Abstract: Provided are compositions and methods for determining baseline serum autoantibodies (autoAbs) for use in patient selection and for treatment with immune checkpoint blockade agents to promote avoidance of development of severe immune related adverse events (IRAEs). The treatments include administering anti-cancer agents that are not predicted to cause toxicity to selected patients, and administering agents to reduce predicted toxicity in selected patients.

Abstract: Provided are compositions and methods for determining whether or not an individual who has cancer is likely to develop immune-related adverse events (irAEs) because of treatment with an immune checkpoint inhibitor such as an anti-Programmed cell death protein 1 (anti-PD-1) checkpoint inhibitor, and/or anti-Cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) checkpoint inhibitor. Also provided are methods for treating an individual who has cancer with a checkpoint inhibitor and an agent to reduce the risk of toxicity from the checkpoint inhibitor, as well as administering agents to prevent or reduce the risk of toxicity during treatment.

Abstract: Provided are compositions and methods for determining whether or not an individual who has cancer is likely to develop immune-related adverse events (irAEs) because of treatment with an immune checkpoint inhibitor such as an anti-Programmed cell death protein 1 (anti-PD-1) checkpoint inhibitor, and/or anti-Cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) checkpoint inhibitor. Also provided are methods for treating an individual who has cancer with a checkpoint inhibitor and an agent to reduce the risk of toxicity from the checkpoint inhibitor, as well as administering agents to prevent or reduce the risk of toxicity during treatment.

Abstract: The present invention relates to method for predicting a subject's relative response to cancer immunotherapy treatment. The methods involve providing a sample comprising a tumor cell or a peripheral blood cell from the subject; measuring the expression level of matrix metalloproteinase-23 (“MMP-23”) by the tumor cell or the peripheral blood cell; comprising the measured expression level of MMP-23 with a control or standard value; and determining the subject's predicted response to cancer immunotherapy, where, based on said comparing, a higher MMP-23 expression level compared to the control or standard value predicts the subject will have a poor response to cancer immunotherapy. The present invention also relates to methods for increasing production of tumor infiltrating leucocytes (“TILs”) in a subject, methods of identifying a subject as a candidate for adoptive T-cell therapy using T-cells that primarily express KCa3.

Abstract: The invention relates to miRNA-based methods for prognosis of melanoma brain metastasis and related methods and kits. In one embodiment, the invention provides a method for predicting the likelihood of developing melanoma brain metastasis (B-Met) in a subject diagnosed with primary melanoma, said method comprising determining the levels of miR-150-5p, miR-15b-5p, miR-16-5p, and miR-374b-3p in a primary melanoma sample collected from the subject.

Abstract: Described herein are compositions and methods for the prognosis, prevention and treatment of melanoma or melanoma associated symptoms. The compositions are microRNA molecules associated with melanoma or with melanoma brain tropism, as well as various nucleic acid molecules relating thereto or derived therefrom.

Abstract: The present invention relates to serum marker microRNAs (miRNAs) which are associated with cancer, particularly melanoma, and to the assessment thereof in the prognosis, treatment and management of cancer. Embodiments include methods, compositions, kits and isolated nucleic acids. The present invention is directed to methods and compositions for prognosing melanoma and monitoring for recurrence by monitoring serum miRNAs, and the use of miRNAs and antagonists thereof, particularly antagomirs, for predicting and assessing risk and/or likelihood of recurrence in a melanoma patient. The present invention relates to biomarkers for melanoma, particularly serum markers and sets thereof which are relevant and significant as prognostic indicators of melanoma disease and patient risk for recurrence.

Abstract: The present invention relates to method for predicting a subject's relative response to cancer immunotherapy treatment. The methods involve providing a sample comprising a tumor cell or a peripheral blood cell from the subject; measuring the expression level of matrix metalloproteinase-23 (“MMP-23”) by the tumor cell or the peripheral blood cell; comprising the measured expression level of MMP-23 with a control or standard value; and determining the subject's predicted response to cancer immunotherapy, where, based on said comparing, a higher MMP-23 expression level compared to the control or standard value predicts the subject will have a poor response to cancer immunotherapy. The present invention also relates to methods for increasing production of tumor infiltrating leucocytes (“TILs”) in a subject, methods of identifying a subject as a candidate for adoptive T-cell therapy using T-cells that primarily express KCa3.

Abstract: Described herein are miRNA-based methods for prognosis of recurrence of melanoma and related methods and kits. The present invention addresses these and other needs by providing a method for predicting the likelihood of recurrence of melanoma (including distal metastasis and locoregional recurrence) in a subject diagnosed with melanoma. In a separate aspect, the invention provides a method for treatment of a melanoma recurrence (including distal metastasis and locoregional recurrence) in a subject in need thereof.

Abstract: Described herein are compositions and methods for the prognosis, prevention and treatment of melanoma or melanoma associated symptoms. The compositions are microRNA molecules associated with melanoma or with melanoma brain tropism, as well as various nucleic acid molecules relating thereto or derived therefrom.

Abstract: The present invention relates to a method for detecting the presence of circulating mutant BRAF DNA, which may be present in circulating melanoma cells or as DNA shed from tumor cells. Methods, compositions and kits which employ one or more sets of BRAF mutant specific primer pairs for detection of circulating mutant BRAF DNA are presented. Also provided are methods for diagnosing and/or determining stage/progression of a melanoma in a mammal based on detection of a BRAF mutant nucleic acid sequence. Such methods are also well suited to monitoring disease activity in patients with active disease or those in remission.

Abstract: The present invention relates to a method for detecting the presence of circulating mutant BRAF DNA, which may be present in circulating melanoma cells or as DNA shed from tumor cells. Methods, compositions and kits which employ one or more sets of BRAF mutant specific primer pairs for detection of circulating mutant BRAF DNA are presented. Also provided are methods for diagnosing and/or determining stage/progression of a melanoma in a mammal based on detection of a BRAF mutant nucleic acid sequence. Such methods are also well suited to monitoring disease activity in patients with active disease or those in remission.