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Report for Clinical Trial NCT03088176

Developed by Shray Alag, 2020.
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 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