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Report for Clinical Trial NCT03101254

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT03101254 Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

3 Interventions

Name: LY3022855

Description: LY3022855 is a colony-stimulating factor-1 receptor (CSF-1R) inhibitor
Type: Drug
Group Labels: 1

LY3022855 + Vemurafenib + Cobimetinib

Name: Vemurafenib

Description: Vemurafenib is a BRAF inhibitor that works by blocking altered BRAF proteins from stimulating the growth of melanoma cancer cells
Type: Drug
Group Labels: 1

LY3022855 + Vemurafenib + Cobimetinib

Name: Cobimetinib

Description: Cobimetinib works by blocking a protein called MEK that has been known to promote melanoma growth
Type: Drug
Group Labels: 1

LY3022855 + Vemurafenib + Cobimetinib


Primary Outcomes

Description: Time from initiation of study therapy until documentation of disease progression by RECIST criteria

Measure: Progression Free Survival

Time: 2 years

Secondary Outcomes

Description: Ability to give these three medications in combination without a dose limiting side effect. Assessment of side effects that do occur

Measure: Side effects from therapy

Time: 2 years

Description: Rate of patients with a complete response or partial response as assessed by RECIST criteria

Measure: Overall Response Rate

Time: 2 years

Description: At least a 30% decrease in the sum of the diameters of target lesions.

Measure: Partial Response Rate

Time: 2 years

Description: Disease that is less than a 30% decrease or 20% increase in the sum of the diameters of the target lesions.

Measure: Stable Disease

Time: 2 years

Description: At least a 20% increase in the sum of the diameters of target lesions.

Measure: Progressive Disease

Time: 2 years

Description: Time from initiation of study therapy to death.

Measure: Overall Survival

Time: 2 years

Description: Disappearance of all target lesions.

Measure: Complete response

Time: 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 V600E

LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma 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 Progression Free Survival. --- V600E ---

Disappearance of all target lesions.. Inclusion Criteria: - For enrollment to the phase I portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. --- V600E ---

- For enrollment to the phase II portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) and cannot have received prior BRAF or MEK inhibitor therapy. --- V600E ---

Inclusion Criteria: - For enrollment to the phase I portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. --- V600E ---


2 V600K

LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma 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 Progression Free Survival. --- V600E --- --- V600K ---

Disappearance of all target lesions.. Inclusion Criteria: - For enrollment to the phase I portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. --- V600E --- --- V600K ---

- For enrollment to the phase II portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) and cannot have received prior BRAF or MEK inhibitor therapy. --- V600E --- --- V600K ---

Inclusion Criteria: - For enrollment to the phase I portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. --- V600E --- --- V600K ---



HPO Nodes


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