SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03101254

Developed by Shray Alag, 2019.
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

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

LY3022855 + Vemurafenib + Cobimetinib

Name: Cobimetinib

Description: Cobimetinib works by blocking a protein called MEK that has been known to promote melanoma growth

Type: Drug

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: Toxicity

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

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


HPO:
Cutaneous melanoma
Genes 11
BRAF HRAS XPC CDKN2A POLH ERCC3 BAP1 CXCR4 MC1R NRAS WRN
Melanoma
Genes 64
RAD51 RAD51C TYR RAD51D CDKN2A KRAS CDKN2B RAF1 CDKN2D MRE11 CYSLTR2 ERCC2 KLLN PTPN11 ERCC3 BRIP1 ERCC4 ERCC5 ERCC6 SF3B1 NRAS MGMT BRCA1 MBTPS2 BRAF ACD BRCA2 PIK3CA CXCR4 CTSC POLH POT1 MC1R MITF WRN CHEK2 HRAS BARD1 NBN AKT1 SLC45A2 GNA11 TRPV3 XPA OCA2 XPC GNAQ PTEN MDM2 TERT DDB2 RNF43 PALLD PALB2 TERF2IP SEC23B TP53 SDHB SDHC SDHD SMAD4 BAP1 CDK4 RAD50