Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dabrafenib · 1 trial · 1 indication
Proportion of patients with a complete absence of residual melanoma cells in the planned resected tumour site(s) at week 6 surgery.
| Arm | Type | Description |
|---|---|---|
| Sequential D + T, THEN Pembrolizumab | EXPERIMENTAL | Dabrafenib 150mg orally twice a day + Trametinib 2mg orally once a day for 1 week, then followed by treatment with Pembrolizumab 2mg/kg delivered intravenously at weeks 1, 3, and 6, then once every 3 weeks from week 6 for 46 weeks. |
| Concurrent D + T AND Pembrolizumab | EXPERIMENTAL | Dabrafenib 150mg orally twice a day + Trametinib 2mg orally once a day + Pembrolizumab 200mg intravenously once every 3 weeks for 6 weeks, the Pembrolizumab alone for 46 weeks |
| Pembrolizumab ONLY | EXPERIMENTAL | Pembrolizumab 200mg intravenously once every 3 weeks alone for 52 weeks. |
| Name | Type | Description |
|---|---|---|
| Dabrafenib | DRUG | Dabrafenib, a 4-(3-aminosulfonylphenyl)-5-(pyrimidine-3-yl) thiazole, is a potent and selective inhibitor of B-RAF kinase activity with a mode of action consistent with adenosine triphosphate (ATP)-competitive inhibition, and is approved as monotherapy in BRAF V600E-mutant advanced/metastatic melanoma. |
| Trametinib | DRUG | Trametinib, a pyrido - pyrimidine derivative, is a potent and highly selective allosteric non-competitive inhibitor of MEK1/MEK2 activation and kinase activity has been approved as monotherapy in BRAF (V600E)-mutant and BRAF (V600K)-mutant melanoma. |
| Pembrolizumab | DRUG | Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. |
Inclusion Criteria: * ≥18 years of age * Written informed consent. * Histologically confirmed, resectable American Joint Committee on Cancer (AJCC, 8th edition) stage IIIB, IIIC (Tx, T0, T1-4, N1b, N2b, N3b, M0) cutaneous melanoma or unknown primary melanoma with sufficient cutaneous and/or nodal d...
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Dabrafenib is an investigational small molecule being studied for the treatment of melanoma. It is currently in Phase 2 clinical development for this indication. The drug is being evaluated in a clinical trial for patients with BRAF mutant resectable Stage III melanoma.
Dabrafenib targets the BRAF protein, specifically the BRAF V600 mutation. This is a key driver in melanoma, and the drug is designed to inhibit this mutated protein. The clinical trial for Dabrafenib requires patients to have a BRAF mutation, as it is a biomarker-selected study.
Dabrafenib is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting a Phase 2 clinical trial for this drug in melanoma.
Dabrafenib is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing trial is active but not recruiting participants.
Dabrafenib is being studied in a single Phase 2 clinical trial with the identifier NCT02858921. This trial is titled 'Neoadjuvant Dabrafenib, Trametinib and/or Pembrolizumab in BRAF Mutant Resectable Stage III Melanoma' and is being conducted in Australia with an enrollment of 60 patients.
Dabrafenib is a distinct drug, but it is being studied in combination with other agents. The clinical trial NCT02858921 evaluates Dabrafenib alone or in combination with trametinib and/or pembrolizumab. These are separate drugs with different mechanisms of action.