An Observational Study of BRAF Inhibitors Effectiveness in Patients With Newly Diagnosed Metastatic Melanoma
1 other identifier
observational
403
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedStudy Start
First participant enrolled
June 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2016
CompletedJune 27, 2017
June 1, 2017
2.5 years
May 19, 2014
June 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
2 years
Secondary Outcomes (6)
Progression-free survival
2 years
Best Overall Response Rate (BORR)
2 years
Time to response
2 years
Duration of response
2 years
ECOG performance status
2 years
- +1 more secondary outcomes
Study Arms (1)
Cohort
Eligibility Criteria
Patients with newly diagnosed unresectable or metastatic melanoma
You may qualify if:
- 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
You may not qualify if:
- Prior systemic therapy for metastatic disease
- Participation in interventional clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
Chieti, Abruzzo, 66100, Italy
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, Apulia, 70124, Italy
IRCCS IST. Tumori Fondaz. Pascale; S.C. Oncologia Medica,Melanoma,Immunoterapia E Terapie Innovative
Napoli, Campania, 80131, Italy
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, 40138, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST);U.O. di Immunoterapia
Meldola, Emilia-Romagna, 47014, Italy
Arcispedale Santa Maria Nuova; Oncologia
Reggio Emilia, Emilia-Romagna, 42100, Italy
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Rome, Lazio, 00128, Italy
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
Rome, Lazio, 00161, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genoa, Liguria, 16132, Italy
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardy, 24128, Italy
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
Brescia, Lombardy, 25123, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, 20133, Italy
Irccs Istituto Europeo Di Oncologia (Ieo); Unita' Di Ricerca Traslazionale Del Melanoma
Milan, Lombardy, 20141, Italy
Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
Candiolo, Piedmont, 10060, Italy
Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica
Cuneo, Piedmont, 12100, Italy
Ospedale Maggiore Della Carita; Oncologia Medica
Novara, Piedmont, 28100, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Piedmont, 10126, Italy
Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1
Palermo, Sicily, 90127, Italy
Ospedale S. Vincenzo; Oncologia Medica
Taormina, Sicily, 98030, Italy
Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica
Florence, Tuscany, 50125, Italy
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
Pisa, Tuscany, 56100, Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena, Tuscany, 53100, Italy
Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia
Cona (FE), Veneto, 44124, Italy
Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Oncologia Medica
Verona, Veneto, 37134, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2014
First Posted
May 21, 2014
Study Start
June 27, 2014
Primary Completion
December 30, 2016
Study Completion
December 30, 2016
Last Updated
June 27, 2017
Record last verified: 2017-06