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PIVOT IO 011: 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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04540705
Collaborator
Nektar Therapeutics (Industry)
251
Enrollment
39
Locations
4
Arms
64.2
Anticipated Duration (Months)
6.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
251 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Sep 11, 2020
Anticipated Primary Completion Date :
Dec 26, 2024
Anticipated Study Completion Date :
Jan 17, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1A (Part 1): Nivolumab + Bempegaldesleukin + Axitinib

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • OPDIVO

    • Biological: Bempegaldesleukin
    Specified dose on specified days
    Other Names:
  • BMS-986321, NKTR-214, bempegaldesleukin

    • Drug: Axitinib
    Specified dose on specified days
    Other Names:
  • INLYTA

    		•
    Experimental: Part 1B (Part 1): Nivolumab + Bempegaldesleukin + Cabozantinib

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • OPDIVO

    • Biological: Bempegaldesleukin
    Specified dose on specified days
    Other Names:
  • BMS-986321, NKTR-214, bempegaldesleukin

    • Drug: Cabozantinib
    Specified dose on specified days
    Experimental: Arm A (Part 2): Nivolumab + Bempegaldesleukin + Cabozantinib

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • OPDIVO

    • Biological: Bempegaldesleukin
    Specified dose on specified days
    Other Names:
  • BMS-986321, NKTR-214, bempegaldesleukin

    • Drug: Cabozantinib
    Specified dose on specified days
    Experimental: Arm B (Part 2): Nivolumab + Cabozantinib

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • OPDIVO

    • Drug: Cabozantinib
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events (AEs) by severity (Part 1) [Up to 5 years]

    2. Incidence of serious adverse events (SAEs) (Part 1) [Up to 5 years]

    3. Incidence of dose-limiting toxicities (DLTs) (Part 1) [Up to 5 years]

    4. Incidence of AEs leading to discontinuation (Part 1) [Up to 5 years]

    5. Incidence of immune-mediated adverse events (imAEs) (Part 1) [Up to 5 years]

    6. Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1) [Up to 5 years]

    7. Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1) [Up to 5 years]

    8. Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1) [Up to 5 years]

    9. Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator (Part 2) [Up to 20 months from start of Part 2]

    Secondary Outcome Measures

    1. Progression-free survival (PFS) by RECIST 1.1 by Investigator (Part 2) [Up to 32 months from start of Part 2]

    2. Overall survival (OS) (Part 2) [Up to 60 months]

    3. Incidence of AEs by severity (Part 2) [Up to 5 years]

    4. Incidence of SAEs (Part 2) [Up to 5 years]

    5. Incidence of AEs leading to discontinuation (Part 2) [Up to 5 years]

    6. Incidence of imAEs (Part 2) [Up to 5 years]

    7. Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 2) [Up to 5 years]

    8. Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 2) [Up to 5 years]

    9. Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 2) [Up to 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution - 0005 Springdale Arkansas United States 72762
    2 Local Institution Louisville Kentucky United States 40202
    3 Local Institution - 0001 Saint Louis Missouri United States 63110
    4 Local Institution - 0009 New York New York United States 10065
    5 Local Institution Portland Oregon United States 97213
    6 Local Institution Nashville Tennessee United States 37232
    7 Local Institution - 0014 Houston Texas United States 77030-3721
    8 Local Institution - 0007 Seattle Washington United States 98109
    9 Local Institution Mar del Plata Buenos Aires Argentina B7600
    10 Local Institution Rio Cuarto Cordoba Argentina 5800
    11 Local Institution Buenos Aires Distrito Federal Argentina C1419AHN
    12 Local Institution San Juan Argentina 5400
    13 Local Institution Belo Horizonte Minas Gerais Brazil 30130-090
    14 Local Institution Curitiba Parana Brazil 80730-150
    15 Local Institution Porto Alegre RIO Grande DO SUL Brazil 91350-200
    16 Local Institution Santa Cruz do Sul RIO Grande DO SUL Brazil 96810-110
    17 Local Institution Barretos SAO Paulo Brazil 14784-400
    18 Local Institution Edmonton Alberta Canada T6G 1Z2
    19 Local Institution - 0015 Vancouver British Columbia Canada V5Z 4E6
    20 Local Institution - 0008 Toronto Ontario Canada M5G 1Z5
    21 Local Institution Bordeaux France 33075
    22 Local Institution Brest France 29200
    23 Local Institution Lyon France 69008
    24 Local Institution - 0079 Marseille France 13273
    25 Local Institution Nice cedex 2 France 06189
    26 Local Institution Strasbourg France 67200
    27 Local Institution - 0045 Hannover Germany 30625
    28 Local Institution - 0044 Munich Germany 81675
    29 Local Institution - 0046 Würzburg Germany 97080
    30 Local Institution Mexico City Distrito Federal Mexico 14080
    31 Local Institution Zapopan Jalisco Mexico 45070
    32 Local Institution Monterrey Nuevo LEON Mexico 64460
    33 Local Institution Queretaro Mexico 76000
    34 Local Institution - 0059 Moscow Russian Federation 115478
    35 Local Institution - 0052 Moscow Russian Federation 121205
    36 Local Institution - 0087 Moscow Russian Federation 121359
    37 Local Institution - 0051 Novosibirsk Russian Federation 630099
    38 Local Institution - 0085 Omsk Russian Federation 644013
    39 Local Institution - 0058 Saint Petersburg Russian Federation 197758

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • Nektar Therapeutics

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT04540705
    Other Study ID Numbers:
    • CA045-011
    • 2018-003200-39
    • 18-214-15
    First Posted:
    Sep 7, 2020
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    NKTR-214
    nivolumab
    bempeg
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell
    Nivolumab
    Axitinib

    Study Results

    No Results Posted as of Jun 6, 2022