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Checkpoint Inhibitor

Nivolumab for Cancer Post-Surgery (CheckMate 274 Trial)

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumor tissue must be provided for biomarker analysis
Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
Must not have
Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 53 months
Awards & highlights
Pivotal Trial

Summary

This trial will compare the effectiveness of the drug Nivolumab to a placebo in patients who have had surgery for urothelial cancer.

Who is the study for?
This trial is for patients who've had surgery to remove high-risk invasive urothelial cancer from the bladder, ureter, or renal pelvis. They should be currently free of disease (confirmed by imaging), have not received cisplatin chemotherapy before surgery unless ineligible or refusing further cisplatin treatment.
What is being tested?
The study is testing Nivolumab, an immunotherapy drug, against a placebo to see if it's more effective in preventing cancer recurrence after radical surgery. Participants will randomly receive either Nivolumab or a placebo without knowing which one they're getting.
What are the potential side effects?
Nivolumab can cause immune-related side effects such as inflammation in various organs like lungs and intestines, skin rash, liver problems, hormone gland issues (like thyroid), fatigue and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can provide a sample of my tumor for testing.
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I had a high-risk bladder, ureter, or kidney cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken steroids or immune-weakening drugs in the last 14 days.
Select...
I have no active cancers in the last 3 years, except for treated and cured local cancers.
Select...
I have had part of my bladder or kidney removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 53 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 53 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Free Survival (DFS)
Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
Secondary study objectives
Disease Specific Survival
Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%
Non-Urothelial Tract Recurrence Free Survival
+3 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NivolumabExperimental Treatment1 Intervention
Nivolumab dose as specified
Group II: PlaceboPlacebo Group1 Intervention
Placebo dose as specified
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdIndustry Sponsor
174 Previous Clinical Trials
95,229 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,691 Previous Clinical Trials
4,096,879 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02632409 — Phase 3
Cancer Research Study Groups: Nivolumab, Placebo
Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02632409 — Phase 3
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02632409 — Phase 3
~73 spots leftby Dec 2025
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