Pembro and Vorinostat for Patients With Stage IV Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT02638090
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    Administered per treatment arm guidelines.
  • Pembrolizumab — DRUG
    Administered per treatment arm guidelines.

Study Details

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.

Key Dates

Start date
Mar 22, 2016
Status verified
Dec 2025
Primary completion
Jan 21, 2024
Completion
Jul 31, 2026

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Dose Escalation
    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
  • Experimental: Phase Ib Expansion
    Pembrolizumab plus Vorinostat. Level 1: Maximum Tolerated Dose (MTD)
  • Active Comparator: Arm A: Pembrolizumab
    Pembrolizumab treatment only. Level 1: Pembrolizumab 200 mg Q3 wks
  • Active Comparator: Arm B: Pembrolizumab plus Vorinostat
    Pembrolizumab plus Vorinostat treatment. Level 1: MTD

Primary Outcome Measure

Phase I: Maximum Tolerated Dose (MTD) [ Time Frame: Up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Related coverage on Hipa.ai

Find similar trials in Tampa, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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