Active — Not RecruitingPhase 1/2

Study of Pembrolizumab (MK-3475) in Combination With Romidepsin

United States39 participantsStarted 2017-11-14

Plain-language summary

This phase I/II trial studies the side effects of pembrolizumab and romidepsin and to see how well they work in treating participants with peripheral T-cell lymphoma that has come back 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 tumor cells to grow and spread. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and romidepsin may work better than pembrolizumab alone in treating participants with recurrent or refractory peripheral T-cell lymphoma.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with peripheral T-cell lymphoma (including but not limited to PTCL-NOS, angioimmunoblastic T-cell lymphoma, anaplastic large T-cell lymphoma). Patients with mycosis fungoides with large cell transformation with measurable disease are eligible.
✓. Disease status defined as refractory to or relapsed after ≥ 1 prior treatment lines.
✓. Patients irrespective of transplant eligibility status can be enrolled; however patients can be seen by SCT team in anticipation for SCT.
✓. Subjects with ALK+ ALCL should have been treated with, be ineligible for, or have refused chemotherapy and brentuximab prior to enrollment on the current study.
✓. Patients with a measurable disease, defined by a node or mass with the longest diameter ≥ 1.5cm.
✓. Be willing and able to provide written informed consent/assent for the trial.
✓. Be 18 years of age on day of signing informed consent.
✓. Patients with PTCL should have radiographically measurable disease \>/= 1.5cm.

Exclusion criteria

What they're measuring

Dose limiting toxicity (Phase I)

Timeframe: Up to 21 days

Overall response (OR) (Phase II)

Timeframe: Up to 3 years

Trial details

NCT IDNCT03278782

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

View on ClinicalTrials.gov More Recurrent Anaplastic Large Cell Lymphoma trials