This early phase I trial investigates how well radiation therapy, plasma exchange, and pembrolizumab or nivolumab work in treating patients with melanoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Plasma exchange (also known as “plasmapheresis”) is a way to "clean" or “flush out” the blood. Immunotherapy with monoclonal antibodies, such as pembrolizumab 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. Plasma exchange may help to improve the effect of standard radiation therapy and immunotherapy treatment on tumor cells of patients with melanoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04581382.
PRIMARY OBJECTIVE:
I. To determine the kinetics of soluble (s)PD-L1 removal and regeneration by plasma exchange in patients with melanoma.
SECONDARY OBJECTIVES:
I. To observe response at 3 months after plasma exchange plus immunotherapy.
II. To observe ongoing response at approximate 3 month intervals after plasma exchange plus immunotherapy.
CORRELATIVE RESEARCH OBJECTIVES:
I. To determine the effects of plasma exchange on immune cell function.
II. To observe the kinetics of extracellular vesicles (EVs) after plasma exchange in patients with melanoma.
OUTLINE:
Patients undergo radiation therapy daily on days 1-5 (weekdays). Patients then undergo therapeutic plasma exchange over 1-2 hours on the first session starting on the last day of radiation therapy and the last session ending prior to immunotherapy. Beginning day 5, patients receive pembrolizumab intravenously (IV) or nivolumab IV. Treatment with pembrolizumab continues every 3 weeks or treatment with nivolumab continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study and standard of care (SOC) computed tomography (CT), positron emission tomography (PET), and/or magnetic resonance imaging (MRI) scans as clinically indicated during follow-up.
After completion of study treatment, patients are followed up at 3 weeks and then for up to 2 years.
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorJacob Orme
