This research study is studying a combination of drugs as a possible treatment for metastatic
colorectal cancer characterized by BRAF V600E mutation.
The names of the study drugs involved in this study are:
This research study is a Phase II clinical trial. Phase II clinical trials test the
safety and effectiveness of an investigational drug combination to learn whether the
drug combination works in treating a specific disease. "Investigational" means that the
drug combination is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved PDR001 as a
treatment for any disease.
The FDA has not approved dabrafenib and trametinib for your specific disease but it
has been approved for other uses, whether alone as single agents, or given together
as in this study.
This research study is studying a combination of drugs as a possible treatment for
metastatic colorectal cancer characterized by BRAF V600E mutation.
All humans have a gene called BRAF which is responsible for sending signals to
proteins called B-Raf inside of cells that help them grow. In some metastatic
colorectal patients, this gene mutates and causes cancer cells to grow in
--- Dabrafenib is a drug that is thought to inhibit the mutant BRAF activity, which
may serve to slow or stop cell growth of metastatic colon cancer.
Mitogen-activated protein kinase (MAPK) is a pathway that helps to activate the
BRAF mutated genes. The MAPK pathway is commonly found to be overactivated in BRAF
mutated tumor cells. MEK (which refers to MAPK/ERK Kinase) enzymes are essential to
the activity of the MAPK pathway.
Trametinib inhibits the MEK enzymes in order to shut down the MAPK pathway,
thus blocking the pathway that helps the cancer cells grow uncontrollably.
PDR001 is a drug which binds to PD1 on immune cells and is believed to block
binding of PD-L1 and PD-L2. PD-L1/PDL1 and PD-L2/PDL2 are often used by cancer
cells and to escape the power of the body's immune system so that they cannot
be fought. By blocking that binding of the molecules, the body's immune system
may reach and fight the cancer cells. Researchers are hoping that
administration of all three of these drugs may help anti-cancer activities
work together to slow or stop the cancer growth and may help your own immune
system damage or destroy the existing cancer cells.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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