drugset / Trial / NCT02437136
Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in participants with NSCLC. Additionally, the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in participants with NSCLC, Melanoma, and Mismatch-Repair Proficient CRC.
Timeline
- Start
- 2015-08-26
- Primary completion
- 2022-09-29
- Completion
- 2022-09-29
Outcome
Missed primary endpoint
paper did not achieve the primary response rate endpoint PMID 33203644 ↗
Publications
- Background Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
- Hellmann MD, Janne PA, Opyrchal M, Hafez N, Raez LE, Gabrilovich DI, Wang F, Trepel JB, Lee MJ, Yuno A, Lee S, Brouwer S, Sankoh S, Wang L, Tamang D, Schmidt EV, Meyers ML, Ramalingam SS, Shum E, Ordentlich P. Entinostat plus Pembrolizumab in Patients with Metastatic NSCLC Previously Treated with Anti-PD-(L)1 Therapy. Clin Cancer Res. 2021 Feb 15;27(4):1019-1028. doi: 10.1158/1078-0432.CCR-20-3305. Epub 2020 Nov 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entinostat | Small molecule | 3 mg | Oral |
| Subject | Entinostat | Small molecule | 5 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |