A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-21... | EligiMed

A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients

CompletadoFase 2ClinicalTrials.gov

ID: NCT03785925Tipo: INTERVENTIONALInicio: 29 de abr de 2019Fin estimado: 30 de jun de 2022

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Provide written, informed consent to participate in the study and follow the study procedures
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Measurable disease per RECIST 1.1 criteria
Histologically or cytologically documented inoperable, locally advanced or metastatic urothelial cell carcinoma (also termed TCC)
Fresh biopsy or archival tissue
No prior systemic chemotherapy or investigational agent for inoperable locally advanced or mUC
Ineligible for cisplatin

Criterios de exclusión

Patients who have an active, known or suspected autoimmune disease
Patients must not have received prior IL-2 therapy
Prior treatment with an anti PD-1, anti PD-L1, or anti cytotoxic T lymphocyte associated protein 4 (anti CTLA-4) antibody, agents that target IL-2 pathway, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Patients with hypertension must be on a stable antihypertensive regimen for the 14 days prior to Cycle 1 Day 1

Intervenciones

biological

Bempegaldesleukin

Specified dose on specified days

biological

Nivolumab

Specified dose on specified days

Ubicaciones

Centro de Investigación Clínica - Clínica Viedma

Viedma, Río Negro Province, Argentina

Instituto de Oncologia de Rosario

Rosario, Santa Fe Province, Argentina

CAIPO Centro para la atención integral del paciente oncológico

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Alemán

Buenos Aires, Argentina

Instituto Médico Especializado Alexander Fleming

Buenos Aires, Argentina

Centro Médico Privado CEMAIC

Córdoba, Argentina

Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.

Córdoba, Argentina

Patrocinadores

PrincipalNektar Therapeutics

ColaboradorBristol-Myers Squibb

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