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A Phase Ib Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)

Clinical Trial Details

The purpose of this study is to test the safety of the anti-cancer immunotherapy drug called nivolumab in patients with cancer and autoimmune disorders. This study is part of a larger study that looks at several different autoimmune disorders including Systemic lupus erythematosus, Dermatomyositis/systemic sclerosis, Multiple sclerosis, Rheumatoid arthritis, Ulcerative colitis, Crohn's disease, Sjogren's syndrome, Psoriasis, Psoriatic arthritis or other autoimmune diseases not specified. 
Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for several types of cancer but is not FDA-approved for cancer is people with auto-immune diseases. It is an antibody that can block signals that some types of tumors may use to suppress the immune system. We are doing this study because we want to find out if this approach is better or worse than the usual approach. The usual approach for patients who are not in a study is treatment with surgery, radiation, chemotherapy, or targeted therapy. 
Participants in this study will get Nivolumab through a vein in their arm every 4 weeks, on the first day of each cycle. Each cycle lasts 28 days and this study has 24 cycles. Participants will also receive physical exams each cycle to monitor their health. 

Total study participation will last approximately 2 years, with additional time for follow up after treatment.

Key Eligibility: 
  1. Open to men and women, aged 18 or older, who have confirmed, evaluable malignancy as well as an autoimmune disease. 
  2. Participants must not be pregnant and must agree to use adequate contraception. 
  3. Participants must not have had prior allogenic hematologic transplant. 

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan


Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:






Open to Enrollment

Age Group