A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

CompletadoFase 2ClinicalTrials.gov

ID: NCT03994601Tipo: INTERVENTIONALInicio: 6 de sept de 2019Fin estimado: 31 de ago de 2024

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies

Criterios de exclusión

Active, known or suspected autoimmune disease
Active malignancy requiring concurrent intervention
Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded

Intervenciones

drug

BMS-986288

Specified dose on specified days

drug

Nivolumab

Specified dose on specified days

drug

Regorafenib

Specified dose on specified days

Ubicaciones

Local Institution - 0011

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0074

Buenos Aires, Buenos Aires F.D., Argentina

Local Institution - 0014

Córdoba, Córdoba Province, Argentina

Local Institution - 0013

Río Cuarto, Córdoba Province, Argentina

Local Institution - 0008

ABB, Distrito Federal, Argentina

Local Institution - 0012

CABA, Distrito Federal, Argentina

Local Institution - 0017

Buenos Aires, Argentina

Local Institution - 0016

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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