Clinical Research Directory

Inclusion Criteria: * Patients with malignant melanoma (with confirmed histopathological diagnosis) stages III and IV not amenable to locoregional treatment or curative treatment * Measurable disease by RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 * Up to 1 (one) line of prior treatment with palliative chemotherapy (monotherapy), with documented progression and no residual toxicities greater than grade 1 according to CTCAE * Estimated life expectancy greater than 12 weeks * Adequate renal function, defined as creatinine clearance estimated by the Cockcroft-Gault equation equal to or greater than 30 mL/min; * Adequate liver function, defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels equal to or less than 2.0 times the upper limit of normal and total bilirubin less than 2 times the upper limit of normal; * Hemoglobin greater than or equal to 8 g/dL; neutrophil count equal to or greater than 1,000/mm3; platelet count equal to or greater than 100,000/mm3; * Ability to understand and adhere to study procedures; * Age over 18 years; * Absence of active treatment for the underlying disease, with the exception of the use of bisphosphonates; Exclusion Criteria: * Uncontrolled Central Nervous System (CNS) metastases: active symptomatic disease in the central nervous system, requiring doses of corticosteroids greater than the equivalent of 10 mg/day of prednisone. Patients previously submitted to local treatment, such as radiotherapy, will be eligible if they have demonstrated clinical stability in the 2 weeks prior to the start of treatment; * Diagnosis of uveal or mucosal melanoma; * Diagnosis of acral melanoma; * Leptomeningeal disease * Pregnancy; effective contraceptive methods should be recommended to women of childbearing age; * Uncontrolled associated disease; * Known active hepatitis B and C; * HIV with detectable viral load or CD4\<350; * Active autoimmune disease with use of immunosuppressive therapy or history of autoimmune disease whose risk of recurrence is considered high by the investigator; * More than one line of prior systemic therapy in the context of metastatic or advanced disease or prior use of polychemotherapy; * Prior use of anti-PD-1 in the (neo)adjuvant setting; * Concomitant active malignant neoplasia; * History of malignant neoplasia in the last 5 years, with the exception of squamous cell carcinoma, basal cell carcinoma of the skin, in situ tumors, prostate adenocarcinoma gleason \<=6; * Infection with systemic involvement in the last 2 weeks; * Use of corticosteroids in a dose equivalent to greater than 10 mg/d of prednisone on a continuous basis. * History of solid organ transplantation under immunosuppression.