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A Phase I Study of Ipilimumab and Nivolumab in Advanced HIV- Associated Solid Tumors, with Expansion Cohorts in HIV-Associated Solid tumors and a Cohort of HIV- Associated Classical Hodgkin Lymphoma
This phase I trial studies the side effects and best dose of nivolumab when given with ipilimumab in treating patients with human immunodeficiency virus (HIV) associated classical Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment, or solid tumors that have spread to other places in the body or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ipilimumab is an antibody that acts against a molecule called cytotoxic T-lymphocyte antigen 4 (CTLA-4). CTLA-4 controls a part of your immune system by shutting it down. Nivolumab is a type of antibody that is specific for human programmed cell death 1 (PD-1), a protein that is responsible for destruction of immune cells. Giving ipilimumab with nivolumab may work better in treating patients with HIV associated classical Hodgkin lymphoma or solid tumors compared to ipilimumab with nivolumab alone. Moffit is participating in the expansion cohort for non-small cell lung cancer only.
Primary Objective Dose De-Escalation and Dose Expansion Cohorts: To demonstrate safety and feasibility of ipilimumab and nivolumab at the standard doses of drug in solid tumor and relapsed refractory HIV-cHL participants with human immunodeficiency virus (HIV) infection given the possibility of increased toxicity based on immune activation, co-morbidity, or interference with HAART therapy. The purpose for this would be to provide appropriate experience and guidelines, if necessary, to allow participants with HIV infections to participate in ongoing trials.
BMS-936558 (Nivolumab); Ipilimumab (); Nivolumab (Opdivo); Yervoy (Ipilimumab)