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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)

Must not have

Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the initial treatment to 36 21-day cycles.

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pneumonitis treated with steroids or have it now.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

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I had a stem cell transplant in the last 5 years and need medicine to suppress my immune system or have signs of graft-versus-host disease.

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I had a stem cell transplant using my own cells within the last 2 months.

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I cannot swallow pills or have a condition affecting my gut's ability to absorb nutrients.

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I have an active tuberculosis infection.

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I have been diagnosed with HIV.

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from initial study treatment to 90 days post-last dose, up to 27 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) on Vorinostat

Number of Participants With Dose-limiting Toxicities (DLT)

Number of Patients With Grade 3-5 Adverse Events

Secondary study objectives

Complete Response Rate (CR)

Overall Response Rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Vorinostat

2014

Completed Phase 3

~1600

Pembrolizumab

2017

Completed Phase 3

~3150