18 and older, any sex, with 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.
Percentage of Participants Affected by AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQSecondary· Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
This outcome describes the percentage of participants experiencing at least 1 AE in the MedDRA Anaphylactic Reaction narrow scope SMQ. The narrow scope SMQ is composed of a large list of terms, including (but not limited to) anaphylactic shock and reaction, shock and shock symptoms, and circulatory collapse, among the others.
Group
Value
95% CI
Fixed Ratio Combination
0.0
0.0 – 6.7
Sequential Combination
0.0
0.0 – 6.7
Percentage of Participants Affected by Hypersensitivity/Infusion Reaction Select AEsSecondary· Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
This outcome describes the percentage of participants experiencing at least 1 AE in the Hypersensitivity/Infusion select AEs category. The select AEs consist of a list of preferred terms defined by the Sponsor and represent AEs with a potential immune-mediated etiology. The following 5 MedDRA preferred terms are included in the hypersensitivity/infusion reaction select AE category: Anaphylactic Reaction, Anaphylactic Shock, Bronchospasm, Hypersensitivity, and Infusion Related Reaction
Group
Value
95% CI
Fixed Ratio Combination
7.5
Sequential Combination
9.4
Percentage of Participants Affected by All Causality Grade 3 - 5 AEsSecondary· From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)
This outcome describes the percentage of participants who experienced at least 1 AE of Grade 3 or higher defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria
Group
Value
95% CI
Fixed Ratio Combination
69.8
Sequential Combination
56.6
Percentage of Participants Affected by Drug-related Grade 3 - 5 AEsSecondary· From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)
This outcome describes the percentage of participants who experienced at least 1 Drug-related AE of Grade 3 or higher defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria
Group
Value
95% CI
Fixed Ratio Combination
58.5
Sequential Combination
47.2
Geometric Mean Concentration of Ipilimumab at End of Infusion (EOI)Secondary· From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported.
Cycle 1 Day 1
Group
Value
95% CI
Fixed Ratio Combination
60.4
± 93.0
Sequential Combination
61.5
± 72.3
Cycle 2 Day 1
Group
Value
95% CI
Fixed Ratio Combination
66.8
± 134
Sequential Combination
72.1
± 71.8
Cycle 4 Day 1
Group
Value
95% CI
Fixed Ratio Combination
77.9
± 94.2
Sequential Combination
84.6
± 104
Geometric Mean Concentration of Nivolumab at End of Infusion (EOI)Secondary· From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported
Cycle 1 Day 1
Group
Value
95% CI
Fixed Ratio Combination
20.9
± 77.3
Sequential Combination
21.8
± 117
Cycle 2 Day 1
Group
Value
95% CI
Fixed Ratio Combination
24.2
± 122
Sequential Combination
22.4
± 101
Cycle 4 Day 1
Group
Value
95% CI
Fixed Ratio Combination
27.9
± 79.8
Sequential Combination
27.4
± 79.9
Geometric Mean Trough Concentration of IpilimumabSecondary· From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.
Cycle 2 Day 1
Group
Value
95% CI
Fixed Ratio Combination
10.8
± 30.2
Sequential Combination
9.94
± 38.9
Cycle 4 Day 1
Group
Value
95% CI
Fixed Ratio Combination
16.5
± 36.9
Sequential Combination
13.7
± 46.0
Geometric Mean Trough Concentration of NivolumabSecondary· From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.
Cycle 2 Day 1
Group
Value
95% CI
Fixed Ratio Combination
3.94
± 56.6
Sequential Combination
2.75
± 65.9
Cycle 4 Day 1
Group
Value
95% CI
Fixed Ratio Combination
6.50
± 44.6
Sequential Combination
4.05
± 75.3
Objective Response Rate (ORR)Secondary· Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression (approximately 20 months)
The ORR is defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first.
Group
Value
95% CI
Fixed Ratio Combination
52.8
38.6 – 66.7
Sequential Combination
60.4
46.0 – 73.5
Progression Free Survival (PFS)Secondary· From the date of randomization to the first date of documented progression (approximately 26 months)
PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first.
Group
Value
95% CI
Fixed Ratio Combination
10.25
2.96 – NA
Sequential Combination
NA
4.96 – NA
Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ)Primary· Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
This outcome describes the percentage of participants experiencing at least 1 AE in the MedDRA Anaphylactic Reaction broad scope SMQ. Such AEs include any acute systemic reaction characterized by a large list of terms, including (but not limited to) pruritus, urticaria, flushing, hypotension, respiratory distress, and vascular insufficiency. It also includes other signs and symptoms such as asthma, choking sensation, coughing, sneezing, and difficulty breathing due to laryngeal spasm and/or bronchospasm. Less frequent clinical presentations are also captured and include hyperventilation, sensa
Group
Value
95% CI
Fixed Ratio Combination
15.1
6.7 – 27.6
Sequential Combination
17.0
8.1 – 29.8
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose to 100 days following administration of the last dose (approximately 27 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Fixed Ratio Combination
Serious: 35/53 (66%)
Deaths: 14/53
Sequential Combination
Serious: 35/53 (66%)
Deaths: 14/53
Serious adverse events (84 terms)
Reaction
System
Fixed Ratio Combination
Sequential Combination
Pyrexia
General disorders
—
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· Phase 3
· not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
· Phase 2
· not yet recruiting
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Currently open trials in the same condition.
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· recruiting
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· recruiting
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Other Bristol-Myers Squibb trials
Trials by the same sponsor.
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· Phase 3
· not yet recruiting
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· Phase 4
· not yet recruiting
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· 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
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· not yet recruiting
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: 17 December 2020
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/NCT02905266.