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Completed

NCT Number: NCT02143999

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

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.

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica, Chieti, Abruzzo, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 2 years

Secondary outcomes

  1. Progression-free survival

    Time frame: 2 years

  2. Best Overall Response Rate (BORR)

    Time frame: 2 years

  3. Time to response

    Time frame: 2 years

  4. Duration of response

    Time frame: 2 years

  5. ECOG performance status

    Time frame: 2 years

  6. Safety: Incidence of adverse events

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 21, 2014
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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