A Randomized Phase Ii Study Of Ipilimumab (Ipi) With Carboplatin And Paclitaxel (Cp) In Patients With Unresectable Stage Iii Or Iv Metastatic Melanoma (Mm).

9066 Background: MM has been one of the most treatment-resistant human malignancies. Recently, IPI, a fully human anti-CTLA4 monoclonal antibody has been widely approved for patients (pts) with MM on the basis of increased overall survival (OS). CP is one of few therapies available to pts with BRAF wild type MM that is progressing rapidly. We hypothesized that cytoreduction by CP might both provide time for IPI response, as well as expose immune cells to tumor antigens. In addition to safety and anti-tumor activity, immune biomarker studies were performed. Methods: Thirty pts with no prior treatment or one BRAF targeted regimen were randomized in a 1:2 ratio to either concurrent (arm A) or sequential (arm B) CP (AUC6 + 175mg/m2 x 5) with IPI (3mg/kg x 4) given every 3 weeks either concurrently or delayed by one week. Tumor assessments were conducted at week 8, 16 and 24. Results: We enrolled 24 cutaneous, 2 mucosal, 3 ocular and 1 unknown primary melanoma. Median age was 55 years and 6 of 8 BRAF mutated p...