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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Clinical Trials of Interest

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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 (PIVOT IO 011)

  • Clinicaltrials.gov identifier

    NCT04540705

  • Recruitment Status

    Recruiting

  • First Posted

    September 7, 2020

  • Last update posted

    October 4, 2021

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:Renal Cell Carcinoma
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Bempegaldesleukin
    Drug: Axitinib
    Drug: Cabozantinib
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated 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: September 2020
  • Estimated Primary Completion Date: December 2024
  • Estimated Study Completion Date: January 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A (Part 2): Nivolumab + Bempegaldesleukin + Cabozantinib
Biological: Nivolumab
Specified dose on specified days

Biological: Bempegaldesleukin
Specified dose on specified days

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

Drug: Cabozantinib
Specified dose on specified days
Experimental: Part 1A (Part 1): Nivolumab + Bempegaldesleukin + Axitinib
Biological: Nivolumab
Specified dose on specified days

Biological: Bempegaldesleukin
Specified dose on specified days

Drug: Axitinib
Specified dose on specified days
Experimental: Part 1B (Part 1): Nivolumab + Bempegaldesleukin + Cabozantinib
Biological: Nivolumab
Specified dose on specified days

Biological: Bempegaldesleukin
Specified dose on specified days

Drug: Cabozantinib
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of adverse events (AEs) by severity (Part 1) [ Time Frame: Up to 5 years ]
  • 2. Incidence of serious adverse events (SAEs) (Part 1) [ Time Frame: Up to 5 years ]
  • 3. Incidence of dose-limiting toxicities (DLTs) (Part 1) [ Time Frame: Up to 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 5 years ]
  • 7. Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1) [ Time Frame: Up to 5 years ]
  • 8. Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1) [ Time Frame: Up to 5 years ]
  • 9. Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator (Part 2) [ Time Frame: 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) [ Time Frame: Up to 32 months from start of Part 2 ]
  • 2. Overall survival (OS) (Part 2) [ Time Frame: Up to 60 months ]
  • 3. Incidence of AEs by severity (Part 2) [ Time Frame: Up to 5 years ]
  • 4. Incidence of SAEs (Part 2) [ Time Frame: Up to 5 years ]
  • 5. Incidence of AEs leading to discontinuation (Part 2) [ Time Frame: Up to 5 years ]
  • 6. Incidence of imAEs (Part 2) [ Time Frame: Up to 5 years ]
  • 7. Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 2) [ Time Frame: Up to 5 years ]
  • 8. Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 2) [ Time Frame: Up to 5 years ]
  • 9. Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 2) [ Time Frame: Up to 5 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Arkansas
Local Institution
Springdale

United States, Connecticut
Local Institution
New Haven

United States, Kentucky
Local Institution
Louisville

United States, Maryland
Local Institution
Baltimore

United States, Missouri
Washington University School Of Medicine
Saint Louis

United States, New York
Memorial Sloan Kettering Cancer Center
New York

United States, Oregon
Local Institution
Portland

United States, Tennessee
Local Institution
Nashville

United States, Texas
Local Institution
Dallas

United States, Texas
Local Institution
Houston

United States, Utah
Local Institution
Salt Lake City

United States, Washington
University of Washington - Seattle Cancer Care Alliance
Seattle

Argentina, Buenos Aires
Local Institution
Mar del Plata

Argentina, Cordoba
Local Institution
Rio Cuarto

Argentina, Distrito Federal
Local Institution
Buenos Aires

Argentina
Local Institution
San Juan

Brazil, Minas Gerais
Local Institution
Belo Horizonte

Brazil, Parana
Local Institution
Curitiba

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, RIO Grande DO SUL
Local Institution
Santa Cruz do Sul

Brazil, SAO Paulo
Local Institution
Barretos

Canada, British Columbia
Local Institution
Vancouver

Canada, Nova Scotia
Local Institution
Halifax

Canada, Ontario
Local Institution
Toronto

France
Local Institution
Marseille

France
Local Institution
Nice cedex 2

Germany
Local Institution
Essen

Germany
Local Institution
Hannover

Germany
Local Institution
Jena

Germany
Local Institution
Muenchen

Germany
Local Institution
Nuremberg

Germany
Local Institution
Würzburg

Mexico, Jalisco
Local Institution
Zapopan

Mexico, Nuevo LEON
Local Institution
Monterrey

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Novosibirsk

Russian Federation
Local Institution
Omsk

Russian Federation
Local Institution
Saint-Petersburg

Spain
Local Institution
Barcelona

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Sevilla

Sponsors and Collaborators

Bristol-Myers Squibb

Nektar Therapeutics

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04540705 History of Changes
  • Other Study ID Numbers: CA045-011, 2018-003200-39, 18-214-15
  • First Posted: September 7, 2020 Key Record Dates
  • Last Update Posted: October 4, 2021
  • Last Verified: September 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: bempeg
    nivolumab
    NKTR-214
  • Additional relevant MeSH terms: Carcinoma, Renal Cell Carcinoma