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NCT04540705CompletedPhase 1

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

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)

Source: ClinicalTrials.gov · Last updated 28 Feb 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
30 (actual)
First submitted
3 Sept 2020
Start date
11 Sept 2020
Primary completion date
18 Jan 2024
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT04540705
EudraCT number
2018-003200-39

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 30
  • From 11 Sept 2020 to the primary completion date, 18 Jan 2024
  • 39 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Active, known or suspected autoimmune disease
  • Inadequately treated adrenal insufficiency

Other

  • Active CNS brain metastases or leptomeningeal metastases

Who the study is looking for

  • 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:
    • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (39)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 0026
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Buenos AiresArgentinaUnknown status
Local Institution - 0025
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Mar del PlataArgentinaUnknown status
Local Institution - 0075
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Río CuartoArgentinaUnknown status
Local Institution - 0024
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San JuanArgentinaUnknown status
Local Institution - 0032
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BarretosBrazilUnknown status
Local Institution - 0030
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Belo HorizonteBrazilUnknown status
Local Institution - 0035
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CuritibaBrazilUnknown status
Local Institution - 0028
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Porto AlegreBrazilUnknown status
Local Institution - 0036
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Santa Cruz do SulBrazilUnknown status
Local Institution - 0029
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São José do Rio PretoBrazilUnknown status
Local Institution - 0056
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EdmontonCanadaUnknown status
Local Institution - 0022
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St. John'sCanadaUnknown status
Local Institution - 0008
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TorontoCanadaUnknown status
Local Institution - 0015
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VancouverCanadaUnknown status
Local Institution - 0042
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EssenGermanyUnknown status
Local Institution - 0045
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HanoverGermanyUnknown status
Local Institution - 0040
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JenaGermanyUnknown status
Local Institution - 0044
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MunichGermanyUnknown status
Local Institution - 0041
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NurembergGermanyUnknown status
Local Institution - 0046
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WürzburgGermanyUnknown status
Local Institution - 0079
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MarseilleFranceUnknown status
Local Institution - 0048
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Mexico CityMexicoUnknown status
Local Institution - 0049
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MonterreyMexicoUnknown status
Local Institution - 0055
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QuerétaroMexicoUnknown status
Local Institution - 0050
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ZapopanMexicoUnknown status
Local Institution - 0052
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MoscowRussiaUnknown status
Local Institution - 0087
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MoscowRussiaUnknown status
Local Institution - 0059
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MoscowRussiaUnknown status
Local Institution - 0051
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NovosibirskRussiaUnknown status
Local Institution - 0085
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OmskRussiaUnknown status
Local Institution - 0058
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Saint PetersburgRussiaUnknown status
Local Institution - 0014
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HoustonUnited StatesUnknown status
Local Institution
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LouisvilleUnited StatesUnknown status
Local Institution
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NashvilleUnited StatesUnknown status
Local Institution - 0009
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New YorkUnited StatesUnknown status
Local Institution
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PortlandUnited StatesUnknown status
Local Institution - 0007
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SeattleUnited StatesUnknown status
Local Institution - 0005
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SpringdaleUnited StatesUnknown status
Local Institution - 0001
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St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.