Perlmutter Cancer Center

Nivolumab will be investigated at the Food and Drug Administration (FDA)-approved dose of 480 mg intravenous (IV) every 4 weeks until unacceptable toxicity, disease progression, or completion of 2 years of therapy. If that dose and schedule have unacceptable toxicity, then enrollment will cease for that particular disorder/severity group. Depending on accumulated experience from this study and other emerging literature, additional doses and schedules may be considered. This study is designed to enroll cohorts of up to 12 patients for each disease cohort who will be treated with nivolumab at the standard dose at each disease severity level. For each autoimmune disorder, patients with different severity of the disease, as defined by disease-specific severity indices, will be assessed. Patients will initially be enrolled into the mild and moderate cohorts (exact designations in Table 1). If nivolumab is well tolerated in this study population, then enrollment to more severe cohorts will be opened following discussions with Cancer Therapy Evaluation Program (CTEP)/National Cancer Institute (NCI) and study teams at participating sites.