A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors

CompletadoFase 1ClinicalTrials.gov

ID: NCT04943900Tipo: INTERVENTIONALInicio: 9 de ago de 2021Fin estimado: 27 de feb de 2025

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor
Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC)
Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit
Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
Disease amenable to serial biopsy

Criterios de exclusión

Uncontrolled or significant cardiovascular disease
Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted)

Intervenciones

drug

BMS-986416

Specified dose on specified days

drug

Nivolumab

Specified dose on specified days

Ubicaciones

Local Institution - 0021

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0027

ABB, Buenos Aires F.D., Argentina

Local Institution - 0022

CABA, Buenos Aires F.D., Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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