drugset / Trial / NCT03618641
CMP-001 in Combo With Nivolumab in Stage IIIB/C/D Melanoma Patients With Clinically Apparent Lymph Node Disease
NaSequentialOpen-labelTreatment
Summary
The purpose this research study is to determine if the combination of nivolumab and CMP-001 improves the likelihood of eradicating (destroying) disease in the lymph node (pathologic response rate).
Timeline
- Start
- 2018-08-08
- Primary completion
- 2020-08-20
- Completion
- 2023-12-31
Publications
- Results Davar D, Morrison RM, Dzutsev AK, Karunamurthy A, Chauvin JM, Amatore F, Deutsch JS, Das Neves RX, Rodrigues RR, McCulloch JA, Wang H, Hartman DJ, Badger JH, Fernandes MR, Bai Y, Sun J, Cole AM, Aggarwal P, Fang JR, Deitrick C, Bao R, Duvvuri U, Sridharan SS, Kim SW, A Choudry H, Holtzman MP, Pingpank JF, O'Toole JP, DeBlasio R, Jin Y, Ding Q, Gao W, Groetsch C, Pagliano O, Rose A, Urban C, Singh J, Divarkar P, Mauro D, Bobilev D, Wooldridge J, Krieg AM, Fury MG, Whiteaker JR, Zhao L, Paulovich AG, Najjar YG, Luke JJ, Kirkwood JM, Taube JM, Park HJ, Trinchieri G, Zarour HM. Neoadjuvant vidutolimod and nivolumab in high-risk resectable melanoma: A prospective phase II trial. Cancer Cell. 2024 Nov 11;42(11):1898-1918.e12. doi: 10.1016/j.ccell.2024.10.007. Epub 2024 Oct 31.
- 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 | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | Vidutolimod | Other / unclassified | 5 mg | Other |