Pembrolizumab + Vorinostat for Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByAlex F Herrera

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best dose of vorinostat when given together with pembrolizumab in treating patients with diffuse large B-cell lymphoma, follicular lymphoma, or Hodgkin lymphoma that has come back after a period of improvement or that does not respond to treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of cancer cells to grow and spread. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vorinostat and pembrolizumab together may work better than pembrolizumab alone in treating patients with diffuse large B-cell lymphoma, follicular lymphoma, or Hodgkin lymphoma.

Eligibility Criteria

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.

Inclusion Criteria

My follicular lymphoma is graded 1, 2, 3A, or 3B.

My hemoglobin level is at least 8 g/dL without needing transfusions or EPO.

My kidney function is within the required range for the study.

My lymphoma is one of the specified aggressive types.

My Hodgkin lymphoma is not the nodular lymphocyte-predominant type.

I have a tumor that is larger than 1.5 cm, confirmed by a scan.

I am fully active or restricted in physically strenuous activity but can do light work.

My lymphoma type is confirmed by a biopsy and matches specific types.

I cannot or do not want to undergo a stem cell transplant for my Hodgkin lymphoma or diffuse large B-cell lymphoma.

Exclusion Criteria

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

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

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.

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

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

I have an active tuberculosis infection.

I have been diagnosed with HIV.

I am currently being treated for an infection.

Participant Groups

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.

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.

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

🇺🇸 Approved in United States as KEYTRUDA for: