NCT03251924 is a Phase 1, PHASE2 clinical trial of BMS-986226 in Cancer, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT03251924?

NCT03251924 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT03251924?

Interventions in NCT03251924: BMS-986226, Nivolumab, Ipilimumab, Tetanus Vaccine.

What condition does NCT03251924 study?

NCT03251924 studies Cancer, Tumors, Neoplasm, Malignancy.

Is NCT03251924 still recruiting?

NCT03251924 is currently terminated. Last updated 28 February 2023.

Are results published for NCT03251924?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-02-28 · How we verify

NCT03251924

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors

Terminated Phase 1, PHASE2 Results posted Last updated 28 February 2023

What this trial tests

Phase 1, PHASE2 trial testing BMS-986226 in Cancer in 80 participants. Terminated before completion.

Timeline

1 September 2017

Primary endpoint
20 December 2021

20 December 2021

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	1 September 2017
Primary completion	20 December 2021
Estimated completion	20 December 2021
Sites	13 locations across Switzerland, Canada, United States, Spain

Drugs / interventions tested

BMS-986226
Nivolumab (nivolumab) — full drug profile →
Ipilimumab — full drug profile →
Tetanus Vaccine — full drug profile →

Conditions studied

Cancer — all drugs for Cancer →
Tumors — all drugs for Tumors →
Neoplasm — all drugs for Neoplasm →
Malignancy — all drugs for Malignancy →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Cancer or Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Participants Experiencing Adverse Events (AEs) Primary · From first dose up to 100 days post last dose, up to approximately 31 months

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	6
Preliminary - BMS-986226 8 mg	7
Part A - BMS-986226 25 mg	7
Part A - BMS-986226 80 mg	11
Part A - BMS-986226 200 mg	9
Part A - BMS-986226 400 mg	9
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	10
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	12
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	9

The Number of Participants Experiencing Serious Adverse Events (SAEs) Primary · From first dose up to 100 days post last dose, up to approximately 31 months

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	2
Preliminary - BMS-986226 8 mg	3
Part A - BMS-986226 25 mg	2
Part A - BMS-986226 80 mg	10
Part A - BMS-986226 200 mg	5
Part A - BMS-986226 400 mg	9
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	5
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	9
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	5

The Number of Participants Experiencing Adverse Events (AEs) Meeting Dose Limiting Toxicity (DLT) Criteria Primary · From first dose up to 100 days post last dose, up to approximately 31 months

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Dose limiting toxicity (DLT) is defined based on the incidence, intensity, and duration of AEs for which no clear alternative cause is identified. The DLT period will be 28 days (4 weeks) in the Preliminary Safety Cohorts. Any toxicities that occur beyond the 4-week DLT period will also be considered in dose-level decisions. For th

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	0
Preliminary - BMS-986226 8 mg	0
Part A - BMS-986226 25 mg	0
Part A - BMS-986226 80 mg	1
Part A - BMS-986226 200 mg	0
Part A - BMS-986226 400 mg	0
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	1
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0

The Number of Participants Experiencing Adverse Events Leading to Discontinuation Primary · From first dose up to 100 days post last dose, up to approximately 31 months

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	0
Preliminary - BMS-986226 8 mg	0
Part A - BMS-986226 25 mg	0
Part A - BMS-986226 80 mg	1
Part A - BMS-986226 200 mg	1
Part A - BMS-986226 400 mg	4
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	3
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	2

The Number of Participants Experiencing Adverse Events Resulting in Death Primary · From first dose up to 100 days post last dose, up to approximately 31 months

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	5
Preliminary - BMS-986226 8 mg	3
Part A - BMS-986226 25 mg	5
Part A - BMS-986226 80 mg	8
Part A - BMS-986226 200 mg	5
Part A - BMS-986226 400 mg	7
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	7
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	8
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	5

The Number of Participants Experiencing Clinical Laboratory Abnormalities Primary · From first dose up to 30 days post last dose (approximately 28 months)

The number of participants experiencing abnormal laboratory results of Grade 3 or higher. Laboratory values will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 with Grade 3=severe and Grade 4=life threatening.

HEMOGLOBIN

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	1
Preliminary - BMS-986226 8 mg	0
Part A - BMS-986226 25 mg	0
Part A - BMS-986226 80 mg	1
Part A - BMS-986226 200 mg	1
Part A - BMS-986226 400 mg	2
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	1
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	1

LYMPHOCYTES (ABSOLUTE)

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	0
Preliminary - BMS-986226 8 mg	1
Part A - BMS-986226 25 mg	1
Part A - BMS-986226 80 mg	3
Part A - BMS-986226 200 mg	2
Part A - BMS-986226 400 mg	3
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	2
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	4
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	3

LYMPHOCYTES (RELATIVE)

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	0
Preliminary - BMS-986226 8 mg	1
Part A - BMS-986226 25 mg	0
Part A - BMS-986226 80 mg	0
Part A - BMS-986226 200 mg	0
Part A - BMS-986226 400 mg	1
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	1
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	0
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0

ALKALINE PHOSPHATASE

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	0
Preliminary - BMS-986226 8 mg	0
Part A - BMS-986226 25 mg	0
Part A - BMS-986226 80 mg	2
Part A - BMS-986226 200 mg	1
Part A - BMS-986226 400 mg	2
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	3
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	2
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0

ASPARTATE AMINOTRANSFERASE

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	0
Preliminary - BMS-986226 8 mg	0
Part A - BMS-986226 25 mg	0
Part A - BMS-986226 80 mg	1
Part A - BMS-986226 200 mg	1
Part A - BMS-986226 400 mg	0
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	1
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	1
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	1

ALANINE AMINOTRANSFERASE

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	0
Preliminary - BMS-986226 8 mg	0
Part A - BMS-986226 25 mg	0
Part A - BMS-986226 80 mg	0
Part A - BMS-986226 200 mg	1
Part A - BMS-986226 400 mg	0
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	1
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	0
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	1

G-GLUTAMYL TRANSFERASE

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	1
Preliminary - BMS-986226 8 mg	2
Part A - BMS-986226 25 mg	1
Part A - BMS-986226 80 mg	4
Part A - BMS-986226 200 mg	3
Part A - BMS-986226 400 mg	2
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	6
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	3
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	1

BILIRUBIN, TOTAL

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	0
Preliminary - BMS-986226 8 mg	0
Part A - BMS-986226 25 mg	0
Part A - BMS-986226 80 mg	2
Part A - BMS-986226 200 mg	1
Part A - BMS-986226 400 mg	0
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	0
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0

Objective Response Rate (ORR) Secondary · From first dose up to documented disease progression, up to 48 months

ORR is defined as the percentage of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) as assessed by investigator per RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. BOR for a participant is defined as the best response designation recorded be

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	0	0.0 – 45.9
Preliminary - BMS-986226 8 mg	0	0.0 – 41.0
Part A - BMS-986226 25 mg	0	0.0 – 41.0
Part A - BMS-986226 80 mg	0	0.0 – 28.5
Part A - BMS-986226 200 mg	0	0.0 – 33.6
Part A - BMS-986226 400 mg	0	0.0 – 33.6
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0	0.0 – 30.8
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	8.3	0.2 – 38.5
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0	0.0 – 33.6

Median Duration of Response (DOR) Secondary · From first dose up to the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 24 months)

DOR for a participant with confirmed response is defined as the time from the date of first response CR or PR to the date of first objectively documented tumor progression as determined using RECIST v1.1 or death due to any cause, whichever occurs first. Participant who remain alive and have not progressed will be censored on the date of their last tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance

Group	Value	95% CI
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	NA	23.4 – 23.4

Progression Free Survival (PFS) Rate at 24 Weeks Secondary · At 24 weeks

The PFSR is defined as the Kaplan Meier estimate of percentage of treated participants remaining progression free and surviving at the prespecified timepoint of 24 weeks since the first dosing date. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of 1 or more new lesions is also considere

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	16.7	0.8 – 51.7
Preliminary - BMS-986226 8 mg	0	0 – 0
Part A - BMS-986226 25 mg	0	0 – 0
Part A - BMS-986226 80 mg	0	0 – 0
Part A - BMS-986226 200 mg	0	0 – 0
Part A - BMS-986226 400 mg	0	0 – 0
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0	0 – 0
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	8.3	0.5 – 31.1
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	18.8	1.1 – 53.5

Number of Participants With Anti-Drug Antibodies (ADA) for BMS-986226 Secondary · Predose on cycles 1-6, post dose on C1D15, and 30, 60, and 100 days post last dose (up to approximately 31 months)

ADA for BMS-986226 is defined as the number of participants found to have seroconverted or boosted their pre-existing ADA during the study period. Baseline ADA positive is defined as ADA is detected in the last sample before initiation of treatment. ADA positive is defined as 1) an ADA detected (positive seroconversion) sample in a participant for whom ADA is not detected at baseline, or (2) an ADA detected sample with ADA titer to be at least 4-fold or greater (≥) than baseline positive titer.

Baseline ADA Positive

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	0
Preliminary - BMS-986226 8 mg	0
Part A - BMS-986226 25 mg	0
Part A - BMS-986226 80 mg	1
Part A - BMS-986226 200 mg	0
Part A - BMS-986226 400 mg	1
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	0
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	0

ADA Positive after initiation of treatment

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	4
Preliminary - BMS-986226 8 mg	6
Part A - BMS-986226 25 mg	3
Part A - BMS-986226 80 mg	8
Part A - BMS-986226 200 mg	4
Part A - BMS-986226 400 mg	4
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	8
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	9
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	8

Changes From Baseline in Cell Surface ICOS Expression on T Cells Secondary · From baseline up to pre-dose and 4 hours post dose on C1D1 and pre-dose and 4 hours post dose on C2D1 (approximately 31 months)

Summary measures of changes in Median of Fluorescence of ICOS (MFI) from baseline to the last evaluable time point in cell surface Inducible Costimulator (ICOS) expression on T cells. Baseline = last non missing value prior or on to the first dosing. MFI is a unit for median fluorescence intensity. This unit allows for measurement of relative expression of cell surface markers by a flow cytometer. For the ICOS expression assay, whole blood samples collected from patients on study were incubated with fluorescently labeled antibodies that specifically bind to ICOS. Samples were then analyzed for

Baseline Response

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	985.5	554 – 1243
Preliminary - BMS-986226 8 mg	659.0	455 – 775
Part A - BMS-986226 25 mg	878.0	599 – 1361
Part A - BMS-986226 80 mg	482	197 – 912
Part A - BMS-986226 200 mg	434.0	169 – 884
Part A - BMS-986226 400 mg	634.0	94 – 1166
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	592.0	162 – 933
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	714.0	234 – 1438
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	506.5	20 – 943

C1D1- Pre-Dose

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	-394.0	-394 – 394
Part A - BMS-986226 400 mg	-636.0	-636 – -636

C1D1- 4 hours post dose

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	-1049.0	-1049 – -1049
Preliminary - BMS-986226 8 mg	-603.0	-603 – -603
Part A - BMS-986226 25 mg	-762.0	-847 – -565
Part A - BMS-986226 80 mg	-391.0	-635 – -176
Part A - BMS-986226 200 mg	-324.0	-481 – -95
Part A - BMS-986226 400 mg	-545.0	-1029 – -184
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	-382.5	-649 – -116
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	-654.5	-1405 – -214
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	-490.0	-928 – -429

C2D1- Pre-Dose

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	-421.0	-729 – -31
Preliminary - BMS-986226 8 mg	-26.0	-538 – 104
Part A - BMS-986226 25 mg	-414.0	-1101 – 630
Part A - BMS-986226 80 mg	-153.0	-774 – -38
Part A - BMS-986226 200 mg	-185.0	-865 – -177
Part A - BMS-986226 400 mg	-627.0	-632 – -622
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	-294.0	-500 – 308
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	-185.5	-1155 – 430
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	11.5	-104 – 148

C2D1- 4 hours post dose

Group	Value	95% CI
Part A - BMS-986226 80 mg	-167.5	-229 – -106
Part A - BMS-986226 200 mg	-336.5	-507 – -166
Part A - BMS-986226 400 mg	-567.0	-615 – -372
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	-465.5	-911 – 254

Changes From Baseline in ICOS Ligand+ B Cells Secondary · From baseline up to pre-dose and 4 hours post dose on C1D1, 72 hours post dose on C1D4, and pre-dose on C2D1 (approximately 31 months)

Summary measures of changes in Median of Fluorescence of ICOS (MFI) from baseline to the last evaluable time point in ICOS ligand+ B cells in the tumor and peripheral blood. Baseline = last non missing value prior or on to the first dosing. MFI is a unit for median fluorescence intensity. This unit allows for measurement of relative expression of cell surface markers by a flow cytometer. For the ICOS expression assay, whole blood samples collected from patients on study were incubated with fluorescently labeled antibodies that specifically bind to ICOS. Samples were then analyzed for changes i

Baseline Response

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	-9.0	-94 – 185
Preliminary - BMS-986226 8 mg	-33.0	-70 – 67
Part A - BMS-986226 25 mg	2.5	-99 – 95
Part A - BMS-986226 80 mg	40.5	-90 – 127
Part A - BMS-986226 200 mg	-60.5	-171 – 74
Part A - BMS-986226 400 mg	57.0	-100 – 182
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	-15.0	-79 – 70
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	-11.5	-113 – 41
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	39.0	-56 – 103

C1D1 - 4 hours post dose

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	-106.0	-106 – -106
Preliminary - BMS-986226 8 mg	-2.0	-2 – -2
Part A - BMS-986226 25 mg	-3.0	-48 – 37
Part A - BMS-986226 80 mg	1.0	-9 – 23
Part A - BMS-986226 200 mg	-13.5	-55 – 0
Part A - BMS-986226 400 mg	9.5	-16 – 99
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	3.5	1 – 6
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	0.0	-14 – 37
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	-6.0	-21 – 40

C1D4- 72 hours post dose

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	11.0	-181 – 58
Preliminary - BMS-986226 8 mg	102.0	-28 – 190
Part A - BMS-986226 25 mg	170.0	118 – 210
Part A - BMS-986226 80 mg	37.0	-143 – 231
Part A - BMS-986226 200 mg	64.5	-71 – 127
Part A - BMS-986226 400 mg	29.0	-106 – 88
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	90.0	17 – 163
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	70.0	3 – 143
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	33.5	-28 – 121

C2D1- Pre dose

Group	Value	95% CI
Preliminary - BMS-986226 2 mg	-4.0	-267 – 54
Preliminary - BMS-986226 8 mg	-24.0	-211 – 24
Part A - BMS-986226 25 mg	96.0	-167 – 207
Part A - BMS-986226 80 mg	-17.0	-100 – 170
Part A - BMS-986226 200 mg	103.5	-39 – 216
Part A - BMS-986226 400 mg	-28.0	-74 – 18
Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	-9.0	-129 – 83
Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg	61.5	-20 – 186
Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg	-17.0	-175 – 103

Adverse events — posted to ClinicalTrials.gov

Time frame: Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 50 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 31 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Preliminary - BMS-986226 2 mg

Serious: 2/6 (33%)

Deaths: 5/6

Preliminary - BMS-986226 8 mg

Serious: 3/7 (43%)

Deaths: 3/7

Part A - BMS-986226 25 mg

Serious: 2/7 (29%)

Deaths: 5/7

Part A - BMS-986226 80 mg

Serious: 10/11 (91%)

Deaths: 8/11

Part A - BMS-986226 200 mg

Serious: 5/9 (56%)

Deaths: 5/9

Part A - BMS-986226 400 mg

Serious: 9/9 (100%)

Deaths: 7/9

Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg

Serious: 5/10 (50%)

Deaths: 7/10

Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg

Serious: 9/12 (75%)

Deaths: 8/12

Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg

Serious: 5/9 (56%)

Deaths: 5/9

Total

Serious: 50/80 (63%)

Deaths: 53/80

Serious adverse events (46 terms)

Reaction	System	Preliminary - BMS-986226 2…	Preliminary - BMS-986226 8…	Part A - BMS-986226 25 mg	Part A - BMS-986226 80 mg	Part A - BMS-986226 200 mg	Part A - BMS-986226 400 mg	Part C1 - BMS-986226 25 mg…	Part C1 - BMS-986226 200 m…	Part C2 - BMS-986226 25 mg…	Total
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—
Large intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Myocarditis	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Pericarditis	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—
Biliary obstruction	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—
Jaundice	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—	—	—	—	—	—	—

Other adverse events (139 terms — click to expand)

Reaction	System	Preliminary - BMS-986226 2…	Preliminary - BMS-986226 8…	Part A - BMS-986226 25 mg	Part A - BMS-986226 80 mg	Part A - BMS-986226 200 mg	Part A - BMS-986226 400 mg	Part C1 - BMS-986226 25 mg…	Part C1 - BMS-986226 200 m…	Part C2 - BMS-986226 25 mg…	Total
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Skin infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Amylase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Malignant neoplasm progression, Abdominal pain, Intestinal obstruction, Hyperbilirubinaemia, Large intestinal obstruction, Rectal haemorrhage, General physical health deterioration, Pneumonia.

Data from ClinicalTrials.gov NCT03251924 adverse events section.

Sponsor's own description

The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Hallmarks of response, resistance, and toxicity to immune checkpoint blockade.
Morad G, Helmink BA, Sharma P, Wargo JA. · · 2021 · cited 1197× · PMID 34624224 · DOI 10.1016/j.cell.2021.09.020
ICOS+ Tregs: A Functional Subset of Tregs in Immune Diseases.
Li DY, Xiong XZ. · · 2020 · cited 122× · PMID 32983168 · DOI 10.3389/fimmu.2020.02104
Targeting Negative and Positive Immune Checkpoints with Monoclonal Antibodies in Therapy of Cancer.
Marhelava K, Pilch Z, Bajor M, Graczyk-Jarzynka A, et al · · 2019 · cited 100× · PMID 31717326 · DOI 10.3390/cancers11111756
Beyond PD-1/PD-L1 Inhibition: What the Future Holds for Breast Cancer Immunotherapy.
Chrétien S, Zerdes I, Bergh J, Matikas A, et al · · 2019 · cited 47× · PMID 31060337 · DOI 10.3390/cancers11050628
The landscape of CD28, CD80, CD86, CTLA4, and ICOS DNA methylation in head and neck squamous cell carcinomas.
de Vos L, Grünwald I, Bawden EG, Dietrich J, et al · · 2020 · cited 35× · PMID 32281488 · DOI 10.1080/15592294.2020.1754675
Immune profiling and immunotherapeutic targets in pancreatic cancer.
Lenzo FL, Kato S, Pabla S, DePietro P, et al · · 2021 · cited 18× · PMID 33569421 · DOI 10.21037/atm-20-1076
Post-translational modifications of cancer immune checkpoints: mechanisms and therapeutic strategies.
Jia H, Jiang L, Shen X, Ye H, et al · · 2025 · cited 13× · PMID 40629335 · DOI 10.1186/s12943-025-02397-5
Transcriptome profile and clinical characterization of ICOS expression in gliomas.
Wang J, Shi F, Shan A. · · 2022 · cited 9× · PMID 36276141 · DOI 10.3389/fonc.2022.946967

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Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03251924 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 28 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03251924.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing