A Phase 2/3 interventional study of Pumitamig and FOLFOX in Untreated, Unresectable, or Metastatic Colorectal Cancer, sponsored by Bristol-Myers Squibb. Recruiting at 286 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Bristol-Myers Squibb · Phase 2/3, Interventional, and Treatment
Among 20 studies in Colorectal Neoplasms by Bristol-Myers Squibb — 3 open to participants now, 6 under way, 2 of them phase 3. Colorectal Neoplasms · Bristol-Myers Squibb.
Among the 20 studies in Colorectal Neoplasms by Bristol-Myers Squibb, this one has the largest planned enrollment of the 19 interventional ones that give a count, is one of 4 that started in 2025, is one of 2 in phase 2/3, and was the 19th registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
Browse Colorectal Neoplasms studies →3 of the 20 studies in Colorectal Neoplasms by Bristol-Myers Squibb are open now, in 12 countries. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in United States, Canada, Spain
Bristol-Myers Squibb · Sites in United States, Australia, Canada
By country, each count listing its studies:
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 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.
20 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 13 · Phase 2 12 · Phase 3 4
First in 2006; this study’s year is marked. 4 started in 2025.
This study's planned enrollment of 990 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 213 across the 19 interventional studies, 124 across the 1 observational. Of the 14 that completed or were terminated, 7 (50%) 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 1,561 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.
2 of the studies in Colorectal 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 |
|---|---|
| NCT06544655Bristol-Myers SquibbA Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors | 2027-10-14 |
| NCT06764771Bristol-Myers SquibbA Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors | 2027-10-15 |
Among the 20 studies in Colorectal 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 bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
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.
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.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
Drug: Pumitamig · Drug: FOLFOX · Drug: FOLFIRI
Drug: Pumitamig · Drug: FOLFOX · Drug: FOLFIRI
Drug: FOLFOX · Drug: FOLFIRI · Drug: Bevacizumab
Drug: Pumitamig · Drug: FOLFOX · Drug: FOLFIRI · Drug: CAPOX
Drug: FOLFOX · Drug: FOLFIRI · Drug: Bevacizumab · Drug: CAPOX
Specified dose on specified days
Also known as: BMS-986545, BNT327, PM8002
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
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 5 years
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
Phase 3
Time frame: Up to 5 years
Overall Survival (OS)
Phase 3
Time frame: Up to 5 years
PFS by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to 5 years
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to 5 years
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to 5 years
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 5 years
Recommended dose of Pumitamig for Phase 3
Phase 2
Time frame: Up to 5 years
OR by RECIST v1.1 per BICR
Phase 3
Time frame: Up to 5 years
DOR by RECIST v1.1 per BICR
Phase 3
Time frame: Up to 5 years
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 286 sites across 25 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 Dec 2025 (actual). Primary completion is estimated for Feb 2030, 49 months after the start.
Of 36 phase 2/3 interventional studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 105. This study's planned 49 months is below 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