Kidney Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT04540705

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 39 Locations for this study

See Locations Near You

Local Institution - 0005
Springdale Arkansas, 72762, United States
Local Institution
Louisville Kentucky, 40202, United States
Local Institution - 0001
Saint Louis Missouri, 63110, United States
Local Institution - 0009
New York New York, 10065, United States
Local Institution
Portland Oregon, 97213, United States
Local Institution
Nashville Tennessee, 37232, United States
Local Institution - 0014
Houston Texas, 77030, United States
Local Institution - 0007
Seattle Washington, 98109, United States
Local Institution - 0025
Mar del Plata Buenos Aires, 7600, Argentina
Local Institution - 0075
Río Cuarto Córdoba, X5800, Argentina
Local Institution - 0026
Buenos Aires , 1419, Argentina
Local Institution - 0024
San Juan , 5400, Argentina
Local Institution - 0030
Belo Horizonte Minas Gerais, 30130, Brazil
Local Institution - 0035
Curitiba Parana, 80730, Brazil
Local Institution - 0028
Porto Alegre RIO Grande DO SUL, 91350, Brazil
Local Institution - 0036
Santa Cruz do Sul RIO Grande DO SUL, 96830, Brazil
Local Institution - 0032
Barretos SAO Paulo, 14784, Brazil
Local Institution - 0029
Sao Jose do Rio Preto SAO Paulo, 15090, Brazil
Local Institution - 0056
Edmonton Alberta, T6G 1, Canada
Local Institution - 0015
Vancouver British Columbia, V5Z 4, Canada
Local Institution - 0022
St. Johns Newfoundland and Labrador, A1B 3, Canada
Local Institution - 0008
Toronto Ontario, M5G 1, Canada
Local Institution - 0079
Marseille , 13273, France
Local Institution - 0042
Essen , 45147, Germany
Local Institution - 0045
Hannover , 30625, Germany
Local Institution - 0040
Jena , 07747, Germany
Local Institution - 0044
Munich , 81675, Germany
Local Institution - 0041
Nürnberg , 90419, Germany
Local Institution - 0046
Würzburg , 97080, Germany
Local Institution - 0048
Mexico City Distrito Federal, 14080, Mexico
Local Institution - 0050
Zapopan Jalisco, 45070, Mexico
Local Institution - 0049
Monterrey Nuevo LEON, 66460, Mexico
Local Institution - 0055
Queretaro , 76000, Mexico
Local Institution - 0059
Moscow , 11547, Russian Federation
Local Institution - 0052
Moscow , 12120, Russian Federation
Local Institution - 0087
Moscow , 12135, Russian Federation
Local Institution - 0051
Novosibirsk , 63009, Russian Federation
Local Institution - 0085
Omsk , 64401, Russian Federation
Local Institution - 0058
Saint Petersburg , 19775, Russian Federation

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT04540705

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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