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

TerminadoFase 3ClinicalTrials.gov

ID: NCT03729245RENIS: IS002492Tipo: INTERVENTIONALInicio: 18 de dic de 2018Fin estimado: 19 de oct de 2022

Traducción no disponible, mostrando original

Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

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

Ubicaciones

Centro de Investigación Clínica - Clínica Viedma

Viedma, Río Negro Province, 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

Patrocinadores

PrincipalNektar Therapeutics

ColaboradorBristol-Myers Squibb

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