Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors

CompletadoFase 2ClinicalTrials.gov

ID: NCT02913313Tipo: INTERVENTIONALInicio: 30 de nov de 2016Fin estimado: 25 de ene de 2024

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization

Criterios de exclusión

Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll
Other active malignancy requiring concurrent intervention
Uncontrolled or significant cardiovascular disease
Active, known, or suspected autoimmune disease
NSCLC without prior treatment in the advanced or metastatic setting (Part 2C)

Intervenciones

drug

BMS-986207

Specified dose on specified days

biological

Nivolumab

Specified dose on specified days

biological

Ipilimumab

Specified dose on specified days

Ubicaciones

Local Institution - 0023

CABA, Buenos Aires F.D., Argentina

Local Institution - 0019

Córdoba, Córdoba Province, Argentina

Local Institution - 0022

Buenos Aires, Distrito Federal, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorOno Pharmaceutical Co. Ltd

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