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Indications

Prescribing Information

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Medication Guide

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Potential OPDIVO® (nivolumab) user embracing her husband, outside their house.
Potential OPDIVO® (nivolumab) user embracing her husband, outside their house.

Clinical trial results for
bladder or urinary tract
cancer after surgery

To help prevent a type of bladder or urinary
tract cancer (urothelial carcinoma) from
coming back after it was removed by surgery

Actor portrayals.

An FDA-approved immunotherapy that helped reduce the risk of cancer 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 709 people who had surgery to remove cancer in the lining of the bladder or urinary tract, 353 people were given OPDIVO and 356 people were given a placebo.

People given OPDIVO lived longer without their cancer coming back after
surgery compared to placebo

At 21 months, half the people given OPDIVO® did not have their cancer return.
OPDIVO

Half the people did not have their cancer return

At 11 months, half the people given a placebo did not have their cancer return.
Placebo

Half the people did not have their cancer return

People given OPDIVO had a 30% lower risk of their cancer returning after surgery than those given placebo.

Overall survival benefit data is not available at this time.

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 with a type of bladder or urinary tract cancer (urothelial carcinoma) to help prevent it from coming back after it was removed by surgery

OPDIVO® (nivolumab) is a prescription medicine used to treat adults with cancer of the lining of the urinary tract (including the bladder, ureters, or renal pelvis) [urothelial carcinoma] to help prevent cancer of the urinary tract from coming back after it was 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.