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Checkpoint Inhibitor

Pembrolizumab + Vorinostat for Lymphoma

Phase 1
Waitlist Available
Led By Alex F Herrera
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
FL: grade 1, 2, 3A, or 3B are eligible
Hemoglobin >= 8 g/dL without transfusion or EPO dependency (within 7 days of assessment (within 14 days of treatment initiation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initial study treatment to two cycles of study treatment
Awards & highlights

Study Summary

This trial is testing vorinostat + pembrolizumab to see if it's more effective than pembrolizumab alone in treating patients with DLBCL, FL, or HL.

Who is the study for?
This trial is for patients with certain types of lymphoma (diffuse large B-cell, follicular, or Hodgkin) that have returned or resisted treatment. Participants must have measurable disease, adequate organ function, and not be candidates for a stem cell transplant. They should agree to use contraception and can't join if they're pregnant/breastfeeding, have had recent immunotherapy or live vaccines, suffer from severe infections like TB/HIV/hepatitis B/C, or are on immunosuppressants.Check my eligibility
What is being tested?
The trial tests the combination of Pembrolizumab (an immune system-boosting drug) with Vorinostat (a drug that blocks enzymes needed by cancer cells to grow). It aims to find the safest dose and see if this combo is more effective than Pembrolizumab alone in treating relapsed/refractory lymphomas.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's increased activity which might affect organs; fatigue; digestive issues; changes in blood counts leading to higher infection risk; potential infusion-related reactions; and enzyme imbalances due to Vorinostat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My follicular lymphoma is graded 1, 2, 3A, or 3B.
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My hemoglobin level is at least 8 g/dL without needing transfusions or EPO.
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My kidney function is within the required range for the study.
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My lymphoma is one of the specified aggressive types.
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My Hodgkin lymphoma is not the nodular lymphocyte-predominant type.
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I have a tumor that is larger than 1.5 cm, confirmed by a scan.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lymphoma type is confirmed by a biopsy and matches specific types.
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I cannot or do not want to undergo a stem cell transplant for my Hodgkin lymphoma or diffuse large B-cell lymphoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initial study treatment to 90 days post-last dose, up to 27 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initial study treatment to 90 days post-last dose, up to 27 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) on Vorinostat
Number of Participants With Dose-limiting Toxicities (DLT)
Number of Patients With Grade 3-5 Adverse Events
Secondary outcome measures
Complete Response Rate (CR)
Overall Response Rate (ORR)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Vorinostat 200mg + Pembrolizumab 200mgExperimental Treatment3 Interventions
Patients receive Vorinostat 200mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Group II: Vorinostat 100mg + Pembrolizumab 200mgExperimental Treatment3 Interventions
Patients receive Vorinostat 100mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
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?

City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,488 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,262 Total Patients Enrolled
Alex F HerreraPrincipal InvestigatorCity of Hope Medical Center
11 Previous Clinical Trials
1,509 Total Patients Enrolled
~7 spots leftby Jun 2025
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