Ignite Creation Date:
2024-05-06 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03455764
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2018-02-28
Brief Title:
MCS110 With BRAFMEK Inhibition in Patients With Melanoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase III Study of MCS110 With BRAFMEK Inhibition in Patients With Melanoma After Progression on BRAFMEK Inhibition
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
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 targeted therapies as a possible treatment for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation
The interventions involved in this study are
MCS110
Dabrafenib
Trametinib
The interventions involved in this study are
MCS110
Dabrafenib
Trametinib
Detailed Description:
This is a Phase III clinical trial A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies Investigational means that the intervention is being studied
The FDA the US Food and Drug Administration has not approved MSC110 as a treatment for any disease
The FDA has approved dabrafenib and trametinib as treatment options for this disease
Dabrafenib and trametinib attack different proteins that promote the growth of cancerous cells These two treatments work in cancers with a mutation in the BRAF gene which alters a protein signaling pathway in cancer cells The BRAF mutation status will be confirmed during this trial by review or procedure in order to make sure this clinical trial is right for the participant Dabrafenib is a BRAF inhibitor that works by preventing altered BRAF proteins from stimulating the growth of the melanoma cancer cells Trametinib works by blocking a protein related to BRAF called MEK that has been known to stimulate cells that also promote melanoma growth In order to participate in the study the participant disease needs to be tested positive for a mutation a permanent change in the DNA sequence of a gene of the BRAF gene that belongs to a class of genes known as oncogenes When mutated oncogenes have the potential to cause normal cells to become cancerous Once the BRAF gene is mutated the normal functioning of the BRAF protein may be changed It is normal for patients with a BRAF mutation to receive these types of inhibitor therapies at some point in their treatment
MCS110 is a colony-stimulating factor-1 CSF-1 inhibitor It is a human monoclonal antibody which binds CSF-1 A monoclonal antibody is a type of protein made in the laboratory that can locate and bind to substances in the body including tumor cells MCS110 is being developed as a treatment for patients with advanced cancer
In this research study the investigators are adding MCS110 to the treatment with dabrafenib and trametinib at the time when the participants disease is growing despite these medications The hope is that MCS110 will enhance how the cancer will respond to dabrafenib and trametinib and overcome any resistance to these medications that has developed In previous laboratory studies performed by treating melanoma cancer cells with a CSF-1R CSF-1 Receptor which interacts with the CSF-1 protien inhibitor and a BRAF inhibitor it was found that the CSF-1R inhibitor was successful in increasing efficacy
The FDA the US Food and Drug Administration has not approved MSC110 as a treatment for any disease
The FDA has approved dabrafenib and trametinib as treatment options for this disease
Dabrafenib and trametinib attack different proteins that promote the growth of cancerous cells These two treatments work in cancers with a mutation in the BRAF gene which alters a protein signaling pathway in cancer cells The BRAF mutation status will be confirmed during this trial by review or procedure in order to make sure this clinical trial is right for the participant Dabrafenib is a BRAF inhibitor that works by preventing altered BRAF proteins from stimulating the growth of the melanoma cancer cells Trametinib works by blocking a protein related to BRAF called MEK that has been known to stimulate cells that also promote melanoma growth In order to participate in the study the participant disease needs to be tested positive for a mutation a permanent change in the DNA sequence of a gene of the BRAF gene that belongs to a class of genes known as oncogenes When mutated oncogenes have the potential to cause normal cells to become cancerous Once the BRAF gene is mutated the normal functioning of the BRAF protein may be changed It is normal for patients with a BRAF mutation to receive these types of inhibitor therapies at some point in their treatment
MCS110 is a colony-stimulating factor-1 CSF-1 inhibitor It is a human monoclonal antibody which binds CSF-1 A monoclonal antibody is a type of protein made in the laboratory that can locate and bind to substances in the body including tumor cells MCS110 is being developed as a treatment for patients with advanced cancer
In this research study the investigators are adding MCS110 to the treatment with dabrafenib and trametinib at the time when the participants disease is growing despite these medications The hope is that MCS110 will enhance how the cancer will respond to dabrafenib and trametinib and overcome any resistance to these medications that has developed In previous laboratory studies performed by treating melanoma cancer cells with a CSF-1R CSF-1 Receptor which interacts with the CSF-1 protien inhibitor and a BRAF inhibitor it was found that the CSF-1R inhibitor was successful in increasing efficacy
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