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Checkpoint Inhibitor

Nivolumab vs Ipilimumab for Preventing Melanoma Recurrence (CheckMate 238 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
Stage IIIb/C or Stage IV before complete resection
No previous anti-cancer treatment
Must not have
Ocular or uveal melanoma
History of carcinomatosis meningitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing if nivolumab is better than ipilimumab to keep melanoma from returning.

Who is the study for?
This trial is for individuals at least 15 years old who have had melanoma surgically removed within the past 12 weeks and are now in Stage IIIb/C or IV. They should not have received any anti-cancer treatments post-surgery, and those with ocular melanoma, carcinomatosis meningitis, or auto-immune diseases cannot participate.
What is being tested?
The study aims to see if Nivolumab can better prevent melanoma from coming back compared to Ipilimumab after complete surgical removal. Participants will be randomly given either Nivolumab, a placebo matching it, Ipilimumab, or its matching placebo.
What are the potential side effects?
Nivolumab and Ipilimumab may cause immune system-related side effects such as inflammation of organs (like colitis), skin reactions (rash), endocrine issues (thyroid dysfunction), fatigue, and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer was stage IIIb/C or IV before it was fully removed.
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I have not received any anti-cancer treatments before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with eye melanoma.
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I have had cancer spread to the lining of my brain and spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 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
Health Related Quality of Life (HRQoL) Evaluation
Overall Survival (OS)
Recurrence-free Survival by PD-L1 Expression
+4 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
Group I: Nivolumab and Placebo matching IpilimumabExperimental Treatment2 Interventions
Group II: Ipilimumab and Placebo matching NivolumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2015
Completed Phase 3
~3070
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,682 Previous Clinical Trials
4,128,663 Total Patients Enrolled
179 Trials studying Melanoma
56,809 Patients Enrolled for Melanoma
Ono Pharmaceutical Co. LtdIndustry Sponsor
171 Previous Clinical Trials
94,830 Total Patients Enrolled
2 Trials studying Melanoma
624 Patients Enrolled for Melanoma

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02388906 — Phase 3
Melanoma Research Study Groups: Ipilimumab and Placebo matching Nivolumab, Nivolumab and Placebo matching Ipilimumab
Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02388906 — Phase 3
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02388906 — Phase 3
~85 spots leftby Nov 2025
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