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Nivolumab Summary

Nivolumab + Yervoy (ipilimumab) combination therapy has shown superior efficacy to nivolumab monotherapy in several types of cancers, but combination therapy is also often associated with a higher incidence and increased severity of adverse effects.

Oncology Term

In Short

3D rendering of PD-1 and PD-1L protein molecules on t cell and cancer cells binding as part of a immune checkpoint

By Dan Reef, MD and Nancy Mills, MD

Definition of Nivolumab

Nivolumab is an immune checkpoint inhibitor used in treatment of an ever-expanding set of cancers. More specifically, nivolumab is a fully-human monoclonal IgG4 anti-programmed death-1 receptor (PD-1) antibody. Activated T cells express PD-1. When PD-1 interacts with its ligands, PD-L1 and PD-L2, on tumor cells and/or stromal cells surrounding a tumor, PD-1 signalling suppresses T cell function. Nivolumab blocks the interaction between PD-1 and its ligands, thereby disinhibiting T cell function and and allowing T cells to attack tumor cells. Basically, it impedes the brakes on the immune system allowing increased functioning of the immune system to attack the cancer.


Nivolumab is administered by intravenous infusion over 30 minutes. Contraindications would include severe autoimmune disease as it can cause a range of autoimmune toxicities.


Nivolumab is indicated for the treatment of:


  • BRAF V600 wild-type, Unresectable or metastatic

  • BRAF V600 mutation-positive, Unresectable or metastatic

  • Unresectable or metastatic, In combination with Yervoy (ipilimumab)

  • With lymph node involvement or metastatic disease, After complete resection, In the adjuvant setting

Squamous cell carcinoma of the head and neck

  • With recurrence or metastatic disease

  • With disease progression on or after platinum-based chemotherapy

Non-small cell lung cancer

  • With disease progression on or after platinum-based chemotherapy

  • Note: In patients with EGFR or ALK tumor mutations, disease progression should occur on indicated targeted therapy before treatment with nivolumab.

Renal cell carcinoma

  • With advanced disease, With previous anti-angiogenic therapy

  • With intermediate or poor risk, Without previous treatment, In combination with Yervoy (ipilimumab)

Urothelial carcinoma

  • With locally advanced or metastatic disease

  • With disease progression on or after platinum-based chemotherapy

  • With disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy

Colorectal cancer

  • In patients 12 years and older

  • Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

  • With progression following treatment with a fluoropyrimidine + oxaliplatin + irinotecan

Hepatocellular carcinoma

  • With previous sorafenib therapy

Classical Hodgkin lymphoma

  • In adult patients

  • With relapse or progression after either (1) autologous hematopoietic stem cell transplantation (HSCT) + brentuximab vedotin, or (2) three or more lines of systemic therapy that includes autologous HSCT

more about Nivolumab adverse effects and Pearls-to-Know in our FibonacciMD Compendium




Brahmer JR, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, Caterino JM, et al. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. Journal of Clinical Oncology.0(0):JCO.2017.77.6385. doi: 10.1200/jco.2017.77.6385. PubMed PMID: 29442540.

Motzer RJ, Tannir NM, McDermott DF, Arén Frontera O, Melichar B, Choueiri TK, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018;378(14):1277-90. Epub 2018/03/21. doi: 10.1056/NEJMoa1712126. PubMed PMID: 29562145.

Opdivo (nivolumab) [package insert]. New York, NY: Bristol-Myers Squibb Company; April 2018.

Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012;366(26):2443-54. Epub 2012/06/02. doi: 10.1056/NEJMoa1200690. PubMed PMID: 22658127; PubMed Central PMCID: PMCPMC3544539.

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