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Renal Cell CarcinomaPhase 3NCT03729245

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)

A Phase 3 study testing bempegaldesleukin, sunitinib and nivolumab in people with Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by Nektar Therapeutics at 96 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bempegaldesleukin, sunitinib and nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
623 participants
Where
96 sitesin 10 countries
Study dates
18 Dec 2018to 19 Oct 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

96 sites in 10 countries.

96 sites in 10 countries

Brazil27 sites

  • Fundação Pio XII Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400

  • Cenantron - Centro Avancado de Tratamento Oncologico Ltda

    Belo Horizonte, Minas Gerais, 30190-130

  • Oncocentro, Belo Horizonte

    Belo Horizonte, Minas Gerais, 30360-680

  • Hospital das Clinicas - UNICAMP

    Campinas, São Paulo, 13083-887

  • Instituto de Pesquisas Clínicas Para Estudos Multicêntricos

    Caxias do Sul, 95070-560

  • Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

    Curitiba, Paraná, 80060-900

  • Instituto Do Câncer Do Ceará ICC

    Fortaleza, 60430-230

  • Associação Hospital de Caridade Ijuí

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Instituto Joinvilense de Hematologia E Oncologia

    Joinville, Santa Catarina, 89201-260

  • Animi

    Lages, 88501-001

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-000

  • Liga Norte Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59075-740

  • Universidade Federal do Rio Grande do Sul - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Câncer

    Rio de Janeiro, 20231-050

  • Instituto COI de Pesquisa, Educação e Gestão

    Rio de Janeiro, 22793-080

  • Clínica de Oncologia de Porto Alegre SS Ltda

    Rio Grande, Rio Grande do Sul, 90430-090

  • Centro de Oncologia Da Bahia

    Salvador, Estado de Bahia, 41820-021

  • Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética

    Salvador, Estado de Bahia, 41950-610

  • Fundação do ABC - Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-650

  • Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto

    São José do Rio Preto, 15090-000

  • Hospital Alemão Oswaldo Cruz

    São Paulo, 01323-903

  • Fundação Antônio Prudente - AC Camargo Câncer Center

    São Paulo, 01508-010

  • Hospital Santa Marcelina

    São Paulo, 08270-120

Other trials in Brazil

United States20 sites

  • Lehigh Valley Physician Group (LVPG) - Hematology Oncology

    Allentown, Pennsylvania, 18103

  • Alaska Urological

    Anchorage, Alaska, 99503

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Western Regional Medical Center - CTCA - PPDS

    Goodyear, Arizona, 85338

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89106

  • CARTI Cancer Center

    Little Rock, Arkansas, 72205

  • University of Miami

    Miami, Florida, 33136

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

  • University of California Irvine

    Orange, California, 92868

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Eastern Regional Medical Center - CTCA

    Philadelphia, Pennsylvania, 19124

  • North Shore Hematology Oncology Association PC

    Port Jefferson Station, New York, 11776

  • Providence Cancer Institute, Franz Clinic

    Portland, Oregon, 97213

  • Huntsman Cancer Hospital - PPDS

    Salt Lake City, Utah, 84112

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

Russia13 sites

  • Altay Regional Oncology Center

    Barnaul, 656049

  • Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk, 454087

  • LLC Evimed

    Chelyabinsk, 454087

  • Kursk Regional Oncology Centre

    Kursk, 305035

  • Central Clinical Hospital With Polyclinic of President Administration of RF

    Moscow, 121359

  • Federal State Institution Medical Radiology Research Center

    Obninsk, 249036

  • Clinical Oncology Dispensary

    Omsk, 644013

  • PMI Euromedservice

    Pushkin, 196603

  • Hospital Orkli LLC

    Saint Petersburg, 194044

  • Railway Clinical Hospital JSC RZhD

    Saint Petersburg, 195271

  • Hospital Orkli LLC

    Saint Petersburg, 197136

  • State Institution of Healthcare "Volgograd Regional Urology and Nephrology Centre"

    Volzhskiy, 404120

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150040

Other trials in Russia

Argentina11 sites

  • Centro de Investigación Pergamino S.A

    Buenos Aires, 2700

  • Centro Médico Austral

    Buenos Aires, C1019ABS

  • Instituto Médico Especializado Alexander Fleming

    Buenos Aires, C1426ANZ

  • Centro Médico Privado CEMAIC

    Córdoba, X5000HHW

  • Sanatorio Allende S.A.

    Córdoba, X5000JHQ

  • Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.

    Córdoba, X5002AOQ

  • Centro Oncologico Riojano Integral (cori)

    La Rioja, F5300COE

  • Hospital Provincial Del Centenario

    Rosario, S2002KDS

  • CAIPO Centro para la atención integral del paciente oncológico

    San Miguel de Tucumán, 4000

  • Sanatorio Parque de Rosario

    Santa Fe, S2000DSV

  • Centro de Investigación Clínica - Clínica Viedma

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

Chile8 sites

  • Corporacion de Beneficencia Osorno

    Osorno, Los Lagos Region, 5311092

  • Oncovida

    Santiago, 7500000

  • Clinica Santa Maria

    Santiago, 7520349

  • Fundación Arturo López Pérez (FALP) - PPDS

    Santiago, 7850000

  • Centro Investigacion Clinica Del Sur

    Temuco, 4810371

  • Clinical Research Chile SpA

    Valdivia, Los Ríos Region, 5090000

  • Oncocentro APYS

    Viña del Mar, 2520612

  • Centro de Investigaciones Clínicas Vina del Mar

    Viña del Mar, 2540364

Other trials in Chile

Australia5 sites

  • Adelaide Cancer Centre

    Kurralta Park, South Australia, 5037

  • Orange Cancer Centre

    Orange, New South Wales, 2800

  • Barwon Health

    Parkville, Victoria, 3050

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065

  • Macquarie University

    Sydney, New South Wales, 2109

Other trials in Australia

Mexico5 sites

  • Health Pharma Professional Research S.A de C.V.

    Mexico City, Mexico City, 03810

  • Axis Heilsa S. De R.L. de C.V.

    Monterrey, Nuevo León, 64060

  • Accelerium, S. de R.L. de C.V.

    Monterrey, 64000

  • Centro de Investigacion Clinica Chapultepec S.A. de C.V.

    Morelia, Michoacán, 58260

  • Unidad Médica Onco-Hematológica

    Puebla City, CP 72530

Other trials in Mexico

Peru4 sites

  • Clinica Internacional S.A. - Sede San Borja

    Lima, 15036

  • ONCOCARE S.A.C. (Clinica Aliada)

    Lima, 15036

  • Hospital Nacional Cayetano Heredia

    Lima, 15102

  • Clinica Peruana Americana

    Trujillo, La Lobertad, 13000

Other trials in Peru

Singapore2 sites

  • National Cancer Centre

    Singapore, 169610

  • Oncocare Cancer Centre

    Singapore, 258500

Other trials in Singapore

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: 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).

Being tested
bempegaldesleukin, sunitinib, nivolumab, cabozantinib
Keywords
Kidney Cancer, Kidney Neoplasms, Renal Cancer, Renal Neoplasms, CD122, CD122-Biased Agonist, CD122-Biased Cytokine, IL-2 receptor agonist, Immuno-oncology therapy, NKTR-214, Nivolumab, Opdivo®, PD-L1, PD-1, Bempegaldesleukin, IL-2, BEMPEG, CD122-Preferential, IL-2 pathway agonist, Checkpoint inhibition
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bempegaldesleukinBiological

    Also called BEMPEG, BMS-986321

    Specified dose on specified days

  • sunitinibDrug

    Also called Sutent®

    Specified dose on specified days

  • nivolumabBiological

    Also called Opdivo®, BMS-936558

    Specified dose on specified days

  • cabozantinibDrug

    Also called Cabometyx®

    Specified dose on specified days

Study groups in NCT03729245
Study groupRoleWhat they receive
Combination of bempegaldesleukin + nivolumabExperimentalPatients in Arm A will receive bempegaldesleukin in combination with nivolumab.
Receives: Biological: bempegaldesleukin; Biological: nivolumab
sunitinib or cabozantinibActive comparatorPatients in Arm B will receive the Investigator's choice of either one of two treatment options.
Receives: Drug: sunitinib; Drug: cabozantinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: Approximately 32 months

  2. Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC

    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.

    Measured: Approximately 32 months

Secondary outcomes (1)

  1. 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

    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.

    Measured: Approximately 32 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2018
  2. Study start18 Dec 2018
  3. Primary completion7 Jan 2022
  4. Study completion19 Oct 2022

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
623 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03729245
Sponsor's protocol ID
17-214-09
Other IDs
CA045002
Status last verified
Mar 2023
First submitted
29 Oct 2018
Last updated
11 Apr 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Tannir NM, Formiga MN, Penkov K, Kislov N, Vasiliev A, Gunnar Skare N, Hong W, Dai S, Tang L, Qureshi A, Zalevsky J, Tagliaferri MA, George D, Agarwal N, Pal S. Bempegaldesleukin Plus Nivolumab Versus Sunitinib or Cabozantinib in Previously Untreated Advanced Clear Cell Renal Cell Carcinoma: A Phase III Randomized Study (PIVOT-09). J Clin Oncol. 2024 Aug 10;42(23):2800-2811. doi: 10.1200/JCO.23.02082. Epub 2024 Jun 5.

    PubMed 38838287

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bempegaldesleukin, sunitinib and nivolumab in people with Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, run by Nektar Therapeutics at 96 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in Brazil, United States, Russia, Argentina, Chile and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03729245, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.

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