OncoMatch/Clinical Trials/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)
Is NCT07221149 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments including Pumitamig and Folfox for untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma.
Treatment: Pumitamig · Folfox · Capox · Nivolumab — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) overexpression (PD-L1 ≥ 1)
Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1.
Required: HER2 (ERBB2) negative
Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.
Disease stage
Metastatic disease required
Prior therapy
Lab requirements
Cardiac function
No significant cardiovascular disease (myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months, uncontrolled hypertension ≥ 160/100 mm Hg despite optimal medical management, or congenital long QT syndrome)
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Local Institution - 0284 · Phoenix, Arizona
- Local Institution - 0437 · Los Angeles, California
- Local Institution - 0277 · Orange, California
- Local Institution - 0428 · San Francisco, California
- Florida Cancer Specialists - South · Fort Myers, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07221149 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify