A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)

March 17, 2023 updated by: Nektar Therapeutics

A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma

The main purpose of this study is to compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

623

Phase

  • Phase 3

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, C1426ANZ
        • Instituto Medico Especializado Alexander Fleming
      • Buenos Aires, Argentina, C1019ABS
        • Centro Medico Austral
      • Buenos Aires, Argentina, 2700
        • Centro de Investigación Pergamino S.A
      • Córdoba, Argentina, X5000JHQ
        • Sanatorio Allende S.A.
      • Córdoba, Argentina, X5000HHW
        • Centro Medico Privado CEMAIC
      • Córdoba, Argentina, X5002AOQ
        • Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral (Cori)
      • Rosario, Argentina, S2002KDS
        • Hospital Provincial del Centenario
      • San Miguel De Tucumán, Argentina, 4000
        • CAIPO Centro para la Atencion Integral del Paciente Oncologico
      • Santa Fe, Argentina, S2000DSV
        • Sanatorio Parque de Rosario
    • Rio Negro
      • Viedma, Rio Negro, Argentina, R8500ACE
        • Centro de Investigación Clínica - Clínica Viedma
  • Australia
    • New South Wales
      • Orange, New South Wales, Australia, 2800
        • Orange Cancer Centre
      • Saint Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Sydney, New South Wales, Australia, 2109
        • Macquarie University
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Adelaide Cancer Centre
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Barwon Health
  • Brazil
      • Caxias Do Sul, Brazil, 95070-560
        • Instituto de Pesquisas Clínicas Para Estudos Multicêntricos
      • Fortaleza, Brazil, 60430-230
        • Instituto Do Câncer Do Ceará ICC
      • Lages, Brazil, 88501-001
        • ANIMI
      • Rio De Janeiro, Brazil, 20231-050
        • Instituto Nacional de Câncer
      • Rio De Janeiro, Brazil, 22793-080
        • Instituto COI de Pesquisa, Educação e Gestão
      • São José Do Rio Preto, Brazil, 15090-000
        • Hospital de Base da Faculdade de Medicina de São José do Rio Preto
      • São Paulo, Brazil, 01323-903
        • Hospital Alemao Oswaldo Cruz
      • São Paulo, Brazil, 08270-120
        • Hospital Santa Marcelina
      • São Paulo, Brazil, 01508-010
        • Fundação Antônio Prudente - AC Camargo Câncer Center
    • Bahia
      • Salvador, Bahia, Brazil, 41820-021
        • Centro de Oncologia da Bahia
      • Salvador, Bahia, Brazil, 41950-610
        • Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30190-130
        • Cenantron - Centro Avancado de Tratamento Oncologico Ltda
      • Belo Horizonte, Minas Gerais, Brazil, 30360-680
        • Oncocentro, Belo Horizonte
    • Parana
      • Curitiba, Parana, Brazil, 80060-900
        • Liga Paranaense de Combate ao Câncer - Hospital Erasto Gaertner
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59075-740
        • Liga Norte Riograndense Contra O Cancer
    • Rio Grande Do Sul
      • Ijuí, Rio Grande Do Sul, Brazil, 98700-000
        • Associacao Hospital de Caridade Ijui
      • Lajeado, Rio Grande Do Sul, Brazil, 95900-000
        • Hospital Bruno Born
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
        • Hospital Mae de Deus
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
        • Irmandade da Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Universidade Federal do Rio Grande do Sul - UFRGS
      • Rio Grande, Rio Grande Do Sul, Brazil, 90430-090
        • Clínica de Oncologia de Porto Alegre SS Ltda
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89201-260
        • Instituto Joinvilense de Hematologia e Oncologia
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Fundacao Pio Xii Hospital de Cancer de Barretos
      • Campinas, Sao Paulo, Brazil, 13083-887
        • Hospital das Clinicas - UNICAMP
      • Santo André, Sao Paulo, Brazil, 09060-650
        • Fundacao do ABC - Faculdade de Medicina do ABC
    • São Paulo
      • Jaú, São Paulo, Brazil, 17210-120
        • Hospital Amaral Carvalho
  • Chile
      • Santiago, Chile, 7520349
        • Clinica Santa Maria
      • Santiago, Chile, 7500000
        • Oncovida
      • Santiago, Chile, 7850000
        • Fundación Arturo López Pérez (FALP) - PPDS
      • Temuco, Chile, 4810371
        • Centro Investigacion Clinica Del Sur
      • Viña Del Mar, Chile, 2540364
        • Centro de Investigaciones Clinicas Viña del Mar
      • Viña Del Mar, Chile, 2520612
        • Oncocentro Apys
    • Los Lagos
      • Osorno, Los Lagos, Chile, 5311092
        • Corporacion de Beneficencia Osorno
    • Los Rios
      • Valdivia, Los Rios, Chile, 5090000
        • Clinical Research Chile SpA
  • Mexico
      • Monterrey, Mexico, 64000
        • Accelerium, S. de R.L. de C.V.
      • Puebla, Mexico, CP 72530
        • Unidad Médica Onco-hematológica
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico, 03810
        • Health Pharma Professional Research S.A de C.V.
    • Michoacan
      • Morelia, Michoacan, Mexico, 58260
        • Centro de Investigacion Clinica Chapultepec S.A. de C.V.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64060
        • Axis Heilsa S. de R.L. de C.V.
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
  • Peru
      • Lima, Peru, 15102
        • Hospital Nacional Cayetano Heredia
      • Lima, Peru, 15036
        • Clinica Internacional S.A. - Sede San Borja
      • Lima, Peru, 15036
        • ONCOCARE S.A.C. (Clinica Aliada)
    • La Lobertad
      • Trujillo, La Lobertad, Peru, 13000
        • Clinica Peruana Americana
  • Russian Federation
      • Barnaul, Russian Federation, 656049
        • Altay Regional Oncology Center
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Clinical Oncology Dispensary
      • Chelyabinsk, Russian Federation, 454087
        • LLC Evimed
      • Kursk, Russian Federation, 305035
        • Kursk Regional Oncology Centre
      • Moscow, Russian Federation, 121359
        • Central Clinical Hospital With Polyclinic of President Administration of RF
      • Obninsk, Russian Federation, 249036
        • Federal State Institution Medical Radiology Research Center
      • Omsk, Russian Federation, 644013
        • Clinical Oncology Dispensary
      • Pushkin, Russian Federation, 196603
        • PMI Euromedservice
      • Saint Petersburg, Russian Federation, 195271
        • Railway Clinical Hospital JSC RZhD
      • Saint Petersburg, Russian Federation, 194044
        • Hospital OrKli LLC
      • Saint Petersburg, Russian Federation, 197136
        • Hospital OrKli LLC
      • Volzhskiy, Russian Federation, 404120
        • State Institution of Healthcare "Volgograd Regional Urology and Nephrology Centre"
      • Yaroslavl, Russian Federation, 150040
        • Regional Clinical Oncology Hospital
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre
      • Singapore, Singapore, 258500
        • Oncocare Cancer Centre
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99503
        • Alaska Urological
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Western Regional Medical Center - CTCA - PPDS
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • CARTI Cancer Center
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Orange, California, United States, 92868
        • University of California Irvine
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Greenebaum Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Comprehensive Cancer Centers of Nevada
    • New York
      • Port Jefferson Station, New York, United States, 11776
        • North Shore Hematology Oncology Association PC
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Cancer Institute, Franz Clinic
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Physician Group (LVPG) - Hematology Oncology
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19124
        • Eastern Regional Medical Center - CTCA
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Hospital - PPDS

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Provide written, informed consent to participate in the study and follow the study procedures
  • Karnofsky Performance Status (KPS) of at least 70%
  • Measurable disease per mRECIST 1.1 criteria
  • Histologically confirmed RCC with a clear-cell component (may have sarcomatoid features); advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
  • Patients with any International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score (favorable-, intermediate-, or poor-risk) are eligible. At least one IMDC prognostic factor must be present to qualify as either intermediate- or poor-risk renal cell carcinoma.
  • No prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) for RCC

Key Exclusion Criteria:

  • An active, known or suspected autoimmune disease that has required systemic treatment within the past 3 months (exceptions exist)
  • Patients who have a known additional malignancy that is progressing or requires active treatment (exceptions exist)
  • Any tumor invading the wall of a major blood vessels
  • Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 28 days prior to randomization
  • Need for >2 medications for management of hypertension (including diuretics)
  • History of pulmonary embolism, deep vein thrombosis (not including tumor thrombus), or clinically significant thromboembolic event within 3 months of randomization

Additional protocol defined inclusion/exclusion criteria and exceptions 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination of bempegaldesleukin + nivolumab
Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.
Biological: nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo®
Biological: bempegaldesleukin
Specified dose on specified days
Other Names:
  • BMS-986321
  • BEMPEG
Active Comparator: sunitinib or cabozantinib
Patients in Arm B will receive the Investigator's choice of either one of two treatment options.
Drug: sunitinib
Specified dose on specified days
Other Names:
  • Sutent®
Drug: cabozantinib
Specified dose on specified days
Other Names:
  • Cabometyx®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC
Time Frame: Approximately 32 months

ORR using modified Response Evaluation Criteria in Solid Tumors (mRECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) All-risk patients and intermediate- or poor-risk patients.

ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.
Approximately 32 months
Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC
Time Frame: Approximately 32 months
OS is defined as the time from date of first dose to the date of death from any cause. Patients without a date of death were censored at their last known alive date.
Approximately 32 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC
Time Frame: Approximately 32 months
Progression-free survival is defined as the time between the date of randomization and the first date of documented tumor progression using mRECIST 1.1 per BICR or death due to any cause, whichever comes first.
Approximately 32 months

Collaborators and Investigators

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

Sponsor

Nektar Therapeutics

Collaborators

Bristol-Myers Squibb

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)

December 18, 2018

Primary Completion (Actual)

January 7, 2022

Study Completion (Actual)

October 19, 2022

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-214-09
  • CA045002 (Other Identifier: Bristol-Myers Squibb Protocol ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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