Nivolumab

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 relapsed (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 transplant.¹
• Colorectal cancer in adults and children 12 years and older. Nivolumab is used alone or with ipilimumab to treat metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer that got worse after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan hydrochloride.¹
• Esophageal cancer or gastroesophageal junction adenocarcinoma. Nivolumab is used:
  • In patients whose esophageal cancer or gastroesophageal junction adenocarcinoma 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.
  • In patients whose squamous cell carcinoma of the esophagus cannot be removed by surgery and has spread or come back after treatment with a fluoropyrimidine and platinum chemotherapy.¹
• Gastric (stomach) cancer, gastroesophageal junction adenocarcinoma, or esophageal cancer that has spread. Nivolumab is used with a fluoropyrimidine and platinum chemotherapy.¹
• Hepatocellular carcinoma (a type of liver cancer). Nivolumab is used with ipilimumab in patients who have already been treated with sorafenib.¹
• 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:
  • In patients whose cancer cannot be removed by surgery or has metastasized. Nivolumab is sometimes used with ipilimumab.
  • In patients who have had surgery to remove melanoma that has spread to the lymph nodes or has metastasized.
• Non-small cell lung cancer. Nivolumab is used:
  • As the first treatment with ipilimumab in adults whose cancer is metastatic and has the PD-L1 protein but does not have mutations in the EGFR or ALK gene.
  • As the first treatment with ipilimumab and platinum chemotherapy in adults whose cancer is metastatic or recurrent but does not have mutations in the EGFR or ALK gene.
  • In patients whose cancer is metastatic and has gotten worse during or after treatment with platinum chemotherapy. Patients whose cancer has a mutation in the EGFR or ALK gene should receive nivolumab only if their cancer got worse after treatment with FDA-approved therapy for these gene mutations.
  • As the first treatment with ipilimumab in adults whose cancer is metastatic and has the PD-L1 protein but does not have mutations in the EGFR or ALK gene.
  • As the first treatment with ipilimumab and platinum chemotherapy in adults whose cancer is metastatic or recurrent but does not have mutations in the EGFR or ALK gene.
  • In patients whose cancer is metastatic and has gotten worse during or after treatment with platinum chemotherapy. Patients whose cancer has a mutation in the 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. Nivolumab is used:
  • In patients 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 is metastatic or recurrent. Nivolumab is used in patients whose cancer got worse during or after treatment with platinum chemotherapy.
• Urothelial carcinoma (a type of cancer in the bladder or urinary tract). Nivolumab is used:
  • After surgery to remove the cancer in patients whose cancer has a high risk of coming back.
  • In patients whose cancer was treated with platinum chemotherapy, but it did not work or is no longer working or that got worse after treatment with platinum chemotherapy.

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 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

Targeted Cancer Therapies

Nivolumab and Relatlimab Combination Shows Promise in Advanced Melanoma

Nivolumab-Based Combinations Improve Survival in Advanced Esophageal Cancer

Study Details Long-Term Side Effects of Immune Checkpoint Inhibitors

Nivolumab Improves Survival for Some Patients with Advanced Stomach Cancer

For Esophageal Cancer, Immunotherapy Likely to Play Larger Role

Monoclonal Antibodies

Immune Checkpoint Inhibitors

Clinical Trials Accepting Patients

Find Clinical Trials for Nivolumab - Check for trials from NCI's list of cancer clinical trials now accepting patients.