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Phase II study of nivolumab and ipilimumab for treatment of advanced adenoid cystic carcinoma and non-adenoid cystic carcinoma
Purpose The purpose of this study is to look at the efficacy (the effect on the tumor) and the safety (the effect on the body) of the study drugs when given as a combination in participants with this type of cancer. Another purpose of the study is to see which tumor markers (proteins in the blood that the body produces in response to the cancer) lead to better results in participants treated with the study drugs. Overview Nivolumab and ipilimumab are antibodies, which are human proteins that recognize and attach to a part of the tumor and/or body‰Ûªs immune cells. They work in slightly different ways to activate the immune system and help the body‰Ûªs immune system to work against tumor cells. The combination of these drugs is already approved by the FDA to treat advanced melanoma (a type of skin cancer). Nivolumab and ipilimumab are investigational because they are not approved by the FDA to be used for the type of cancer being studied. Description of Treatment All study participants will receive the same study drugs, nivolumab/ipilimumab combination, over periods called cycles (1 cycle = 12 weeks / 84 days). Nivolumab will be given through a vein over 30 minutes once every 2 weeks for the first 16 weeks. It will then be given over 60 minutes once every 4 weeks for as long as participants are benefitting. Ipilimumab will be given through a vein over 90 minutes every 6 weeks (twice each cycle). Participants will take part in the study as long as they are benefitting from the study drugs.
Some of the eligibility criteria include:
- Participants must be > 18 years old.
- Participants must have histologically or cytologically confirmed metastatic/recurrent adenoid cystic carcinoma (ACC) or non-adenoid cystic carcinomas (non-ACC) of major or minor salivary glands
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.