The current version can be obtained by contacting PIO@CTEP.NCI.NIH.GOV . Your name, the name of the investigator, the protocol and the agent should be included in the e-mail. 2INCB024360 can result in severe an d potentially fatal immune-med iated adverse events. These include (but are not limited to) autoimmune hepatitis and autoimmune hypophysitis. Adverse events reported on INCB024360 trials, but for which there is insufficient eveidence to suggest that there was a reasonable po ssibility that INCB024360 caused the adverse event : Investigations – GGT increased NCI Protocol #: CITN-04 Version Date: 27 Jan 2016 42 Metabolism and nutrition disorders – Hypernatremia Respiratory, thoracic and mediastinal disorders – Pneumonitis Vascular disorders - Hypertension Note: INCB024360 in combination with other agents could cause an exacer bation of any adverse event currently known to be caused by the other agent, or the co mbination may result in events never previously associated with either agent. No AEs have been reported consis tent with the serotonin syndrome. 7.1.2.1 Suspected, Unexpected Serious Adverse Reactions A single suspected, unexpected, serious adverse reaction (SUSAR) reported in any ongoing clinical study of INCB024360 up to th e clinical cutoff date for data inclusion in the Investigator Brochure (03 December 2013) is listed in Table 7.1.2.1 . Table 7.1.2.1. Adverse Events Occurring in ≥20% of Subjects MedDRA System Organ Class Worst Seriousness Criteria Preferred Term Study Drug Injury, poisoning, and procedural complications Hospitalized Radiation pneumonitis INCB024360 General disorders and administration site conditions Hospitalized Pyrexia INCB024360 General disorders and administration site conditions Hospitalized Pyrexia INCB024360 General disorders and administration site conditions Hospitalized Abdominal pain INCB024360 Infections and infestations Hospitalized Pneumonia INCB024360 Infections and infestations Hospitalized Colitis INCB024360+ ipilimumab Infections and infestations Medically significant Infection INCB024360 + ipilimumab Investigations Medically significant, hospitalized Alanine aminotransferase increased INCB024360 + ipilimumab Investigations Medically significant, hospitalized Aspartate aminotransferase increased INCB024360 + ipilimumab Investigations Medically significant Alanine aminotransferase increased INCB024360 + ipilimumab Investigations Medically significant Aspartate aminotransferase increased INCB024360 + ipilimumab Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities. NCI Protocol #: CITN-04 Version Date: 27 Jan 2016 43 7.1.3 CAEPRs for MELITAC 12.1 7.1.3.1 12-MP and Peptide-tet vaccine There is no reason to expect di rect toxicity of the melanoma peptides, as they are not directly cytotoxic in vitro. On the other hand, because some of these peptides are identical or similar to a portion of a normal protein, risks of autoimmunity in humans are important to evaluate. Because no murine sy stem adequately models the human immune response to these peptides, the most meani ngful evaluation of th is peptide vaccine mixture is in participants w ith melanoma. We will focus th is study on participants with advanced melanoma (i.e., unresectable st age III or stage IV melanoma). These individuals face a high risk (>90%) of prematur e death, and the antici pated risk of short- term or long-term toxicity of this vaccine preparation is minimal ( Table 7.1.4.1 ), although it might delay or decrease the risk of morbid ity and mortality due to melanoma in these participants. The potential implications of autoimmunity against cells of melanocytic lineage are illustrated by reported cases of vitiligo occurring coincident with regressions of melanoma. Most of thes e are limited, often occurri ng in skin surrounding the regressing melanoma, but occas ionally occurring systemically. While pathogenesis of this phenomenon can only be hypothesized, it is r easonable to consider this a worst-case scenario. **All participants should be closely observ ed for AEs for at least 20 minutes after each vaccination. Any time thereafter, part icipants should report any AEs to their treating physician.