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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

NCT04540705

Description:

The purpose of this study is to first, in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination and then, in Part 2, to evaluate the effectiveness of nivolumab, bempegaldesleukin, and cabozantinib when compared with nivolumab and cabozantinib in participants with previously untreated kidney cancer that has advanced or has spread.

Related Conditions:
  • Clear Cell Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: A Phase 1/2 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)

Clinical Trial IDs

  • ORG STUDY ID: CA045-011
  • SECONDARY ID: 2018-003200-39
  • SECONDARY ID: 18-214-15
  • NCT ID: NCT04540705

Conditions

  • Renal Cell Carcinoma

Interventions

DrugSynonymsArms
NivolumabOPDIVOArm A (Part 2): Nivolumab + Bempegaldesleukin + Cabozantinib
BempegaldesleukinBMS-986321, NKTR-214, bempegaldesleukinArm A (Part 2): Nivolumab + Bempegaldesleukin + Cabozantinib
AxitinibINLYTAPart 1A (Part 1): Nivolumab + Bempegaldesleukin + Axitinib
CabozantinibArm A (Part 2): Nivolumab + Bempegaldesleukin + Cabozantinib

Purpose

The purpose of this study is to first, in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination and then, in Part 2, to evaluate the effectiveness of nivolumab, bempegaldesleukin, and cabozantinib when compared with nivolumab and cabozantinib in participants with previously untreated kidney cancer that has advanced or has spread.

Trial Arms

NameTypeDescriptionInterventions
Part 1A (Part 1): Nivolumab + Bempegaldesleukin + AxitinibExperimental
  • Nivolumab
  • Bempegaldesleukin
  • Axitinib
Part 1B (Part 1): Nivolumab + Bempegaldesleukin + CabozantinibExperimental
  • Nivolumab
  • Bempegaldesleukin
  • Cabozantinib
Arm A (Part 2): Nivolumab + Bempegaldesleukin + CabozantinibExperimental
  • Nivolumab
  • Bempegaldesleukin
  • Cabozantinib
Arm B (Part 2): Nivolumab + CabozantinibExperimental
  • Nivolumab
  • Cabozantinib

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        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)

        NOTE: Other protocol defined inclusion/exclusion criteria apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of adverse events (AEs) by severity (Part 1)
Time Frame:Up to 5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free survival (PFS) by RECIST 1.1 by Investigator (Part 2)
Time Frame:Up to 32 months from start of Part 2
Safety Issue:
Description:
Measure:Overall survival (OS) (Part 2)
Time Frame:Up to 60 months
Safety Issue:
Description:
Measure:Incidence of AEs by severity (Part 2)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of SAEs (Part 2)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of AEs leading to discontinuation (Part 2)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of imAEs (Part 2)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 2)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 2)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 2)
Time Frame:Up to 5 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Trial Keywords

  • NKTR-214
  • nivolumab
  • bempeg

Last Updated

February 26, 2021