Recurrent Nervous System Lymphoma Clinical Trial
Official title:
Phase I Clinical Trial for Evaluation of Nivolumab and Pomalidomide Combination for Relapsed/Refractory Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma
This phase I trials studies side effects and best dose of pomalidomide when given together with nivolumab in treating patients with primary central nervous system diffuse large B cell lymphoma or primary vitreoretinal diffuse large B cell lymphoma that has come back or that has not responded to treatment. Immunotherapy with monoclonal antibodies, such as pomalidomide 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.
PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) of pomalidomide which can be safely combined with the fixed dose schedule of nivolumab in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) and primary vitreoretinal lymphoma (PVRL). (Phase I) SECONDARY OBJECTIVES: I. To evaluate the overall response rate (ORR) and progression free survival (PFS) of nivolumab and pomalidomide combination in patients with relapsed/refractory PCNSL and PVRL. OUTLINE: This is dose-escalation study of pomalidomide. Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and pomalidomide orally (PO) on days 1-14. Treatment repeats every 4 weeks until disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 weeks, then every 3 months for 4 years. ;