NCT03101254

LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma

A Phase I/II Study of LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a Phase I/II 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 U.S. 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, participant's 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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	LY3022855	LY3022855 is a colony-stimulating factor-1 receptor (CSF-1R) inhibitor
DRUG	Vemurafenib	Vemurafenib is a BRAF inhibitor that works by blocking altered BRAF proteins from stimulating the growth of melanoma cancer cells
DRUG	Cobimetinib	Cobimetinib works by blocking a protein called MEK that has been known to promote melanoma growth

Timeline

• Start date: 2017-06-06
• Primary completion: 2020-10-21
• Completion: 2020-11-11
• First posted: 2017-04-05
• Last updated: 2024-07-17
• Results posted: 2024-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study