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NCT03553329: SVALMEL
Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK
trial testing dabrafenib in Unresecable Stage IIIc or IV Melanoma in 20 participants. Completed in 2 June 2018.
2 June 2018
Quick facts
| Lead sponsor | Poitiers University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 2 June 2018 |
| Primary completion | 2 June 2018 |
| Estimated completion | 2 June 2018 |
| Sites | 1 location across France |
Drugs / interventions tested
- dabrafenib (dabrafenib) — full drug profile →
Conditions studied
- Unresecable Stage IIIc or IV Melanoma — all drugs for Unresecable Stage IIIc or IV Melanoma →
Sponsor
Poitiers University Hospital
Who can join
Adults 18 to 100, any sex, with Unresecable Stage IIIc or IV Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03553329
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of dabrafenib
Trials testing the same drug.
- NCT04961619 — Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma. · completed
- NCT05299580 — "Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II · Phase 2 · withdrawn
- NCT04666272 — Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With St · active not recruiting
- NCT03975829 — Pediatric Long-Term Follow-up and Rollover Study · Phase 4 · active not recruiting
- NCT03340506 — Dabrafenib and/or Trametinib Rollover Study · Phase 4 · recruiting
Other Poitiers University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03553329 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Poitiers University Hospital
- Last refreshed: 12 June 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03553329.
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