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Indications

Prescribing Information

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Medication Guide

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Potential OPDIVO® (nivolumab) user and her husband standing on a beach.
Potential OPDIVO® (nivolumab) user and her husband standing on a beach.

Clinical trial results for
previously treated
advanced liver cancer

For adults with liver cancer (hepatocellular carcinoma) previously treated with sorafenib

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An FDA-approved combination of two immunotherapies that could make tumors either shrink or disappear completely

About the clinical trial

In a clinical trial, the overall response rate and duration of response to OPDIVO + YERVOY were looked at in 49 people with hepatocellular carcinoma whose cancer spread or grew after treatment with sorafenib or who could not tolerate sorafenib therapy.

People saw their tumors shrink or disappear completely
with OPDIVO + YERVOY

OPDIVO + YERVOY

Tumors disappeared completely 
(complete response)

4 out of 49 people, or 8%, saw tumors disappear completely in response to OPDIVO® + YERVOY® for hepatocellular carcinoma.

Tumors shrank
(partial response)

12 out of 49 people, or 24%, saw tumors shrink in response to OPDIVO® + YERVOY® for hepatocellular carcinoma.

Tumors shrank or disappeared completely (overall response)

16 out of 49 people, or 33%, saw tumors shrink or disappear completely in response to OPDIVO® + YERVOY® for HCC.

Half of the people who responded to OPDIVO + YERVOY continued to respond for at least 17.5 months, also known as median duration of response. The shortest response lasted 4.6 months and the longest response lasted 30.5 months.

88% of people who responded had a response for six months or longer.

56% of people who responded had a response for 1 year or longer.

31% of people who responded had a response for 2 years or longer.

Words to know

Overall response rate is the percentage of patients who responded to treatment. These patients saw their tumors either shrink or disappear completely.

Partial response is when a tumor reacts to treatment and shrinks.

Complete response is when a tumor reacts to treatment and disappears completely. This is the disappearance of any measurable tumors in response to treatment. This does not mean the cancer has been cured.

Duration of response is the measure of how long these responses lasted. The median duration of response is the length of time half of the patients were still responding to treatment.

OPDIVO + YERVOY 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

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Getting an infusion

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

For adults whose liver cancer (hepatocellular carcinoma) has spread or grown after treatment with sorafenib

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults with liver cancer (hepatocellular carcinoma) if you have previously received treatment with sorafenib. OPDIVO in combination with YERVOY was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO in combination with YERVOY for this use.

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.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.