What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly immune checkpoint inhibitors like nivolumab, are associated with several side effects. These include immune-related adverse events such as skin reactions, endocrine events, and pneumonitis. Severe adverse events can include diarrhea, infusion-related reactions, and in rare cases, fatal outcomes like hepatic toxicity and acute renal failure. Combination therapies, such as nivolumab with ipilimumab, may increase the frequency and severity of these side effects.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of melanoma, focusing on drugs that block PD-1 to enhance the immune response against cancer cells. Nivolumab (Opdivo) and pembrolizumab (Keytruda) are two such drugs. Nivolumab has been approved for use in various settings, including as a single agent and in combination with ipilimumab (another checkpoint inhibitor targeting CTLA-4) for advanced melanoma. Pembrolizumab has also been approved for advanced melanoma and can be administered on an every-three-week or every-six-week schedule. Both drugs have shown significant improvements in progression-free survival and overall survival in clinical trials.

What other types of research exist?

Promising alternatives to Nivolumab for melanoma patients include Pembrolizumab (another PD-1 inhibitor), Ipilimumab (CTLA-4 inhibitor), and combination therapies such as Nivolumab plus Ipilimumab. Additionally, Relatlimab (an anti-LAG-3 antibody) in combination with Nivolumab has shown efficacy in recent trials. These options provide various mechanisms to enhance the immune response against melanoma cells.

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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

Must not have

Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways

History of ocular or mucosal 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

Pivotal Trial

Summary

This trial is testing if nivolumab can help prevent melanoma from returning in patients who have had their cancer surgically removed but are at high risk for it coming back. Nivolumab boosts the immune system to fight any remaining cancer cells. Nivolumab is used for the treatment of malignant melanoma and has shown promising anticancer activity in various cancers.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with specific immune system targeting drugs before.

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I have had melanoma in my eyes or mucous membranes.

Timeline

Screening ~ 3 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recurrence Free Survival (RFS)

Secondary study objectives

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 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%

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

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immune checkpoint inhibitors, such as nivolumab, work by blocking proteins like PD-1 on T cells, which cancer cells often exploit to evade immune detection. By inhibiting PD-1, these drugs enhance the immune system's ability to recognize and attack melanoma cells. This mechanism is crucial for melanoma patients as it can lead to improved survival rates and durable responses, especially in those with advanced or high-risk disease. Other similar treatments include pembrolizumab (another PD-1 inhibitor) and ipilimumab, which targets CTLA-4, another checkpoint protein. These therapies have transformed melanoma treatment by offering new hope for long-term remission.