Unresecable Stage IIIc or IV Melanoma Clinical Trial
— SVALMELOfficial 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
| NCT number | NCT03553329 |
| Other study ID # | SVALMEL |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2, 2018 |
| Est. completion date | June 2, 2018 |
| Verified date | June 2018 |
| Source | Poitiers University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | June 2, 2018 |
| Est. primary completion date | June 2, 2018 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU DE Poitiers | Poitiers |
| Lead Sponsor | Collaborator |
|---|---|
| Poitiers University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated by dabrafenib and trametinib | Biological assessment | 1 months | |
| Primary | Analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated by dabrafenib and trametinib | Biological assessment | 3 months |