Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT02638090
Phase: Phase I/II
Principal Investigator: Gray, Jhanelle
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.
PRIMARY OBJECTIVES Phase 1 Escalation: Primary Objective: To determine the safety, tolerability and feasibility of concurrent administration of vorinostat and Pembrolizumab. Phase 1b Expansion (Single Arm, Pre-treated Cohort): Primary Objective: To determine whether concurrent administration of vorinostat and Pembrolizumab will be effective in NSCLC patients who have been previously exposed to anti-PD-1 or anti-PD-L1 therapy. Phase II (Randomized, Treatment Naïve Cohort): Primary Objective: To determine whether concurrent administration of vorinostat and Pembrolizumab is more effective than Pembrolizumab alone. SECONDARY OBJECTIVES Secondary Objectives (Phase 1 expansion and phase II Arms A and B): 1.To determine immunogenicity molecular profiles that correlate with outcome measures. 2.To determine immunogenicity profiles that correlate with resistance to therapy.
Immunotherapy; Therapy (NOS)
Pembrolizumab (Keytruda); SAHA (Vorinostat); Vorinostat (); Zolinza (Vorinostat); suberoylanilide hydroxamic acid (Vorinostat)
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
Back to top
Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.
NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.
REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.
Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.
Moffitt Cancer Center is committed to the health and safety of our patients and their families. For more information on how we’re protecting our new and existing patients, visit our COVID-19 Info Hub
Our patient services specialists can assist you with scheduling an appointment, questions about medical records, insurance, billing and more.
Patient Appointment Center Hours: 7 a.m. to 7 p.m. Monday - Friday; 8 a.m. to noon Saturday