A Phase 1 Study to Compare Bempegaldesleukin Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011)

CompletadoFase 1ClinicalTrials.gov

ID: NCT04540705Tipo: INTERVENTIONALInicio: 11 de sept de 2020Fin estimado: 18 de ene de 2024

Traducción no disponible, mostrando original

Resumen

The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histological confirmation of renal cell carcinoma (RCC) with clear cell component including participants who may also have sarcomatoid features
Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer (AJCC) Stage 4) RCC
No prior systemic therapy, including prior PD-L1 therapy, for RCC is allowed with the following exception:
i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed. Therapy must have included an agent that targets vascular endothelial growth factor (VEGF) pathway or VEGF receptors and recurrence must have occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
Life Expectancy ≥ 12 weeks
Karnofsky Performance Status (KPS) of at least 70%
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria
Males and females must agree to follow specific methods of contraception, if applicable

Criterios de exclusión

Active CNS brain metastases or leptomeningeal metastases
Active, known or suspected autoimmune disease
Inadequately treated adrenal insufficiency
History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA/TIA arterial thromboembolic event (eg, internal jugular vein thrombosis) within 3 months prior to treatment assignment (Part 1) and randomization (Part 2)

Intervenciones

biological

Nivolumab

Specified dose on specified days

drug

Axitinib

Specified dose on specified days

drug

Cabozantinib

Specified dose on specified days

Ubicaciones

Local Institution - 0025

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0075

Río Cuarto, Córdoba Province, Argentina

Local Institution - 0026

Buenos Aires, Argentina

Local Institution - 0024

San Juan, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorNektar Therapeutics

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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