A Phase I Study of REGN3767 and/or REGN2810 Immunotherapy in Patients with Advanced Lymphoma

Full Title

R3767-ONC-1613: A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (anti-LAG-3 mAb) Administered Alone or in Combination with REGN2810 (anti-PD-1 mAb) in Patients with Advanced Malignancies

Purpose

The purpose of this study is to evaluate the safety and preliminary effectiveness of the investigational immunotherapy drug REGN3767 alone or with another investigational immunotherapy, REGN2810, in patients with diffuse large B-cell lymphoma (DLBCL) that has come back or continued to grow despite prior therapy and cannot be successfully treated with stem cell transplantation.

REGN3767 and REGN2810 both work by inhibiting proteins that normally put the brakes on the immune system. REGN3767 blocks a protein called LAG-3 and REGN2810 inhibits PD-1. By impairing the ability of these proteins to do their jobs, REGN3767 and REGN2810 boost the power of the immune system to detect and destroy cancer cells.

Patients in this study will receive REGN3767 alone or in combination with REGN2810. Both drugs 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 must have DLBCL that has come back or continued to grow despite prior therapy.
  • Patients should have already had an autologous (self) stem cell transplant or be ineligible for this treatment.
  • Patients must not have previously received immunotherapy that targeted PD-1 or LAG-3.
  • 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. M. Lia Palomba at 212-639-7186.

Protocol

17-421

Phase

I

Investigator

Co-Investigators

Moskowitz, Craig, MD