Active not recruitingPHASE3INTERVENTIONAL

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma

This research study is investigating a new way to prevent melanoma, a type of skin cancer, from returning after surgery. It focuses on people who have already had their melanoma completely removed, specifically those with Stage IIB/C melanoma, as they have a higher chance of the cancer coming back. The study aims to find out if a drug called nivolumab, a type of immunotherapy, is better than a dummy treatment (placebo) at keeping the cancer away. Immunotherapy drugs like nivolumab work by helping your own immune system fight cancer cells. Both adults and children aged 12 and over are being included to see if this treatment can be effective in a wider range of patients at risk.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

790

Start

28 Oct 2019

Estimated completion

29 Jun 2027

Melanoma

Results

Results from this study

Posted July 2023

Results have been published for this study.

Primary outcome

Recurrence Free Survival (RFS)

Recurrence Free Survival (RFS) is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not recurred or did not die, RFS will be censored on the date of last evaluable disease assessment. For those participants who remained alive and had no recorded post-randomization tumor assessment, RFS will be censored on the day of randomization.

Full results on the registry

What is this study about?

This study is focused on a type of skin cancer called melanoma. When melanoma is found and removed early, it often doesn't come back. However, for some people, especially those with more advanced early stages like Stage IIB or IIC melanoma, there's a higher chance of the cancer returning even after surgery. This can be a very worrying time for patients and their families.

The main goal of this research is to see if a drug called nivolumab can help prevent the melanoma from coming back after it has been completely removed by surgery. Nivolumab is a type of immunotherapy. This means it works by boosting your body's natural defence system, called the immune system, to find and destroy any remaining cancer cells. The study compares nivolumab to a placebo, which looks like the real drug but contains no active medicine. This comparison is vital to understand if any benefits seen are truly due to nivolumab.

By taking part, individuals would help doctors understand if nivolumab can offer a new and effective way to lower the risk of melanoma recurrence. This could potentially improve long-term outcomes for many people who have had melanoma. The study includes both adults and young people aged 12 and over to gather comprehensive information about the drug's effectiveness across different age groups facing this challenge.

Key takeaways

This study is for people with Stage IIB/C melanoma that has been completely removed.
It tests if an immunotherapy drug, nivolumab, can prevent melanoma from returning.
Participants will receive either nivolumab or a dummy treatment (placebo).
It includes both adults and children aged 12 and over.
Taking part involves regular hospital visits, treatments, and check-ups.
Your normal medical care will not be affected if you choose to leave the study.

Who may be eligible?

To join this study, people must have been diagnosed with a specific type of melanoma (Stage IIB or IIC) that has been completely removed by surgery. They must generally be in good health and have no history of the melanoma spreading to their lymph nodes (checked by a sentinel lymph node biopsy, which should have been clear). This study is for people who have not been treated for melanoma before, apart from having the initial cancer surgically removed.

There are also some reasons why someone might not be able to join. This includes if they have had certain other types of melanoma, such as those in the eye or on mucous membranes. Pregnant or breastfeeding women cannot take part. People with active autoimmune diseases (where the immune system attacks the body) or a known allergy to the study medication cannot participate. Also, if someone has previously received certain types of immunotherapy drugs, they would not be eligible for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have had surgery to completely remove a Stage IIB or IIC melanoma.
My lymph node biopsy (sentinel lymph node) was clear of cancer.
I have not had any previous drug treatments for melanoma.
I am generally feeling well and able to carry out daily activities.
I am not pregnant or breastfeeding.
I do not have an active autoimmune disease or certain other medical conditions.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the study drug, nivolumab, or a placebo (dummy treatment) for a set period. Both are typically given by infusion into a vein. You would have regular visits to the hospital or clinic for these treatments and for check-ups. These visits will involve physical examinations, blood tests, and scans to monitor your health and to see how the treatment is working. Doctors and nurses will carefully check for any side effects. After finishing the treatment, you would continue to have follow-up appointments to see if the melanoma returns. The total duration of your involvement, including treatment and follow-up, would be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. The potential benefit of this study is that nivolumab might reduce the chance of your melanoma returning, which could improve your long-term health. However, there's no guarantee it will work for everyone, and it's also possible you could receive the placebo. Potential risks include side effects from the study drug, which could be mild or severe, as nivolumab affects the immune system. The full list of potential side effects would be discussed with you in detail. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (130)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Local Institution - 0088
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Birmingham, United States
Local Institution - 0126
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Tucson, United States
Local Institution - 0087
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Springdale, United States
Local Institution - 0080
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Los Angeles, United States
Local Institution - 0077
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San Francisco, United States
Local Institution - 0119
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San Francisco, United States
Local Institution - 0122
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San Jose, United States
Local Institution - 0121
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Vallejo, United States
Local Institution - 0109
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Vallejo, United States
Local Institution - 0120
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Vallejo, United States
Local Institution - 0091
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Aurora, United States
Local Institution - 0089
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Washington D.C., United States

Common questions

What is nivolumab?

Nivolumab is a type of medicine called an immunotherapy. It works by helping your body's own immune system find and fight cancer cells.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps doctors see if the study drug is truly effective.

Who is at 'high risk for recurrence'?

This refers to people with specific stages of melanoma (Stage IIB/C) where, even after surgery, there's a greater chance the cancer might come back.

Can children join this study?

Yes, this study is open to both adults and young people aged 12 years and older who meet the other study requirements.

Will I know if I'm getting nivolumab or the placebo?

No, during the study, neither you nor your doctors will know which treatment you are receiving. This is to ensure the results are unbiased and reliable.