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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 53 months
Awards & highlights
CheckMate 274 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.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.
CheckMate 274 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a sample of my tumor for testing.
Select...
I had a high-risk bladder, ureter, or kidney cancer.
CheckMate 274 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 53 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 53 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Free Survival (DFS)
Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
Secondary outcome measures
Disease Specific Survival
Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%
Non-Urothelial Tract Recurrence Free Survival
+3 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
CheckMate 274 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
~4750
Find a Location
Who is running the clinical trial?
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,814 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,127,805 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide a sample of my tumor for testing.I haven't taken steroids or immune-weakening drugs in the last 14 days.I had a high-risk bladder, ureter, or kidney cancer.I had major surgery to remove my bladder within the last 4 months.I have not had cisplatin before surgery and cannot or will not have cisplatin after surgery.I have no active cancers in the last 3 years, except for treated and cured local cancers.I have had part of my bladder or kidney removed.I had chemotherapy for bladder cancer after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the more popular reasons why doctors prescribe Nivolumab?
"Nivolumab can be used as a treatment for malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
Nivolumab has received FDA clearance, correct?
"Nivolumab's safety is rated highly by our team at Power. This is due to the fact that this medication has reached Phase 3 in clinical trials, suggesting both efficacy and a strong safety profile."
Answered by AI
Does lenalidomide have a clinical presence in Canada?
"The trial is currently taking place at 75 different locations, such as Local Institution - 0009 in Chattanooga, Local Institution - 0003 in Omaha, and Local Institution - 0112 in Sherbrooke."
Answered by AI
How many individuals are being monitored during this research project?
"Unfortunately, this particular clinical trial is no longer recruiting patients. The study was initially posted on March 22nd 2016 but the most recent update occurred on October 12th 2022. Although this specific trial is not currently running, there are 749 other studies for Nivolumab that are actively searching for participants as well as 2 studies related to malignant neoplasms."
Answered by AI
Is Nivolumab a common drug used in clinical trials?
"Out of the 82 current Phase 3 trials for Nivolumab, 749 are ongoing. The majority of these clinical tests are situated in Basel, BE; however, there are a total of 40524 locations running studies involving Nivolumab."
Answered by AI
Is this research study the initial step in its field?
"Nivolumab has seen a lot of clinical activity in the last decade, with 749 ongoing studies involving 50 different nations. The first Nivolumab trials started back in 2010 and, to date, have included over 18000 patients."
Answered by AI
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