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04540705
Other study ID # CA045-011
Secondary ID 2018-003200-3918
Status Completed
Phase Phase 1
First received
Last updated
Start date September 11, 2020
Est. completion date January 18, 2024

Study information

Verified date February 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 18, 2024
Est. primary completion date January 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
Nivolumab
Specified dose on specified days
Drug:
Axitinib
Specified dose on specified days
Cabozantinib
Specified dose on specified days

Locations

Country Name City State
Argentina Local Institution - 0026 Buenos Aires
Argentina Local Institution - 0025 Mar del Plata Buenos Aires
Argentina Local Institution - 0075 Río Cuarto Córdoba
Argentina Local Institution - 0024 San Juan
Brazil Local Institution - 0032 Barretos SAO Paulo
Brazil Local Institution - 0030 Belo Horizonte Minas Gerais
Brazil Local Institution - 0035 Curitiba Parana
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 - 0029 Sao Jose do Rio Preto SAO Paulo
Canada Local Institution - 0056 Edmonton Alberta
Canada Local Institution - 0022 St. Johns Newfoundland and Labrador
Canada Local Institution - 0008 Toronto Ontario
Canada Local Institution - 0015 Vancouver British Columbia
France Local Institution - 0079 Marseille
Germany Local Institution - 0042 Essen
Germany Local Institution - 0045 Hannover
Germany Local Institution - 0040 Jena
Germany Local Institution - 0044 Munich
Germany Local Institution - 0041 Nürnberg
Germany Local Institution - 0046 Würzburg
Mexico Local Institution - 0048 Mexico City Distrito Federal
Mexico Local Institution - 0049 Monterrey Nuevo LEON
Mexico Local Institution - 0055 Queretaro
Mexico Local Institution - 0050 Zapopan Jalisco
Russian Federation Local Institution - 0052 Moscow
Russian Federation Local Institution - 0059 Moscow
Russian Federation Local Institution - 0087 Moscow
Russian Federation Local Institution - 0051 Novosibirsk
Russian Federation Local Institution - 0085 Omsk
Russian Federation Local Institution - 0058 Saint Petersburg
United States Local Institution - 0014 Houston Texas
United States Local Institution Louisville Kentucky
United States Local Institution Nashville Tennessee
United States Local Institution - 0009 New York New York
United States Local Institution Portland Oregon
United States Local Institution - 0001 Saint Louis Missouri
United States Local Institution - 0007 Seattle Washington
United States Local Institution - 0005 Springdale Arkansas

Sponsors (2)

Lead Sponsor Collaborator
Bristol-Myers Squibb Nektar Therapeutics

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  France,  Germany,  Mexico,  Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) by severity (Part 1) Up to 2.5 years
Primary Incidence of serious adverse events (SAEs) (Part 1) Up to 2.5 years
Primary Incidence of dose-limiting toxicities (DLTs) (Part 1) Up to 2.5 years
Primary Incidence of AEs leading to discontinuation (Part 1) Up to 5 years
Primary Incidence of immune-mediated adverse events (imAEs) (Part 1) Up to 5 years
Primary Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1) Up to 2.5 years
Primary Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1) Up to 2.5 years
Primary Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1) Up to 2.5 years
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