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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)

Primary Purpose

Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bempegaldesleukin
sunitinib
nivolumab
cabozantinib
Sponsored by
Nektar Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring 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, Immune checkpoint inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alaska Urological
  • Western Regional Medical Center - CTCA - PPDS
  • CARTI Cancer Center
  • City of Hope National Medical Center
  • University of California Irvine
  • Innovative Clinical Research Institute
  • University of Miami
  • Winship Cancer Institute, Emory University
  • Tulane Medical Center
  • University of Maryland Greenebaum Cancer Center
  • Comprehensive Cancer Centers of Nevada
  • North Shore Hematology Oncology Association PC
  • Kettering Medical Center
  • Providence Cancer Institute, Franz Clinic
  • Lehigh Valley Physician Group (LVPG) - Hematology Oncology
  • Penn State Milton S Hershey Medical Center
  • Thomas Jefferson University
  • Eastern Regional Medical Center - CTCA
  • MD Anderson Cancer Center
  • Huntsman Cancer Hospital - PPDS
  • Centro de Investigación Clínica - Clínica Viedma
  • Centro de Investigación Pergamino S.A
  • Centro Médico Austral
  • Instituto Médico Especializado Alexander Fleming
  • Centro Médico Privado CEMAIC
  • Sanatorio Allende S.A.
  • Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.
  • Centro Oncologico Riojano Integral (cori)
  • Hospital Provincial Del Centenario
  • CAIPO Centro para la atención integral del paciente oncológico
  • Sanatorio Parque de Rosario
  • Orange Cancer Centre
  • Royal North Shore Hospital
  • Macquarie University
  • Adelaide Cancer Centre
  • Barwon Health
  • Centro de Oncologia Da Bahia
  • Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética
  • Cenantron - Centro Avancado de Tratamento Oncologico Ltda
  • Oncocentro, Belo Horizonte
  • Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
  • Liga Norte Riograndense Contra O Cancer
  • Associação Hospital de Caridade Ijuí
  • Hospital Bruno Born
  • Universidade Federal do Rio Grande do Sul - UFRGS
  • Irmandade Da Santa Casa de Misericordia de Porto Alegre
  • Hospital Mae de Deus
  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
  • Clínica de Oncologia de Porto Alegre SS Ltda
  • Instituto Joinvilense de Hematologia E Oncologia
  • Fundação Pio XII Hospital de Câncer de Barretos
  • Hospital das Clinicas - UNICAMP
  • Fundação do ABC - Faculdade de Medicina do ABC
  • Hospital Amaral Carvalho
  • Instituto de Pesquisas Clínicas Para Estudos Multicêntricos
  • Instituto Do Câncer Do Ceará ICC
  • Animi
  • Instituto Nacional de Câncer
  • Instituto COI de Pesquisa, Educação e Gestão
  • Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
  • Hospital Alemão Oswaldo Cruz
  • Fundação Antônio Prudente - AC Camargo Câncer Center
  • Hospital Santa Marcelina
  • Corporacion de Beneficencia Osorno
  • Clinical Research Chile SpA
  • Oncovida
  • Clinica Santa Maria
  • Fundación Arturo López Pérez (FALP) - PPDS
  • Centro Investigacion Clinica Del Sur
  • Oncocentro APYS
  • Centro de Investigaciones Clínicas Vina del Mar
  • Health Pharma Professional Research S.A de C.V.
  • Centro de Investigacion Clinica Chapultepec S.A. de C.V.
  • Axis Heilsa S. De R.L. de C.V.
  • Accelerium, S. de R.L. de C.V.
  • Unidad Médica Onco-Hematológica
  • Auckland City Hospital
  • Clinica Peruana Americana
  • Clinica Internacional S.A. - Sede San Borja
  • ONCOCARE S.A.C. (Clinica Aliada)
  • Hospital Nacional Cayetano Heredia
  • Altay Regional Oncology Center
  • Chelyabinsk Regional Clinical Oncology Dispensary
  • LLC Evimed
  • Kursk Regional Oncology Centre
  • Central Clinical Hospital With Polyclinic of President Administration of RF
  • Federal State Institution Medical Radiology Research Center
  • Clinical Oncology Dispensary
  • PMI Euromedservice
  • Hospital Orkli LLC
  • Railway Clinical Hospital JSC RZhD
  • Hospital Orkli LLC
  • State Institution of Healthcare "Volgograd Regional Urology and Nephrology Centre"
  • Regional Clinical Oncology Hospital
  • National Cancer Centre
  • Oncocare Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination of bempegaldesleukin + nivolumab

sunitinib or cabozantinib

Arm Description

Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.

Patients in Arm B will receive the Investigator's choice of either one of two treatment options.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 29, 2018
Last Updated
March 17, 2023
Sponsor
Nektar Therapeutics
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03729245
Brief Title
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)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
January 7, 2022 (Actual)
Study Completion Date
October 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nektar Therapeutics
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 patients with previously untreated advanced renal cell carcinoma (RCC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
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, Immune checkpoint inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
623 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination of bempegaldesleukin + nivolumab
Arm Type
Experimental
Arm Description
Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.
Arm Title
sunitinib or cabozantinib
Arm Type
Active Comparator
Arm Description
Patients in Arm B will receive the Investigator's choice of either one of two treatment options.
Intervention Type
Biological
Intervention Name(s)
bempegaldesleukin
Other Intervention Name(s)
BEMPEG, BMS-986321
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
sunitinib
Other Intervention Name(s)
Sutent®
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
nivolumab
Other Intervention Name(s)
Opdivo®, BMS-936558
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
cabozantinib
Other Intervention Name(s)
Cabometyx®
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Approximately 32 months
Title
Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC
Description
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.
Time Frame
Approximately 32 months
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Approximately 32 months

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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)

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