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.
For adults with liver cancer (hepatocellular carcinoma) previously treated with sorafenib
Discover a Different Choice With OPDIVO + YERVOY
How People Responded To
OPDIVO + YERVOY in a Clinical Trial
About the Clinical Trial
OPDIVO + YERVOY was studied in 49 people with HCC
whose cancer spread or grew after treatment with
sorafenib or who could not tolerate sorafenib therapy.
The study was designed to look at overall overall response rate and duration of responseresponse. This study is ongoing.
Clinical Trial Results
24% (12 of 49)
saw their tumors shrink (partial response)
8% (4 of 49)
saw their tumors disappear completely (complete response)
*The disappearance of any measurable tumors in response to treatment. This does not necessarily mean the cancer has been cured.
HCC=hepatocellular carcinoma.
How Long Did People Respond To OPDIVO + YERVOY in the Clinical Trial?
Of those who responded, half the people whose tumors shrank or disappeared continued to respond to OPDIVO + YERVOY for at least
At the time the data were collected, the shortest response lasted
4.6 months
The longest response lasted
30.5 months
88% of
people
had a response
for 6 months
or longer
56% of
people
had a response
for 12 months
or longer
31% of
people
had a response
for 24 months
or longer
OPDIVO + YERVOY will not work for everyone. Individual results may vary.
SELECT IMPORTANT FACTS
What are the serious side effects of OPDIVO + YERVOY?
A serious side effect is a side effect that can sometimes become severe or life-threatening and can lead to death. They may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time.
- lung problems
- intestinal problems
- liver problems
- hormone gland problems
- kidney problems
- skin problems
- eye problems
- severe infusion reactions
- complications, including graft-versus-host disease (GVHD), of bone marrow (stem cell) transplant that uses donor stem cells (allogeneic)
Problems can also happen in other organs and tissues. These are not all the signs and symptoms of immune system problems that can happen with OPDIVO and YERVOY. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:
- Chest pain, irregular heartbeat, shortness of breath, swelling of ankles
- Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
- Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
- Persistent or severe muscle pain or weakness, muscle cramps
- Low red blood cells, bruising
What are the most common side effects of OPDIVO + YERVOY?
The most common side effects of OPDIVO when used in combination with YERVOY include:
- feeling tired
- diarrhea
- rash
- itching
- nausea
- pain in muscles, bones, and joints
- fever
- cough
- decreased appetite
- vomiting
- stomach-area (abdominal) pain
- shortness of breath
- upper respiratory tract infection
- headache
- low thyroid hormone levels (hypothyroidism)
- constipation
- decreased weight
- dizziness
These are not all the possible side effects. Talk to your healthcare team or pharmacist for more information. You are encouraged to report side effects of prescription drugs to the FDA. Call
