An Observational Study of BRAF Inhibitors Effectiveness in Patients With Newly Diagnosed Metastatic Melanoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02143999

Enrollment

403

Registered

2014-05-21

Start date

2014-06-27

Completion date

2016-12-30

Last updated

2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

Brief summary

This observational study will evaluate the effectiveness of BRAF inhibitors and current therapies in patients with newly diagnosed metastatic melanoma with or without BRAF V600 mutation. Patients will be treated per the locally approved therapeutic options in clinical practice. The observation period for each patient will be up to 24 months.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients, \>/= 18 years of age at diagnosis * Histologically confirmed new diagnosis of unresectable or metastatic melanoma * Patients with tumor samples available for assessment of BRAF V600 mutation

Exclusion criteria

* Prior systemic therapy for metastatic disease * Participation in interventional clinical trials

Design outcomes

Primary

Measure	Time frame
Overall survival	2 years

Secondary

Measure	Time frame
Best Overall Response Rate (BORR)	2 years
Time to response	2 years
Progression-free survival	2 years
ECOG performance status	2 years
Safety: Incidence of adverse events	2 years
Duration of response	2 years

Countries

Italy

Outcome results