Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma

Inclusion Criteria

• •1. Provision to sign and date the consent form.
• •2. Stated willingness to comply with all study procedures and be available for the duration of the study.
• •3. Be a male or female aged 18-100.
• •4. Histologically confirmed diagnosis of advanced mucosal melanoma (unresectable Stage III or Stage IV Melanoma). Anatomical locations for primary site of mucosal melanoma include oral cavity (excluding lip), nasopharynx, vagina/vulva, and rectum.
• •5. Prior immune checkpoint blockade therapy, including anti-PD1 and anti-CTLA4 for unresectable locally advanced or metastatic disease, is allowed. The combination of anti-PD1 and anti-CTLA4 is also allowed as a prior line of therapy. Study therapy must be initiated within 30 days of previous immune checkpoint blockade therapy (excluding adjuvant anti-PD1 and anti-CTLA4).
• •6. Patients must have systemic cross-sectional imaging (PET/CT or CT of chest, abdomen, and pelvis) with radiographically measurable, by immune-RECIST (RECIST) criteria, or clinically measurable disease.
• •7. Previously treated brain metastatic disease is allowed. Stability of brain metastases must be confirmed by MRI \> 4 weeks from most recent treatment and within 4 weeks of initiating study therapy.
• •8. Patients must have an ECOG performance status of 0 or 1 (Table 5).
• •9. Patients must have adequate bone marrow function as evidenced by all of the following: ANC ≥ 2,500 microliter (mcL); platelets ≥ 100,000/mcL; Hemoglobin ≥ 10 g/dL.
• •10. Patients must have adequate hepatic function as evidenced by the following: total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (except Gilbert's Syndrome, who must have a total bilirubin \< 3.0 mg/dL), and SGOT (AST) and SGPT (ALT) and alkaline phosphatase ≤ 2.5 x ULN.
• •11. Patients must have adequate renal function as evidenced by ONE of the following: serum creatinine ≤ 2.0 x ULN OR measured or calculated creatinine clearance ≥ 40 mL/min.
• •13. Women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. Women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 120 days after the last dose of study medication. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. A woman is considered to be of "reproductive potential" as defined in section 5.3.2.
• •14. Patients must be willing to have archived tumor specimens utilized for correlative studies if available.
• •15. Patients must consent to have biopsies performed prior to treatment and around cycle 2 during study. However, in the event that tumor is inaccessible, the biopsy is not in the subject's best interest, or the patient refuses biopsy during course of the study, patients will be allowed to remain on study.