An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer (CheckMate 274)

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ClinicalTrials.gov Identifier: NCT02632409

Recruitment Status : Active, not recruiting

First Posted : December 16, 2015

Results First Posted : December 1, 2021

Last Update Posted : January 8, 2024

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Sponsor:

Collaborator:

Ono Pharmaceutical Co. Ltd

Information provided by (Responsible Party):

Bristol-Myers Squibb

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition	Various Advanced Cancer
Interventions	Biological: Nivolumab Other: Placebo
Enrollment	709

Participant Flow

Recruitment Details
Pre-assignment Details	709 Participants Randomized, 699 Treated


Arm/Group Title	Placebo	Nivolumab
Arm/Group Description	Placebo	Nivolumab 240mg IV Q2W
Arm/Group Description	Placebo	Nivolumab 240mg IV Q2W
Period Title: Randomized
Started ^[1]	356	353
Completed ^[2]	348	351
Not Completed	8	2
Reason Not Completed
AE unrelated to study Drug	0	1
Participant withdrew consent	2	1
No Longer meets study criteria	5	0
other reasons	1	0
[1] = Randomized [2] = Treated
Period Title: Treatment Period
Started ^[1]	348	351
Completed	132	143
Not Completed	216	208
Reason Not Completed
Ongoing Treatment	20	21
Disease Recurrence	147	90
Study Drug Toxicity	8	49
Death	1	0
AE unrelated to study drug	15	16
Request to discontinue treatment	4	19
Participant withdrew consent	7	5
Lost to Follow-up	0	1
Maximum clinical benefit	1	0
No longer meets study criteria	3	0
Administrative Reason by sponsor	0	1
Other Reasons	10	6
[1] = Randomized and Treated

Baseline Characteristics

Arm/Group Title		Placebo	Nivolumab	Total
Arm/Group Description		Placebo	Nivolumab 240mg IV Q2W	Total of all reporting groups
Arm/Group Description		Placebo	Nivolumab 240mg IV Q2W	Total of all reporting groups
Overall Number of Baseline Participants		356	353	709
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All randomized participants
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	356 participants	353 participants	709 participants
		65.9 (8.9)	65.3 (10.1)	65.6 (9.5)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	356 participants	353 participants	709 participants
	Female	81 22.8%	88 24.9%	169 23.8%
	Male	275 77.2%	265 75.1%	540 76.2%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	356 participants	353 participants	709 participants
	Hispanic or Latino	21 5.9%	16 4.5%	37 5.2%
	Not Hispanic or Latino	143 40.2%	142 40.2%	285 40.2%
	Unknown or Not Reported	192 53.9%	195 55.2%	387 54.6%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	356 participants	353 participants	709 participants
	American Indian or Alaska Native	0 0.0%	1 0.3%	1 0.1%
	Asian	75 21.1%	80 22.7%	155 21.9%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	3 0.8%	2 0.6%	5 0.7%
	White	272 76.4%	264 74.8%	536 75.6%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	6 1.7%	6 1.7%	12 1.7%

Outcome Measures

1.Primary Outcome


Title	Disease Free Survival (DFS)
Description	The time between the date of randomization and the date of first docum...
Description	The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Time Frame	approximately up to 48 months

Outcome Measure Data

Analysis Population Description

All Randomized Participants


Arm/Group Title	Placebo	Nivolumab
Arm/Group Description:	Placebo	Nivolumab 240mg IV Q2W
Arm/Group Description:	Placebo	Nivolumab 240mg IV Q2W
Overall Number of Participants Analyzed	356	353
Median (95% Confidence Interval) Unit of Measure: Months
	10.84 (8.25 to 13.86)	20.76 (16.49 to 27.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Nivolumab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0008
	Comments	[Not Specified]
	Method	Stratified Cox Proportional hazard model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 98.22% 0.55 to 0.90
	Estimation Comments	[Not Specified]

2.Primary Outcome


Title	Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
Description	The time between the date of randomization and the date of first docum...
Description	The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Time Frame	approximately up to 48 months

Outcome Measure Data

Analysis Population Description

All Randomized Participants with PD-L1 expression ≥ 1%


Arm/Group Title	Placebo	Nivolumab
Arm/Group Description:	Placebo	Nivolumab 240mg IV Q2W
Arm/Group Description:	Placebo	Nivolumab 240mg IV Q2W
Overall Number of Participants Analyzed	142	140
Median (95% Confidence Interval) Unit of Measure: Months
	8.41 (5.59 to 21.19)	NA ^[1] (22.01 to NA)

[1]

Insufficient number of events to calculate median value. Upper limit number not reached

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Nivolumab
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0005
	Comments	[Not Specified]
	Method	Stratified Cox Proportional hazard model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 98.72% 0.35 to 0.84
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Non-Urothelial Tract Recurrence Free Survival
Description	The time between the date of randomization and the date of first docum...
Description	The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Time Frame	up to 53 months

Outcome Measure Data

Analysis Population Description

All Randomized Participants


Arm/Group Title	Placebo	Nivolumab
Arm/Group Description:	Placebo	Nivolumab 240mg IV Q2W
Arm/Group Description:	Placebo	Nivolumab 240mg IV Q2W
Overall Number of Participants Analyzed	356	353
Median (95% Confidence Interval) Unit of Measure: Months
	13.70 (8.41 to 20.34)	22.93 (19.15 to 33.41)

4.Secondary Outcome


Title	Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population
Description	The time between the date of randomization and the date of first docum...
Description	The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Time Frame	up to 53 months

Outcome Measure Data

Analysis Population Description

All Randomized Participants with PD-L1 expression ≥ 1%


Arm/Group Title	Placebo	Nivolumab
Arm/Group Description:	Placebo	Nivolumab 240mg IV Q2W
Arm/Group Description:	Placebo	Nivolumab 240mg IV Q2W
Overall Number of Participants Analyzed	142	140
Median (95% Confidence Interval) Unit of Measure: Months
	10.84 (5.65 to 22.14)	NA ^[1] (24.57 to NA)

[1]

Insufficient number of events to calculate median value. Upper limit number not reached

5.Secondary Outcome


Title	Overall Survival
Description	the time from randomization to the date of death from any cause.
Description	the time from randomization to the date of death from any cause.
Time Frame	on going

Outcome Measure Data Not Reported

6.Secondary Outcome


Title	Overall Survival in Participants With PD-L1 Expression ≥ 1%
Description	the time from randomization to the date of death from any cause.
Description	the time from randomization to the date of death from any cause.
Time Frame	on going

Outcome Measure Data Not Reported

7.Secondary Outcome


Title	Disease Specific Survival
Description	the time from randomization to the date of death due to disease (uroth...
Description	the time from randomization to the date of death due to disease (urothelial cancer).
Time Frame	on going

Outcome Measure Data Not Reported

8.Secondary Outcome


Title	Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%
Description	the time from randomization to the date of death due to disease (uroth...
Description	the time from randomization to the date of death due to disease (urothelial cancer).
Time Frame	on going

Outcome Measure Data Not Reported

Adverse Events

Time Frame	appoximately up to 55 months
Adverse Event Reporting Description	All Treated Participants All cause mortality is currently blinded at this time and will not be reported.

Arm/Group Title	Placebo	Nivolumab
Arm/Group Description	Placebo	Nivolumab 240mg IV Q2W
Arm/Group Description	Placebo	Nivolumab 240mg IV Q2W
All-Cause Mortality
	Placebo	Nivolumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0
Serious Adverse Events Serious Adverse Events
	Placebo	Nivolumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	129/348 (37.07%)	122/351 (34.76%)
Blood and lymphatic system disorders
Anaemia ^† 1	1/348 (0.29%)	0/351 (0.00%)
Bone marrow failure ^† 1	0/348 (0.00%)	1/351 (0.28%)
Febrile neutropenia ^† 1	1/348 (0.29%)	1/351 (0.28%)
Neutropenia ^† 1	1/348 (0.29%)	0/351 (0.00%)
Cardiac disorders
Arteriosclerosis coronary artery ^† 1	1/348 (0.29%)	1/351 (0.28%)
Atrial fibrillation ^† 1	0/348 (0.00%)	3/351 (0.85%)
Atrioventricular block ^† 1	0/348 (0.00%)	1/351 (0.28%)
Atrioventricular block complete ^† 1	1/348 (0.29%)	1/351 (0.28%)
Cardiac failure ^† 1	2/348 (0.57%)	0/351 (0.00%)
Cardiac failure congestive ^† 1	0/348 (0.00%)	1/351 (0.28%)
Coronary artery disease ^† 1	0/348 (0.00%)	3/351 (0.85%)
Coronary artery stenosis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Immune-mediated myocarditis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Myocardial infarction ^† 1	1/348 (0.29%)	0/351 (0.00%)
Myocarditis ^† 1	0/348 (0.00%)	2/351 (0.57%)
Ear and labyrinth disorders
Vertigo ^† 1	1/348 (0.29%)	0/351 (0.00%)
Endocrine disorders
Adrenal insufficiency ^† 1	0/348 (0.00%)	1/351 (0.28%)
Hyperparathyroidism ^† 1	0/348 (0.00%)	1/351 (0.28%)
Secondary adrenocortical insufficiency ^† 1	0/348 (0.00%)	1/351 (0.28%)
Eye disorders
Ocular hypertension ^† 1	0/348 (0.00%)	1/351 (0.28%)
Gastrointestinal disorders
Colitis ^† 1	2/348 (0.57%)	4/351 (1.14%)
Colitis ischaemic ^† 1	1/348 (0.29%)	0/351 (0.00%)
Diarrhoea ^† 1	1/348 (0.29%)	3/351 (0.85%)
Duodenitis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Enterocele ^† 1	1/348 (0.29%)	0/351 (0.00%)
Enterovesical fistula ^† 1	0/348 (0.00%)	1/351 (0.28%)
Gastrointestinal haemorrhage ^† 1	1/348 (0.29%)	0/351 (0.00%)
Ileus ^† 1	0/348 (0.00%)	1/351 (0.28%)
Immune-mediated enterocolitis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Intestinal obstruction ^† 1	6/348 (1.72%)	5/351 (1.42%)
Nausea ^† 1	0/348 (0.00%)	2/351 (0.57%)
Necrotising oesophagitis ^† 1	1/348 (0.29%)	0/351 (0.00%)
Pancreatitis ^† 1	2/348 (0.57%)	1/351 (0.28%)
Pouchitis ^† 1	1/348 (0.29%)	0/351 (0.00%)
Small intestinal obstruction ^† 1	5/348 (1.44%)	1/351 (0.28%)
Subileus ^† 1	0/348 (0.00%)	1/351 (0.28%)
Umbilical hernia ^† 1	1/348 (0.29%)	0/351 (0.00%)
Vomiting ^† 1	1/348 (0.29%)	0/351 (0.00%)
General disorders
Catheter site extravasation ^† 1	0/348 (0.00%)	1/351 (0.28%)
Complication associated with device ^† 1	0/348 (0.00%)	1/351 (0.28%)
Fatigue ^† 1	0/348 (0.00%)	1/351 (0.28%)
Generalised oedema ^† 1	1/348 (0.29%)	0/351 (0.00%)
Multiple organ dysfunction syndrome ^† 1	0/348 (0.00%)	1/351 (0.28%)
Non-cardiac chest pain ^† 1	0/348 (0.00%)	1/351 (0.28%)
Pain ^† 1	1/348 (0.29%)	0/351 (0.00%)
Pyrexia ^† 1	1/348 (0.29%)	3/351 (0.85%)
Sudden death ^† 1	2/348 (0.57%)	1/351 (0.28%)
Hepatobiliary disorders
Bile duct stone ^† 1	0/348 (0.00%)	1/351 (0.28%)
Cholecystitis ^† 1	1/348 (0.29%)	3/351 (0.85%)
Drug-induced liver injury ^† 1	0/348 (0.00%)	2/351 (0.57%)
Hepatic function abnormal ^† 1	0/348 (0.00%)	2/351 (0.57%)
Hepatitis ^† 1	1/348 (0.29%)	0/351 (0.00%)
Infections and infestations
Abscess limb ^† 1	1/348 (0.29%)	0/351 (0.00%)
Appendicitis ^† 1	1/348 (0.29%)	0/351 (0.00%)
Bacteraemia ^† 1	1/348 (0.29%)	2/351 (0.57%)
Bronchiolitis ^† 1	1/348 (0.29%)	0/351 (0.00%)
Cellulitis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Chest wall abscess ^† 1	0/348 (0.00%)	1/351 (0.28%)
Citrobacter sepsis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Device related infection ^† 1	1/348 (0.29%)	1/351 (0.28%)
Diverticulitis ^† 1	1/348 (0.29%)	0/351 (0.00%)
Erysipelas ^† 1	0/348 (0.00%)	1/351 (0.28%)
Escherichia sepsis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Escherichia urinary tract infection ^† 1	0/348 (0.00%)	1/351 (0.28%)
Gastroenteritis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Infected lymphocele ^† 1	0/348 (0.00%)	2/351 (0.57%)
Infection ^† 1	2/348 (0.57%)	0/351 (0.00%)
Influenza ^† 1	1/348 (0.29%)	0/351 (0.00%)
Klebsiella infection ^† 1	1/348 (0.29%)	0/351 (0.00%)
Lower respiratory tract infection ^† 1	0/348 (0.00%)	1/351 (0.28%)
Penile infection ^† 1	1/348 (0.29%)	0/351 (0.00%)
Peritonitis ^† 1	2/348 (0.57%)	0/351 (0.00%)
Pneumonia ^† 1	5/348 (1.44%)	1/351 (0.28%)
Pyelonephritis ^† 1	2/348 (0.57%)	1/351 (0.28%)
Pyelonephritis acute ^† 1	2/348 (0.57%)	1/351 (0.28%)
Respiratory tract infection viral ^† 1	0/348 (0.00%)	1/351 (0.28%)
Sepsis ^† 1	4/348 (1.15%)	5/351 (1.42%)
Septic encephalopathy ^† 1	1/348 (0.29%)	0/351 (0.00%)
Septic shock ^† 1	2/348 (0.57%)	0/351 (0.00%)
Skin infection ^† 1	0/348 (0.00%)	1/351 (0.28%)
Soft tissue infection ^† 1	0/348 (0.00%)	1/351 (0.28%)
Urinary tract infection ^† 1	21/348 (6.03%)	12/351 (3.42%)
Urinary tract infection bacterial ^† 1	2/348 (0.57%)	0/351 (0.00%)
Urosepsis ^† 1	9/348 (2.59%)	3/351 (0.85%)
Wound infection ^† 1	0/348 (0.00%)	1/351 (0.28%)
Injury, poisoning and procedural complications
Craniocerebral injury ^† 1	1/348 (0.29%)	0/351 (0.00%)
Femoral neck fracture ^† 1	0/348 (0.00%)	1/351 (0.28%)
Hand fracture ^† 1	0/348 (0.00%)	1/351 (0.28%)
Hypobarism ^† 1	0/348 (0.00%)	1/351 (0.28%)
Incisional hernia ^† 1	0/348 (0.00%)	3/351 (0.85%)
Infusion related reaction ^† 1	1/348 (0.29%)	2/351 (0.57%)
Overdose ^† 1	1/348 (0.29%)	0/351 (0.00%)
Pelvic fracture ^† 1	1/348 (0.29%)	0/351 (0.00%)
Penetrating abdominal trauma ^† 1	0/348 (0.00%)	1/351 (0.28%)
Procedural pneumothorax ^† 1	1/348 (0.29%)	0/351 (0.00%)
Spinal compression fracture ^† 1	0/348 (0.00%)	1/351 (0.28%)
Stab wound ^† 1	1/348 (0.29%)	0/351 (0.00%)
Stoma site erythema ^† 1	0/348 (0.00%)	1/351 (0.28%)
Subdural haematoma ^† 1	0/348 (0.00%)	1/351 (0.28%)
Urinary tract stoma complication ^† 1	1/348 (0.29%)	0/351 (0.00%)
Urostomy complication ^† 1	1/348 (0.29%)	2/351 (0.57%)
Investigations
Alanine aminotransferase increased ^† 1	0/348 (0.00%)	1/351 (0.28%)
Amylase increased ^† 1	1/348 (0.29%)	0/351 (0.00%)
Aspartate aminotransferase increased ^† 1	0/348 (0.00%)	1/351 (0.28%)
Blood alkaline phosphatase increased ^† 1	0/348 (0.00%)	1/351 (0.28%)
Blood bilirubin increased ^† 1	1/348 (0.29%)	0/351 (0.00%)
Blood magnesium decreased ^† 1	1/348 (0.29%)	0/351 (0.00%)
Clostridium test positive ^† 1	1/348 (0.29%)	0/351 (0.00%)
Lipase increased ^† 1	1/348 (0.29%)	1/351 (0.28%)
Platelet count decreased ^† 1	0/348 (0.00%)	1/351 (0.28%)
Transaminases increased ^† 1	0/348 (0.00%)	1/351 (0.28%)
Metabolism and nutrition disorders
Dehydration ^† 1	0/348 (0.00%)	1/351 (0.28%)
Diabetic ketoacidosis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Diabetic metabolic decompensation ^† 1	1/348 (0.29%)	0/351 (0.00%)
Hypercalcaemia ^† 1	1/348 (0.29%)	0/351 (0.00%)
Hyperglycaemia ^† 1	1/348 (0.29%)	0/351 (0.00%)
Hyperkalaemia ^† 1	1/348 (0.29%)	2/351 (0.57%)
Malnutrition ^† 1	0/348 (0.00%)	1/351 (0.28%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	0/348 (0.00%)	1/351 (0.28%)
Osteitis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Osteonecrosis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Pathological fracture ^† 1	1/348 (0.29%)	0/351 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer ^† 1	1/348 (0.29%)	0/351 (0.00%)
Bladder cancer recurrent ^† 1	0/348 (0.00%)	1/351 (0.28%)
Colon cancer ^† 1	0/348 (0.00%)	1/351 (0.28%)
Haemangioma of bone ^† 1	0/348 (0.00%)	1/351 (0.28%)
Leiomyosarcoma ^† 1	1/348 (0.29%)	0/351 (0.00%)
Lung adenocarcinoma ^† 1	0/348 (0.00%)	1/351 (0.28%)
Lung neoplasm malignant ^† 1	0/348 (0.00%)	1/351 (0.28%)
Malignant melanoma ^† 1	1/348 (0.29%)	0/351 (0.00%)
Malignant neoplasm progression ^† 1	39/348 (11.21%)	15/351 (4.27%)
Metastases to central nervous system ^† 1	1/348 (0.29%)	0/351 (0.00%)
Nodular melanoma ^† 1	1/348 (0.29%)	0/351 (0.00%)
Rectal cancer ^† 1	1/348 (0.29%)	0/351 (0.00%)
Recurrent cancer ^† 1	2/348 (0.57%)	2/351 (0.57%)
Squamous cell carcinoma of skin ^† 1	1/348 (0.29%)	0/351 (0.00%)
Transitional cell carcinoma metastatic ^† 1	1/348 (0.29%)	0/351 (0.00%)
Urinary tract carcinoma in situ ^† 1	1/348 (0.29%)	0/351 (0.00%)
Nervous system disorders
Cerebral infarction ^† 1	1/348 (0.29%)	0/351 (0.00%)
Cerebrovascular accident ^† 1	0/348 (0.00%)	1/351 (0.28%)
Demyelination ^† 1	0/348 (0.00%)	1/351 (0.28%)
Dizziness ^† 1	0/348 (0.00%)	1/351 (0.28%)
Embolic stroke ^† 1	0/348 (0.00%)	1/351 (0.28%)
Haemorrhage intracranial ^† 1	1/348 (0.29%)	0/351 (0.00%)
Ischaemic cerebral infarction ^† 1	1/348 (0.29%)	0/351 (0.00%)
Myasthenia gravis ^† 1	0/348 (0.00%)	2/351 (0.57%)
Seizure ^† 1	0/348 (0.00%)	1/351 (0.28%)
Subarachnoid haemorrhage ^† 1	0/348 (0.00%)	1/351 (0.28%)
Syncope ^† 1	1/348 (0.29%)	0/351 (0.00%)
Transient ischaemic attack ^† 1	1/348 (0.29%)	0/351 (0.00%)
Product Issues
Device malfunction ^† 1	1/348 (0.29%)	0/351 (0.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	3/348 (0.86%)	6/351 (1.71%)
Autoimmune nephritis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Haematuria ^† 1	3/348 (0.86%)	0/351 (0.00%)
Hydronephrosis ^† 1	4/348 (1.15%)	3/351 (0.85%)
Nephrolithiasis ^† 1	1/348 (0.29%)	0/351 (0.00%)
Pyelocaliectasis ^† 1	1/348 (0.29%)	0/351 (0.00%)
Renal failure ^† 1	1/348 (0.29%)	1/351 (0.28%)
Ureteric stenosis ^† 1	1/348 (0.29%)	0/351 (0.00%)
Urinary retention ^† 1	0/348 (0.00%)	2/351 (0.57%)
Urinary tract obstruction ^† 1	5/348 (1.44%)	3/351 (0.85%)
Reproductive system and breast disorders
Pelvic fluid collection ^† 1	1/348 (0.29%)	0/351 (0.00%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease ^† 1	1/348 (0.29%)	0/351 (0.00%)
Emphysema ^† 1	0/348 (0.00%)	1/351 (0.28%)
Haemothorax ^† 1	0/348 (0.00%)	1/351 (0.28%)
Immune-mediated pneumonitis ^† 1	0/348 (0.00%)	1/351 (0.28%)
Interstitial lung disease ^† 1	0/348 (0.00%)	2/351 (0.57%)
Pneumonitis ^† 1	0/348 (0.00%)	6/351 (1.71%)
Pneumothorax ^† 1	0/348 (0.00%)	1/351 (0.28%)
Pulmonary embolism ^† 1	1/348 (0.29%)	3/351 (0.85%)
Skin and subcutaneous tissue disorders
Pemphigoid ^† 1	0/348 (0.00%)	1/351 (0.28%)
Rash ^† 1	1/348 (0.29%)	1/351 (0.28%)
Vascular disorders
Aortic aneurysm ^† 1	0/348 (0.00%)	1/351 (0.28%)
Aortic rupture ^† 1	0/348 (0.00%)	1/351 (0.28%)
Deep vein thrombosis ^† 1	2/348 (0.57%)	0/351 (0.00%)
Hypotension ^† 1	0/348 (0.00%)	1/351 (0.28%)
Peripheral ischaemia ^† 1	0/348 (0.00%)	1/351 (0.28%)
Venous thrombosis limb ^† 1	1/348 (0.29%)	0/351 (0.00%)
1 Term from vocabulary, 23.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo	Nivolumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	307/348 (88.22%)	332/351 (94.59%)
Blood and lymphatic system disorders
Anaemia ^† 1	41/348 (11.78%)	53/351 (15.10%)
Endocrine disorders
Hyperthyroidism ^† 1	4/348 (1.15%)	37/351 (10.54%)
Hypothyroidism ^† 1	9/348 (2.59%)	41/351 (11.68%)
Gastrointestinal disorders
Abdominal pain ^† 1	42/348 (12.07%)	37/351 (10.54%)
Constipation ^† 1	57/348 (16.38%)	50/351 (14.25%)
Diarrhoea ^† 1	92/348 (26.44%)	105/351 (29.91%)
Dry mouth ^† 1	2/348 (0.57%)	20/351 (5.70%)
Nausea ^† 1	52/348 (14.94%)	63/351 (17.95%)
Vomiting ^† 1	31/348 (8.91%)	31/351 (8.83%)
General disorders
Asthenia ^† 1	31/348 (8.91%)	42/351 (11.97%)
Fatigue ^† 1	89/348 (25.57%)	99/351 (28.21%)
Oedema peripheral ^† 1	26/348 (7.47%)	32/351 (9.12%)
Pyrexia ^† 1	40/348 (11.49%)	37/351 (10.54%)
Infections and infestations
Nasopharyngitis ^† 1	25/348 (7.18%)	23/351 (6.55%)
Upper respiratory tract infection ^† 1	26/348 (7.47%)	31/351 (8.83%)
Urinary tract infection ^† 1	55/348 (15.80%)	68/351 (19.37%)
Investigations
Alanine aminotransferase increased ^† 1	17/348 (4.89%)	23/351 (6.55%)
Amylase increased ^† 1	29/348 (8.33%)	46/351 (13.11%)
Aspartate aminotransferase increased ^† 1	17/348 (4.89%)	19/351 (5.41%)
Blood alkaline phosphatase increased ^† 1	9/348 (2.59%)	18/351 (5.13%)
Blood creatinine increased ^† 1	49/348 (14.08%)	51/351 (14.53%)
Lipase increased ^† 1	30/348 (8.62%)	40/351 (11.40%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	30/348 (8.62%)	49/351 (13.96%)
Hyperglycaemia ^† 1	25/348 (7.18%)	19/351 (5.41%)
Hyperkalaemia ^† 1	26/348 (7.47%)	21/351 (5.98%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	45/348 (12.93%)	40/351 (11.40%)
Back pain ^† 1	44/348 (12.64%)	47/351 (13.39%)
Myalgia ^† 1	12/348 (3.45%)	22/351 (6.27%)
Pain in extremity ^† 1	21/348 (6.03%)	24/351 (6.84%)
Nervous system disorders
Dizziness ^† 1	29/348 (8.33%)	32/351 (9.12%)
Headache ^† 1	30/348 (8.62%)	33/351 (9.40%)
Psychiatric disorders
Insomnia ^† 1	17/348 (4.89%)	24/351 (6.84%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	39/348 (11.21%)	48/351 (13.68%)
Dyspnoea ^† 1	21/348 (6.03%)	42/351 (11.97%)
Skin and subcutaneous tissue disorders
Dry skin ^† 1	16/348 (4.60%)	25/351 (7.12%)
Pruritus ^† 1	56/348 (16.09%)	107/351 (30.48%)
Rash ^† 1	36/348 (10.34%)	67/351 (19.09%)
Rash maculo-papular ^† 1	9/348 (2.59%)	22/351 (6.27%)
Vascular disorders
Hypertension ^† 1	19/348 (5.46%)	16/351 (4.56%)
1 Term from vocabulary, 23.0 † 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):

Bajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Neif Antonio J Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2021 Jun 3;384(22):2102-2114. doi: 10.1056/NEJMoa2034442. Erratum In: N Engl J Med. 2021 Aug 26;385(9):864.

Layout table for additonal information

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT02632409
Other Study ID Numbers:	CA209-274 2014-003626-40 ( EudraCT Number )
First Submitted:	December 14, 2015
First Posted:	December 16, 2015
Results First Submitted:	July 16, 2021
Results First Posted:	December 1, 2021
Last Update Posted:	January 8, 2024

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