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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
CheckMate 238 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.Check my eligibility
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.See study design
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.
CheckMate 238 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer was stage IIIb/C or IV before it was fully removed.
Select...
I have not received any anti-cancer treatments before.
CheckMate 238 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
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
Health Related Quality of Life (HRQoL) Evaluation
Overall Survival (OS)
Recurrence-free Survival by PD-L1 Expression
+4 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%
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
CheckMate 238 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
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,127,608 Total Patients Enrolled
177 Trials studying Melanoma
56,637 Patients Enrolled for Melanoma
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,617 Total Patients Enrolled
2 Trials studying Melanoma
624 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at least 15 years old, or 18 where required by local laws.My cancer was stage IIIb/C or IV before it was fully removed.I have been diagnosed with eye melanoma.I have had cancer spread to the lining of my brain and spinal cord.I have not received any anti-cancer treatments before.You have had an autoimmune disease in the past.My melanoma was fully removed by surgery within the last 12 weeks.I received treatment for melanoma after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Ipilimumab and Placebo matching Nivolumab
- Group 2: Nivolumab and Placebo matching Ipilimumab
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 other scientific papers exist on Nivolumab?
"Nivolumab was first trialed in 2009 at Texas Children's Hospital. 362 studies have completed since then. Right now, there are 796 different ongoing trials for this medication, with a large concentration of these clinical trials taking place in Atlanta, Georgia."
Answered by AI
What is the FDA's official stance on Nivolumab?
"On a scale from 1 to 3, our team at Power estimates the safety of Nivolumab to be a 3 because this is a Phase 3 trial."
Answered by AI
Are there other hospitals or research centers participating in this study within the state?
"This clinical trial is accepting patients at Winship Cancer Institute. in Atlanta, Georgia, Dana Farber Cancer Institute in Boston, Massachusetts, and University Of Michigan Health System in Ann Arbor, Michigan as well as other sites 80 other locations."
Answered by AI
What autoimmune diseases does Nivolumab typically help to ameliorate?
"Nivolumab is indicated for the treatment of unresectable melanoma, malignant neoplasms, and patients that have undergone anti-angiogenic therapy."
Answered by AI
How many people are involved in this experiment?
"Presently, this study is not looking for any more participants. It was originally posted on March 16th, 2015 and was updated September 1st, 2022. For those exploring other studies, 1838 trials for patients with melanoma are actively recruiting and 796 studies involving Nivolumab are as well."
Answered by AI
Are researchers currently looking for new participants in this trial?
"Unfortunately, this particular clinical trial is not recruiting new patients at the moment. However, there are 796 other trials for Nivolumab that are still enrolling individuals."
Answered by AI
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