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
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.
Directions
Nivolumab is administered by intravenous infusion over 30 minutes. Contraindications would include severe autoimmune disease as it can cause a range of autoimmune toxicities.
Indications
Nivolumab is indicated for the treatment of:
Melanoma
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
Sources:
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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