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Indications

Prescribing Information

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Medication Guide

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Potential OPDIVO® (nivolumab) user sitting in a field and drinking coffee with her partner.
Potential OPDIVO® (nivolumab) user sitting in a field and drinking coffee with her partner.

Clinical trial results for
advanced bladder or
urinary tract cancer

For certain previously untreated adults with
bladder cancer or urinary tract cancer
(urothelial carcinoma) that has spread or
cannot be removed by surgery

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An FDA-approved combination of immunotherapy and chemotherapy that helped people live longer compared to chemotherapy alone

About the clinical trial

In a clinical trial of 608 people with previously untreated advanced bladder or urinary tract cancer (urothelial carcinoma), 304 people were given OPDIVO + chemotherapy and 304 people were given chemotherapy alone. The chemotherapy medicines used for both groups in this clinical trial were cisplatin and gemcitabine.

People given OPDIVO + chemotherapy lived longer compared to
chemotherapy alone

At 22 months, half the people given OPDIVO® and chemotherapy were alive.
OPDIVO + chemotherapy

Half the people were alive

At 19 months, half the people given chemotherapy alone were alive.
Chemotherapy alone

Half the people were alive

People given OPDIVO + chemotherapy had a 22% lower risk of dying than those given chemotherapy alone.

People given OPDIVO + chemotherapy had a 38% lower risk of their cancer spreading, growing, or getting worse compared to those given chemotherapy alone.

OPDIVO + chemotherapy 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 previously untreated adults with urinary tract cancer (urothelial carcinoma) that has spread or cannot be removed by surgery

OPDIVO® (nivolumab), in combination with chemotherapy medicines cisplatin and gemcitabine, is a prescription medicine used as a first treatment for adults with urinary tract cancer (urothelial carcinoma) that has spread or cannot be 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.