Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03668431
Status:
UNKNOWN
Last Update Posted:
2022-06-27
First Post:
2018-09-11
Brief Title:
Dabrafenib Trametinib PDR001 In Colorectal Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase 2 Study of Dabrafenib and Trametinib in Combination With PDR001 in Patients With BRAFV600E Metastatic Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Dabrafenib
Trametinib
PDR001
The names of the study drugs involved in this study are
Dabrafenib
Trametinib
PDR001
Detailed Description:
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 US 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 uncontrolled ways
--- 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 MAPKERK 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-L1PDL1 and PD-L2PDL2 are often used by cancer cells and to escape the power of the bodys immune system so that they cannot be fought By blocking that binding of the molecules the bodys 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
The FDA the US 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 uncontrolled ways
--- 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 MAPKERK 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-L1PDL1 and PD-L2PDL2 are often used by cancer cells and to escape the power of the bodys immune system so that they cannot be fought By blocking that binding of the molecules the bodys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None