MelanomaMELANISNCT03139513
A Study of Adult Participants With BRAF V600 Mutation-Positive Advanced Melanoma Treated With Cobimetinib (Cotellic®) During the French Early Access Program (Temporary Authorization for Use [TAU])
An observational study of Melanoma, run by Hoffmann-La Roche at 33 sites in France.
Trial summary
This is a multicentre, ambispective (both retrospective and prospective), and non-interventional study conducted in France in adult participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib (Zelboraf®). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Cobimetinib and Vemurafenib
- How many people
- 200 participants
- Where
- 33 sitesFrance
- Study dates
- 27 Oct 2016to 22 Aug 2018
- 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: Participants with BRAF V600 mutation-positive advanced melanoma treated with cobimetinib during the French early access program (TAU).
Who may be able to join
- Participants included in the TAU from 26 February 2015
- Participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib
- For alive participants: participants who have been informed verbally and in writing about this study who do not object to their data being electronically processed or subjected to data quality control
- For participants who died before the inclusion period: participants who did not express their opposition when they were alive
Who cannot join
- Alive participants unable to give informed consent
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
France33 sites
Centre Hospitalier d'Albi
Albi, 81013
Hopital Prive D Antony; Dermatologie
Antony, 92166
Chic Cote Basque Bayonne; Medecine II
Bayonne, 64109
CHU Besançon - Hôpital Jean Minjoz
Besançon, 25030
Hopital Avicenne; Dermatologie
Bobigny, 93009
CH Fleyriat
Bourg-en-Bresse, 01000
CH Metropole de Savoie
Chambéry, 73011
Chu Estaing; Dermatologie
Clermont-Ferrand, 63003
Hopital Louis Pasteur; Sce Dermatologie
Colmar, 68024
Centre Georges Francois Leclerc
Dijon, 21000
Chu Site Du Bocage;Dermatologie
Dijon, 21079
Centre Hospitalier Le Mans; Dermatologie
Le Mans, 72037
Hopital Claude Huriez; Sce Dermatologie
Lille, 59037
CHU de Limoges - Hôpital Dupuytren
Limoges, 87042
Hopital Timone Adultes; Dermatologie
Marseille, 13385
Hopital Jacques Monod; Dermatologie
Montivilliers, 76290
Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie
Montpellier, 34295
CH de Mulhouse Hôpital Emile Muller
Mulhouse, 68070
Hopital l Archet 2; Ginestriere, Service de; Dermatologie
Nice, 06200
Hopital Cochin; Dermatologie
Paris, 75006
Groupe Hospitalier Bichat Claude Bernard
Paris, 75018
CENTRE HOSPITALIER ANNECY-GENEVOIS; Dematologie
Pringy
Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer
Rennes, 35000
CHU Rouen - CH C. Nicolle - Clinique dermatologique
Rouen, 76031
CHU de Saint-Etienne - Hopital Nord
Saint-Etienne, 42055
CHI de Poissy St Germain
Saint-Germain, 07810
Hopital Broussais
St-Malo, 35403
Pole de Cancerologie Prive Strasbourgeois
Strasbourg, 67000
Hopital Bel Air
Thionville, 57126
Hia Sainte Anne; Medecine Interne Oncologie
Toulon, 83041
CHU de Toulouse - Hôpital Larrey
Toulouse, 31059
Centre Hospitalier Valence
Valence, 26953
Institut Gustave Roussy; Dermatologie
Villejuif, 94805
About this study
Official title: Survival in Adult Patients With BRAF V600 Mutation-Positive Advanced Melanoma: A Non-Interventional Ambispective Study of a Cohort of Patients Treated With Cobimetinib During the French Early Access Program (TAU)
This is a multicentre, ambispective (both retrospective and prospective), and non-interventional study conducted in France in adult participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib (Zelboraf®).
Read the detailed description
Concomitantly to the marketing authorization applications for cobimetinib and vemurafenib to European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) in 2014, a French TAU program was initiated in February 2015. This study will enroll participants under this program.
- Conditions
- Melanoma
- Being tested
- Cobimetinib, Vemurafenib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CobimetinibDrug
Also called Cotellic®
Participants will receive cobimetinib as per local guidelines and/or routine clinical practice.
VemurafenibDrug
Also called Zelboraf®
Participants will receive vemurafenib as per local guidelines and/or routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Melanoma | Participants with BRAF V600 mutation-positive unresectable or metastatic melanoma, having started treatment with cobimetinib in combination with vemurafenib as per local guidelines and/or routine clinical practice in context of TAU program, will be observed. Receives: Drug: Cobimetinib; Drug: Vemurafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)
Secondary outcomes (6)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
Percentage of Participants with Complete Response (CR) or Partial Response (PR) to Treatment According to RECIST as Assessed by Physician
Measured: From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
Time to Cobimetinib Treatment Discontinuation
Measured: From first intake of cobimetinib up to cobimetinib treatment discontinuation (assessed up to 18 months)
Percentage of Participants by Treatments After Disease Progression or Permanent Cobimetinib Treatment Discontinuation
Measured: From disease progression or permanent cobimetinib treatment discontinuation up to overall study completion (assessed up to 18 months)
Retrospective Period: Percentage of Participants with Targeted Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with following targeted adverse events will be reported: fever (pyrexia), diarrhea, hepatic abnormalities, creatinine phosphokinapse (CPK) increased, rhabdomyolysis, retinal serous detachment, decrease in left ventricular ejection fraction (LVEF), squamous cell skin carcinoma and keratoacanthom, renal failure, drug reaction (or rash) with eosinophilia and systemic syndrome (DRESS), rash not otherwise specified (NOS), and photosensitivity.
Measured: From first intake of cobimetinib up to inclusion in the study (up to Day 1)
Prospective Period: Percentage of Participants with Adverse Events (AEs)
Measured: From first intake of cobimetinib up to overall study completion (assessed up to 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start27 Oct 2016
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Enrolment
- 200 participants (estimated)
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
- NCT03139513
- Sponsor's protocol ID
- ML29964
- Acronym
- MELANIS
- Status last verified
- Jan 2019
- First submitted
- 2 May 2017
- Last updated
- 22 Jan 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival in Adult Patients With BRAF V600 Mutation-Positive Advanced Melanoma: A Non-Interventional Ambispective Study of a Cohort of Patients Treated With Cobimetinib During the French Early Access Program (TAU)
- ClinicalTrials.gov ID
- NCT03139513
- Acronym / sponsor ID
- MELANIS / ML29964
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2016 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 4 May 2017 (actual)
- 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 is a multicentre, ambispective (both retrospective and prospective), and non-interventional study conducted in France in adult participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib (Zelboraf®).
Detailed description
Concomitantly to the marketing authorization applications for cobimetinib and vemurafenib to European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) in 2014, a French TAU program was initiated in February 2015. This study will enroll participants under this program.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Melanoma | – | Drug: Cobimetinib, Drug: VemurafenibParticipants with BRAF V600 mutation-positive unresectable or metastatic melanoma, having started treatment with cobimetinib in combination with vemurafenib as per local guidelines and/or routine clinical practice in context of TAU program, will be observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with BRAF V600 mutation-positive advanced melanoma treated with cobimetinib during the French early access program (TAU).
Key inclusion criteria (4 listed)
- Participants included in the TAU from 26 February 2015
- Participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib
- For alive participants: participants who have been informed verbally and in writing about this study who do not object to their data being electronically processed or subjected to data quality control
- For participants who died before the inclusion period: participants who did not express their opposition when they were alive
Key exclusion criteria (1 listed)
- Alive participants unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CobimetinibAlso: Cotellic®Participants will receive cobimetinib as per local guidelines and/or routine clinical practice. | Drug | Metastatic Melanoma |
| VemurafenibAlso: Zelboraf®Participants will receive vemurafenib as per local guidelines and/or routine clinical practice. | Drug | Metastatic Melanoma |
Primary outcome
Overall Survival (OS)
Time frame: From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)
6 secondary outcomes
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
Percentage of Participants with Complete Response (CR) or Partial Response (PR) to Treatment According to RECIST as Assessed by Physician
Time frame: From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months)
Time to Cobimetinib Treatment Discontinuation
Time frame: From first intake of cobimetinib up to cobimetinib treatment discontinuation (assessed up to 18 months)
Percentage of Participants by Treatments After Disease Progression or Permanent Cobimetinib Treatment Discontinuation
Time frame: From disease progression or permanent cobimetinib treatment discontinuation up to overall study completion (assessed up to 18 months)
Retrospective Period: Percentage of Participants with Targeted Adverse Events (AEs)
Time frame: From first intake of cobimetinib up to inclusion in the study (up to Day 1)
Prospective Period: Percentage of Participants with Adverse Events (AEs)
Time frame: From first intake of cobimetinib up to overall study completion (assessed up to 18 months)
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 22 Jan 2019.
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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
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Hoffmann-La Roche at 33 sites in France.
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 4 inclusion and 1 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 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France. 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 (OS) (time frame: From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)). 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 22 Jan 2019.