LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03101254|
Recruitment Status : Active, not recruiting
First Posted : April 5, 2017
Last Update Posted : February 5, 2020
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:
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: LY3022855 Drug: Vemurafenib Drug: Cobimetinib||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma|
|Actual Study Start Date :||June 6, 2017|
|Actual Primary Completion Date :||April 12, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: LY3022855 + Vemurafenib + Cobimetinib
LY3022855 administered intravenously every week Vemurafenib administered by mouth twice daily Cobimetinib administered by mouth once daily on days 1-21of each cycle
LY3022855 is a colony-stimulating factor-1 receptor (CSF-1R) inhibitor
Vemurafenib is a BRAF inhibitor that works by blocking altered BRAF proteins from stimulating the growth of melanoma cancer cells
Other Name: Zelboraf
Cobimetinib works by blocking a protein called MEK that has been known to promote melanoma growth
Other Name: Cotellic
- Progression Free Survival [ Time Frame: 2 years ]Time from initiation of study therapy until documentation of disease progression by RECIST criteria
- Side effects from therapy [ Time Frame: 2 years ]Ability to give these three medications in combination without a dose limiting side effect. Assessment of side effects that do occur
- Overall Response Rate [ Time Frame: 2 years ]Rate of patients with a complete response or partial response as assessed by RECIST criteria
- Partial Response Rate [ Time Frame: 2 years ]At least a 30% decrease in the sum of the diameters of target lesions.
- Stable Disease [ Time Frame: 2 years ]Disease that is less than a 30% decrease or 20% increase in the sum of the diameters of the target lesions.
- Progressive Disease [ Time Frame: 2 years ]At least a 20% increase in the sum of the diameters of target lesions.
- Overall Survival [ Time Frame: 2 years ]Time from initiation of study therapy to death.
- Complete response [ Time Frame: 2 years ]Disappearance of all target lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101254
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Elizabeth Buchbinder, MD||Dana-Farber Cancer Institute|