A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05152147RENIS: IS003536Tipo: INTERVENTIONALInicio: 2 de dic de 2021Fin estimado: 31 de jul de 2027

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Resumen

This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Subjects with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at the time of enrollment
Assessable (measurable or non-measurable) disease as defined by RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed within 3 days prior to randomization
Adequate organ function
Left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA)

Criterios de exclusión

Prior treatment with a HER2-targeted agent, with the exception of subjects who received HER2-targeted treatment for breast cancer \> 5 years prior to initial diagnosis of GEA
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Prior treatment with systemic antineoplastic therapy or intraperitoneal chemotherapy for unresectable locally advanced, recurrent or metastatic GEA
Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks prior to randomization. Stable, treated brain metastases are allowed (defined as subjects who are completely off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks prior to randomization)
Known history of or ongoing leptomeningeal disease (LMD)
Known additional malignancy that is not considered cured or that has required treatment within the past 3 years
Known active hepatitis
Any history of human immunodeficiency virus (HIV) infection
Known SARS-CoV-2 infection; subjects with prior infection that has resolved per local institutions' requirements and screening guidance are eligible
QTc Fridericia (QTcF) \> 470 ms
Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF)

Intervenciones

drug

Zanidatamab

Administered IV

drug

Tislelizumab

Administered IV

drug

Trastuzumab

Administered intravenously (IV)

drug

Capecitabine

Administered orally (PO bid)

drug

Oxaliplatin

Administered IV

drug

Cisplatin

Administered IV

drug

5-Fluorouracil

Administered IV

Ubicaciones

Hospital de Gastroenterología Dr Bonorino Udaondo

Buenos Aires, Argentina

Instituto de Investigaciones Metabólicas - IDIM

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Fundación Centro de Medicina Nuclear y Molecular ER

Córdoba, Argentina

Centro Médico Privado CEMAIC

Córdoba, Argentina

Centro de Investigación Pergamino S.A.

Pergamino, Argentina

Centro de Investigación Clínica - Clínica Viedma

Viedma, Argentina

Patrocinadores

PrincipalJazz Pharmaceuticals

ColaboradorBeOne Medicines LTD

ColaboradorBeOne Pharmaceutical Co., Ltd.

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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