Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors

TerminadoFase 2ClinicalTrials.gov

ID: NCT03110107Tipo: INTERVENTIONALInicio: 4 de may de 2017Fin estimado: 4 de abr de 2024

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether BMS-986218 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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable)
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists
Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A)
Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B \& 2C)
Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D)

Criterios de exclusión

Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded
Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted

Intervenciones

biological

Ipilimumab

Specified dose on specified days

biological

BMS-986218

Specified dose on specified days

biological

Nivolumab

Specified dose on specified days

Ubicaciones

Local Institution - 0042

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0053

ABB, Buenos Aires F.D., Argentina

Local Institution - 0057

CABA, Buenos Aires F.D., Argentina

Local Institution - 0062

Córdoba, Córdoba Province, Argentina

Local Institution - 0060

Río Cuarto, Córdoba Province, Argentina

Local Institution - 0047

Villa Siburu, Córdoba Province, Argentina

Local Institution - 0059

Buenos Aires, Distrito Federal, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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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