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Completed

NCT Number: NCT04540705

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

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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0025, Mar del Plata, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Biological

Specified dose on specified days

Other names: OPDIVO

Axitinib

Drug

Specified dose on specified days

Other names: INLYTA

Cabozantinib

Drug

Specified dose on specified days

Other names: Cabometyx

Primary outcomes

  1. Incidence of adverse events (AEs) by severity (Part 1)

    Time frame: Up to 2.5 years

  2. Incidence of serious adverse events (SAEs) (Part 1)

    Time frame: Up to 2.5 years

  3. Incidence of dose-limiting toxicities (DLTs) (Part 1)

    Time frame: Up to 2.5 years

  4. Incidence of AEs leading to discontinuation (Part 1)

    Time frame: Up to 5 years

  5. Incidence of immune-mediated adverse events (imAEs) (Part 1)

    Time frame: Up to 5 years

  6. Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)

    Time frame: Up to 2.5 years

  7. Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)

    Time frame: Up to 2.5 years

  8. Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)

    Time frame: Up to 2.5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Nektar Therapeutics

Registry information

Official study title

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)

Acronym: PIVOT IO 011

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 7, 2020
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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