A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05568095Tipo: INTERVENTIONALInicio: 21 de nov de 2022Fin estimado: 1 de jun de 2026

Traducción no disponible, mostrando original

Resumen

This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.
Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Criterios de exclusión

Underlying medical or psychiatric conditions that, in the investigator's or sponsor's opinion, will make the administration of study-specified therapy hazardous, including but not limited to:
Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization.
Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina, or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization.
History of prior solid-organ transplantation, including allogenic bone marrow transplantation.
Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial.
Known human epidermal growth factor receptor 2 (HER-2) positive tumor.
Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
Disease progression within 6 months of completion of neoadjuvant or adjuvant therapy.

Intervenciones

drug

Domvanalimab

Intravenous (IV) Aqueous Solution

drug

Zimberelimab

IV Aqueous Solution

drug

Capecitabine

Oral Tablets

drug

Fluorouracil

IV Aqueous Solution

drug

Leucovorin

IV Aqueous Solution

drug

Oxaliplatin

IV Aqueous Solution

drug

Nivolumab

IV Aqueous Solution

Ubicaciones

Hospital Británico de Buenos Aires

Buenos Aires, Argentina

CORI

La Rioja, Argentina

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Argentina

Patrocinadores

PrincipalArcus Biosciences, Inc.

ColaboradorGilead Sciences

ColaboradorTaiho Pharmaceutical Co., Ltd.

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