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Report for Clinical Trial NCT03455764

Developed by Shray Alag, 2020.
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 Phase 2 MCS110+ Trametinib + Dabrafenib

Name: Dabrafenib

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

Type: Drug

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

Name: Trametinib

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

Type: Drug

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


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 (Safety and Tolerability)

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 15
HRAS MITF CDKN2A BRAF NRAS NRAS WRN CDKN2A CXCR4 BAP1 POLH CDK4 ERCC3 XPC MC1R
Melanoma
Genes 98
MGMT NRAS POT1 NRAS XPA CTSC BRCA1 SDHC ERCC4 CXCR4 RAD51C CDKN2B ERCC3 XPC PALLD ERCC2 ERCC2 CHEK2 CDKN2A RAD51D GNAQ SDHD KRAS MBTPS2 BAP1 BAP1 CYSLTR2 RNF43 BAP1 CDKN2A PTPN11 CDK4 BRCA2 ERCC3 MITF TERF2IP ERCC4 CHEK2 BRCA1 TRPV3 POT1 OCA2 TERT CDKN2A AKT1 CDKN2A SF3B1 ERCC6 ERCC5 ERCC5 MDM2 BRCA2 BAP1 GNA11 ACD BRIP1 HRAS MRE11 BRAF TYR TP53 KLLN SEC23B PTEN PIK3CA XPA PERP MITF RAF1 BRAF POLH TP53 BARD1 NRAS SMAD4 RAD50 DDB2 ERCC2 NBN TERT MC1R SLC45A2 WRN PALB2 DDB2 PALB2 CDKN2A SDHB MC1R RAD51 TP53 XPC ERCC3 PTEN CDKN2A POLH CDK4 MC1R