A Phase I Study of Pembrolizumab Immunotherapy and TGR-1202 in Patients with Advanced B-Cell Non-Hodgkin Lymphoma

Full Title

A Phase I, Open-label, Dose-escalation Study to Assess the Safety, Tolerability and Efficacy of the combination of Pembrolizumab with TGR-1202 in patients with relapsed/refractory CLL and B-Cell Non-Hodgkin Lymphoma (NHL)

Purpose

The purpose of this study is to find the highest dose of the drug TGR-1202 that can be given safely with pembrolizumab immunotherapy in patients with B-cell non-Hodgkin lymphoma (NHL) that came back or continued to grow despite prior treatment.

TGR-1202 blocks an enzyme in some white blood cells called PI3K. In many B-cell cancers, PI3K triggers cancer cells to develop and helps them survive. Blocking PI3K may therefore slow the spread of B-cell NHL. Pembrolizumab works by blocking a protein that cancer cells use to evade detection by the immune system, thereby boosting the ability of the immune system to find and destroy cancer cells.

The use of TGR-1202 and pembrolizumab together to treat B-cell NHL is considered investigational. TGR-1202 is taken orally (by mouth) and pembrolizumab is given intravenously (by vein).

Eligibility

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

  • Patients must have B-cell NHL that came back or continued to grow despite treatment and cannot be successfully treated with existing therapies.
  • Patients should recover from the serious side effects of previous treatments before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Gottfried von Keudell at 212-639-3748.

Protocol

19-203

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators