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Phase II Study of Pembrolizumab and Ipilimumab Following Initial Anti-PD1/L1 Antibody
The main purpose of this study is to determine whether pembrolizumab in combination with ipilimumab is an effective regimen for participants who have previously received an anti-PD1 antibody such as pembrolizumab or nivolumab.
Primary Objective(s): (1) Objective: To determine the irRECIST response rate of pembrolizumab with ipilimumab following initial progression or stable disease to anti-PD1/L1 antibody (or combination not containing anti-CTLA4) in subjects with advanced melanoma. Secondary Objective(s): (1) Objective: To summarize the progression-free survival (RECIST v1.1 and irRC) of the combination following prior treatment with anti-PD1/L1 antibody. (2) Objective: To assess the safety of the combination following prior treatment with anti-PD1/L1 antibody. Exploratory Objective: (1) Objective: To evaluate changes in the tumor microenvironment and other biospecimens before and after adding ipilimumab to pembrolizumab.