 Please be very careful! Over-t he-counter drugs have a br and name on the label—it’s usually big and catches your eye. They also have a generic name—it’s usually small and located above or below the brand name, and prin ted in the ingredient list. Find the generic name and determine, with the pharmacist’s help, whether there could be an adverse interaction.  Be careful: o If you take acetaminophen regularly: You s hould not take more than 2 grams per day on a regular or ongoing basis. This is equal to approximate ly 6 regular strength tablets or 4 extra strength ta blets per day. Read labels carefully! Acetaminophen is an ingredient in many medici nes for pain, flu, and cold. o You should not be on anticoagulants (b lood thinners) such as Coumadin. Other medicines can be a problem with your study drugs.  You should check with your doctor or pharmacist whenever you need to use an over-the-counter medicine or herbal supplement.  Your regular prescriber should check a medical reference or call your study doctor before prescribing any new medicine for you. NCI Protocol #: CITN-04 Version Date: 27 Jan 2016 86 Your study doctor’s name is: _____________________________________ and he or she can be contacted at _____________________________________ INFORMATION ON POSSIBLE DRUG INTERACTIONS You are enrolled on a clinical trial using the experimental agent INCB024360. This clinical trial is sponsored by the NCI. INCB024360 interacts with drugs that are processed by your liver. Because of this, it is very important to:  Tell your doctors if you stop taking regular medicine or if you start taking a new medicine.  Tell all of your prescribers (doctor, physicians’ assistant, nurse practitioner, pharmacist) that you are taking part in a clinical trial.  Check with your doctor or pharmacist whenever you need to use an over‐the‐counter medicine or herbal supplement. INCB024360 might interact with a specific liver enzyme called UGT1A9 , and must be used very carefully with other medicines that interact with this enzyme.  Before you start the study, your study doctor will work with your regular prescriber to switch any medicines that are considered “strong inducers/inhibitors or substrates of UGT1A9 .”  Befor e prescribing new medicines, your regular prescribers consult a medical reference to see if any medicine they want to prescribe is on a list of drugs to avoid or contact your study doctor.  Your study doctor’s name is _____________________________ and can be contacted at _________________________________. NCI Protocol #: CITN-04 Version Date: 27 Jan 2016 87 APPENDIX D BIOASSAY TEMPLATES 9.1.1.1 Tumor Biopsies 9.1.1.2 Fine-Needle Aspiration (FNA) Biopsy of Tumor 9.1.1.3 Blood for Serum and PBMC Isolation 9.2.1 Immunohistochemical Evalua tion of Tumor Biopsies—Laboratory Correlative Study #1 9.2.2 Gene Expression Analyses of Tumor Biopsies, Fine Needle Aspirates of Metastases, and Peripheral Blood—Laboratory Correlative Study #2 9.2.3 CD8+ T-Cell IFN-gamma Responses to the 12- Peptide Mixture, and CD4+ T-Cell Responses To Tetanus Peptide—Laborat ory Correlative Study #3 9.2.4 Quantification of PBMC and T-Cell Subsets—Laboratory Correlative Study #4 9.2.5 Other Immunologic Assessments—Laboratory Correlative Study #5 9.3 Special Studies: Cytokine and INCB024360 Blood Levels NCI Protocol #: CITN-04 Version Date: 27 Jan 2016 88 APPENDIX E VACCINE PREPARATION 12-MP + Tetanus Peptide Vaccine + Montanide ISA-51 VG Three (3) mL of emulsion will be prepared. Two (2) mL of this emulsion will be administered, with 1 mL administered at each of 2 vaccine sites.