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)

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ClinicalTrials.gov Identifier: NCT02156804

Recruitment Status : Completed

First Posted : June 5, 2014

Results First Posted : February 20, 2020

Last Update Posted : September 11, 2020

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Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Melanoma
Intervention	Drug: Nivolumab (BMS-936558)
Enrollment	1009

Participant Flow

Recruitment Details
Pre-assignment Details	1009 participants were enrolled into the study , 1008 wrere treated, 1 participants was not treated due to withdrew consent


Arm/Group Title	Nivolumab 3mg/kg
Arm/Group Description	Nivolumab 3 mg/kg as a 60-minute IV...
Arm/Group Description	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
Period Title: Overall Study
Started	1009
Completed	1008
Not Completed	1
Reason Not Completed
Withdrawal by Subject	1

Baseline Characteristics

Arm/Group Title		Nivolumab 3mg/kg
Arm/Group Description		Nivolumab 3 mg/kg as a 60-minute IV...
Arm/Group Description		Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
Overall Number of Baseline Participants		1008
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All Treated Participants
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	1008 participants
		60.1 (13.84)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1008 participants
	Female	451 44.7%
	Male	557 55.3%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1008 participants
	Hispanic or Latino	27 2.7%
	Not Hispanic or Latino	972 96.4%
	Unknown or Not Reported	9 0.9%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1008 participants
	American Indian or Alaska Native	0 0.0%
	Asian	3 0.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	3 0.3%
	White	987 97.9%
	More than one race	0 0.0%
	Unknown or Not Reported	15 1.5%

Outcome Measures

1.Primary Outcome


Title	the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Description	The number of participants who reported high-grade (CTCAE v4.0 Grade 3...
Description	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.
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

All treated participants


Arm/Group Title	Nivolumab 3mg/kg
Arm/Group Description:	Nivolumab 3 mg/kg as a 60-minute IV...
Arm/Group Description:	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
Overall Number of Participants Analyzed	1008
Measure Type: Number Unit of Measure: Number of Participants
Gastrointestinal Adverse events (Grade 3-4)	16
Gastrointestinal adverse events (Grade 5)	0
Hepatic adverse events (Grade 3-4)	30
Hepatic adverse events (Grade 5)	0
Pulmonary adverse events(Grade 3-4)	6
Pulmonary adverse events(Grade 5)	0
Renal adverse events (Grade 3-4)	4
Renal adverse events (Grade 5)	0
Skin adverse events ( Grade 3-4)	13
Skin adverse events ( Grade 5)	0
Hypersensitivity adverse event( Grade 3-4)	1
Hypersensitivity adverse event( Grade 5)	0
Endocrine adverse events(Grade 3-4)	18
Endocrine adverse events(Grade 5)	0

2.Secondary Outcome


Title	The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Description	The number of Participants who reported high-grade (CTCAE v4.0 Grade 3...
Description	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.
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

All treated Participants


Arm/Group Title	Nivolumab 3mg/kg
Arm/Group Description:	Nivolumab 3 mg/kg as a 60-minute IV...
Arm/Group Description:	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
Overall Number of Participants Analyzed	1008
Measure Type: Number Unit of Measure: Number of Participants
Gastrointestinal Adverse events (Grade 3-4)	24
Gastrointestinal adverse events (Grade 5)	0
Hepatic adverse events (Grade 3-4)	52
Hepatic adverse events (Grade 5)	1
Pulmonary adverse events(Grade 3-4)	7
Pulmonary adverse events(Grade 5)	1
Renal adverse events (Grade 3-4)	12
Renal adverse events (Grade 5)	1
Skin adverse events ( Grade 3-4)	19
Skin adverse events ( Grade 5)	0
Hypersensitivity adverse event( Grade 3-4)	2
Hypersensitivity adverse event( Grade 5)	0
Endocrine adverse events(Grade 3-4)	24
Endocrine adverse events(Grade 5)	0

3.Secondary Outcome


Title	Median Time to Onset (Grades 3-4) of Select Adverse Events
Description	Select AEs were summarized according to their incidence as well as the...
Description	Select AEs were summarized according to their incidence as well as their time to onset.
Time Frame	Up to 2 years.

Outcome Measure Data

Analysis Population Description

All Treated Participants.


Arm/Group Title	Nivolumab 3mg/kg
Arm/Group Description:	Nivolumab 3 mg/kg as a 60-minute IV...
Arm/Group Description:	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
Overall Number of Participants Analyzed	1008
Median (Full Range) Unit of Measure: Weeks
Endocrine Adverse Events	12 (0.3 to 88.4)
Gastrointestinal Adverse Events	23.50 (0.3 to 93.0)
Hepatic Adverse Events	10.14 (0.1 to 116.0)
Pulmonary Adverse Events	14.86 (1.3 to 64.9)
Renal Adverse Events	11.71 (1.1 to 60.0)
Skin Adverse Events	34.36 (1.1 to 88.0)
Hypersensitivity/infusion reaction Adverse Events	29.57 (29.57 to 29.57)

4.Secondary Outcome


Title	Median Time to Resolution (Grades 3-4) of Select Adverse Events
Description	Select AEs were summarized according to their incidence as well as the...
Description	Select AEs were summarized according to their incidence as well as their time to resolution
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

All Treated Participants


Arm/Group Title	Nivolumab 3mg/kg
Arm/Group Description:	Nivolumab 3 mg/kg as a 60-minute IV...
Arm/Group Description:	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
Overall Number of Participants Analyzed	1008
Median (Full Range) Unit of Measure: Weeks
Endocrine Adverse Events	2.43 (0.4 to 138.0)
Gastrointestinal Adverse Events	3.71 (0.1 to 85.9)
Hepatic Adverse Events	9.43 (0.1 to 128.1)
Pulmonary Adverse Events	2.57 (0.1 to 20.4)
Renal Adverse Events	1.93 (1.29 to 3.29)
Skin Adverse Events	5.07 (0.1 to 121.1)
Hypersensitivity/infusion reaction Adverse Events	0.29 (0.29 to 0.29)

5.Secondary Outcome


Title	Overall Survival
Description	The time from first dosing date to the date of death.
Description	The time from first dosing date to the date of death.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

All Treated Participants


Arm/Group Title	Nivolumab 3mg/kg
Arm/Group Description:	Nivolumab 3 mg/kg as a 60-minute IV...
Arm/Group Description:	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
Overall Number of Participants Analyzed	1008
Median (95% Confidence Interval) Unit of Measure: Months
	21.2 (18.2 to 24.4)

Adverse Events

Time Frame	Between first dose and 30 days after last dose ( up to 2 years)
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	NIVOLUMAB 3 MG/KG IV
Arm/Group Description	Nivolumab 3 mg/kg as a 60-minute IV...
Arm/Group Description	Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
All-Cause Mortality
	NIVOLUMAB 3 MG/KG IV
	Affected / at Risk (%)
Total	527/1008 (52.28%)
Serious Adverse Events Serious Adverse Events
	NIVOLUMAB 3 MG/KG IV
	Affected / at Risk (%)
Total	593/1008 (58.83%)
Blood and lymphatic system disorders
Anaemia ^† 1	10/1008 (0.99%)
Haemorrhagic anaemia ^† 1	1/1008 (0.10%)
Thrombocytopenia ^† 1	1/1008 (0.10%)
Cardiac disorders
Acute coronary syndrome ^† 1	2/1008 (0.20%)
Acute myocardial infarction ^† 1	1/1008 (0.10%)
Angina pectoris ^† 1	2/1008 (0.20%)
Atrial fibrillation ^† 1	3/1008 (0.30%)
Atrial flutter ^† 1	1/1008 (0.10%)
Cardiac failure ^† 1	1/1008 (0.10%)
Cardiopulmonary failure ^† 1	1/1008 (0.10%)
Coronary artery occlusion ^† 1	1/1008 (0.10%)
Ischaemic cardiomyopathy ^† 1	1/1008 (0.10%)
Myocardial infarction ^† 1	2/1008 (0.20%)
Myocarditis ^† 1	1/1008 (0.10%)
Pericardial effusion ^† 1	1/1008 (0.10%)
Cardio-respiratory arrest ^† 1	1/1008 (0.10%)
Coronary artery disease ^† 1	1/1008 (0.10%)
Coronary artery insufficiency ^† 1	1/1008 (0.10%)
Supraventricular tachycardia ^† 1	1/1008 (0.10%)
Ear and labyrinth disorders
Vertigo ^† 1	2/1008 (0.20%)
Endocrine disorders
Addison's disease ^† 1	1/1008 (0.10%)
Adrenal insufficiency ^† 1	5/1008 (0.50%)
Autoimmune thyroiditis ^† 1	2/1008 (0.20%)
Hyperthyroidism ^† 1	1/1008 (0.10%)
Hypophysitis ^† 1	4/1008 (0.40%)
Hypopituitarism ^† 1	3/1008 (0.30%)
Hypothyroidism ^† 1	3/1008 (0.30%)
Lymphocytic hypophysitis ^† 1	1/1008 (0.10%)
Secondary adrenocortical insufficiency ^† 1	1/1008 (0.10%)
Steroid withdrawal syndrome ^† 1	1/1008 (0.10%)
Adrenal haemorrhage ^† 1	1/1008 (0.10%)
Eye disorders
Ectropion ^† 1	1/1008 (0.10%)
Iridocyclitis ^† 1	1/1008 (0.10%)
Iritis ^† 1	1/1008 (0.10%)
Macular hole ^† 1	1/1008 (0.10%)
Ulcerative keratitis ^† 1	1/1008 (0.10%)
Uveitis ^† 1	1/1008 (0.10%)
Vision blurred ^† 1	1/1008 (0.10%)
Retinal detachment ^† 1	1/1008 (0.10%)
Vitreous haemorrhage ^† 1	1/1008 (0.10%)
Gastrointestinal disorders
Abdominal pain ^† 1	13/1008 (1.29%)
Ascites ^† 1	5/1008 (0.50%)
Autoimmune colitis ^† 1	3/1008 (0.30%)
Autoimmune pancreatitis ^† 1	1/1008 (0.10%)
Colitis ^† 1	7/1008 (0.69%)
Colitis ischaemic ^† 1	1/1008 (0.10%)
Constipation ^† 1	2/1008 (0.20%)
Diarrhoea ^† 1	14/1008 (1.39%)
Dyspepsia ^† 1	1/1008 (0.10%)
Food poisoning ^† 1	1/1008 (0.10%)
Gastritis ^† 1	3/1008 (0.30%)
Gastrointestinal haemorrhage ^† 1	2/1008 (0.20%)
Ileal perforation ^† 1	1/1008 (0.10%)
Inguinal hernia ^† 1	2/1008 (0.20%)
Intestinal fistula ^† 1	1/1008 (0.10%)
Intestinal obstruction ^† 1	4/1008 (0.40%)
Intussusception ^† 1	2/1008 (0.20%)
Large intestinal obstruction ^† 1	1/1008 (0.10%)
Melaena ^† 1	3/1008 (0.30%)
Nausea ^† 1	8/1008 (0.79%)
Oesophagitis ^† 1	1/1008 (0.10%)
Pancreatitis ^† 1	1/1008 (0.10%)
Pancreatitis acute ^† 1	1/1008 (0.10%)
Rectal haemorrhage ^† 1	2/1008 (0.20%)
Small intestinal obstruction ^† 1	1/1008 (0.10%)
Small intestinal perforation ^† 1	1/1008 (0.10%)
Stomatitis ^† 1	1/1008 (0.10%)
Upper gastrointestinal haemorrhage ^† 1	1/1008 (0.10%)
Vomiting ^† 1	10/1008 (0.99%)
Anal haemorrhage ^† 1	1/1008 (0.10%)
Gastrointestinal disorder ^† 1	1/1008 (0.10%)
Gastrooesophageal reflux disease ^† 1	1/1008 (0.10%)
Ileus ^† 1	1/1008 (0.10%)
Subileus ^† 1	1/1008 (0.10%)
General disorders
Asthenia ^† 1	5/1008 (0.50%)
Chest pain ^† 1	2/1008 (0.20%)
Disease progression ^† 1	2/1008 (0.20%)
Fatigue ^† 1	7/1008 (0.69%)
General physical health deterioration ^† 1	22/1008 (2.18%)
Generalised oedema ^† 1	1/1008 (0.10%)
Malaise ^† 1	3/1008 (0.30%)
Nodule ^† 1	1/1008 (0.10%)
Oedema peripheral ^† 1	4/1008 (0.40%)
Pyrexia ^† 1	9/1008 (0.89%)
Sudden death ^† 1	3/1008 (0.30%)
Treatment failure ^† 1	1/1008 (0.10%)
Multiple organ dysfunction syndrome ^† 1	2/1008 (0.20%)
Pain ^† 1	1/1008 (0.10%)
Hepatobiliary disorders
Autoimmune hepatitis ^† 1	8/1008 (0.79%)
Cholecystitis ^† 1	1/1008 (0.10%)
Cholelithiasis ^† 1	2/1008 (0.20%)
Hepatic failure ^† 1	1/1008 (0.10%)
Hepatic function abnormal ^† 1	1/1008 (0.10%)
Hepatic pain ^† 1	3/1008 (0.30%)
Hepatomegaly ^† 1	1/1008 (0.10%)
Hypertransaminasaemia ^† 1	1/1008 (0.10%)
Immune-mediated hepatitis ^† 1	4/1008 (0.40%)
Jaundice ^† 1	2/1008 (0.20%)
Jaundice cholestatic ^† 1	1/1008 (0.10%)
Liver disorder ^† 1	1/1008 (0.10%)
Immune system disorders
Anaphylactic shock ^† 1	1/1008 (0.10%)
Autoimmune disorder ^† 1	1/1008 (0.10%)
Contrast media allergy ^† 1	2/1008 (0.20%)
Drug hypersensitivity ^† 1	1/1008 (0.10%)
Infections and infestations
Abdominal infection ^† 1	4/1008 (0.40%)
Abdominal sepsis ^† 1	2/1008 (0.20%)
Anal abscess ^† 1	1/1008 (0.10%)
Appendiceal abscess ^† 1	1/1008 (0.10%)
Appendicitis ^† 1	2/1008 (0.20%)
Arthritis bacterial ^† 1	1/1008 (0.10%)
Bronchitis ^† 1	2/1008 (0.20%)
Bronchopulmonary aspergillosis allergic ^† 1	1/1008 (0.10%)
Cellulitis ^† 1	6/1008 (0.60%)
Conjunctivitis ^† 1	2/1008 (0.20%)
Cystitis ^† 1	1/1008 (0.10%)
Device related infection ^† 1	3/1008 (0.30%)
Device related sepsis ^† 1	1/1008 (0.10%)
Diarrhoea infectious ^† 1	1/1008 (0.10%)
Enterocolitis infectious ^† 1	1/1008 (0.10%)
Erysipelas ^† 1	7/1008 (0.69%)
Escherichia urinary tract infection ^† 1	1/1008 (0.10%)
Gastroenteritis ^† 1	4/1008 (0.40%)
Haematoma infection ^† 1	1/1008 (0.10%)
Herpes zoster ^† 1	1/1008 (0.10%)
Infected dermal cyst ^† 1	1/1008 (0.10%)
Infected lymphocele ^† 1	1/1008 (0.10%)
Infection ^† 1	5/1008 (0.50%)
Infective exacerbation of chronic obstructive airways disease ^† 1	1/1008 (0.10%)
Influenza ^† 1	1/1008 (0.10%)
Latent tuberculosis ^† 1	1/1008 (0.10%)
Lower respiratory tract infection ^† 1	9/1008 (0.89%)
Lung infection ^† 1	1/1008 (0.10%)
Perirectal abscess ^† 1	1/1008 (0.10%)
Pneumococcal sepsis ^† 1	1/1008 (0.10%)
Pneumonia ^† 1	13/1008 (1.29%)
Pneumonia legionella ^† 1	1/1008 (0.10%)
Pseudomembranous colitis ^† 1	1/1008 (0.10%)
Pyelonephritis ^† 1	1/1008 (0.10%)
Respiratory tract infection ^† 1	5/1008 (0.50%)
Sepsis ^† 1	8/1008 (0.79%)
Septic encephalopathy ^† 1	1/1008 (0.10%)
Sinusitis ^† 1	2/1008 (0.20%)
Soft tissue infection ^† 1	1/1008 (0.10%)
Tonsillitis ^† 1	1/1008 (0.10%)
Tooth abscess ^† 1	2/1008 (0.20%)
Tooth infection ^† 1	1/1008 (0.10%)
Tracheobronchitis ^† 1	1/1008 (0.10%)
Urinary tract infection ^† 1	11/1008 (1.09%)
Urosepsis ^† 1	4/1008 (0.40%)
Vascular device infection ^† 1	1/1008 (0.10%)
Viral diarrhoea ^† 1	1/1008 (0.10%)
Viral infection ^† 1	1/1008 (0.10%)
Wound infection ^† 1	2/1008 (0.20%)
Gastroenteritis viral ^† 1	1/1008 (0.10%)
Gastrointestinal infection ^† 1	1/1008 (0.10%)
Meningitis ^† 1	1/1008 (0.10%)
Septic shock ^† 1	1/1008 (0.10%)
Tuberculosis ^† 1	1/1008 (0.10%)
Upper respiratory tract infection ^† 1	1/1008 (0.10%)
Injury, poisoning and procedural complications
Accidental overdose ^† 1	1/1008 (0.10%)
Ankle fracture ^† 1	1/1008 (0.10%)
Craniocerebral injury ^† 1	1/1008 (0.10%)
Dose calculation error ^† 1	1/1008 (0.10%)
Fall ^† 1	4/1008 (0.40%)
Femoral neck fracture ^† 1	1/1008 (0.10%)
Femur fracture ^† 1	2/1008 (0.20%)
Fractured sacrum ^† 1	1/1008 (0.10%)
Joint dislocation ^† 1	1/1008 (0.10%)
Overdose ^† 1	5/1008 (0.50%)
Procedural headache ^† 1	1/1008 (0.10%)
Radiation necrosis ^† 1	2/1008 (0.20%)
Radius fracture ^† 1	1/1008 (0.10%)
Spinal compression fracture ^† 1	1/1008 (0.10%)
Spinal fracture ^† 1	1/1008 (0.10%)
Subdural haematoma ^† 1	1/1008 (0.10%)
Ulna fracture ^† 1	1/1008 (0.10%)
Hip fracture ^† 1	1/1008 (0.10%)
Pubis fracture ^† 1	1/1008 (0.10%)
Investigations
Alanine aminotransferase increased ^† 1	3/1008 (0.30%)
Aspartate aminotransferase increased ^† 1	2/1008 (0.20%)
Blood creatinine increased ^† 1	1/1008 (0.10%)
CSF test abnormal ^† 1	1/1008 (0.10%)
Gamma-glutamyltransferase increased ^† 1	1/1008 (0.10%)
General physical condition abnormal ^† 1	1/1008 (0.10%)
International normalised ratio increased ^† 1	1/1008 (0.10%)
Lipase increased ^† 1	2/1008 (0.20%)
Pancreatic enzymes increased ^† 1	1/1008 (0.10%)
Transaminases increased ^† 1	2/1008 (0.20%)
Troponin T increased ^† 1	1/1008 (0.10%)
Metabolism and nutrition disorders
Cachexia ^† 1	1/1008 (0.10%)
Dehydration ^† 1	4/1008 (0.40%)
Diabetes mellitus ^† 1	3/1008 (0.30%)
Hypercalcaemia ^† 1	1/1008 (0.10%)
Hyperglycaemia ^† 1	7/1008 (0.69%)
Hyperkalaemia ^† 1	2/1008 (0.20%)
Hypernatraemia ^† 1	1/1008 (0.10%)
Hypocalcaemia ^† 1	2/1008 (0.20%)
Hypoglycaemia ^† 1	5/1008 (0.50%)
Hyponatraemia ^† 1	6/1008 (0.60%)
Hypoproteinaemia ^† 1	1/1008 (0.10%)
Ketoacidosis ^† 1	1/1008 (0.10%)
Type 1 diabetes mellitus ^† 1	1/1008 (0.10%)
Decreased appetite ^† 1	1/1008 (0.10%)
Metabolic acidosis ^† 1	1/1008 (0.10%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/1008 (0.10%)
Arthritis ^† 1	1/1008 (0.10%)
Back pain ^† 1	8/1008 (0.79%)
Bone pain ^† 1	2/1008 (0.20%)
Fistula ^† 1	1/1008 (0.10%)
Flank pain ^† 1	1/1008 (0.10%)
Groin pain ^† 1	1/1008 (0.10%)
Mobility decreased ^† 1	2/1008 (0.20%)
Muscular weakness ^† 1	1/1008 (0.10%)
Musculoskeletal chest pain ^† 1	2/1008 (0.20%)
Myositis ^† 1	1/1008 (0.10%)
Osteoarthritis ^† 1	1/1008 (0.10%)
Osteochondrosis ^† 1	1/1008 (0.10%)
Tendonitis ^† 1	1/1008 (0.10%)
Pain in extremity ^† 1	1/1008 (0.10%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma ^† 1	1/1008 (0.10%)
Adenocarcinoma of colon ^† 1	1/1008 (0.10%)
Anal neoplasm ^† 1	1/1008 (0.10%)
Basal cell carcinoma ^† 1	4/1008 (0.40%)
Bowen's disease ^† 1	1/1008 (0.10%)
Breast cancer ^† 1	1/1008 (0.10%)
Cancer pain ^† 1	5/1008 (0.50%)
Chronic lymphocytic leukaemia ^† 1	2/1008 (0.20%)
Infected neoplasm ^† 1	1/1008 (0.10%)
Intracranial tumour haemorrhage ^† 1	2/1008 (0.20%)
Malignant ascites ^† 1	1/1008 (0.10%)
Malignant melanoma ^† 1	3/1008 (0.30%)
Malignant neoplasm of spinal cord ^† 1	1/1008 (0.10%)
Malignant neoplasm progression ^† 1	278/1008 (27.58%)
Melanoma recurrent ^† 1	1/1008 (0.10%)
Metastases to abdominal cavity ^† 1	1/1008 (0.10%)
Metastases to adrenals ^† 1	3/1008 (0.30%)
Metastases to bladder ^† 1	1/1008 (0.10%)
Metastases to bone ^† 1	2/1008 (0.20%)
Metastases to central nervous system ^† 1	16/1008 (1.59%)
Metastases to liver ^† 1	3/1008 (0.30%)
Metastases to lung ^† 1	1/1008 (0.10%)
Metastases to meninges ^† 1	1/1008 (0.10%)
Metastases to peritoneum ^† 1	1/1008 (0.10%)
Metastases to skin ^† 1	3/1008 (0.30%)
Metastases to spine ^† 1	1/1008 (0.10%)
Metastasis ^† 1	5/1008 (0.50%)
Metastatic malignant melanoma ^† 1	15/1008 (1.49%)
Neoplasm ^† 1	1/1008 (0.10%)
Pituitary tumour benign ^† 1	1/1008 (0.10%)
Renal cell carcinoma ^† 1	1/1008 (0.10%)
Squamous cell carcinoma ^† 1	2/1008 (0.20%)
Squamous cell carcinoma of skin ^† 1	1/1008 (0.10%)
Tonsil cancer ^† 1	1/1008 (0.10%)
Tumour associated fever ^† 1	2/1008 (0.20%)
Tumour flare ^† 1	1/1008 (0.10%)
Tumour haemorrhage ^† 1	8/1008 (0.79%)
Tumour necrosis ^† 1	3/1008 (0.30%)
Non-Hodgkin's lymphoma ^† 1	1/1008 (0.10%)
Tumour pain ^† 1	1/1008 (0.10%)
Nervous system disorders
Altered state of consciousness ^† 1	1/1008 (0.10%)
Aphasia ^† 1	3/1008 (0.30%)
Brachial plexopathy ^† 1	2/1008 (0.20%)
Brain injury ^† 1	1/1008 (0.10%)
Brain oedema ^† 1	3/1008 (0.30%)
Brain stem haemorrhage ^† 1	1/1008 (0.10%)
Central nervous system lesion ^† 1	1/1008 (0.10%)
Cerebral haematoma ^† 1	1/1008 (0.10%)
Cerebral haemorrhage ^† 1	1/1008 (0.10%)
Cerebrovascular accident ^† 1	7/1008 (0.69%)
Encephalopathy ^† 1	1/1008 (0.10%)
Epilepsy ^† 1	3/1008 (0.30%)
Facial paralysis ^† 1	2/1008 (0.20%)
Facial paresis ^† 1	1/1008 (0.10%)
Haemorrhage intracranial ^† 1	2/1008 (0.20%)
Headache ^† 1	3/1008 (0.30%)
Hemiparesis ^† 1	1/1008 (0.10%)
Hepatic encephalopathy ^† 1	1/1008 (0.10%)
Hypertensive encephalopathy ^† 1	1/1008 (0.10%)
Lumbar radiculopathy ^† 1	1/1008 (0.10%)
Miller Fisher syndrome ^† 1	1/1008 (0.10%)
Myasthenia gravis ^† 1	1/1008 (0.10%)
Narcolepsy ^† 1	1/1008 (0.10%)
Nervous system disorder ^† 1	3/1008 (0.30%)
Peripheral nerve lesion ^† 1	1/1008 (0.10%)
Peripheral sensorimotor neuropathy ^† 1	1/1008 (0.10%)
Polyneuropathy ^† 1	1/1008 (0.10%)
Seizure ^† 1	6/1008 (0.60%)
Sensorimotor disorder ^† 1	2/1008 (0.20%)
Spinal cord compression ^† 1	4/1008 (0.40%)
Status epilepticus ^† 1	1/1008 (0.10%)
Syncope ^† 1	3/1008 (0.30%)
Diabetic hyperosmolar coma ^† 1	1/1008 (0.10%)
Generalised tonic-clonic seizure ^† 1	1/1008 (0.10%)
Lethargy ^† 1	1/1008 (0.10%)
Neurological decompensation ^† 1	1/1008 (0.10%)
Sciatica ^† 1	1/1008 (0.10%)
Pregnancy, puerperium and perinatal conditions
Pregnancy ^† 1	1/1008 (0.10%)
Product Issues
Device dislocation ^† 1	1/1008 (0.10%)
Psychiatric disorders
Confusional state ^† 1	4/1008 (0.40%)
Depression ^† 1	3/1008 (0.30%)
Personality change ^† 1	1/1008 (0.10%)
Schizophrenia ^† 1	1/1008 (0.10%)
Psychotic disorder ^† 1	1/1008 (0.10%)
Renal and urinary disorders
Acute kidney injury ^† 1	9/1008 (0.89%)
Autoimmune nephritis ^† 1	1/1008 (0.10%)
Bladder pain ^† 1	1/1008 (0.10%)
Hydronephrosis ^† 1	2/1008 (0.20%)
Nephrolithiasis ^† 1	1/1008 (0.10%)
Postrenal failure ^† 1	1/1008 (0.10%)
Renal failure ^† 1	4/1008 (0.40%)
Renal impairment ^† 1	1/1008 (0.10%)
Tubulointerstitial nephritis ^† 1	2/1008 (0.20%)
Ureteric stenosis ^† 1	1/1008 (0.10%)
Urinary tract obstruction ^† 1	2/1008 (0.20%)
Urinary retention ^† 1	1/1008 (0.10%)
Reproductive system and breast disorders
Ovarian cyst ruptured ^† 1	1/1008 (0.10%)
Pelvic pain ^† 1	1/1008 (0.10%)
Penile oedema ^† 1	1/1008 (0.10%)
Testicular oedema ^† 1	1/1008 (0.10%)
Vaginal haemorrhage ^† 1	1/1008 (0.10%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure ^† 1	2/1008 (0.20%)
Aspiration ^† 1	1/1008 (0.10%)
Atelectasis ^† 1	3/1008 (0.30%)
Cough ^† 1	1/1008 (0.10%)
Dyspnoea ^† 1	8/1008 (0.79%)
Haemoptysis ^† 1	1/1008 (0.10%)
Interstitial lung disease ^† 1	2/1008 (0.20%)
Pleural effusion ^† 1	9/1008 (0.89%)
Pneumonia aspiration ^† 1	2/1008 (0.20%)
Pneumonitis ^† 1	10/1008 (0.99%)
Pneumothorax ^† 1	1/1008 (0.10%)
Pulmonary embolism ^† 1	14/1008 (1.39%)
Pulmonary toxicity ^† 1	1/1008 (0.10%)
Respiratory failure ^† 1	2/1008 (0.20%)
Respiratory muscle weakness ^† 1	1/1008 (0.10%)
Skin and subcutaneous tissue disorders
Dermatitis ^† 1	1/1008 (0.10%)
Dermatitis exfoliative ^† 1	1/1008 (0.10%)
Drug eruption ^† 1	1/1008 (0.10%)
Erythema ^† 1	1/1008 (0.10%)
Generalised erythema ^† 1	1/1008 (0.10%)
Pemphigoid ^† 1	2/1008 (0.20%)
Pruritus generalised ^† 1	1/1008 (0.10%)
Rash generalised ^† 1	1/1008 (0.10%)
Rash maculo-papular ^† 1	2/1008 (0.20%)
Skin ulcer ^† 1	3/1008 (0.30%)
Erythema multiforme ^† 1	1/1008 (0.10%)
Rash macular ^† 1	1/1008 (0.10%)
Vascular disorders
Angiopathy ^† 1	1/1008 (0.10%)
Circulatory collapse ^† 1	1/1008 (0.10%)
Deep vein thrombosis ^† 1	1/1008 (0.10%)
Embolism ^† 1	1/1008 (0.10%)
Extremity necrosis ^† 1	1/1008 (0.10%)
Hypertension ^† 1	2/1008 (0.20%)
Hypertensive crisis ^† 1	3/1008 (0.30%)
Hypotension ^† 1	4/1008 (0.40%)
Jugular vein thrombosis ^† 1	1/1008 (0.10%)
Lymphoedema ^† 1	3/1008 (0.30%)
Peripheral venous disease ^† 1	1/1008 (0.10%)
Superior vena cava syndrome ^† 1	1/1008 (0.10%)
Thrombosis ^† 1	1/1008 (0.10%)
Vascular occlusion ^† 1	1/1008 (0.10%)
Lymphocele ^† 1	1/1008 (0.10%)
1 Term from vocabulary, MedDRA 21.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	NIVOLUMAB 3 MG/KG IV
	Affected / at Risk (%)
Total	857/1008 (85.02%)
Blood and lymphatic system disorders
Anaemia ^† 1	126/1008 (12.50%)
Endocrine disorders
Hypothyroidism ^† 1	114/1008 (11.31%)
Gastrointestinal disorders
Abdominal pain ^† 1	102/1008 (10.12%)
Abdominal pain upper ^† 1	58/1008 (5.75%)
Constipation ^† 1	132/1008 (13.10%)
Diarrhoea ^† 1	210/1008 (20.83%)
Nausea ^† 1	212/1008 (21.03%)
Vomiting ^† 1	120/1008 (11.90%)
Dry mouth ^† 1	51/1008 (5.06%)
General disorders
Asthenia ^† 1	168/1008 (16.67%)
Fatigue ^† 1	295/1008 (29.27%)
Oedema peripheral ^† 1	81/1008 (8.04%)
Pyrexia ^† 1	130/1008 (12.90%)
Infections and infestations
Nasopharyngitis ^† 1	88/1008 (8.73%)
Urinary tract infection ^† 1	54/1008 (5.36%)
Investigations
Alanine aminotransferase increased ^† 1	83/1008 (8.23%)
Aspartate aminotransferase increased ^† 1	78/1008 (7.74%)
Blood alkaline phosphatase increased ^† 1	52/1008 (5.16%)
Lipase increased ^† 1	79/1008 (7.84%)
Weight decreased ^† 1	63/1008 (6.25%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	143/1008 (14.19%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	148/1008 (14.68%)
Back pain ^† 1	116/1008 (11.51%)
Musculoskeletal pain ^† 1	55/1008 (5.46%)
Myalgia ^† 1	62/1008 (6.15%)
Pain in extremity ^† 1	93/1008 (9.23%)
Nervous system disorders
Headache ^† 1	122/1008 (12.10%)
Psychiatric disorders
Insomnia ^† 1	55/1008 (5.46%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	134/1008 (13.29%)
Dyspnoea ^† 1	81/1008 (8.04%)
Skin and subcutaneous tissue disorders
Dry skin ^† 1	54/1008 (5.36%)
Pruritus ^† 1	115/1008 (11.41%)
Pruritus generalised ^† 1	89/1008 (8.83%)
Rash ^† 1	54/1008 (5.36%)
Vitiligo ^† 1	77/1008 (7.64%)
1 Term from vocabulary, MedDRA 21.1 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Bristol-Myers Squibb Study Director
Organization:	Bristol-Myers Squibb
Phone:	Please email
EMail:	Clinical.Trials@bms.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schadendorf D, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Munoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Nathan P. Safety and efficacy of nivolumab in challenging subgroups with advanced melanoma who progressed on or after ipilimumab treatment: A single-arm, open-label, phase II study (CheckMate 172). Eur J Cancer. 2019 Nov;121:144-153. doi: 10.1016/j.ejca.2019.08.014. Epub 2019 Sep 30.

Nathan P, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Munoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Schadendorf D. Safety and efficacy of nivolumab in patients with rare melanoma subtypes who progressed on or after ipilimumab treatment: a single-arm, open-label, phase II study (CheckMate 172). Eur J Cancer. 2019 Sep;119:168-178. doi: 10.1016/j.ejca.2019.07.010. Epub 2019 Aug 21.

Layout table for additonal information

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT02156804
Other Study ID Numbers:	CA209-172 2014-001286-28 ( EudraCT Number )
First Submitted:	May 29, 2014
First Posted:	June 5, 2014
Results First Submitted:	January 10, 2020
Results First Posted:	February 20, 2020
Last Update Posted:	September 11, 2020

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