At a glance
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A Phase I/II Study of Regorafenib and Pembrolizumab in Metastatic Colorectal Cancer Patients in 3rd and 4th Line Setting
In Brief
A Phase 1 clinical trial evaluating Pembrolizumab and Regorafenib for Colorectal Cancer and Colorectal Cancer Metastatic. Active but no longer recruiting, targeting 73 participants across 3 sites.
Signals
Detailed Summary
This phase I/II studies the side effects and best dose of regorafenib when given together with pembrolizumab in treating participants with colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as regorafenib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving regorafenib and pembrolizumab may work better at treating colorectal cancer.
Study Details
Timeline
Arms & Interventions
Participants receive pembrolizumab IV over 30 minutes on day 1 and regorafenib PO QD on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given PO