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Report for Clinical Trial NCT03944356

Developed by Shray Alag, 2020.
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


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