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A Phase II and Pilot Trial of PD-1 Blockade with MK-3475 (Pembrolizumab) in Patients with Resectable or Unsectable Desmoplastic Melanoma (DM)
The purpose of this study is to test any good and bad effects of the study drug MK-3475 (also called pembrolizumab).
1.1 Primary Objective: a.) Cohort A - To evaluate the pathologic complete response rate (pCR as defined in Section 10.0) in patients with resectable desmoplastic melanoma treated with neoadjuvant MK-3475 (pembrolizumab). b.) Cohort B - To evaluate the complete response rate (confirmed and unconfirmed) in patients with unresectable desmoplastic melanoma treated with MK-3475 (pembrolizumab). 1.2 Secondary Objectives: Cohort A a.) To estimate the 9 week response rate (RR) (unconfirmed complete and partial responses). b.) To estimate the median overall survival (OS). c.) To evaluate safety and tolerability of MK-3475 (pembrolizumab) in the neoadjuvant setting. Cohort B d.) To estimate the median progression-free survival (PFS). e.) To estimate the median overall survival (OS). f.) To evaluate safety and tolerability of MK-3475 (pembrolizumab) in this setting. 1.3 Other Objectives (all patients): a.) To evaluate the hypothesis that higher mutational load in the patient derived baseline tumor biopsy samples is associated with higher response rate (RR). b.) To evaluate T cell infiltration into the tumors in DM patients and correlate with response to PD-1 blockade. c.) To evaluate the clonality of tumor infiltrating T cells in DM patients and correlate with response to PD-1 blockade. d.) To evaluate adaptive immune resistant mechanism in DM tumors.