Melanoma Clinical Trial
Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma
Summary
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.
Full Description
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 days 4-6 or 5-7. Beginning on day 7, 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.
After completion of study treatment, patients are followed up at 3 weeks and then for up to 2 years.
Eligibility Criteria
Inclusion Criteria:
Histological confirmation of melanoma. Patients may have completed biopsy outside of Mayo Clinic, but there must be an internal review done to confirm diagnosis prior to confirming eligibility
Measurable or non-measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 3
sPD-L1 levels > 1.7 ng/ml by enzyme-linked immunosorbent assay (ELISA)
Negative pregnancy test done =< 7 days prior to radiation therapy, for women of childbearing potential only
Provide written informed consent
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
Willing to provide blood samples for correlative research purposes
Exclusion Criteria:
Persons taking a biotin supplement
sPD-L1 level < 1.7 ng/ml by ELISA
Pregnant or nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
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There is 1 Location for this study
Rochester Minnesota, 55905, United States
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