Clinical trial NCT02143999: An Observational Study of BRAF Inhibitors Effectiveness in Patients With Newly Diagnosed Metastatic Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Melanoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed unresectable or metastatic 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2 years
measure: Best Overall Response Rate (BORR)
timeFrame: 2 years
measure: Time to response
timeFrame: 2 years
measure: Duration of response
timeFrame: 2 years
measure: ECOG performance status
timeFrame: 2 years
measure: Safety: Incidence of adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
state: Abruzzo
city: Napoli
country: Italy
facility: IRCCS IST. Tumori Fondaz. Pascale; S.C. Oncologia Medica,Melanoma,Immunoterapia E Terapie Innovative
state: Campania
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
state: Emilia-Romagna
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST);U.O. di Immunoterapia
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova; Oncologia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
state: Lazio
city: Roma
country: Italy
facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
state: Lazio
city: Genova
country: Italy
facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
state: Liguria
city: Bergamo
country: Italy
facility: Asst Papa Giovanni XXIII; Oncologia Medica
state: Lombardia
city: Brescia
country: Italy
facility: Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (Ieo); Unita' Di Ricerca Traslazionale Del Melanoma
state: Lombardia
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
state: Piemonte
city: Cuneo
country: Italy
facility: Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica
state: Piemonte
city: Novara
country: Italy
facility: Ospedale Maggiore Della Carita; Oncologia Medica
state: Piemonte
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
state: Piemonte
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
state: Puglia
city: Palermo
country: Italy
facility: Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1
state: Sicilia
city: Taormina
country: Italy
facility: Ospedale S. Vincenzo; Oncologia Medica
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica
state: Toscana
city: Pisa
country: Italy
facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
state: Toscana
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
state: Toscana
city: Cona (FE)
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia
state: Veneto
city: Verona
country: Italy
facility: Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Oncologia Medica
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: