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Indications

Prescribing Information

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Potential OPDIVO® (nivolumab) user looking at the ocean with an arm around his wife.
Potential OPDIVO® (nivolumab) user looking at the ocean with an arm around his wife.

Clinical trial results for
Stage 2B or Stage 2C
melanoma after surgery

To help prevent a type of skin cancer called
melanoma from coming back in adults and
children 12 years and older with Stage IIB or
Stage IIC melanoma after it has been
completely removed by surgery

Actor portrayals.

An FDA-approved immunotherapy that may help reduce the risk of melanoma coming back after surgery compared to placebo

Having surgery was an important step for you to take in treating your cancer, but to make sure your cancer doesn't return, your doctor may recommend adjuvant therapy. This is a type of treatment used after surgery to help prevent cancer from coming back by making sure no hidden or hard-to-see cells are left after surgery.

About the clinical trial

In a clinical trial of 790 people who had their Stage 2B or 2C melanoma completely removed by surgery, 526 people were given OPDIVO and 264 people were given placebo.

More people did not have their melanoma return after surgery compared to
placebo at 1 year

At 12 months, 89% of those given OPDIVO® did not have their melanoma return after surgery, versus 79% given a placebo.

In the clinical trial, people given OPDIVO had a 58% lower risk of their melanoma returning after surgery than those given placebo.

OPDIVO will not work for everyone. Individual results may vary.

Hands exploring how OPDIVO® (nivolumab) works and learning how this treatment may help fight cancer.

How treatment works

See how this treatment may help your body fight cancer

OPDIVO® (nivolumab) side effects.

Side effects

View side effects of treatment and learn how to manage them

Nurse monitoring a gentleman's infusion of OPDIVO® (nivolumab) immunotherapy treatment.

Getting an infusion

See your recommended treatment plan and what to expect from an infusion

For adults and children 12 years of age and older to help prevent Stage IIB or Stage IIC melanoma from coming back after it has been completely removed by surgery

OPDIVO® (nivolumab) is a prescription medicine used to treat a kind of skin cancer called melanoma. It may be used alone in adults and children 12 years and older with Stage IIB or Stage IIC melanoma to help prevent melanoma from coming back after it has been completely removed by surgery.

It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.

It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.



466-US-2400051   04/24