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Recruiting Phase 2/3 NCT07221149

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)

Phase 2/3 – combined trial
Conditions: Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
The purpose of this study is 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
Who can participate
Inclusion Criteria * 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. Exclusion Criteria * 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.
Locations 20
Argentina (1)
Local Institution - 0061
Ciudad Autónoma de Buenos Aires , Buenos Aires
NOT_YET_RECRUITING
Australia (1)
Local Institution - 0176
Liverpool , New South Wales
NOT_YET_RECRUITING
Brazil (1)
Local Institution - 0208
Fortaleza , Ceará
NOT_YET_RECRUITING
Canada (1)
Local Institution - 0088
Calgary , Alberta
NOT_YET_RECRUITING
Chile (1)
Local Institution - 0068
Santiago , Santiago Metropolitan
NOT_YET_RECRUITING
China (1)
Beijing Cancer hospital
Beijing , Beijing Municipality
Lin Shen, Site 0418
Colombia (1)
Local Institution - 0399
Pasto , Departamento de Nariño
NOT_YET_RECRUITING
France (1)
Local Institution - 0064
Brest , Finistère
NOT_YET_RECRUITING
Germany (1)
Local Institution - 0089
Berlin
NOT_YET_RECRUITING
India (1)
Local Institution - 0306
Nashik , Dādra and Nagar Haveli and Damān and Diu
NOT_YET_RECRUITING
Italy (1)
Local Institution - 0167
Naples , Campania
NOT_YET_RECRUITING
Japan (1)
Local Institution - 0014
Chiba , Chiba
NOT_YET_RECRUITING
Mexico (1)
Local Institution - 0396
Mexico City , DIF
NOT_YET_RECRUITING
Poland (1)
Local Institution - 0336
Jelenia Góra , Lower Silesian Voivodeship
NOT_YET_RECRUITING
Romania (1)
Local Institution - 0010
Cluj-Napoca , Cluj
NOT_YET_RECRUITING
South Korea (1)
Local Institution - 0034
Seongnam , Kyǒnggi-do
NOT_YET_RECRUITING
Spain (1)
Local Institution - 0388
Barcelona , Barcelona [Barcelona]
NOT_YET_RECRUITING
Turkey (1)
Local Institution - 0111
Ankara
NOT_YET_RECRUITING
United Kingdom (1)
Local Institution - 0316
London , London, City of
NOT_YET_RECRUITING
United States (1)
Local Institution - 0284
Phoenix , Arizona
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
13.03.2026
Completion date
11.09.2032
Registry ID
NCT07221149
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.