The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type. Patients will be screened within 28 days prior to the start of dosing. Eligible patients will be enrolled in either of the two cohorts. Patients will receive treatment every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. Subjects will be permitted to continue treatment beyond initial RECIST 1.1.
Description: The DLT determination period is the first six weeks after cycle 1 day 1. Dose limiting toxicities are further defined in the trial protocol.Measure: Dose-Limiting Toxicity (DLT) Time: 48 Months
Description: Overall response rate is defined to be the best objective status recorded from the start of the treatment until disease progression/recurrenceMeasure: Overall Response Rate Time: 48 Months
Description: Progression-free survival will be evaluated for each cohort using Kaplan-Meier estimator.Measure: Progression-Free Survival Time: 48 Months
Description: Overall survival will be evaluated for each cohort using Kaplan-Meier estimator.Measure: Overall Survival Time: 48 Months
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4. Patients should have received at least one platinum-based chemotherapy regimen for recurrent or metastatic disease or have received platinum-based chemotherapy as part of adjuvant or neoadjuvant therapy and experienced progression of disease within 6 months of completing therapy. 5. Patients with tumor genetic alterations such as EGFR, ALK, ROS1 or BRAF V600E alterations for which there is FDA-approved targeted therapy must have been treated with the appropriate targeted inhibitors in prior therapy 6. --- V600E ---