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Monoclonal Antibodies

Pembrolizumab + Romidepsin for Lymphoma

Phase 1 & 2

Waitlist Available

Led By Michelle A Fanale

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be 18 years of age on day of signing informed consent

Patients with PTCL should have radiographically measurable disease ≥ 1.5cm

Must not have

Active infection requiring systemic therapy

Known history of non-infectious pneumonitis that required systemic steroid use, or has active pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing pembrolizumab, an immunotherapy, in combination with romidepsin, a cancer growth inhibitor, to treat participants with peripheral T-cell lymphoma that has come back or does not respond to treatment.

Who is the study for?

This trial is for people with peripheral T-cell lymphoma that's come back or didn't respond to treatment. They must have had at least one prior treatment, be in good physical condition (ECOG 0 or 1), and have adequate organ function. Pregnant women can't participate, and participants must agree to use contraception.

What is being tested?

The study tests pembrolizumab combined with romidepsin against recurrent or refractory peripheral T-cell lymphoma. Pembrolizumab boosts the immune system to fight cancer, while romidepsin blocks enzymes needed for tumor cell growth.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal organs, infusion-related reactions, fatigue, nausea, blood disorders like anemia or clotting problems, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old.

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My PTCL is visible on scans and is larger than 1.5cm.

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I have a type of peripheral T-cell lymphoma or mycosis fungoides with measurable disease.

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I have a tumor or lymph node that is at least 1.5cm big.

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I have ALK+ ALCL and cannot or have not used chemotherapy or brentuximab.

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My skin lymphoma has returned or didn't respond to treatment, and it's aggressive with significant lymph node involvement.

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My condition did not improve after at least one treatment.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

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

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I am currently on medication for an infection.

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I have had or currently have lung inflammation treated with steroids.

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I have not used any experimental drugs or devices in the last 4 weeks.

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I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.

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I have active brain metastases or cancer in the lining of my brain.

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I have been treated for an autoimmune disease in the last 2 years.

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I have a history of HIV or active Hepatitis B or C.

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I have had a stem cell transplant from a donor.

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I am not taking strong drugs that affect liver enzyme CYP3A4.

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I have an active tuberculosis infection.

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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose limiting toxicity (Phase I)

Overall response (OR) (Phase II)

Secondary study objectives

Complete response

Duration of response

Overall survival

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (romidepsin, pembrolizumab)Experimental Treatment2 Interventions

Participants receive romidepsin IV over 4 hours on days 1 and 8 or day 8 of cycle 1 and days 1 and 8 of subsequent cycles and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Romidepsin

FDA approved

0 / 20Eligibility criteria met