RecruitingPHASE2, PHASE3INTERVENTIONAL

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)

This research study is investigating two drug combinations for people with advanced or spread stomach (gastric), gastroesophageal junction (the area where the food pipe meets the stomach), or oesophageal (food pipe) cancer, who haven't received prior treatment for their advanced disease. One combination involves a new drug called Pumitamig, given alongside standard chemotherapy (Folfox or Capox). The other combination uses Nivolumab, an existing immunotherapy drug, also with chemotherapy. The main goal is to compare the safety of these two approaches and see how well each combination helps to control the cancer. This is a large, multi-stage study, involving many participants to gather robust information.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

690

Start

13 Mar 2026

Estimated completion

11 Sep 2032

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

What is this study about?

This study is about finding better ways to treat advanced stomach, gastroesophageal junction (the area where your food pipe meets your stomach), or oesophageal (food pipe) cancer that has spread or can’t be removed by surgery. If you haven't received treatment for your advanced cancer yet, this study might be relevant to you.

The study is comparing two different treatment approaches. One approach involves a new, investigational drug called Pumitamig, given together with standard chemotherapy. The other approach uses an existing immune-boosting drug called Nivolumab, also given with standard chemotherapy. Chemotherapy options mentioned are Folfox or Capox, which are common treatments for these types of cancer. Doctors want to understand if Pumitamig with chemotherapy is a safe and effective option, and how it compares to Nivolumab with chemotherapy.

The study has two parts (Phase 2 and Phase 3). Phase 2 is usually a smaller study to get an initial idea of safety and effectiveness, while Phase 3 is a larger study designed to confirm these findings. By comparing these treatments, the researchers hope to find improved options for people living with these cancers.

Key takeaways

Tests new drug Pumitamig or existing drug Nivolumab, both with standard chemotherapy.
For advanced stomach, gastroesophageal junction, or oesophageal cancer.
Participants must not have received prior treatment for their advanced cancer.
Aims to compare safety and effectiveness of these two treatment approaches.
Involves regular medical checks and monitoring.
Participation is voluntary; you can withdraw at any time.

Who may be eligible?

To be considered for this study, you must have advanced stomach, gastroesophageal junction, or oesophageal cancer that has spread and you haven't received any previous treatment for this advanced stage of your cancer. Your cancer will need to be confirmed as HER2-negative, and doctors will also check specific markers in your cancer tissue called PD-L1. You will also need to have areas of cancer that can be measured to see if the treatment is working.

There are also certain health conditions that would prevent you from taking part. For example, if you have untreated cancer that has spread to your brain or spinal cord, or if you have serious heart problems, blood clotting issues, or recent major surgery, you would likely not be able to join. The doctors will conduct thorough checks to ensure the study is safe for you.

Your study doctor will carefully go through all the detailed requirements with you to see if this study could be a suitable option.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have advanced stomach, gastroesophageal junction, or oesophageal cancer that has spread?
Have you *not* had any previous drug treatment for your advanced cancer?
Has your cancer been confirmed as HER2-negative?
Have doctors identified specific markers (PD-L1) in your cancer tissue?
Do you have areas of cancer that can be measured on scans?
Do you have any serious heart conditions or recent major surgery? (These might prevent you from joining)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either Pumitamig with chemotherapy (Folfox or Capox) or Nivolumab with chemotherapy. The specific schedule of treatments, doctor visits, and blood tests will be explained in detail. You will have regular appointments and medical checks to monitor your health and how the treatment is affecting your cancer. These checks will include scans and other tests. The total duration of your participation will depend on how you respond to the treatment and the study's design, but it will involve ongoing assessments and follow-up.

Potential risks and benefits

Like all medical treatments, those in this study have potential benefits and potential risks. The potential benefit is that one of these new combinations might help control your cancer more effectively than other treatments. However, there's no guarantee the treatment will work for everyone, and all medications can cause side effects. These could range from mild to serious, and the study team will discuss all known and potential side effects with you before you agree to take part. Remember, joining any clinical trial is entirely voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (163)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Local Institution - 0284
Verified postcode
Phoenix, United States· Not yet recruiting
Local Institution - 0437
Verified postcode
Los Angeles, United States· Not yet recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Verified postcode
Orange, United States· Recruiting
Local Institution - 0428
Verified postcode
San Francisco, United States· Not yet recruiting
Florida Cancer Specialists - South
Verified postcode
Fort Myers, United States· Recruiting
Local Institution - 0433
Verified postcode
Jacksonville, United States· Not yet recruiting
Florida Cancer Specialists - North
Verified postcode
St. Petersburg, United States· Recruiting
Local Institution - 0246
Verified postcode
Tampa, United States· Not yet recruiting
Local Institution - 0377
Verified postcode
Atlanta, United States· Not yet recruiting
Local Institution - 0379
Verified postcode
Chicago, United States· Not yet recruiting
Local Institution - 0268
Verified postcode
Iowa City, United States· Not yet recruiting
Local Institution - 0259
Verified postcode
Rochester, United States· Not yet recruiting

Common questions

What type of cancer is this study for?

This study is for advanced stomach, gastroesophageal junction (where the food pipe meets the stomach), or oesophageal (food pipe) cancer that has spread.

What does 'untreated' mean in this study?

It means you haven't had any previous drug treatments (like chemotherapy) specifically for your advanced or spread cancer.

What are the treatments being looked at?

The study is comparing two approaches: the new drug Pumitamig with chemotherapy, or Nivolumab (an existing drug) with chemotherapy.

Will I know which treatment I'm getting?

In many trials like this, participants are randomly assigned to one treatment group or another, and sometimes neither you nor your doctor will know which one you are receiving (this is called 'blinded'). Your study team will explain how this works.

Can I leave the study if I change my mind?

Yes, taking part in a clinical trial is always voluntary. You can choose to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.