ROSETTA Gastric-204: Estudio Ciego, Aleatorizado de Fase 2/3 de Pumitamig en Combinación con Quimioterapia Versus Nivolumab en Combinación con Quimioterapia en Participantes con Adenocarcinoma Gástrico, de la Unión Gastroesofágica o Esofágico Avanzado o Metastásico no Tratado Previamente

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07221149Tipo: INTERVENTIONALInicio: 31 de mar de 2026Fin estimado: 11 de sept de 2032

Resumen

El objetivo de este estudio es evaluar la seguridad y eficacia de pumitamig en combinación con quimioterapia versus nivolumab en combinación con quimioterapia en participantes con adenocarcinoma gástrico, de la unión gastroesofágica o esofágico avanzado o metastásico no tratado previamente.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.
Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1.
Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.
Participants must have measurable disease as defined by RECIST v1.1.

Criterios de exclusión

Participants must not have untreated known central nervous system (CNS) metastases.
Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
Participants must not have evidence of major coagulation disorders (eg, hemophilia).
Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a prophylactic dose.
Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.
Participants must not have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.

Intervenciones

drug

Pumitamig

Specified dose on specified days

drug

Folfox

Specified dose on specified days

drug

Capox

Specified dose on specified days

drug

Nivolumab

Specified dose on specified days

Ubicaciones

Local Institution - 0061

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site 0061

NOT_YET_RECRUITING

Local Institution - 0066

ABB, Buenos Aires F.D., Argentina

Site 0066

NOT_YET_RECRUITING

Local Institution - 0069

Buenos Aires, Argentina

Site 0069

NOT_YET_RECRUITING

Local Institution - 0054

Buenos Aires, Argentina

Site 0054

NOT_YET_RECRUITING

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorBioNTech SE

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

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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