drugset / Trial / NCT02858921
Neoadjuvant Dabrafenib, Trametinib and/or Pembrolizumab in BRAF Mutant Resectable Stage III Melanoma
Phase 2
Unknown
60 enrolled
Melanoma Institute Australia
Merck Sharp & Dohme LLC · collabNovartis · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to determine which of 3 drug combinations best reduces the size of tumour prior to surgery for advanced melanoma and prevents the recurrence of melanoma after surgery.
Timeline
- Start
- 2017-11-08
- Primary completion
- 2022-01-02
- Completion
- 2024-11
Publications
- Long GV, Carlino MS, Au-Yeung G, Spillane AJ, Shannon KF, Gyorki DE, Hsiao E, Kapoor R, Thompson JR, Batula I, Howle J, Ch'ng S, Gonzalez M, Saw RPM, Pennington TE, Lo SN, Scolyer RA, Menzies AM. Neoadjuvant pembrolizumab, dabrafenib and trametinib in BRAFV600-mutant resectable melanoma: the randomized phase 2 NeoTrio trial. Nat Med. 2024 Sep;30(9):2540-2548. doi: 10.1038/s41591-024-03077-5. Epub 2024 Jun 21.
- Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabrafenib | Small molecule | 150 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Trametinib | Small molecule | 2 mg | Oral |