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 (PIVOT IO 011)

February 26, 2024 updated by: Bristol-Myers Squibb

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1419
        • Local Institution - 0026
      • San Juan, Argentina, 5400
        • Local Institution - 0024
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Local Institution - 0025
    • Córdoba
      • Río Cuarto, Córdoba, Argentina, X5800ALB
        • Local Institution - 0075
  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Local Institution - 0030
    • Parana
      • Curitiba, Parana, Brazil, 80730-150
        • Local Institution - 0035
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil, 91350-200
        • Local Institution - 0028
      • Santa Cruz do Sul, RIO Grande DO SUL, Brazil, 96830-180
        • Local Institution - 0036
    • SAO Paulo
      • Barretos, SAO Paulo, Brazil, 14784400
        • Local Institution - 0032
      • Sao Jose do Rio Preto, SAO Paulo, Brazil, 15090-000
        • Local Institution - 0029
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0056
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Local Institution - 0015
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Local Institution - 0022
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Local Institution - 0008
  • France
      • Marseille, France, 13273
        • Local Institution - 0079
  • Germany
      • Essen, Germany, 45147
        • Local Institution - 0042
      • Hannover, Germany, 30625
        • Local Institution - 0045
      • Jena, Germany, 07747
        • Local Institution - 0040
      • Munich, Germany, 81675
        • Local Institution - 0044
      • Nürnberg, Germany, 90419
        • Local Institution - 0041
      • Würzburg, Germany, 97080
        • Local Institution - 0046
  • Mexico
      • Queretaro, Mexico, 76000
        • Local Institution - 0055
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14080
        • Local Institution - 0048
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45070
        • Local Institution - 0050
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 66460
        • Local Institution - 0049
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Local Institution - 0059
      • Moscow, Russian Federation, 121205
        • Local Institution - 0052
      • Moscow, Russian Federation, 121359
        • Local Institution - 0087
      • Novosibirsk, Russian Federation, 630099
        • Local Institution - 0051
      • Omsk, Russian Federation, 644013
        • Local Institution - 0085
      • Saint Petersburg, Russian Federation, 197758
        • Local Institution - 0058
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Local Institution - 0005
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Local Institution
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 0001
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 0009
    • Oregon
      • Portland, Oregon, United States, 97213
        • Local Institution
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Local Institution
    • Texas
      • Houston, Texas, United States, 77030-3721
        • Local Institution - 0014
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution - 0007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1A (Part 1): Nivolumab + Axitinib
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • OPDIVO
Drug: Axitinib
Specified dose on specified days
Other Names:
  • INLYTA
Experimental: Part 1B (Part 1): Nivolumab + Cabozantinib
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • OPDIVO
Drug: Cabozantinib
Specified dose on specified days
Other Names:
  • Cabometyx

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Nektar Therapeutics

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2020

Primary Completion (Actual)

January 18, 2024

Study Completion (Actual)

January 18, 2024

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA045-011
  • 2018-003200-39 (EudraCT Number)
  • 18-214-15 (Other Identifier: Nektar Therapeutics)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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