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)

A Phase 1b/2, Open-label, Dose Escalation Study of Entinostat in Combination With Pembrolizumab in Patients With Non-small Cell Lung Cancer, With Expansion Cohorts in Patients With Non-small Cell Lung Cancer, Melanoma, and Mismatch Repair-Proficient Colorectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Syndax Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer
• Melanoma
• Mismatch Repair-Proficient Colorectal Cancer

Interventions

Type	Name	Description
DRUG	entinostat	An orally available histone deacetylases inhibitor (HDACs)
DRUG	pembrolizumab	A selective humanized monoclonal antibody (mAb)

Timeline

• Start date: 2015-08-26
• Primary completion: 2022-09-29
• Completion: 2022-09-29
• First posted: 2015-05-07
• Last updated: 2025-03-20
• Results posted: 2025-03-20

Locations

11 sites across 1 country: United States