Oncology Cardiology / Cardiovascular Respiratory / COPD / Asthma Infectious Disease Gastroenterology Neurology Rheumatology Diabetes / Metabolic Mental Health / Psychiatry Women's Health Dermatology Men's Health Rare Diseases
Clinical Trial ● Currently Recruiting Phase II 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)

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…

📅 02 Apr 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase II
NCT ID
NCT07221149
Sponsor
Bristol-Myers Squibb
Start
2026-03-13
ClinicaliQ Trial Snapshot
  • 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) — Recruiting • Phase II •….
  • 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.
  • Sponsor: Bristol-Myers Squibb.

Verify eligibility, endpoints and current status on the original source registry before acting on this summary.

Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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

Eligibility Snapshot
  • * 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.

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
View Trial ↗
Share: Twitter/X LinkedIn
Related

Related Clinical Intelligence

Guidelines, Drug Science, safety briefs and education connected to this trial area.

Guideline
Nivolumab with chemotherapy for untreated unresectable or metastatic urothelial cancer (terminated appraisal)
Oncology · 17 Mar 2026
I appreciate your request, but I need to be transparent: the content provided only includes the title, metadata, and editorial notes -…
View guideline →
Guideline
Oesophago-Gastric Cancer: Assessment and Management (NICE NG83)
Oncology · 27 Mar 2026
Multimodal treatment with neoadjuvant chemotherapy followed by surgical resection improves survival for locally advanced oesophago-gastric junction and gastric adenocarcinomas. HER2 testing is…
View guideline →
Guideline
EMA Reflection Paper on Extrapolation of Efficacy in Oncology
Oncology · 30 Mar 2026
This EMA guideline addresses EMA Reflection Paper on Extrapolation of Efficacy in Oncology in Oncology. Use it to review current recommendation wording,…
View guideline →
Guideline
Pembrolizumab for neoadjuvant and adjuvant treatment of resectable locally advanced head and neck squamous cell carcinoma
Oncology · 21 Apr 2026
Pembrolizumab is recommended as neoadjuvant treatment prior to surgery for resectable locally advanced head and neck squamous cell carcinoma, followed by adjuvant…
View guideline →
Guideline
Zanidatamab for treating HER2-positive advanced biliary tract cancer after 1 or more lines of systemic treatment
Oncology · 07 May 2026
Zanidatamab is recommended by NICE as an option for HER2-positive advanced biliary tract cancer only after 1 or more prior lines of…
View guideline →
Guideline
Head and Neck Cancers: Diagnosis and Management (NICE NG36)
Oncology · 27 Mar 2026
Refer urgently (two-week wait) any adult with unexplained persistent hoarseness, dysphagia, otalgia, oral ulceration lasting more than 3 weeks, or suspicious neck…
View guideline →