18 and older, any sex, with Cancer or Melanoma. 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.
Number of Participants Experiencing Adverse Events (AEs) - Part 1Primary· From first dose up to 100 days after last dose (up to 65 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events a
Group
Value
95% CI
Part 1: 600 Q4W
16
Part 1: 1200 Q4W
14
Part 1: 2400 Q4W
18
Part 1: 1200 Q2W
12
Part 1: 2400 Q2W
60
Part 1: 3600 Q2W
20
Part 1: 3600Q2W + Nivo + Ipi
15
Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 1Primary· From first dose up to 100 days after last dose (up to 65 months)
A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
This endpoint was prespecified in the protocol to include only participants in Part 1.
Group
Value
95% CI
Part 1: 600 Q4W
13
Part 1: 1200 Q4W
10
Part 1: 2400 Q4W
13
Part 1: 1200 Q2W
7
Part 1: 2400 Q2W
31
Part 1: 3600 Q2W
12
Part 1: 3600Q2W + Nivo + Ipi
9
Number of Participants Experiencing Dose Limiting Toxicities (DLTs) - Part 1Primary· From first dose up to 100 days after last dose (up to 65 months)
Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment, as advised by the Dose Review Team. DLTs will be defined based on the incidence, intensity, and duration of AEs that are possibly related to study treatment. DLTs will include gastrointestinal, hepatic, hematologic, dermatologic, and other AEs.
This endpoint was prespecified in the protocol to include only participants in Part 1.
Group
Value
95% CI
Part 1: 600 Q4W
0
Part 1: 1200 Q4W
0
Part 1: 2400 Q4W
0
Part 1: 1200 Q2W
0
Part 1: 2400 Q2W
0
Part 1: 3600 Q2W
0
Part 1: 3600Q2W + Nivo + Ipi
0
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 1Primary· From first dose up to 100 days after last dose (up to 65 months)
Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
This endpoint was prespecified in the protocol to include only participants in Part 1.
Group
Value
95% CI
Part 1: 600 Q4W
3
Part 1: 1200 Q4W
2
Part 1: 2400 Q4W
3
Part 1: 1200 Q2W
3
Part 1: 2400 Q2W
7
Part 1: 3600 Q2W
1
Part 1: 3600Q2W + Nivo + Ipi
3
Number of Participants Who Died - Part 1Primary· From first dose up to 100 days after last dose (up to 65 months)
The number of participants who died due to any cause are summarized. This endpoint was prespecified in the protocol to include only participants in Part 1.
Group
Value
95% CI
Part 1: 600 Q4W
14
Part 1: 1200 Q4W
15
Part 1: 2400 Q4W
17
Part 1: 1200 Q2W
10
Part 1: 2400 Q2W
53
Part 1: 3600 Q2W
13
Part 1: 3600Q2W + Nivo + Ipi
8
Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1Primary· From first dose up to 30 days after last dose (up to 63 months)
Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
This endpoint was prespecified in the protocol to include only participants in Part 1.
Hemoglobin - Grade 3
Group
Value
95% CI
Part 1: 600 Q4W
2
Part 1: 1200 Q4W
1
Part 1: 2400 Q4W
2
Part 1: 1200 Q2W
2
Part 1: 2400 Q2W
7
Part 1: 3600 Q2W
3
Part 1: 3600Q2W + Nivo + Ipi
3
Alanine aminotransferase - Grade 3
Group
Value
95% CI
Part 1: 600 Q4W
0
Part 1: 1200 Q4W
1
Part 1: 2400 Q4W
0
Part 1: 1200 Q2W
0
Part 1: 2400 Q2W
0
Part 1: 3600 Q2W
0
Part 1: 3600Q2W + Nivo + Ipi
2
Alkaline phosphatase - Grade 3
Group
Value
95% CI
Part 1: 600 Q4W
0
Part 1: 1200 Q4W
0
Part 1: 2400 Q4W
2
Part 1: 1200 Q2W
0
Part 1: 2400 Q2W
2
Part 1: 3600 Q2W
3
Part 1: 3600Q2W + Nivo + Ipi
2
Aspartate aminotransferase - Grade 3
Group
Value
95% CI
Part 1: 600 Q4W
0
Part 1: 1200 Q4W
1
Part 1: 2400 Q4W
0
Part 1: 1200 Q2W
0
Part 1: 2400 Q2W
0
Part 1: 3600 Q2W
2
Part 1: 3600Q2W + Nivo + Ipi
1
Phosphate - Grade 3
Group
Value
95% CI
Part 1: 600 Q4W
0
Part 1: 1200 Q4W
1
Part 1: 2400 Q4W
2
Part 1: 1200 Q2W
0
Part 1: 2400 Q2W
3
Part 1: 3600 Q2W
1
Part 1: 3600Q2W + Nivo + Ipi
0
Sodium - Grade 3
Group
Value
95% CI
Part 1: 600 Q4W
0
Part 1: 1200 Q4W
2
Part 1: 2400 Q4W
1
Part 1: 1200 Q2W
0
Part 1: 2400 Q2W
5
Part 1: 3600 Q2W
1
Part 1: 3600Q2W + Nivo + Ipi
2
Lipase - Grade 3
Group
Value
95% CI
Part 1: 600 Q4W
1
Part 1: 1200 Q4W
1
Part 1: 2400 Q4W
2
Part 1: 1200 Q2W
1
Part 1: 2400 Q2W
3
Part 1: 3600 Q2W
0
Part 1: 3600Q2W + Nivo + Ipi
2
Lipase - Grade 4
Group
Value
95% CI
Part 1: 600 Q4W
0
Part 1: 1200 Q4W
0
Part 1: 2400 Q4W
0
Part 1: 1200 Q2W
1
Part 1: 2400 Q2W
2
Part 1: 3600 Q2W
0
Part 1: 3600Q2W + Nivo + Ipi
2
Objective Response Rate (ORR) - Part 1Secondary· From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)
Objective Response Rate per investigator is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before
Group
Value
95% CI
Part 1: 600 Q4W
6.3
0.2 – 30.2
Part 1: 1200 Q4W
6.7
0.2 – 31.9
Part 1: 2400 Q4W
16.7
3.6 – 41.4
Part 1: 1200 Q2W
0
0.0 – 26.5
Part 1: 2400 Q2W
3.2
0.4 – 11.0
Part 1: 3600 Q2W
10.0
1.2 – 31.7
Part 1: 3600Q2W + Nivo + Ipi
13.3
1.7 – 40.5
Duration of Response (DOR) - Part 1Secondary· From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the date of first response up to the date of the first objectively documented tumor progression by the investigator per RECIST v1.1 or death, whichever occurs first. Analysis computed using Kaplan-Meier method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =\< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameter
Group
Value
95% CI
Part 1: 600 Q4W
3.7
3.7 – 3.7
Part 1: 1200 Q4W
28.9
28.9 – 28.9
Part 1: 2400 Q4W
44.6
8.4 – 44.6
Part 1: 2400 Q2W
21.09
4.0 – 21.1
Part 1: 3600 Q2W
3.4
3.4 – 3.4
Part 1: 3600Q2W + Nivo + Ipi
NA
3.7 – 24.0
Maximum Concentration (Cmax) - Part 1Secondary· Cycle 1 Day 1
Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and before the administration of a second dose.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Group
Value
95% CI
Part 1: 600 Q4W
142.91
± 52.1
Part 1: 1200 Q4W
352.12
± 62.7
Part 1: 2400 Q4W
779.90
± 43.1
Part 1: 1200 Q2W
325.67
± 24.0
Part 1: 2400 Q2W
919.44
± 32.8
Part 1: 3600 Q2W
1227.67
± 23.3
Part 1: 3600Q2W + Nivo + Ipi
999.60
± 29.4
AUC(0-T)-Area Under Curve From Time Zero up to Last Quantifiable Concentration - Part 1Secondary· 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Cycle 1 Day 1
AUC (0-T) represents the observed exposure to a drug (area under the concentration curve) from first exposure until the last quantifiable concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Group
Value
95% CI
Part 1: 600 Q4W
19594.22
± 52.7
Part 1: 1200 Q4W
44821.39
± 44.5
Part 1: 2400 Q4W
105171.46
± 29.7
Part 1: 1200 Q2W
42835.41
± 28.1
Part 1: 2400 Q2W
112123.35
± 34.2
Part 1: 3600 Q2W
148321.77
± 32.0
Part 1: 3600Q2W + Nivo + Ipi
118041.10
± 40.3
AUC(TAU)-Area Under Curve in 1 Dosing Interval - Part 1Secondary· Cycle 1 Day 1
Area under the concentration-time curve in 1 dosing interval. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)
Group
Value
95% CI
Part 1: 600 Q4W
21301.74
± 49.5
Part 1: 1200 Q4W
48664.06
± 42.9
Part 1: 2400 Q4W
106916.11
± 27.3
Part 1: 1200 Q2W
43844.97
± 24.8
Part 1: 2400 Q2W
113969.47
± 30.8
Part 1: 3600 Q2W
153791.84
± 27.9
Part 1: 3600Q2W + Nivo + Ipi
137809.44
± 29.5
Observed Serum Concentration at the End of a Dosing Interval (Ctau) - Part 1Secondary· Cycle 1 Day 1
BMS-986253 observed serum concentration at the end of a dosing interval (Ctau). Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
1 cycle=28 days for all Arms/Groups except Cycles 1 and 2 (1 cycle=42 days) in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group
Group
Value
95% CI
Part 1: 600 Q4W
6.81
± 173.8
Part 1: 1200 Q4W
14.92
± 144.4
Part 1: 2400 Q4W
23.68
± 692.4
Part 1: 1200 Q2W
55.82
± 53.0
Part 1: 2400 Q2W
141.89
± 42.6
Part 1: 3600 Q2W
181.84
± 46.3
Part 1: 3600Q2W + Nivo + Ipi
175.29
± 46.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part 1: 600 Q4W
Serious: 13/16 (81%)
Deaths: 14/16
Part 1: 1200 Q4W
Serious: 10/15 (67%)
Deaths: 15/15
Part 1: 2400 Q4W
Serious: 13/18 (72%)
Deaths: 17/18
Part 1: 1200 Q2W
Serious: 7/12 (58%)
Deaths: 10/12
Part 1: 2400 Q2W
Serious: 31/63 (49%)
Deaths: 53/63
Part 1: 3600 Q2W
Serious: 12/20 (60%)
Deaths: 13/20
Part 1: 3600Q2W + Nivo + Ipi
Serious: 9/15 (60%)
Deaths: 8/15
Part 2 Arm A: BMS+Nivo+Ipi
Serious: 44/62 (71%)
Deaths: 30/62
Part 2 Arm B: Placebo+Nivo+Ipi
Serious: 42/57 (74%)
Deaths: 17/60
Serious adverse events (146 terms)
Reaction
System
Part 1: 600 Q4W
Part 1: 1200 Q4W
Part 1: 2400 Q4W
Part 1: 1200 Q2W
Part 1: 2400 Q2W
Part 1: 3600 Q2W
Part 1: 3600Q2W + Nivo + Ipi
Part 2 Arm A: BMS+Nivo+Ipi
Part 2 Arm B: Placebo+Nivo…
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
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—
—
—
—
—
—
—
Colitis
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
Pneumonia
Infections and infestations
—
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—
—
—
—
—
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
—
—
—
—
—
—
—
Diarrhoea
Gastrointestinal disorders
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—
—
—
—
—
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Death
General disorders
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—
—
—
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
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—
—
—
—
—
—
—
—
Pyrexia
General disorders
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—
—
—
—
—
—
—
Haemophagocytic lymphohistiocytosis
Immune system disorders
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—
—
—
—
—
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
—
—
—
—
—
—
Alanine aminotransferase increased
Investigations
—
—
—
—
—
—
—
—
—
Anaemia
Blood and lymphatic system disorders
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—
—
—
—
—
—
—
—
Dysphagia
Gastrointestinal disorders
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—
—
—
—
—
—
—
—
Asthenia
General disorders
—
—
—
—
—
—
—
—
—
Fatigue
General disorders
—
—
—
—
—
—
—
—
—
General physical health deterioration
General disorders
—
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—
—
—
—
—
—
—
Cholecystitis
Hepatobiliary disorders
—
—
—
—
—
—
—
—
—
Aspartate aminotransferase increased
Investigations
—
—
—
—
—
—
—
—
—
Hypercalcaemia
Metabolism and nutrition disorders
—
—
—
—
—
—
—
—
—
Haemoptysis
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
Pancytopenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
Acute coronary syndrome
Cardiac disorders
—
—
—
—
—
—
—
—
—
Other adverse events (267 terms — click to expand)
The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04572451 — Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanom
· Phase 1
· recruiting
NCT04347226 — Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19
· Phase 2
· terminated
NCT04123379 — Neoadjuvant Nivolumab with CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carci
· Phase 2
· active not recruiting
NCT03026140 — Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer
· Phase 2
· recruiting
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Trials by the same sponsor.
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NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
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NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S
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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: 24 February 2026
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/NCT03400332.