Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03428126|
Recruitment Status : Enrolling by invitation
First Posted : February 9, 2018
Last Update Posted : September 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasms of Digestive Organs Colorectal Cancer Colon Cancer||Drug: Durvalumab Drug: Trametinib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer|
|Actual Study Start Date :||March 21, 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: Durvalumab + Trametinib
Participants take Trametinib tablets by mouth every day. Trametinib taken alone for the first 7 days of the study then participants begin receiving it in combination with Durvalumab.
Participants receive Durvalumab by vein every 4 weeks.
Each cycle is 28 days.
Dose Escalation and Dose Expansion Dose: 1500 mg by vein every 4 weeks in a 28 day cycle.
Other Name: MEDI4736
Dose Escalation Starting Dose: 2mg by mouth daily in a 28 day cycle.
Dose Expansion Dose: MTD from Dose Escalation.
Other Name: GSK1120212
- Maximum Tolerated Dose (MTD) of Durvalumab and Trametinib in MSS Metastatic Colon Cancer [ Time Frame: 28 days ]
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.
- Best Overall Response (CR+PR) Determined by Immune Response Criteria [ Time Frame: Baseline up to 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428126
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Overman, MD||M.D. Anderson Cancer Center|