SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03455764

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase I/II Study of MCS110 With BRAF/MEK Inhibition in Patients With Melanoma After Progression on BRAF/MEK Inhibition

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: - MCS110 - Dabrafenib - Trametinib

NCT03455764 Melanoma
MeSH: Melanoma
HPO: Cutaneous melanoma Melanoma

3 Interventions

Name: MCS110

Description: MCS110 is a colony-stimulating factor-1 (CSF-1) inhibitor. It is a human monoclonal antibody which binds CSF-1.

Type: Drug

MCS110+ Trametinib + Dabrafenib MCS110 + Trametinib + Dabrafenib Phase 2

Name: Dabrafenib

Description: Dabrafenib attack different proteins that promote the growth of cancerous cells

Type: Drug

MCS110+ Trametinib + Dabrafenib MCS110 + Trametinib + Dabrafenib Phase 2

Name: Trametinib

Description: Trametinib attack different proteins that promote the growth of cancerous cells

Type: Drug

MCS110+ Trametinib + Dabrafenib MCS110 + Trametinib + Dabrafenib Phase 2


Primary Outcomes

Description: Any side effects or severe side effects that require the drug to be held or reduced

Measure: Dose Limiting Toxicity

Time: 2 years

Secondary Outcomes

Description: The percentage of patients that have a reduction of their disease on imaging that meets RECIST criteria

Measure: Overall Response Rate

Time: 2 years

Description: The percentage of patients who have a reduction of their disease on imaging to the point that it can no longer be measured.

Measure: Complete Response rate

Time: 2 years

Description: The percentage of patients who have meet RECIST criteria for having a reduction in their disease on imaging but still have measurable disease.

Measure: Partial Response rate

Time: 2 years

Description: The length of time between participants starting study treatment and having growth of their disease

Measure: Progression Free Survival

Time: 2 years

Description: The amount of time between participants starting study therapy and death

Measure: Overall Survival

Time: 2 years

Description: Any side effects or severe side effects associated with study therapy

Measure: Toxicity

Time: 2 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 V600E

MCS110 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. --- 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 ---

- 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 have had progression of disease on prior BRAF and MEK inhibitor therapy. --- V600E ---


2 V600K

MCS110 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. --- 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 ---

- 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 have had progression of disease on prior BRAF and MEK inhibitor therapy. --- 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