A Phase 2/3 interventional study of Pumitamig and Folfox in Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma, sponsored by Bristol-Myers Squibb. Recruiting at 161 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Bristol-Myers Squibb · Phase 2/3, Interventional, and Treatment
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Among 14 studies in Stomach Neoplasms by Bristol-Myers Squibb — 1 open to participants now, 4 under way, 1 of them phase 3. Stomach Neoplasms · Bristol-Myers Squibb.
Among the 14 studies in Stomach Neoplasms by Bristol-Myers Squibb, this one is the 2nd largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2026, is one of 2 in phase 2/3, and was the 14th registered.
3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.
Browse Stomach Neoplasms studies →1 of the 14 studies in Stomach Neoplasms by Bristol-Myers Squibb is open now, in 12 countries.
By country, each count listing its studies:
Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 7 · Phase 3 3
First in 2001; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 690 is above the median of 66 across 2,500 interventional studies indexed under Stomach Neoplasms.
Median enrollment 143 across the 10 interventional studies, 500 across the 3 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
Bristol-Myers Squibb is the lead sponsor of 1,560 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
1 of the studies in Stomach Neoplasms by Bristol-Myers Squibb that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05165264Bristol-Myers SquibbA Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer | 2026-12-31 |
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Among the 14 studies in Stomach Neoplasms by Bristol-Myers Squibb, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pumitamig · Drug: Folfox · Drug: Capox
Drug: Pumitamig · Drug: Folfox · Drug: Capox
Drug: Pumitamig · Drug: Folfox · Drug: Capox
Drug: Folfox · Drug: Capox · Drug: Nivolumab
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Phase 2
Time frame: Up to 2 years after the last participant is randomized
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
Phase 3
Time frame: Up to approximately 33 months
Overall survival (OS)
Phase 3
Time frame: Up to approximately 47 months
PFS by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to approximately 33 months
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to approximately 33 months
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to approximately 33 months
Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to approximately 33 months
Recommended dose of Pumitamig for Phase 3
Phase 2
Time frame: Up to approximately 33 months
Objective response (OR) by RECIST v1.1 per BICR
Phase 3
Time frame: Up to approximately 33 months
DOR by RECIST v1.1 per BICR
Phase 3
Time frame: Up to approximately 33 months
Showing the first 100 of 161 sites across 20 countries. Choose a country and city above to see the rest.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Mar 2026 (actual). Primary completion is estimated for Nov 2030, 55 months after the start.
Of 26 phase 2/3 interventional studies under Stomach Neoplasms, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 52. This study's planned 55 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Pumitamig