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Immunotherapy for Vulvar Cancer

Immunotherapy is the use of medicines to help a person’s immune system better recognize and destroy cancer cells. Many types of immunotherapy are being tested in clinical trials, and some are used to treat cervical cancer.

Immune checkpoint inhibitors for vulvar cancer

An important part of the immune system is its ability to keep itself from attacking the body's normal cells. To do this, it uses “checkpoint” proteins on immune cells, which act like switches that need to be turned on (or off) to start an immune response. Cancer cells sometimes use these checkpoints to avoid being attacked by the immune system. Drugs that target these checkpoints (called immune checkpoint inhibitors) can be used to treat some vulvar cancers.

PD-1 inhibitors

Pembrolizumab (Keytruda) is a drug that targets PD-1, a checkpoint protein on immune system cells called T cells. PD-1 normally helps keep T cells from attacking other cells in the body (including some cancer cells). By blocking PD-1, this drug boosts the immune response against cancer cells. This can shrink some tumors or slow their growth.

Pembrolizumab can be used along with the chemotherapy drugs cisplatin/carboplatin and paclitaxel with or without bevacizumab to treat vulvar cancer that has spread to other parts of the body.

This drug is given as an intravenous (IV) infusion, typically once every 3 or 6 weeks.

Pembrolizumab can also be used by itself to treat some advanced vulvar cancers, typically after other treatments have been tried, if there are no other good treatment options, and if the cancer cells have been tested and have any of the following:

  • A high level of microsatellite instability (MSI-H) or a defect in a mismatch repair gene (dMMR)
  • A high tumor mutational burden (TMB-H), meaning the cells have many gene mutations
  • A lot of the PD-L1 protein on the tumor cells' surface (the cancer cells are PD-L1 positive).

Nivolumab (Optivo) targets PD-1 and can be used to treat advanced vulvar cancers, after other treatments have been tried, if the tumor cells are HPV (human papillomavirus)-positive. It is given as an IV infusion, typically once every 2 or 4 weeks.

Cemiplimab (Libtayo) also targets PD-1. It can be given to patients with advanced vulvar cancer that recurred after initial systemic treatment, regardless of their PD-L1  status. This drug is given as an IV infusion, typically once every 3 weeks.

Possible side effects of immune checkpoint inhibitors

Side effects of PD-1 inhibitors can include:

  • Feeling tired or weak
  • Fever
  • Cough
  • Nausea
  • Itching
  • Skin rash
  • Loss of appetite
  • Muscle or joint pain
  • Shortness of breath
  • Constipation or diarrhea

Other, more serious side effects occur less often. These can include:

Infusion reactions: Some people might have an infusion reaction while getting this drug. This is like an allergic reaction, and can include fever, chills, flushing of the face, rash, itchy skin, feeling dizzy, wheezing, and trouble breathing. It’s important to tell your doctor or nurse right away if you have any of these symptoms while getting this drug.

Autoimmune reactions: These drugs remove one of the safeguards of the body’s immune system. Sometimes this causes a person's immune system to attack other parts of their body, which can cause serious or even life-threatening problems in the lungs, intestines, liver, hormone-making glands, kidneys, skin, or other organs.

Report any new side effects to your health care team right away. If you do have a serious side effect, treatment may need to be delayed or stopped, and you may be given high doses of corticosteroids to suppress your immune system.

More information about immunotherapy

To learn more about how drugs that work on the immune system are used to treat cancer, see Cancer Immunotherapy.

To learn about some of the side effects listed here and how to manage them, see Managing Cancer-related Side Effects.

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Developed by the American Cancer Society medical and editorial content team with medical review and contribution by the American Society of Clinical Oncology (ASCO).

 

Chargari C, Wasserman J, Gabro A, Canlobre G, Spano JP, Uzan C, Maingon P. Vulvar Carcinoma: Standard of Care and Perspectives. J Clin Oncol. 2024 Mar 10;42(8):961-972.

National Cancer Institute. Vulvar Cancer Treatment (PDQ®)–Patient Version. September 18, 2024. Accessed at www.cancer.gov/types/vulvar/patient/vulvar-treatment-pdq#section/_90 on February 17, 2025.

National Comprehensive Cancer Network. NCCN Clinical Guidelines in Oncology (NCCN Guidelines). Vulvar Cancer (Squamous Cell Carcinoma) Version 1.2025 – Feb 10, 2025.

Olawaiye AB, Cuello MA, Rogers LJ. Cancer of the vulva: 2021 update. Int J Gynaecol Obstet. 2021 Oct;155 Suppl 1(Suppl 1):7-18. 

 

Last Revised: May 2, 2025

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