CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma

Inclusion Criteria

• •Patient is capable of understanding and complying with the protocol requirements and has signed the Informed Consent document.
• •Adults at least 18 years of age
• •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• •Cytologically or histologically confirmed stage IIIB, IIIC, IIID, or IV melanoma that can be surgically removed.
• •Notes:
• •In-transit melanoma is acceptable.
• •Patients can enroll regardless of their BRAF mutational status
• •* 1cm of tumor needs to be visible on standard imaging (i.e. FDG PET or CT scan)
• •* Screening laboratory values must meet the following criteria:
• •WBC ≥ 2.0x109/L
• •Neutrophils ≥ 1.5x109/L
• •Platelets ≥ 100 x109/L
• •Hemoglobin ≥ 5.5 mmol/L
• •Creatinine ≤ 1.5x ULN
• •AST ≤ 1.5 x ULN and ALT ≤ 1.5 x ULN
• •Bilirubin ≤1.5 X ULN
• •* Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of study treatment (ipilimumab/nivolumab)
• •* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of ipilimumab + nivolumab
• •* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of study treatment (ipilimumab/nivolumab)
• •Note: Women who are not of childbearing potential (i.e., who are postmenopausal), or surgically sterile as well as azoospermic men do not require contraception