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Phase II trial of tremelimumab (CP-675,206) in patients with advanced refractory or relapsed melanoma Kirkwood JM; Lorigan P; Hersey P; Hauschild A; Robert C; McDermott D; Marshall MA; Gomez-Navarro J; Liang JQ; Bulanhagui CAClin Cancer Res 2010[Feb]; 16 (3): 1042-8PURPOSE: This phase II study assessed the antitumor activity of tremelimumab, a fully human, anti-CTL-associated antigen 4 monoclonal antibody, in patients with melanoma. EXPERIMENTAL DESIGN: Patients with refractory/relapsed melanoma received 15 mg/kg tremelimumab every 90 days. After 4 doses, patients with tumor response or stable disease were eligible to receive < or =4 additional doses. Primary endpoint was best overall tumor response assessed by an independent endpoint review committee, and secondary endpoints included duration of response, overall survival, progression-free survival, and safety. RESULTS: Of 251 patients enrolled, 246 (241 response-evaluable) received tremelimumab. Objective response rate was 6.6% (16 partial responses); duration of response was 8.9 to 29.8 months. Eight (50%) objective responses occurred in patients with stage IV M(1c) disease, and 11 (69%) were ongoing at last tumor assessment. Eight (3.3%) patients achieved responses in target lesions (Response Evaluation Criteria in Solid Tumors) despite progressive disease within the first cycle. All 8 survived for >20 months; 5 (63%) remained alive. Clinical benefit rate (overall response + stable disease) was 21% (16 partial responses and 35 stable disease), and median overall survival was 10.0 months. Progression-free survival at 6 months was 15%, and survival was 40.3% at 12 months and 22% at 24 months. Common treatment-related adverse events were generally mild to moderate, and grade 3/4 adverse events included diarrhea (n = 28, 11%), fatigue (n = 6, 2%), and colitis (n = 9, 4%). There were 2 (0.8%) treatment-related deaths. CONCLUSIONS: Tremelimumab showed an objective response rate of 6.6%, with all responses being durable > or =170 days since enrollment, suggesting a potential role for tremelimumab in melanoma.|Adolescent[MESH]|Adult[MESH]|Aged[MESH]|Aged, 80 and over[MESH]|Antibodies, Monoclonal, Humanized[MESH]|Antibodies, Monoclonal/adverse effects/*therapeutic use[MESH]|Drug Administration Schedule[MESH]|Drug Resistance, Neoplasm[MESH]|Female[MESH]|Humans[MESH]|Male[MESH]|Melanoma/*drug therapy/pathology[MESH]|Middle Aged[MESH]|Recurrence[MESH]|Skin Neoplasms/*drug therapy/pathology[MESH] |
