drugset / Trial / NCT03554083
Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This trial studies how well vemurafenib, cobimetinib, and atezolizumab work in treating patients with high-risk stage III melanoma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab and tiragolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vemurafenib, cobimetinib, and atezolizumab may work better in treating high-risk stage III melanoma. Giving atezolizumab and tiragolumab together may also work better in treating high-risk stage III melanoma.
Timeline
- Start
- 2018-10-05
- Primary completion
- 2025-04-30
- Completion
- 2025-04-30
Publications
- Results Hieken TJ, Nelson GD, Flotte TJ, Grewal EP, Chen J, McWilliams RR, Kottschade LA, Yang L, Domingo-Musibay E, Dronca RS, Yan Y, Markovic SN, Dimou A, Montane HN, Erskine CL, Piltin MA, Price DL, Khariwala SS, Hui J, Strand CA, Harrington SM, Suman VJ, Dong H, Block MS. Neoadjuvant cobimetinib and atezolizumab with or without vemurafenib for high-risk operable Stage III melanoma: the Phase II NeoACTIVATE trial. Nat Commun. 2024 Feb 16;15(1):1430. doi: 10.1038/s41467-024-45798-8.
- Results Block MS, Nelson GD, Chen J, Johnson S, Yang L, Flotte TJ, Grewal EP, McWilliams RR, Kottschade LA, Domingo-Musibay E, Markovic SN, Dimou A, Montane HN, Piltin MA, Price DL, Khariwala SS, Hui JYC, Erskine CL, Strand CA, Zahrieh D, Dong H, Hieken TJ. Neoadjuvant cobimetinib and atezolizumab with or without vemurafenib for stage III melanoma: outcomes and the impact of the microbiome from the NeoACTIVATE trial. J Immunother Cancer. 2025 Apr 15;13(4):e011706. doi: 10.1136/jitc-2025-011706.
- Results Hieken TJ, Price DL, Piltin MA, Turner HJ, Block MS. Surgeon Assessment of the Technical Impact of Neoadjuvant Systemic Therapy on Operable Stage III Melanoma. Ann Surg Oncol. 2022 Feb;29(2):780-786. doi: 10.1245/s10434-021-11112-9. Epub 2021 Nov 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | — | Intravenous |
| Subject | Cobimetinib | Small molecule | — | Oral |
| Subject | Tiragolumab | Monoclonal antibody | — | Intravenous |
| Subject | Vemurafenib | Small molecule | — | Oral |