A Phase I/II Study of Mogamulizumab and Pembrolizumab Immunotherapy in Recurrent and Persistent Advanced Lymphoma

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Full Title

A phase I and randomized phase II study of KW-0761 (Mogamulizumab) and MK-3475 (Pembrolizumab) in relapsed, refractory diffuse large-B cell lymphoma (NCI 10106)(CIRB)

Purpose

The purpose of this study is to find the highest dose of mogamulizumab that can be given with pembrolizumab immunotherapy in patients with advanced lymphoma that has come back or continued to grow despite treatment. In addition, researchers will determine if the combination of these two drugs is more effective than either of the drugs alone.

Mogamulizumab and pembrolizumab work by complementary mechanisms to boost the immune system’s power to find and kill cancer cells. Their combination is expected to be synergistic (an effect greater than the sum of their parts) and of particular interest in patients following CAR T-cell therapy.

Patients in this study will either participate in the dose-finding portion, or be randomly assigned in the second part of the study to receive mogamulizumab/pembrolizumab or pembrolizumab alone. These medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients in the first part of the study must have recurrent or persistent lymphoma (any subtype). Patients in the second part of the study must have diffuse large B-cell lymphoma that continued to grow despite at least two prior regimens of therapy; they must have previously received, refused, or been deemed ineligible for autologous stem cell transplantation
  • At least 3 weeks must pass since the completion of prior therapy and entry into the study.
  • Patients may not have previously received immunotherapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Erel Joffe at 212-639-8109.

Protocol

19-018

Phase

I/II

Investigator

Co-Investigators