Ignite Creation Date:
2024-05-06 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03101254
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2017-03-30
Brief Title:
LY3022855 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 LY3022855 With BRAFMEK Inhibition in Patients With Melanoma
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
LY3022855
Vemurafenib
Cobimetinib
The interventions involved in this study are
LY3022855
Vemurafenib
Cobimetinib
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 LY3022855 as a treatment for any disease
The FDA has approved vemurafenib and cobimetinib as treatment options for this disease
LY3022855 is a colony-stimulating factor-1 receptor CSF-1R inhibitor It is a human monoclonal antibody 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 By binding to the tumor cells the antibody might prevent the tumor cell from growing and spreading LY3022855 is being developed as a treatment for patients with advanced cancer
Vemurafenib and cobimetinib attack different proteins that promote the growth of cancerous cells Vemurafenib is a BRAF inhibitor that works by blocking altered BRAF proteins from stimulating the growth of melanoma cancer cells Cobimetinib works by blocking a protein called MEK that has been known to promote melanoma growth In order to participate in the study participants 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
In this research study the investigators are combining LY3022855 with vemurafenib and cobimetinib in the hopes that the LY3022855 will enhance how your cancer responds to vemurafenib and cobimetinib
The FDA the US Food and Drug Administration has not approved LY3022855 as a treatment for any disease
The FDA has approved vemurafenib and cobimetinib as treatment options for this disease
LY3022855 is a colony-stimulating factor-1 receptor CSF-1R inhibitor It is a human monoclonal antibody 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 By binding to the tumor cells the antibody might prevent the tumor cell from growing and spreading LY3022855 is being developed as a treatment for patients with advanced cancer
Vemurafenib and cobimetinib attack different proteins that promote the growth of cancerous cells Vemurafenib is a BRAF inhibitor that works by blocking altered BRAF proteins from stimulating the growth of melanoma cancer cells Cobimetinib works by blocking a protein called MEK that has been known to promote melanoma growth In order to participate in the study participants 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
In this research study the investigators are combining LY3022855 with vemurafenib and cobimetinib in the hopes that the LY3022855 will enhance how your cancer responds to vemurafenib and cobimetinib
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