SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03088176

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 1b Trial of Talimogene Laherparepvec in Combination With Dabrafenib and Trametinib in Advanced Melanoma With an Activating BRAF Mutation

The purpose of the study is to determine safety and tolerability of the combination of talimogene laherparepvec in combination with dabrafenib and trametinib in BRAF mutated advanced melanoma.

NCT03088176 Melanoma BRAF Gene Mutation
MeSH: Melanoma
HPO: Cutaneous melanoma Melanoma

4 Interventions

Name: Talimogene Laherparepvec 1 Million Pfu/Ml Inj,Susp,1Ml,Vil

Description: Up to 4mL administered on C1D1 intratumorally

Type: Drug

Combination

Name: Talimogene Laherparep 100 Mil Pfu/Ml 1Ml

Description: Up to 4 ML administered on Week 4 Day 1 and every 2 weeks thereafter

Type: Drug

Combination

Name: Dabrafenib

Description: 150mg PO qday

Type: Drug

Combination

Name: Trametinib

Description: 2mg PO qday

Type: Drug

Combination


Primary Outcomes

Description: Number of DLT seen in the subject population

Measure: Rate of Dose Limiting Toxicities (DLT)

Time: 2 years

Secondary Outcomes

Description: per RECIST 1.1

Measure: Progression Free Survival

Time: 4 years

Description: per RECIST 1.1

Measure: Objective Response Rate

Time: 4 years

Description: Best change in tumor diameters

Measure: Change in tumor burden

Time: 4 years

Description: In responding patients, time from first dose to achieving objective response

Measure: Time to Response

Time: 4 years

Description: In responding patients, time from first evidence of objective response until progression or end of study

Measure: Duration of Response

Time: 4 years

Other Outcomes

Description: Change in diameters of individual lesions

Measure: Lesion-level objective response

Time: 4 years

Description: Exploratory analysis including number of participants with changes in CD8+ tumor infiltrating lymphocytes between pre-study and on-study biopsies

Measure: Biomarker analysis

Time: 4 years

Purpose: Treatment

Single Group Assignment


There are 2 SNPs

SNPs


1 V600E

Primary or recurrent Stage IIIB to IVM1c melanoma for whom surgery is not recommended 3. Activating BRAF mutation (limited to V600E or V600K mutations if being treated first-line, but can include any well-defined BRAF mutation after failure of prior immunotherapy) 4. Measurable disease defined as follows: At least one melanoma lesion that can be accurately and serially measured in one dimension and for which the longest diameter is ≥10 mm as measured by calipers, CT scan, or MRI. --- V600E ---


2 V600K

Primary or recurrent Stage IIIB to IVM1c melanoma for whom surgery is not recommended 3. Activating BRAF mutation (limited to V600E or V600K mutations if being treated first-line, but can include any well-defined BRAF mutation after failure of prior immunotherapy) 4. Measurable disease defined as follows: At least one melanoma lesion that can be accurately and serially measured in one dimension and for which the longest diameter is ≥10 mm as measured by calipers, CT scan, or MRI. --- 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