Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
phase one is safety of the combination and identification of therecommended dose (RD) for combination therapy of regorafenib and pembrolizumab. phase II is preliminary effectiveness and tolerability of the combination RDof regorafenib and pembrolizumab.
Inclusion: histologically or cytologically confirmed advanced or metastaticcolorectal cancer who had failed or are intolerant of oxaliplatin, irinotecan,and 5-FU. Patients with MSI colorectal cancer are not candidate for treatmenton this trial; adequate organ and bone marrow function; Exclusion:history of taking regorafenib or immune check point inhibitors;hypertension that is difficult to control (systolic blood pressure equal to 150 mmHg and diastolic blood pressure equal to 90 mmHg) despite treatment with several hypotensive agents;large amount of pleural effusion or ascites requiring more than weekly drainage;concurrent autoimmune disease, or a history of chronic orrecurrent autoimmune disease
Pembrolizumab IV over 30 minutes once every 21 days; Regorafenib oral daily for days 1-14;Blood work can be done up to 5 days before day 1 of each cycle; CT scans are done every 8 weeks regardless of delays.