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NCT07221149 · ClinicalTrials.gov registry record · Phase 2

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 Phase 2 study of Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma, sponsored by Bristol-Myers Squibb.

Recruiting
Registry status
Phase 2
Development phase
690
Enrollment target
20
Study locations

NCT07221149: Recruiting Phase 2 study of Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma, sponsored by Bristol-Myers Squibb.

NCT07221149 is a Phase 2 study of Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 690 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (419% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07221149, a Phase 2 study of Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma, is actively recruiting participants, sponsored by Bristol-Myers Squibb.

RECRUITING
Registry status
Phase 2
Development phase
690 participants
Enrollment target
20
Study locations

Study Summary

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

Primary Outcome

Phase 2

Conditions Studied

Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Interventions

  • DRUG Nivolumab
  • DRUG Pumitamig
  • DRUG Folfox
  • DRUG Capox

Study Locations (20)

Florida

  • Florida Cancer Specialists - South - Fort Myers
  • Local Institution - 0433 - Jacksonville
  • Florida Cancer Specialists - North - St. Petersburg
  • Local Institution - 0246 - Tampa

California

  • Local Institution - 0437 - Los Angeles
  • Local Institution - 0277 - Orange
  • Local Institution - 0428 - San Francisco

New York

  • Local Institution - 0386 - Lake Success
  • Local Institution - 0242 - New York
  • Local Institution - 0274 - Rochester

Arizona

  • Local Institution - 0284 - Phoenix

Georgia

  • Local Institution - 0377 - Atlanta

Illinois

  • Local Institution - 0379 - Chicago

Iowa

  • Local Institution - 0268 - Iowa City

Minnesota

  • Local Institution - 0259 - Rochester

Trial Details

FieldValue
Enrollment Target 690 participants
Start Date 2026-03-31
Est. Completion 2032-09-11
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What NCT07221149 shows while recruiting

NCT07221149 is an interventional study that assigns participants to a tested intervention. The registered 690 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (419% higher).

The record links to 1 condition, with Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab is the first listed.

NCT07221149 names 20 study sites across 13 states, led by Florida, California, New York.

Frequently Asked Questions

What is clinical trial NCT07221149 about?

NCT07221149 is a clinical study titled "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)". 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

What is the current status of trial NCT07221149?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 690 participants. The study started on 2026-03-31. Estimated completion is 2032-09-11.

What conditions does trial NCT07221149 study?

This clinical trial studies the following conditions: Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma.

What interventions are being tested in trial NCT07221149?

The interventions under investigation include: Nivolumab (DRUG), Pumitamig (DRUG), Folfox (DRUG), Capox (DRUG).

Who is sponsoring clinical trial NCT07221149?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07221149 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT07221149's enrollment target sits among peer trials

690 46th of 2000 higher than 1,955 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07221149

Source: ClinicalTrials.gov NCT07221149, the US trial registry maintained by the National Library of Medicine. NCT07221149 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.