A Phase 1/2 interventional study of Pumitamig and Ipilimumab in Hepatocellular Carcinoma (HCC), sponsored by Bristol-Myers Squibb. Recruiting at 67 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment
Among 21 studies in Carcinoma, Hepatocellular by Bristol-Myers Squibb — 3 open to participants now, 4 under way, 1 of them phase 3. Carcinoma, Hepatocellular · Bristol-Myers Squibb.
Among the 21 studies in Carcinoma, Hepatocellular by Bristol-Myers Squibb, this one is the 10th largest by planned enrollment of the 19 interventional ones that give a count, is one of 2 that started in 2026, is one of 7 in phase 1/2, and was the 20th registered.
3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.
Browse Carcinoma, Hepatocellular studies →3 of the 21 studies in Carcinoma, Hepatocellular by Bristol-Myers Squibb are open now, in 12 countries. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in Japan
Ages 18+
RayzeBio, Inc. · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 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.
21 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 12 · Phase 2 9 · Phase 3 5
First in 2006; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 198 is above the median of 54 across 2,619 interventional studies indexed under Carcinoma, Hepatocellular.
Median enrollment 198 across the 19 interventional studies, 813 across the 2 observational. Of the 17 that completed or were terminated, 8 (47%) 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.
None of the studies under way reaches primary completion within a year.
Among the 21 studies in Carcinoma, Hepatocellular by Bristol-Myers Squibb, from their registry updates:
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 tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)
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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pumitamig · Drug: Ipilimumab
Drug: Pumitamig · Drug: Ipilimumab
Drug: Pumitamig · Drug: Ipilimumab
Drug: Pumitamig · Drug: Ipilimumab
Drug: Pumitamig
Drug: Pumitamig · Drug: Ipilimumab
Drug: Pumitamig · Drug: Ipilimumab
Specified dose on specified days
Also known as: BMS-986545
Specified dose on specified days
Also known as: Yervoy
Number of participants with adverse events (AEs)
Phase 1
Time frame: Up to approximately 25 weeks
Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))
Phase 1
Time frame: Up to approximately 25 weeks
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Phase 1
Time frame: Up to day 21
Number of participants with AEs leading to discontinuation
Phase 1
Time frame: Up to approximately 25 weeks
Number of participants with AEs leading to death
Phase 1
Time frame: Up to approximately 25 weeks
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 week 48
Number of participants with AEs
Phase 2
Time frame: Up to approximately 25 weeks
Number of participants with SAEs (as per CTCAE v5)
Phase 2
Time frame: Up to approximately 25 weeks
Number of participants with treatment-related adverse events (TRAEs)
Phase 2
Time frame: Up to approximately 25 weeks
Number of participants with AEs leading to discontinuation
Phase 2
Time frame: Up to approximately 25 weeks
Number of participants with AEs leading to death
Phase 2
Time frame: Up to approximately 25 weeks
End of infusion concentration of Pumitamig
Phase 2
Time frame: Up to day 21
End of trough concentration of Pumitamig
Phase 2
Time frame: Up to day 21
Trough concentration of Ipilimumab
Phase 2
Time frame: Up to day 21
Incidence of anti-drug antibodies against Pumitamig
Phase 2
Time frame: Up to 5 years
Incidence of anti-drug antibodies against Ipilimumab
Phase 2
Time frame: Up to 5 years
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to 4 years
Duration of response (DOR) (confirmed by PR or CR) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to 4 years
Not enrolling at this site — choose another above.
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 Oct 2029, 42 months after the start.
Of 72 industry-sponsored phase 1/2 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 74. This study's planned 42 months is below that.
Counting every sponsor, half of 136 studies reached it within 53 months; a quarter within 38 and three quarters within 76.
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.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pumitamig