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PD-1 Inhibitor

Pembrolizumab + Vorinostat for Lung Cancer

Phase 1 & 2
Waitlist Available
Led By Jhanelle Gray, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is testing whether combining two drugs, pembrolizumab and vorinostat, can help people with advanced lung cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, digestive issues, changes in blood counts, potential infection risks, and possibly others specific to each drug's profile.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Maximum Tolerated Dose (MTD)
Secondary outcome measures
Phase II: Progression Free Survival (PFS) per Treatment Arm
Other outcome measures
Upper arm

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Vorinostat
2014
Completed Phase 3
~1600

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
549 Previous Clinical Trials
135,586 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,139 Total Patients Enrolled
Jhanelle Gray, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
6 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02638090 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Phase I Dose Escalation, Arm B: Pembrolizumab plus Vorinostat, Phase Ib Expansion, Arm A: Pembrolizumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02638090 — Phase 1 & 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02638090 — Phase 1 & 2
~13 spots leftby Jul 2025