A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

CompletadoFase 2ClinicalTrials.gov

ID: NCT03369223Tipo: INTERVENTIONALInicio: 6 de dic de 2017Fin estimado: 7 de nov de 2024

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists
Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
Willing and able to comply with all study procedures

Criterios de exclusión

Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
Other active malignancy requiring concurrent intervention
Prior organ allograft
Active, known, or suspected autoimmune disease

Intervenciones

biological

BMS-986249

Specified dose on specified days

biological

Nivolumab

Specified dose on specified days

biological

Ipilimumab

Specified dose on specified days

Ubicaciones

Local Institution - 0038

Buenos Aires, Distrito Federal, Argentina

Local Institution - 0052

CABA, Distrito Federal, Argentina

Local Institution - 0037

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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