SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03944356

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients in the Adjuvant Setting: a Non-interventional Observatory Study

Adjuvant therapy with dabrafenib plus trametinib in melanoma was approved in 2018 by the EMA (EUropean Medicines Agency). The purpose of this non-interventional study is to assess the usage of adjuvant dabrafenib and trametinib in clinical practice, where the patient population may differ from study population.

NCT03944356 Melanoma
MeSH: Melanoma
HPO: Cutaneous melanoma Melanoma

1 Interventions

Name: Dabrafenib and Trametinib

Description: Dabrafenib and trametinib treatment under routine conditions according to the applying SmPC.

Type: Drug


Primary Outcomes

Description: Median time on adjuvant dabrafenib + trametinib treatment defined as the interval between start of treatment and permanent discontinuation of treatment.

Measure: Median time on treatment

Time: Date of first dose up to 12 months

Secondary Outcomes

Description: Rate of permanent study drug discontinuation due to any reason.

Measure: Permanent study drug discontinuation due to any reason

Time: From date of first treatment until the date of treatment end, assessed up to 12 months

Description: Rate of permanent study drug discontinuation due to adverse drug reactions (ADRs).

Measure: Permanent study drug discontinuation due to adverse drug reactions

Time: From date of first treatment until the date of treatment end, assessed up to 12 months

Description: Occurrence of pyrexia and related symptoms, listing the grade, number of episodes, and time to resolution.

Measure: Pyrexia and related symptoms

Time: From date of first treatment until the date of treatment end, assessed up to 12 months

Description: Type of adverse drug reaction (ADR) management applied for pyrexia and correlation with occurrence/persistence of pyrexia.

Measure: Adverse drug reaction management: pyrexia

Time: From date of first treatment until the date of treatment end, assessed up to 12 months

Description: ADRs persisting/emerging up to 3 months post-treatment.

Measure: Adverse drug reactions in Follow-up

Time: From date of first treatment until the date of treatment end plus 3 months of follow-up, assessed up to 15 months

Description: Assessment of health-related quality of life (HRQoL), measured by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC-QLQ-C30). The EORTC QLQ-C30 consists of the folowing scales, with each dimension specifying five levels of severity [not at all (level 1), a little (level 2), quite a bit (level 3), very much (level 4)]: functional scales (Physical, Role, Cognitive, Emotional, Social Functioning) symptom scales (Fatigue, Pain and Nausea/Vomiting) single item scales (Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrhoea and Financial Difficulties). Additionally the Global Health Status and QoL scales are incorporated, specifying on a scale from 1 (very poor) to 7 (excellent).

Measure: Health-related quality of life

Time: Over the course of treatment plus 3 months safety follow up, assessed up to 15 months

Description: Relapse free survival (RFS) time and rate

Measure: Relapse free survival

Time: From date of first treatment until the date of treatment end, assessed up to 12 months

Description: Distant metastasis free survival (DMFS) time.

Measure: Distant metastasis free survival time

Time: From date of first treatment until the date of treatment end, assessed up to 12 months

Description: Distant metastasis free survival (DMFS) rate.

Measure: Distant metastasis free survival rate

Time: From date of first treatment until the date of treatment end, assessed up to 12 months

Description: Overall survival (OS) time.

Measure: Overall survival time

Time: From date of first treatment until the date of treatment end, assessed up to 12 months

Description: Overall survival (OS) rate.

Measure: Overall survival rate

Time: From date of first treatment until the date of treatment end, assessed up to 12 months

Description: Correlation between time on treatment and efficacy endpoints (RFS, DMFS, OS).

Measure: Time on treatment and efficacy endpoints

Time: From date of first treatment until the date of treatment end, assessed up to 12 months

Time Perspective: Prospective

Case-Only


There is one SNP

SNPs


1 V600E

- V600E/K mutation-positive cutaneous melanoma - Adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) as indicated in the SmPC (Summary of Product Characteristics) and by prescription, that has been started no longer that 4 weeks before inclusion of the patient into the study or which will be initiated directly after inclusion - Age ≥ 18 years - Signed written informed consent Exclusion Criteria: - Lack of basic demographics and staging information - Current or planned participation within a clinical trial. --- V600E ---

Treatment with the BRAF inhibitor dabrafenib plus the MEK (Mitogen-activated protein kinase kinase) inhibitor trametinib showed improved overall survival in patients with unresectable or metastatic BRAF V600E/K-mutant melanoma (COMBI-d and COMBI-v studies). --- V600E ---



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