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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03729245
Other study ID # 17-214-09
Secondary ID CA045002
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 18, 2018
Est. completion date October 19, 2022

Study information

Verified date March 2023
Source Nektar Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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


Recruitment information / eligibility

Status Terminated
Enrollment 623
Est. completion date October 19, 2022
Est. primary completion date January 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Biological:
bempegaldesleukin
Specified dose on specified days
Drug:
sunitinib
Specified dose on specified days
Biological:
nivolumab
Specified dose on specified days
Drug:
cabozantinib
Specified dose on specified days

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Nektar Therapeutics Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Chile,  Mexico,  New Zealand,  Peru,  Russian Federation,  Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Approximately 32 months
Primary 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. Approximately 32 months
Secondary 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. Approximately 32 months
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