Malignant Melanoma Clinical Trial
| Verified date | June 2017 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 403 |
| Est. completion date | December 30, 2016 |
| Est. primary completion date | December 30, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari | Bari | Puglia |
| Italy | Asst Papa Giovanni XXIII; Oncologia Medica | Bergamo | Lombardia |
| Italy | Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica | Bologna | Emilia-Romagna |
| Italy | Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina | Brescia | Lombardia |
| Italy | Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo | Candiolo | Piemonte |
| Italy | Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica | Chieti | Abruzzo |
| Italy | Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia | Cona (FE) | Veneto |
| Italy | Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica | Cuneo | Piemonte |
| Italy | Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica | Firenze | Toscana |
| Italy | IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A | Genova | Liguria |
| Italy | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST);U.O. di Immunoterapia | Meldola | Emilia-Romagna |
| Italy | Irccs Istituto Europeo Di Oncologia (Ieo); Unita' Di Ricerca Traslazionale Del Melanoma | Milano | Lombardia |
| Italy | Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 | Milano | Lombardia |
| Italy | IRCCS IST. Tumori Fondaz. Pascale; S.C. Oncologia Medica,Melanoma,Immunoterapia E Terapie Innovative | Napoli | Campania |
| Italy | Ospedale Maggiore Della Carita; Oncologia Medica | Novara | Piemonte |
| Italy | Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1 | Palermo | Sicilia |
| Italy | Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2 | Pisa | Toscana |
| Italy | Arcispedale Santa Maria Nuova; Oncologia | Reggio Emilia | Emilia-Romagna |
| Italy | Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche | Roma | Lazio |
| Italy | Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica | Roma | Lazio |
| Italy | Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica | Siena | Toscana |
| Italy | Ospedale S. Vincenzo; Oncologia Medica | Taormina | Sicilia |
| Italy | Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | Piemonte |
| Italy | Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Oncologia Medica | Verona | Veneto |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival | 2 years | ||
| Secondary | Progression-free survival | 2 years | ||
| Secondary | Best Overall Response Rate (BORR) | 2 years | ||
| Secondary | Time to response | 2 years | ||
| Secondary | Duration of response | 2 years | ||
| Secondary | ECOG performance status | 2 years | ||
| Secondary | Safety: Incidence of adverse events | 2 years |
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