Melanoma Clinical Trial
Dendritic Cell Vaccination in Patients With Advanced Melanoma
The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.
This is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with stage III and stage IV melanoma, followed by treatment with pembrolizumab (anti-PD-1 therapy).
Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. Each study subject will receive cyclophosphamide 300mg/m^2 intravenously or by mouth 3 to 4 days prior to the vaccine dose, to deplete regulatory T cells. For each vaccine dose, all subjects will receive autologous dendritic cells pulsed with melanoma tumor-specific peptides. On Day 1, the subject will receive the primer vaccine dose; this will be followed by two booster vaccine doses at 6 weeks apart. Peripheral blood will be taken weekly to monitor the immune response to each peptide by tetramer assay. Re-staging will occur after the 3rd vaccine dose, along with tumor biopsy and second apheresis. Anti PD-1 therapy (standard of care) will commence 7-8 weeks after the subject's last dendritic cell vaccine.
Histologically confirmed stage III and stage IV M1a/M1b/M1c melanoma. Measurable disease is not required for enrollment eligibility and patients with completely resected disease are permitted.
Male or female patients age greater than or equal to 18 years
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
Required initial laboratory values (performed within 14 days prior to eligibility confirmation by physician-investigator):
WBC (white blood cells) >3,000/mm3
Hg (hemoglobin) greater than or equal to 9.0 gm/dl
Serum Bilirubin < 2.0 mg/dl
Serum Creatinine < 2.0 mg/dl
Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial.
Provide written informed consent.
Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilimumab, anti-PD1, or BRAF + MEK inhibitor combination) is permitted.
Active untreated CNS (central nervous system) metastasis
Prior malignancy (except non-melanoma skin cancer) within 3 years
Pregnant or nursing (lactating) women
Concurrent treatment with high-dose systemic corticosteroids; local (inhaled or topical) steroids are permitted
Known allergy to eggs
Prior history of uveitis or autoimmune inflammatory eye disease
Known positivity for hepatitis B antibody, hepatitis C antibody, or HIV antibody
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There is 1 Location for this study
Philadelphia Pennsylvania, 19104, United States
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