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)
NCT02437136 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 191
Last updated 2025-03-20
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
- DRUG
-
entinostat
An orally available histone deacetylases inhibitor (HDACs)
- DRUG
-
A selective humanized monoclonal antibody (mAb)
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Pasi A Janne, MD, PhD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-08-26
- Primary Completion
- 2022-09-29
- Completion
- 2022-09-29
Countries
- United States
Study Locations
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