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Nivolumab for Melanoma Prevention (CheckMate76K 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
ECOG 0 or 1
Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months)
Awards & highlights

CheckMate76K Trial Summary

This trial will test whether nivolumab can prevent Stage IIB/C melanoma from recurring after it has been completely removed.

Who is the study for?
This trial is for adults and kids who've had surgery to remove Stage IIB/C melanoma and are at high risk of it coming back. They should be in good physical shape (ECOG 0 or 1), have not been treated for melanoma before, and can't be pregnant or nursing. People with a history of certain types of melanoma, autoimmune diseases, allergies to the drug's ingredients, or previous treatments targeting immune checkpoints cannot join.Check my eligibility
What is being tested?
The study is testing if Nivolumab, an immunotherapy drug, can prevent melanoma from returning after surgery better than a placebo (a treatment with no active drug). Participants will randomly receive either Nivolumab or the placebo to compare their effectiveness.See study design
What are the potential side effects?
Nivolumab may cause side effects like fatigue, skin reactions, inflammation in organs such as lungs or intestines (colitis), hormonal gland problems (like thyroid issues), liver inflammation (hepatitis), and could potentially worsen autoimmune diseases.

CheckMate76K Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or can carry out light work.
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I was diagnosed with Stage IIB/C melanoma that was surgically removed.
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I have never been treated for melanoma.

CheckMate76K Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence Free Survival (RFS)
Secondary outcome measures
Distant Metastasis-Free Survival (DMFS)
Duration of Treatment on Next Line Therapy Per Investigator Assessment
Number of Participants Experiencing Adverse Events (AEs)
+8 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
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%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
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%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
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%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest 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%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
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

CheckMate76K Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NivolumabExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,127,724 Total Patients Enrolled
177 Trials studying Melanoma
56,753 Patients Enrolled for Melanoma

Media Library

Nivolumab Clinical Trial Eligibility Overview. Trial Name: NCT04099251 — Phase 3
Melanoma Research Study Groups: Placebo, Nivolumab
Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04099251 — Phase 3
Nivolumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04099251 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is Nivolumab typically employed in patient care?

"Nivolumab can be used as an effective treatment against melanoma, squamous cell carcinoma, and other malignant neoplasms that cannot be removed through surgery."

Answered by AI

How many people have volunteered to be a part of this experiment?

"No, this study is not currently looking for more candidates. According to the information on clinicaltrials.gov, recruitment for this trial ended on September 1st, 2022. There are 781 trials related to melanoma and 749 trials involving Nivolumab that are still recruiting patients."

Answered by AI

When was NivolumabGiven the thumbs up by the FDA?

"Nivolumab has received a score of 3 from our team at Power. This is because Nivolumab is in Phase 3 trials, meaning that not only does data support its efficacy, but multiple rounds of testing have shown it to be safe."

Answered by AI

Is this trial taking place mostly in North America or are there other continents with participating hospitals as well?

"This trial has 66 active recruitment sites, which include Local Institution - 0144 in Austin, Juravinski Cancer Centre in Hamilton, and Local Institution - 0124 in Kingston."

Answered by AI

Are there other examples of Nivolumab being used in treatments?

"Nivolumab was first studied in H. Lee Moffitt Cancer Center and Research Institute back in 2010. As of now, a total of 18518 studies have been completed with 749 more currently underway. A large portion of these active trials are occurring within Austin, Texas."

Answered by AI

Is this the inaugural clinical trial of its kind?

"As of now, there are 749 ongoing clinical trials for the drug Nivolumab in 2347 cities and 50 countries. The first study using Nivolumab occurred in 2010 as a part of a Phase 1 127-person trial sponsored by Medarex. Since then, 18518 more studies have been completed."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Local Institution
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
2019. "Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04099251.
All > Melanoma
~146 spots leftby Apr 2025
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