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Checkpoint Inhibitor

Nivolumab for Cancer Post-Surgery (CheckMate 274 Trial)

Albany, NY
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.

See full description
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.Check my eligibility
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.See study design
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.
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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.
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I have no active cancers in the last 3 years, except for treated and cured local cancers.
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I have had part of my bladder or kidney removed.
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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
70%
Fatigue
50%
Headache
45%
Confusional state
45%
Cough
40%
Malignant neoplasm progression
35%
Hemiparesis
35%
Diarrhoea
30%
Gait disturbance
30%
Nausea
30%
Pruritus
25%
Urinary tract infection
25%
Fall
25%
Hyperglycaemia
25%
Muscular weakness
25%
Rash
20%
Constipation
20%
Vomiting
20%
Lethargy
20%
Memory impairment
20%
Urinary incontinence
20%
Dizziness
20%
Nasal congestion
15%
Abdominal pain
15%
Alanine aminotransferase increased
15%
Lymphocyte count decreased
15%
Platelet count decreased
15%
Decreased appetite
15%
Arthralgia
15%
Cognitive disorder
10%
Aspartate aminotransferase increased
10%
Oedema peripheral
10%
Facial paresis
10%
Pyrexia
10%
Candida infection
10%
Depressed level of consciousness
10%
Syncope
10%
Pulmonary embolism
10%
Anaemia
10%
Sinus tachycardia
10%
Anal incontinence
10%
Asthenia
10%
Tooth infection
10%
Upper respiratory tract infection
10%
Lipase increased
10%
Paraesthesia
10%
Psychomotor skills impaired
10%
Seizure
10%
Agitation
10%
Anxiety
10%
Disorientation
10%
Dehydration
10%
Hypoalbuminaemia
10%
Hypokalaemia
10%
Hyponatraemia
10%
Aphasia
10%
Dysarthria
10%
Dyspnoea
10%
Rash maculo-papular
5%
Dermatitis acneiform
5%
Dysphagia
5%
Oedema
5%
Pain
5%
Cardio-respiratory arrest
5%
Autoimmune thyroiditis
5%
Pneumonia
5%
Hip fracture
5%
White blood cell count decreased
5%
Enterocolitis infectious
5%
Tumour flare
5%
Brain oedema
5%
Cerebrovascular accident
5%
Ischaemic stroke
5%
Mental status changes
5%
Aspiration
5%
Herpes zoster
5%
Haemorrhage intracranial
5%
Hypoxia
5%
Pneumonitis
5%
Respiratory distress
5%
Atrial fibrillation
5%
Cushingoid
5%
Hyperthyroidism
5%
Hypothyroidism
5%
Dry eye
5%
Eyelid ptosis
5%
Visual field defect
5%
Visual impairment
5%
Dyspepsia
5%
Oral candidiasis
5%
Stomatitis
5%
Chills
5%
Amylase increased
5%
Blood alkaline phosphatase increased
5%
Blood bilirubin increased
5%
Weight decreased
5%
Weight increased
5%
Tremor
5%
Vasogenic cerebral oedema
5%
Depression
5%
Insomnia
5%
Pollakiuria
5%
Hypocalcaemia
5%
Proteinuria
5%
Back pain
5%
Myalgia
5%
Amnesia
5%
Ataxia
5%
Balance disorder
5%
Dysphonia
5%
Dry skin
5%
Deep vein thrombosis
5%
Hypertension
5%
Hypotension
5%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1b: Arm N3+I1
Cohort 1: Arm N3
Cohort 1: Arm N1+I3
Cohort 2: Arm N3
Part A Cohort 1c: Arm N3+RT+TMZ
Cohort 2: Arm B
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Part A Cohort 1d: Arm N3+RT

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
2014
Completed Phase 3
~3880

Find a Location

Closest Location:New York Oncology Hematology, P.C.· Albany, NY

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdIndustry Sponsor
181 Previous Clinical Trials
96,372 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,730 Previous Clinical Trials
4,128,394 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
~71 spots leftby Mar 2026
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