Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma

Exclusion Criteria

• •Life expectancy of less than three months.
• •Patients with metastatic ocular/ mucosal or other non-cutaneous melanoma.
• •Adjuvant treatment with ipilimumab within 6 months prior to randomization.
• •Requirement for immunosuppressive doses of systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within the last 3 weeks prior to randomization.
• •Patients who have a more than two CNS metastases.
• •Patients who have any CNS lesion that is symptomatic, greater than 1 cm in diameter or show significant surrounding edema on MRI scan will not be eligible until they have been treated and demonstrated no clinical or radiologic CNS progression for at least 2 months.
• •All patients' toxicities due to prior non-systemic treatment must have recovered to a grade 1 or less. Patients may have undergone minor surgical procedures or focal palliative radiotherapy (to non-target lesions) within the past 4 weeks, as long as all toxicities have recovered to grade 1 or less.
• •Women who are pregnant or breastfeeding, because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
• •Any active systemic infections, coagulation disorders or other active major medical illnesses.
• •Any autoimmune disease