At a glance
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A Phase I/II Trial of Pembrolizumab (MK-3475) and Poly-ICLC in Patients With Metastatic Mismatch Repair-proficient (MRP) Colon Cancer
In Brief
A Phase 2 clinical trial evaluating pembrolizumab and Poly-ICLC for Metastatic Colon Cancer and Solid Tumor. Completed, enrolled 42 participants across 1 site.
Detailed Summary
The main purpose of this study is to determine the dose of poly-ICLC that is safe and tolerable when it is combined with pembrolizumab in patients with colon cancer. This study will also evaluate how the combination of pembrolizumab and poly-ICLC activates the immune system in the patient's blood and inside the tumor; how it affects the size and number of tumor(s) in each patient; and how effective the combination is in patients with colon cancer that is unlikely to respond to pembrolizumab alone.
Study Details
Timeline
Interventions
200mg pembrolizumab will be given intravenously on Day 1 of each 3-week cycle
The maximum tolerated dose of Poly ICLC will be given twice weekly, in each 3-week cycle: Week 1, Days 1 and 4 Week 2, Days 8 and 11 Week 3, Days 15 and 18