A Phase II Study of MEDI4736 in Patients with Advanced Colorectal Cancer with Certain Immunological Features

Full Title

Phase II Study to Evaluate the Efficacy of MEDI4736 in Immunological Subsets of Advanced Colorectal Cancer

Purpose

MEDI4736 is an antibody designed to boost the body’s immune system by targeting a protein on tumor cells called PD-L1. PD-L1 normally maintains the balance of the immune system. In cancer, PD-L1 helps tumors evade detection and elimination by the immune system. MEDI4736 may increase the immune system’s ability to identify and destroy cancer cells.

In this study, researchers are assessing the safety and effectiveness of MEDI4736 in patients with advanced colorectal cancer that is no longer responding to standard therapy. This study is specifically assessing MEDI4736 in patients with Lynch syndrome, tumors that contain “DNA mismatch repair deficiency,” or tumors with increased white blood cells. In these patients, MEDI4736 could enhance the ability of the white blood cells to attack the cancer cells. MEDI4736 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 locally advanced or metastatic colorectal cancer that continues to grow despite at least two prior regimens of standard therapies.
  • Patients must have Lynch syndrome or have tumors with increased white blood cells or a DNA mismatch repair deficiency.
  • At least 4 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients may not have previously received treatments that target PD-L1 or PD-1.
  • 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 the office of Dr. Neil H. Segal at 646-888-4187.

Protocol

14-109

Phase

II

Investigator

Co-Investigators

Locations