Melanoma Clinical Trial
Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
The purpose of this study is to assess the safety and efficacy of combined treatment with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.
The successful treatment of melanoma with immune checkpoint inhibitors, such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and Programmed cell death protein 1 (PD-1) antibodies, has altered our thinking and approach to immunotherapy for solid tumors. Despite these advances, only a portion of patients experience a durable response suggesting that there is room for improvement via enhanced immunomodulatory approaches. Anti-CTLA-4 (Ipilimumab) significantly improves overall survival and achieves long-lasting complete responses in some melanoma patients, the number of patients that achieve durable clinical benefit is limited and could be improved by a combined immunomodulatory approach. The objectives of this study are to assess the safety and efficacy of combined treatment with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients. We hypothesize that combined treatment with Ipilimumab and ATRA will improve patient responses, increase tumor antigen-specific T cell responses, and decrease immunosuppressive myeloid-derived suppressor cells (MDSCs) in melanoma patients compared to patients treated with Ipilimumab alone.
Patients over the age of 18 year.
Patients diagnosed with advanced melanoma.
Patients that are considered candidates for ipilimumab therapy.
Patients able to understand and willing to sign a written informed consent documents.
Patients willing to have regular blood draws, one before treatment and four during or after treatment.
Patients under the age of 18.
Patients with Stage I or II, melanoma who are not candidates for Ipilimumab.
Patients that have received systemic treatments within four weeks prior to the beginning of treatment.
Women that are pregnant or nursing.
Patients taking immunosuppressive medications.
Patients with active autoimmune disease.
Patients with known sensitivity to retinoic acid derivatives.
Patients with aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin > 2.5 × ULN.
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There is 1 Location for this study
Aurora Colorado, 80045, United States
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