Clinical trial NCT03729245: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: 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
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2018-11-02
Enrollment: 623
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
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
timeFrame: Approximately 32 months
measure: Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC
timeFrame: Approximately 32 months
Secondary outcomes:
measure: 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
timeFrame: Approximately 32 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Urological
state: Alaska
city: Goodyear
country: United States
facility: Western Regional Medical Center - CTCA - PPDS
state: Arizona
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Cancer Center
state: Maryland
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Port Jefferson Station
country: United States
facility: North Shore Hematology Oncology Association PC
state: New York
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Institute, Franz Clinic
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Physician Group (LVPG) - Hematology Oncology
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Eastern Regional Medical Center - CTCA
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital - PPDS
state: Utah
city: Viedma
country: Argentina
facility: Centro de Investigación Clínica - Clínica Viedma
state: Rio Negro
city: Buenos Aires
country: Argentina
facility: Centro de Investigación Pergamino S.A
city: Buenos Aires
country: Argentina
facility: Centro Médico Austral
city: Buenos Aires
country: Argentina
facility: Instituto Médico Especializado Alexander Fleming
city: Córdoba
country: Argentina
facility: Centro Médico Privado CEMAIC
city: Córdoba
country: Argentina
facility: Sanatorio Allende S.A.
city: Córdoba
country: Argentina
facility: Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral (cori)
city: Rosario
country: Argentina
facility: Hospital Provincial Del Centenario
city: San Miguel De Tucumán
country: Argentina
facility: CAIPO Centro para la atención integral del paciente oncológico
city: Santa Fe
country: Argentina
facility: Sanatorio Parque de Rosario
city: Orange
country: Australia
facility: Orange Cancer Centre
state: New South Wales
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie University
state: New South Wales
city: Kurralta Park
country: Australia
facility: Adelaide Cancer Centre
state: South Australia
city: Parkville
country: Australia
facility: Barwon Health
state: Victoria
city: Salvador
country: Brazil
facility: Centro de Oncologia Da Bahia
state: Bahia
city: Salvador
country: Brazil
facility: Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética
state: Bahia
city: Belo Horizonte
country: Brazil
facility: Cenantron - Centro Avancado de Tratamento Oncologico Ltda
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Oncocentro, Belo Horizonte
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
state: Parana
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
state: Rio Grande Do Norte
city: Ijuí
country: Brazil
facility: Associação Hospital de Caridade Ijuí
state: Rio Grande Do Sul
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul - UFRGS
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
state: Rio Grande Do Sul
city: Rio Grande
country: Brazil
facility: Clínica de Oncologia de Porto Alegre SS Ltda
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Instituto Joinvilense de Hematologia E Oncologia
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundação Pio XII Hospital de Câncer de Barretos
state: Sao Paulo
city: Campinas
country: Brazil
facility: Hospital das Clinicas - UNICAMP
state: Sao Paulo
city: Santo André
country: Brazil
facility: Fundação do ABC - Faculdade de Medicina do ABC
state: Sao Paulo
city: Jaú
country: Brazil
facility: Hospital Amaral Carvalho
state: São Paulo
city: Caxias Do Sul
country: Brazil
facility: Instituto de Pesquisas Clínicas Para Estudos Multicêntricos
city: Fortaleza
country: Brazil
facility: Instituto Do Câncer Do Ceará ICC
city: Lages
country: Brazil
facility: Animi
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Câncer
city: Rio De Janeiro
country: Brazil
facility: Instituto COI de Pesquisa, Educação e Gestão
city: São José Do Rio Preto
country: Brazil
facility: Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
city: São Paulo
country: Brazil
facility: Fundação Antônio Prudente - AC Camargo Câncer Center
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
city: Osorno
country: Chile
facility: Corporacion de Beneficencia Osorno
state: Los Lagos
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA
state: Los Rios
city: Santiago
country: Chile
facility: Oncovida
city: Santiago
country: Chile
facility: Clinica Santa Maria
city: Santiago
country: Chile
facility: Fundación Arturo López Pérez (FALP) - PPDS
city: Temuco
country: Chile
facility: Centro Investigacion Clinica Del Sur
city: Viña Del Mar
country: Chile
facility: Oncocentro APYS
city: Viña Del Mar
country: Chile
facility: Centro de Investigaciones Clínicas Vina del Mar
city: Ciudad de Mexico
country: Mexico
facility: Health Pharma Professional Research S.A de C.V.
state: Distrito Federal
city: Morelia
country: Mexico
facility: Centro de Investigacion Clinica Chapultepec S.A. de C.V.
state: Michoacan
city: Monterrey
country: Mexico
facility: Axis Heilsa S. De R.L. de C.V.
state: Nuevo León
city: Monterrey
country: Mexico
facility: Accelerium, S. de R.L. de C.V.
city: Puebla
country: Mexico
facility: Unidad Médica Onco-Hematológica
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Trujillo
country: Peru
facility: Clinica Peruana Americana
state: La Lobertad
city: Lima
country: Peru
facility: Clinica Internacional S.A. - Sede San Borja
city: Lima
country: Peru
facility: ONCOCARE S.A.C. (Clinica Aliada)
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia
city: Barnaul
country: Russian Federation
facility: Altay Regional Oncology Center
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncology Dispensary
city: Chelyabinsk
country: Russian Federation
facility: LLC Evimed
city: Kursk
country: Russian Federation
facility: Kursk Regional Oncology Centre
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital With Polyclinic of President Administration of RF
city: Obninsk
country: Russian Federation
facility: Federal State Institution Medical Radiology Research Center
city: Omsk
country: Russian Federation
facility: Clinical Oncology Dispensary
city: Pushkin
country: Russian Federation
facility: PMI Euromedservice
city: Saint Petersburg
country: Russian Federation
facility: Hospital Orkli LLC
city: Saint Petersburg
country: Russian Federation
facility: Railway Clinical Hospital JSC RZhD
city: Saint Petersburg
country: Russian Federation
facility: Hospital Orkli LLC
city: Volzhskiy
country: Russian Federation
facility: State Institution of Healthcare "Volgograd Regional Urology and Nephrology Centre"
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Oncology Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Singapore
country: Singapore
facility: Oncocare Cancer Centre
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References: