Nivolumab
Nivolumab works by binding to and blocking the protein PD-1 on the surface of some cancer cells, which keeps cancer cells from suppressing the immune system. This allows the immune system to attack the cancer cells. Nivolumab is a type of immunotherapy drug called an immune checkpoint inhibitor.
FDA label information for this drug is available at DailyMed.
Use in Cancer
Nivolumab is approved to be used alone or with other drugs to treat:
- classic Hodgkin lymphoma in adults whose cancer has come back or has gotten worse after either:
- an autologous stem cell transplant and treatment with brentuximab vedotin¹; or
- at least three other types of treatment including an autologous stem cell transplant¹
- colorectal cancer in adults and children aged 12 years and older whose cancer is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Nivolumab is used:
- alone in patients whose cancer has spread to other parts of the body and got worse after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan hydrochloride
- with ipilimumab in patients whose cancer has spread to other parts of the body or cannot be removed by surgery
- esophageal cancer or gastroesophageal junction adenocarcinoma. Nivolumab is used in adults:
- for esophageal cancer or gastroesophageal junction adenocarcinoma that has been treated with a combination of chemotherapy and radiation therapy and then surgery to completely remove the cancer, but cancer cells were found in the removed tumor or lymph nodes
- for squamous cell carcinoma of the esophagus that cannot be removed by surgery or has spread or come back after treatment with a fluoropyrimidine and platinum-based chemotherapy
- for squamous cell carcinoma of the esophagus that cannot be removed by surgery or has spread to other parts of the body. It is given with either ipilimumab or a fluoropyrimidine and platinum-based chemotherapy as the first treatment.
- gastric (stomach) cancer, gastroesophageal junction adenocarcinoma, or esophageal cancer that has spread. Nivolumab is used with a fluoropyrimidine and platinum-based chemotherapy.¹
- hepatocellular carcinoma (a type of liver cancer) that cannot be removed by surgery or has spread to other parts of the body. Nivolumab is used with ipilimumab in adults as the first treatment or after treatment with sorafenib.
- malignant pleural mesothelioma. Nivolumab is used with ipilimumab as the first treatment in adults whose cancer cannot be removed by surgery.
- melanoma. Nivolumab is used:
- alone or with ipilimumab in adults and children aged 12 years and older whose cancer cannot be removed by surgery or has spread to other parts of the body
- as adjuvant therapy in adults and children aged 12 years and older with one of the following stages of melanoma that has been completely removed by surgery: stage IIB, IIC, IIIA, IIIB, IIIC, IIID, or IV melanoma
- non-small cell lung cancer in adults. Nivolumab is used:
- with platinum-based chemotherapy before surgery for early-stage cancer
- with platinum-based chemotherapy before surgery and then alone after surgery for cancer that does not have an abnormal EGFR or ALK gene
- as the first treatment with ipilimumab for cancer that has spread to other parts of the body and has the PD-L1 protein but does not have an abnormal EGFR or ALK gene
- as the first treatment with ipilimumab and platinum-based chemotherapy for cancer that has spread to other parts of the body or came back but does not have an abnormal EGFR or ALK gene
- for cancer that has spread to other parts of the body and has gotten worse during or after treatment with platinum-based chemotherapy. Patients whose cancer has an abnormal EGFR or ALK gene should receive nivolumab only if their cancer got worse after treatment with FDA-approved therapy for these gene mutations.
- renal cell carcinoma (a type of kidney cancer) that is advanced in adults. Nivolumab is used:
- who have already received angiogenesis inhibitor therapy
- with cabozantinib-s-malate as the first treatment
- with ipilimumab as the first treatment in some patients
- squamous cell carcinoma of the head and neck that has spread to other parts of the body or has come back and got worse during or after treatment with platinum-based chemotherapy
- urothelial carcinoma (a type of cancer in the bladder or urinary tract) in adults. Nivolumab is used:
- with cisplatin and gemcitabine as the first treatment for cancer that cannot be removed by surgery or has spread to other parts of the body
- after surgery to remove cancer that has a high risk of coming back
- for cancer that has spread and was treated with platinum-based chemotherapy, but it did not work, is no longer working, or the cancer has gotten worse
¹This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, a confirmatory trial(s) must show that nivolumab provides a clinical benefit in these patients.
Nivolumab is given by infusion. It is available in a different form, combined with hyaluronidase, that is given subcutaneously. For more information, see the Drug Information Summary for Nivolumab and Hyaluronidase-nvhy. Nivolumab is also available as a combination formulation with a drug called relatlimab. For more information, see the Drug Information Summary for Nivolumab and Relatlimab-rmbw.
Nivolumab is also being studied in the treatment of other types of cancer.
More About Nivolumab
Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug.
MedlinePlus Information on Nivolumab - A lay language summary of important information about this drug that may include the following:
- warnings about this drug,
- what this drug is used for and how it is used,
- what you should tell your doctor before using this drug,
- what you should know about this drug before using it,
- other drugs that may interact with this drug, and
- possible side effects.
Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.
Research Results and Related Resources
FDA Approval Likely to Change Initial Treatment for Some People with Advanced Colorectal Cancer
Nivolumab Appears to Boost Cure Rate in Advanced Hodgkin Lymphoma
Trial Establishes Preferred Treatment for Some People with Esophageal Cancer
What Comes after NCI-MATCH? NCI’s New Precision Medicine Cancer Trials
A Better Biomarker for Cancer Immunotherapy?
Targeted Therapy to Treat Cancer
Clinical Trials Accepting Patients
Find Clinical Trials for Nivolumab - Check for trials from NCI's list of cancer clinical trials now accepting patients.