Trials / Withdrawn
WithdrawnNCT05299580
"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)"
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Fondazione Melanoma Onlus · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
There is evidence from cohort studies and metanalysis that a shift from BRAFWT to BRAF mutated melanomas can occur (Colombino JCO 2012, Valchis EJC 2017). Based on previous studies we expect that 15% of tissue BRAF WT patients treated with anti PD-1 will become circulating free DNA BRAF (CfDNA BRAF) mutation-positive and, at progression, they will be elegible to be treated with dabrafenib/trametinib. We aimed to design a clinical phase II trial in order to evaluate the activity of Dabrafenib and Trametinib in patients with Tissue BRAFWT signature and a molecular shift to circulating free DNA BRAF mutated positive melanomas upon progression to anti PD-1 therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dabrafenib | Dabrafenib 150 mg bid |
| DRUG | Trametinib | Trametinib 2mg qd |
Timeline
- Start date
- 2021-02-18
- Primary completion
- 2023-03-30
- Completion
- 2023-03-30
- First posted
- 2022-03-29
- Last updated
- 2023-09-14
Locations
16 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT05299580. Inclusion in this directory is not an endorsement.