A Phase I Study of Mogamulizumab with Tremelimumab or MEDI4736 in Patients with Advanced Cancers

Full Title

Phase 1 Study of Mogamulizumab (KW-0761) in Combination with MEDI4736 and Mogamulizumab in Combination with Tremelimumab in Subjects with Advanced Solid Tumors

Purpose

Mogamulizumab (also called KW-0761) is an investigational drug designed to reduce cancer growth by targeting a protein on white blood cells (“regulatory T cells”) called CCR4. These T cells can promote cancer growth, and mogamulizumab is designed to eliminate them. The purpose of this study is to find the highest dose of mogamulizumab that can be given safely with each of two other investigational drugs, tremelimumab and MEDI4736, in patients with advanced solid tumors that continued to grow or are not responding to standard treatments.

Tremelimumab blocks cytotoxic T lymphocyte antigen 4 (CTLA4), a protein found on cells of the immune system. CTLA4 puts the brakes on the immune response and may prevent immune cells from attacking cancer cells. Tremelimumab prevents this from happening, potentially enhancing the immune response against the cancer.

MEDI4736 is 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 escape detection and destruction by the immune system. MEDI4736 may increase the immune system’s ability to identify and destroy cancer cells.

Patients will be randomly assigned to receive mogamulizumab with either tremelimumab or MEDI4736. It is hoped that giving two of these drugs together will be more effective and provoke a greater immune response against cancer that either drug alone. All drugs in this study 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 an advanced solid tumor that has not responded to prior treatment or has continued to grow despite at least one prior regimen of therapy.
  • Patients should have recovered from the serious side effects of previous treatment 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 and to inquire about eligibility for this study, please contact the Immunotherapeutics Clinic at 646-888-3359.

Protocol

14-269

Phase

I

Investigator

Co-Investigators

Locations