Skip to main content

Daylight saving gives us one more hour to make a difference. Donate to fund life-saving research.

 

 

showDesktop,showTablet,showMobile

Immunotherapy for Gallbladder 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 gallbladder cancer.

Immune checkpoint inhibitors

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 gallbladder cancers.

PD-1 inhibitors

Pembrolizumab (Keytruda) and nivolumab (Opdivo) are drugs that target 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.

These drugs can be used in different ways to treat gallbladder cancer:

  • Pembrolizumab (Keytruda) with chemotherapy: This drug can be given along with the chemo drugs gemcitabine and cisplatin to treat gallbladder cancer that can’t be removed by surgery or that has spread to other parts of the body.
  • Pembrolizumab (Keytruda) alone: This drug might be used if your tumor has a high number of specific gene changes (a high level of microsatellite instability or MSI-H), if there is a defect in a mismatch repair gene (dMMR), or if your tumor cells have a generally high number of gene changes (a high tumor mutational burden or TMB-H).
  • Nivolumab (Opdivo) with ipilimumab (Yervoy): These drugs might be used together if your tumor cells have a high number of gene mutations (a high mutational burden or TMB-H).

These drugs are given as an intravenous (IV) infusion, typically once every 2 or 6 weeks.

PD-L1 inhibitor

Durvalumab (Imfinzi) is a drug that targets PD-L1, a protein related to PD-1 that is found on some tumor cells and immune cells. Blocking this protein can help boost the immune response against cancer cells.

This drug can be used along with the chemotherapy drugs gemcitabine and cisplatin to treat gallbladder cancer that can’t be removed by surgery or that has spread to other parts of the body.

This drug is given as an intravenous (IV) infusion, typically every 2 to 4 weeks.

CTLA-4 inhibitor

Ipilimumab (Yervoy) is another checkpoint inhibitor, but it has a different target. It blocks CTLA-4, another protein on T cells that normally helps keep them in check.

It might be used with Nivolumab (Opdivo) to treat gallbladder tumors that have a high mutational burden (TMB-H).

This drug is given as an intravenous (IV) infusion, usually once every 3 weeks

Possible side effects of immune checkpoint inhibitors

Some of the more common side effects of these drugs can include fatigue, cough, nausea, skin rash, poor appetite, constipation, joint pain, and diarrhea.

Other, more serious side effects occur less often.

Infusion reactions: Some people might have an infusion reaction while getting these drugs. 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 these drugs.

Autoimmune reactions: These drugs remove one of the safeguards on the body’s immune system. Sometimes the immune system responds by attacking other parts of the body, which can cause serious or even life-threatening problems in the lungs, intestines, liver, hormone-making glands, kidneys, or other organs.

It’s very important to report any new side effects to someone on your health care team as soon as possible. If serious side effects do occur, treatment may need to be stopped and you might 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.

The American Cancer Society medical and editorial content team

Our team is made up of doctors and oncology certified nurses with deep knowledge of cancer care as well as editors and translators with extensive experience in medical writing.

Burris HA 3rd, Okusaka T, Vogel A, Lee MA, Takahashi H, Breder V, Blanc JF, Li J, Bachini M, Żotkiewicz M, Abraham J, Patel N, Wang J, Ali M, Rokutanda N, Cohen G, Oh DY. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer (TOPAZ-1): patient-reported outcomes from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2024 May;25(5):626-635. doi: 10.1016/S1470-2045(24)00082-2. PMID: 38697156.

Kassab J, Saba L, Gebrael G, Kais S, Kassab R, Kourie HR. Update on immunotherapy in the management of gallbladder cancer. Immunotherapy. 2023 Jan;15(1):35-42. doi: 10.2217/imt-2022-0191. Epub 2023 Jan 9. PMID: 36617963.

Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klümpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16. Erratum in: Lancet. 2023 Sep 16;402(10406):964. Erratum in: Lancet. 2024 Mar 23;403(10432):1140. PMID: 37075781.

National Comprehensive Cancer Network, Clinical Practice Guidelines in Oncology (NCCN Guidelines®), Biliary Tract Cancers, Version 2.2024 -- April 19, 2024. Accessed at https://www.nccn.org/professionals/physician_gls/pdf/btc.pdf on May 20, 2024.

Patel SP, Guadarrama E, Chae YK, Dennis MJ, Powers BC, Liao CY, Ferri WA Jr, George TJ, Sharon E, Ryan CW, Othus M, Lopez G, Blanke CD, Kurzrock R. SWOG 1609 cohort 48: anti-CTLA-4 and anti-PD-1 for advanced gallbladder cancer. Cancer. 2024 Feb 15. doi: 10.1002/cncr.35243. Epub ahead of print. PMID: 38358334.

Last Revised: May 22, 2024

American Cancer Society Emails

Sign up to stay up-to-date with news, valuable information, and ways to get involved with the American Cancer Society.