The goal of this clinical research study is to learn if durvalumab and trametinib can help to control microsatellite stable (MSS) colorectal cancer. The safety of these drugs will also be studied. This is an investigational study. Durvalumab is FDA approved and commercially available for the treatment of previously treated advanced bladder cancer. Trametinib is FDA approved in combination with another drug called dabrafenib for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K. It is investigational to use durvalumab and trametinib to treat MSS colorectal cancer. Up to 56 participants will be enrolled in this study. All will take part at MD Anderson.
Name: Durvalumab
Description: Dose Escalation and Dose Expansion Dose: 1500 mg by vein every 4 weeks in a 28 day cycle.Type: DrugDurvalumab + Trametinib
Name: Trametinib
Description: Dose Escalation Starting Dose: 2mg by mouth daily in a 28 day cycle. Dose Expansion Dose: MTD from Dose Escalation.Type: DrugDurvalumab + Trametinib
Description: MTD defined as highest dose level with less than 2 patients with dose limiting toxicity (DLT) out of at least six patients in the cohort. DLT defined as any adverse event (AE) of severity grade 3 or 4 (including serious or life-threatening) considered possibly, probably or definitely related to the combination of Durvalumab and Trametinib determined by NCI CTCAEv4.03.
Measure: Maximum Tolerated Dose (MTD) of Durvalumab and Trametinib in MSS Metastatic Colon Cancer Time: 28 daysSingle Group Assignment
There are 2 SNPs
Trametinib is FDA approved in combination with another drug called dabrafenib for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K. --- V600E ---
Trametinib is FDA approved in combination with another drug called dabrafenib for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K. --- V600E --- --- V600K ---