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A Phase I/II Study of Pembrolizumab and Vorinostat in Patients With Immune Therapy Naïve and Immune Therapy Pretreated Stage IV NSCLC
The main purpose of this study is to see whether the combination of two drugs called pembrolizumab and vorinostat can help people with advanced lung cancer. Researchers also want to find out if the combination of pembrolizumab and vorinostat is safe and tolerable. This study will compare the effects of the combination of two drugs called pembrolizumab and vorinostat with the effects of pembrolizumab alone. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and lung cancer and vorinostat to treat some forms of blood and lymph node cancers.
Details
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 120 |
| Start date | 2016-03-22 |
| Completion | 2026-07 |
Conditions
- Lung Cancer
- Non-small Cell Lung Cancer
Interventions
- Vorinostat
- Pembrolizumab
Primary outcomes
- Phase I: Maximum Tolerated Dose (MTD) — Up to 12 months
The maximum tolerated dose (MTD) corresponding to a risk of dose limiting toxicity (DLT) occurring in 30% of patients. DLTs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03). A DLT will be defined as any Grade 3 or higher toxicity that occurs during the DLT evaluation period. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition.
Countries
United States