A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)
CompletedPhase 2Results postedLast updated 11 September 2020
What this trial tests
Phase 2 trial testing Nivolumab (BMS-936558) in Melanoma in 1,009 participants. Completed in 18 January 2019.
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.
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.Primary· Up to 2 years
The number of participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select AEs (pulmonary,gastrointestinal, skin, renal, hepatic, endocrine) were summarized using the all treated analysis set by system organ class and Medical Dictionary for Regulatory (MedDRA) preferred term.
Gastrointestinal Adverse events (Grade 3-4)
Group
Value
95% CI
Nivolumab 3mg/kg
16
Gastrointestinal adverse events (Grade 5)
Group
Value
95% CI
Nivolumab 3mg/kg
0
Hepatic adverse events (Grade 3-4)
Group
Value
95% CI
Nivolumab 3mg/kg
30
Hepatic adverse events (Grade 5)
Group
Value
95% CI
Nivolumab 3mg/kg
0
Pulmonary adverse events(Grade 3-4)
Group
Value
95% CI
Nivolumab 3mg/kg
6
Pulmonary adverse events(Grade 5)
Group
Value
95% CI
Nivolumab 3mg/kg
0
Renal adverse events (Grade 3-4)
Group
Value
95% CI
Nivolumab 3mg/kg
4
Renal adverse events (Grade 5)
Group
Value
95% CI
Nivolumab 3mg/kg
0
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse EventsSecondary· Up to 2 years
The number of Participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), select AEs were summarized using the all treated analysis set by system organ class and MedDRA preferred term.
Gastrointestinal Adverse events (Grade 3-4)
Group
Value
95% CI
Nivolumab 3mg/kg
24
Gastrointestinal adverse events (Grade 5)
Group
Value
95% CI
Nivolumab 3mg/kg
0
Hepatic adverse events (Grade 3-4)
Group
Value
95% CI
Nivolumab 3mg/kg
52
Hepatic adverse events (Grade 5)
Group
Value
95% CI
Nivolumab 3mg/kg
1
Pulmonary adverse events(Grade 3-4)
Group
Value
95% CI
Nivolumab 3mg/kg
7
Pulmonary adverse events(Grade 5)
Group
Value
95% CI
Nivolumab 3mg/kg
1
Renal adverse events (Grade 3-4)
Group
Value
95% CI
Nivolumab 3mg/kg
12
Renal adverse events (Grade 5)
Group
Value
95% CI
Nivolumab 3mg/kg
1
Median Time to Onset (Grades 3-4) of Select Adverse EventsSecondary· Up to 2 years.
Select AEs were summarized according to their incidence as well as their time to onset.
Endocrine Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
12
0.3 – 88.4
Gastrointestinal Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
23.50
0.3 – 93.0
Hepatic Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
10.14
0.1 – 116.0
Pulmonary Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
14.86
1.3 – 64.9
Renal Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
11.71
1.1 – 60.0
Skin Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
34.36
1.1 – 88.0
Hypersensitivity/infusion reaction Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
29.57
29.57 – 29.57
Median Time to Resolution (Grades 3-4) of Select Adverse EventsSecondary· Up to 2 years
Select AEs were summarized according to their incidence as well as their time to resolution
Endocrine Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
2.43
0.4 – 138.0
Gastrointestinal Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
3.71
0.1 – 85.9
Hepatic Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
9.43
0.1 – 128.1
Pulmonary Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
2.57
0.1 – 20.4
Renal Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
1.93
1.29 – 3.29
Skin Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
5.07
0.1 – 121.1
Hypersensitivity/infusion reaction Adverse Events
Group
Value
95% CI
Nivolumab 3mg/kg
0.29
0.29 – 0.29
Overall SurvivalSecondary· Up to 4 years
The time from first dosing date to the date of death.
Group
Value
95% CI
Nivolumab 3mg/kg
21.2
18.2 – 24.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Between first dose and 30 days after last dose ( up to 2 years).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NIVOLUMAB 3 MG/KG IV
Serious: 593/1008 (59%)
Deaths: 527/1008
Serious adverse events (362 terms)
Reaction
System
NIVOLUMAB 3 MG/KG IV
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
General physical health deterioration
General disorders
—
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Metastatic malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Diarrhoea
Gastrointestinal disorders
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
Abdominal pain
Gastrointestinal disorders
—
Pneumonia
Infections and infestations
—
Urinary tract infection
Infections and infestations
—
Anaemia
Blood and lymphatic system disorders
—
Vomiting
Gastrointestinal disorders
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
Pyrexia
General disorders
—
Lower respiratory tract infection
Infections and infestations
—
Acute kidney injury
Renal and urinary disorders
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
Nausea
Gastrointestinal disorders
—
Autoimmune hepatitis
Hepatobiliary disorders
—
Sepsis
Infections and infestations
—
Back pain
Musculoskeletal and connective tissue disorders
—
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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: 11 September 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/NCT02156804.