Malignant MelanomaNCT02143999
An Observational Study of BRAF Inhibitors Effectiveness in Patients With Newly Diagnosed Metastatic Melanoma
An observational study of Malignant Melanoma, run by Hoffmann-La Roche at 24 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- How many people
- 403 participants
- Where
- 24 sitesItaly
- Study dates
- 27 Jun 2014to 30 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed unresectable or metastatic melanoma
Who may be able to join
- 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
Who cannot join
- Prior systemic therapy for metastatic disease
- Participation in interventional clinical trials
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Italy24 sites
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, Apulia, 70124
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardy, 24128
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, 40138
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
Brescia, Lombardy, 25123
Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo
Candiolo, Piedmont, 10060
Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica
Chieti, Abruzzo, 66100
Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia
Cona (FE), Veneto, 44124
Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica
Cuneo, Piedmont, 12100
Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica
Florence, Tuscany, 50125
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
Genoa, Liguria, 16132
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST);U.O. di Immunoterapia
Meldola, Emilia-Romagna, 47014
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, 20133
Irccs Istituto Europeo Di Oncologia (Ieo); Unita' Di Ricerca Traslazionale Del Melanoma
Milan, Lombardy, 20141
IRCCS IST. Tumori Fondaz. Pascale; S.C. Oncologia Medica,Melanoma,Immunoterapia E Terapie Innovative
Naples, Campania, 80131
Ospedale Maggiore Della Carita; Oncologia Medica
Novara, Piedmont, 28100
Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1
Palermo, Sicily, 90127
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
Pisa, Tuscany, 56100
Arcispedale Santa Maria Nuova; Oncologia
Reggio Emilia, Emilia-Romagna, 42100
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Rome, Lazio, 00128
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
Rome, Lazio, 00161
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena, Tuscany, 53100
Ospedale S. Vincenzo; Oncologia Medica
Taormina, Sicily, 98030
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Piedmont, 10126
Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Oncologia Medica
Verona, Veneto, 37134
About this study
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.
- Conditions
- Malignant Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2 years
Secondary outcomes (6)
Progression-free survival
Measured: 2 years
Best Overall Response Rate (BORR)
Measured: 2 years
Time to response
Measured: 2 years
Duration of response
Measured: 2 years
ECOG performance status
Measured: 2 years
Safety: Incidence of adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study start27 Jun 2014
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143999
- Sponsor's protocol ID
- ML29031
- Status last verified
- Jun 2017
- First submitted
- 19 May 2014
- Last updated
- 27 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of BRAF Inhibitors Effectiveness in Patients With Newly Diagnosed Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT02143999
- Acronym / sponsor ID
- ML29031
- Conditions
- Malignant Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2014 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed unresectable or metastatic melanoma
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Prior systemic therapy for metastatic disease
- Participation in interventional clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 2 years
6 secondary outcomes
Progression-free survival
Time frame: 2 years
Best Overall Response Rate (BORR)
Time frame: 2 years
Time to response
Time frame: 2 years
Duration of response
Time frame: 2 years
ECOG performance status
Time frame: 2 years
Safety: Incidence of adverse events
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Melanoma, run by Hoffmann-La Roche at 24 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.