Dr. Tony Olszanski spoke about “Melanoma/Skin Cancer Clinical Trials at Fox Chase Cancer Center.” The clinical portfolio was discussed to share current activities and relationships with industry. There is some effort on merkle cell tumors and data with immune checkpoint therapies. He spoke about melanoma specific trials and other open trials that may apply to melanoma (numerous trials in the phase I portfolio). Several target RAF although combinations with chemo has been difficult. Others include IFN plus pembrolizumab, anti-VISTA (currently on hold), OX40 agonist plus nivolumab or ipilumumab, anti-TIGIT, ICOS agonist, SYK inhibitor plus immunotherapy, anti-CSF1 (targeting stroma) plus pembrolizumab, anti-CCR4 (used to treat cutaneous T cell lymphomas in Japan) plus nivolumab (or tremelumumab that targets CTLA4), IDO inhibitor plus pembrolizumab, anti-TIM3, MEK plus anti-PD-L1. He mentioned how MEK inhibit plus RAF inhibitor are actually associated with fewer undesirable side effects including fever and squamous cancer. There was discussion that there would be opportunity to test novel agents despite all the immunotherapy trials. There was discussion about BET inhibitors and how they may be incorporated in trials. Dr. Olszanski mentioned that combination immunotherapy shows better outcomes albeit with higher risk of side effects. He spoke about Dr. Zibelman’s trial. Dr. Olszanski sees about 50 patients with metastatic melanoma each year and the surgeons see ~120 patients a year. He spoke further about the TIGIT trial (T cell immunoreceptor with Ig and ITIM domains) ultimately targeting T-reg cells. Dr. Olszanski further described melanoma specific protocols at FCCC. IRB 1082 Durvolumab (PD-L1) or Tremelimumab (CTLA4) plus IMCgp100 (bi-specific T cell receptor technology). HLA-A2 is not melanoma specific. IRB 16-108 involves TAK580 (pan-RAF) plus nivolumab, nivolumab plus anti-CCR2 in second arm, or nivolumab plus ipilumumab plus vedolizumab (anti-integrin to treat associated colitis). IRB 14-032 involves “oncolytic vaccine” talimogene laherparepvec (TVEC) injected into the melanoma plus pembrolizumab; stage IIIB-IV unresected first-line trial. Melanoma specific and stimulates immune response. IRB 15-2008 (ECOG) HD IFN or HD ipilumumab versus pembrolizumab for stage IIIA-IV fully resected disease. Results described at ESMO showing improved DFS and OS. There was further discussion of the effect of dose of anti-CTLA4 ipilumumab in metastatic melanoma. Dr. Olszanski spoke about sequencing trials (immunotherapy and BRAF/MEK inhibitors) in patients. There is less time for BRAF plus MEK to work when given later due to aggressive disease. There was discussion of some open questions such as predicting which patients with earlier stage disease who are likely to recur. There are panels of genes that are being looked at in melanoma. There is a need to develop less toxic therapies due to immune effects, develop “better” combination therapies, understand drug resistance mechanisms and evaluate duration of therapy.
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