Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer

Summary

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.

Timeline

Start

2018-03-21

Primary completion

2022-05-05

Completion

2022-05-05

Outcome

Missed primary endpoint

paper The response rate in the first stage of the study did not meet efficacy criteria to proceed to the second stage. PMID 36007963 ↗

Publications

• Johnson B, Haymaker CL, Parra ER, Soto LMS, Wang X, Thomas JV, Dasari A, Morris VK, Raghav K, Vilar E, Kee BK, Eng C, Parseghian CM, Wolff RA, Lee Y, Lorenzini D, Laberiano-Fernandez C, Verma A, Lang W, Wistuba II, Futreal A, Kopetz S, Overman MJ. Phase II study of durvalumab (anti-PD-L1) and trametinib (MEKi) in microsatellite stable (MSS) metastatic colorectal cancer (mCRC). J Immunother Cancer. 2022 Aug;10(8):e005332. doi: 10.1136/jitc-2022-005332.

Drugs

Indications