A Phase I Study of MEDI4736 in Patients with Advanced Solid Tumors

Protocol
13-198
Full Title
A Phase 1 Study to Evaluate the Safety and Tolerability of anti-PD-L1, MEDI4736, in Combination with Tremelimumab in Subjects With Advanced Solid Tumors
Phase
I
Purpose

The purpose of this study is to find the highest doses of two investigational drugs, tremelimumab and MEDI4736, when given together in patients with advanced solid tumors that have spread and are not responding to standard treatments.

Tremelimumab is an antibody that 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 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.

Laboratory studies suggest that drugs such as tremelimumab and MEDI4736 may work better together than either drug alone for inhibiting cancer growth. 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 advanced ovarian, colorectal, non-small cell lung, head and neck, cervical, or renal cell cancer that has spread and cannot be successfully treated with standard therapies.
  • At least 4 weeks must have passed since completion of prior chemotherapy and 2 weeks since corticosteroid use or immunotherapies and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Margaret Callahan at 646-888-3579.

Disease(s)
Head & Neck Cancer
Kidney Cancer
Lung Cancer, Non-Small Cell
Solid Tumors
Locations