Last updated 11 days ago
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)
690 patients around the world
Available in Chile, Argentina, United States, Mexico, Brazil, Colombia
Bristol-Myers Squibb
10Research sites
690Patients around the world
This study is for people with
Gastric cancer
Gastroesophageal cancer
Gastroesophageal adenocarcinoma
Esophageal adenocarcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.Other protocol-defined Inclusion/Exclusion criteria apply.
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Centro Médico Fleischer
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
NOHC - Núcleo de Oncologia e Hematologia do Ceará
Recruiting
Instituto de Olhos Ciências Médicas - MG
Recruiting
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Hospital de Clínicas de Porto Alegre (HCPA)
Recruiting
Clínica Viver - Santa Maria
Recruiting
StudyROSETTA GI 204
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Gastric cancerGastroesophageal adenocarcinomaEsophageal adenocarcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07221149
