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Study identifier: NCT03816345 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO

Condition: Autoimmune Disease · Crohn Disease · Dermatomyositis  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 1
Planned participants300
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and/or effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

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Locations (52)

University of Alabama at Birmingham Cancer CenterBirmingham, Alabama, United StatesActive Not Recruiting
Stanford Cancer Institute Palo AltoPalo Alto, California, United StatesActive Not Recruiting
University of California Davis Comprehensive Cancer CenterSacramento, California, United StatesRecruiting
Smilow Cancer Center/Yale-New Haven HospitalNew Haven, Connecticut, United StatesRecruiting
Yale UniversityNew Haven, Connecticut, United StatesRecruiting
MedStar Georgetown University HospitalWashington D.C., District of Columbia, United StatesRecruiting
Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia, United StatesActive Not Recruiting
Northwestern UniversityChicago, Illinois, United StatesActive Not Recruiting
University of Chicago Comprehensive Cancer CenterChicago, Illinois, United StatesActive Not Recruiting
University of Kansas Clinical Research CenterFairway, Kansas, United StatesRecruiting
HaysMedHays, Kansas, United StatesRecruiting
University of Kansas Cancer CenterKansas City, Kansas, United StatesRecruiting

+ 40 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT03816345