Pembrolizumab + Vorinostat for Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByJhanelle E. Gray, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18 with Stage IV non-small cell lung cancer (NSCLC) can join this trial. Participants must have measurable disease, adequate organ function, and no prior treatments with certain immune therapies if in Phase II. They should not be on other HDAC inhibitors besides vorinostat or have had recent chemotherapy. Safe sex practices are required to avoid conception during the trial.

Participant Groups

The study tests pembrolizumab alone versus its combination with vorinostat for advanced NSCLC patients. Pembrolizumab is FDA-approved for melanoma and lung cancer; vorinostat is approved for some blood cancers. The goal is to assess the safety and effectiveness of this drug combo.

4Treatment groups

Experimental Treatment

Active Control

Group I: Phase Ib ExpansionExperimental Treatment2 Interventions

Pembrolizumab plus Vorinostat. Level 1: Maximum Tolerated Dose (MTD)

Group II: Phase I Dose EscalationExperimental Treatment2 Interventions

Level 1: Vorinostat 200mg by mouth (PO) Daily; Pembrolizumab 200 mg intravenously (IV) every (Q) 3 weeks. Level 2: Vorinostat 400 mg PO Daily; Pembrolizumab 200 mg IV Q3 weeks

Group III: Arm B: Pembrolizumab plus VorinostatActive Control2 Interventions

Pembrolizumab plus Vorinostat treatment. Level 1: MTD

Group IV: Arm A: PembrolizumabActive Control1 Intervention

Pembrolizumab treatment only. Level 1: Pembrolizumab 200 mg Q3 wks

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: