Clinical trial results for
advanced melanoma
For certain people with melanoma that has spread or cannot be removed by surgery (advanced melanoma)
Actor portrayals.
OPDIVO is not approved for people younger than 12 years of age. OPDIVO Qvantig is not approved for people younger than
18 years of age.
An FDA-approved immunotherapy that helped people live longer compared to YERVOY alone
About the clinical trial
In a clinical trial of 945 people with previously untreated advanced melanoma, 314 people were given OPDIVO + YERVOY, 316 people were given OPDIVO alone, and 315 people were given YERVOY alone. While your doctor may test you for the BRAF biomarker to help you consider your treatment options, OPDIVO is FDA approved to treat advanced melanoma regardless of your test results.
More people given OPDIVO were alive compared to YERVOY alone at the primary analysis with a minimum follow-up of 28 months
In the clinical trial, people given OPDIVO had a 37% lower risk of dying than those given YERVOY alone.
People given OPDIVO lived longer without their cancer spreading, growing, or getting worse compared to YERVOY alone at the primary analysis with a minimum follow-up of 9 months
OPDIVO
Half the people went without their cancer spreading, growing, or getting worse
YERVOY alone
Half the people went without their cancer spreading, growing, or getting worse
In the clinical trial, people given OPDIVO had a 43% lower risk of their cancer spreading, growing, or getting worse than those given YERVOY alone.
More people given OPDIVO saw their tumors shrink or disappear completely compared to YERVOY alone at the primary analysis with a minimum follow-up of 9 months
OPDIVO |
YERVOY alone |
Tumors disappeared completely (complete response)
Tumors shrank (partial response)
Tumors shrank or disappeared completely (overall response)
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.
OPDIVO will not work for everyone. Individual results may vary.
Discover another treatment option for untreated advanced melanoma
OPDIVO Qvantig may be a faster* way to receive treatment.
It is not known if OPDIVO Qvantig is safe and effective in children. OPDIVO Qvantig cannot be used in combination with ipilimumab.
*A 3-5 minute injection time of OPDIVO Qvantig compared to a 30-minute infusion time of OPDIVO. This does not account for all aspects of treatment. Does not include observation time. Actual clinic time may vary.
Getting treatment
See treatment plans and what to expect from an intravenous (IV) infusion or under-the-skin injection (subcutaneous injection)
For certain people with advanced melanoma
As an intravenous infusion
OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age or older with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
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.
As a subcutaneous injection
OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy) is a prescription medicine used alone to treat adults with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
It is not known if OPDIVO Qvantig is safe and effective in children.