Unresecable Stage IIIc or IV MelanomaSVALMELNCT03553329
Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK
An observational study of Unresecable Stage IIIc or IV Melanoma, run by Poitiers University Hospital at 1 site in France.
Trial summary
The therapeutic arsenal of metastatic melanoma has changed considerably over the past 10 years. The treatment of metastatic melanoma is now based on immunotherapy and targeted therapies, while the place of conventional chemotherapy becomes more restricted. Targeted therapies are indicated for BRAF mutated melanomas. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Unresecable Stage IIIc or IV Melanoma
- What is being tested?
- dabrafenib
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2018to 2 Jun 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 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients with unresectable stage IIIc or stage IV melanoma, including the Mekinist research protocol
Who may be able to join
- Age > 18 ans
- the patients with unresecable stage IIIc or IV melanoma with BRAF V600 E or K mutation,
- treated by dabrafenib and trametinib by the program of extended access (research protocol Mekinist)
Who cannot join
- Age < 18 ans
- patients who had less than 3 months of treatment,
- patients for which the albumin level could not be carried out before starting treatment, and after the first month
Trial locations and contacts
1 site in 1 country.
About this study
The therapeutic arsenal of metastatic melanoma has changed considerably over the past 10 years. The treatment of metastatic melanoma is now based on immunotherapy and targeted therapies, while the place of conventional chemotherapy becomes more restricted. Targeted therapies are indicated for BRAF mutated melanomas.
The mutation BRAF leads activation of MAP Kinases pathway and the proliferation of melanoma cell in the body . About 50% of metastatic melanoma is BRAF mutated. The most frequent mutation is the V600E. The targeted therapy by anti BRAF and anti MEK allows the double bloking of the MAP Kinases pathway. This treatment is more efficient than that of the anti BRAF alone. The association of anti BRAF and anti MEK have a global survival global rate of 41% at the 1 year, against 9% for the anti BRAF .
Read more
In 2014, a program of extended access to the association of anti BRAF and anti MEK (dabrafenib and trametinib) started in many french hospitals (Protocol Mekinist, Novartis laboratory). Patients who were included in this program and followed in Poitiers Hospital, had frequent abnormalities of albumin level without any sign of undernutrition.
Hypoabuminemia is a poor prognosis factor described in many cancers, including metastatic melanoma.
The only prognostic factor in metastatic melanoma is the rate of LDH . The level of albumin and its prognostic impact have not been studied for patients with a metastatic melanoma and treated by anti BRAF and anti MEK.
The objective of this studie was to analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated in our Center by dabrafenib and trametinib
- Conditions
- Unresecable Stage IIIc or IV Melanoma
- Being tested
- dabrafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabrafenibDrug
Also called trametinib
Monthly biological assessment which included: blood count, a blood electrolytes, an creatininemia, a dosage of urea, a dosage of transaminases, of gammaGT, of phosphatases alkaline, of LDH and of albumin.
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated by dabrafenib and trametinib
Biological assessment
Measured: 1 months
Analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated by dabrafenib and trametinib
Biological assessment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start2 Jun 2018
- Primary completion2 Jun 2018
- Study completion2 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresecable Stage IIIc or IV MelanomaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553329
- Sponsor's protocol ID
- SVALMEL
- Acronym
- SVALMEL
- Status last verified
- Jun 2018
- First submitted
- 3 Apr 2018
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK
- ClinicalTrials.gov ID
- NCT03553329
- Acronym / sponsor ID
- SVALMEL / SVALMEL
- Conditions
- Unresecable Stage IIIc or IV Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 2 Jun 2018 (actual)
- Primary completion
- 2 Jun 2018 (actual)
- Study completion
- 2 Jun 2018 (actual)
- First posted
- 12 Jun 2018 (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.
The therapeutic arsenal of metastatic melanoma has changed considerably over the past 10 years. The treatment of metastatic melanoma is now based on immunotherapy and targeted therapies, while the place of conventional chemotherapy becomes more restricted. Targeted therapies are indicated for BRAF mutated melanomas.
The mutation BRAF leads activation of MAP Kinases pathway and the proliferation of melanoma cell in the body . About 50% of metastatic melanoma is BRAF mutated. The most frequent mutation is the V600E. The targeted therapy by anti BRAF and anti MEK allows the double bloking of the MAP Kinases pathway. This treatment is more efficient than that of the anti BRAF alone. The association of anti BRAF and anti MEK have a global survival global rate of 41% at the 1 year, against 9% for the anti BRAF .
In 2014, a program of extended access to the association of anti BRAF and anti MEK (dabrafenib and trametinib) started in many french hospitals (Protocol Mekinist, Novartis laboratory). Patients who were included in this program and followed in Poitiers Hospital, had frequent abnormalities of albumin level without any sign of undernutrition.
Hypoabuminemia is a poor prognosis factor described in many cancers, including metastatic melanoma.
The only prognostic factor in metastatic melanoma is the rate of LDH . The level of albumin and its prognostic impact have not been studied for patients with a metastatic melanoma and treated by anti BRAF and anti MEK.
The objective of this studie was to analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated in our Center by dabrafenib and trametinib
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable stage IIIc or stage IV melanoma, including the Mekinist research protocol
Key inclusion criteria (3 listed)
- Age > 18 ans
- the patients with unresecable stage IIIc or IV melanoma with BRAF V600 E or K mutation,
- treated by dabrafenib and trametinib by the program of extended access (research protocol Mekinist)
Key exclusion criteria (3 listed)
- Age < 18 ans
- patients who had less than 3 months of treatment,
- patients for which the albumin level could not be carried out before starting treatment, and after the first month
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 |
|---|---|---|
| dabrafenibAlso: trametinibMonthly biological assessment which included: blood count, a blood electrolytes, an creatininemia, a dosage of urea, a dosage of transaminases, of gammaGT, of phosphatases alkaline, of LDH and of albumin. | Drug | – |
Primary outcome
Analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated by dabrafenib and trametinib
Time frame: 1 months
Biological assessment
Analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated by dabrafenib and trametinib
Time frame: 3 months
Biological assessment
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 12 Jun 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresecable Stage IIIc or IV Melanoma, run by Poitiers University Hospital at 1 site 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 3 inclusion and 3 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 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated by dabrafenib and trametinib (time frame: 1 months). The study lists 2 primary outcomes in all. 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 12 Jun 2018.