A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

CompletadoFase 2ClinicalTrials.gov

ID: NCT03662659Tipo: INTERVENTIONALInicio: 16 de oct de 2018Fin estimado: 18 de ene de 2024

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma
Tumor tissue must be provided for biomarker analyses

Criterios de exclusión

Participants with HER2 positive status
Participants with known untreated central nervous system (CNS) metastases
Uncontrolled or significant cardiovascular disease

Intervenciones

biological

BMS-986213

Relatlimab + Nivolumab specified dose on specified days

biological

Nivolumab

Specified dose on specified days

drug

XELOX

Oxaliplatin + capecitabine

drug

FOLFOX

Oxaliplatin + leucovorin + fluorouracil

drug

SOX

Oxaliplatin + tegafur/gimeracil/oteracil potassium

Ubicaciones

Local Institution - 0010

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0009

Buenos Aires, Buenos Aires F.D., Argentina

Local Institution - 0011

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0078

CABA, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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