A Phase Ib Study of Tremelimumab and MEDI4736 in Patients with Advanced Non-Small Cell Lung Cancer

Protocol
13-197
Full Title
A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination with Tremelimumab in Subjects with Advanced Non-Small Cell Lung Cancer
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 stage IIIB or IV non-small cell lung cancer that has returned despite standard therapy, has stopped responding to standard therapy, or (by patient’s choice) is not being treated with standard therapy.

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.

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 stage IIIB or IV non-small cell lung cancer that has returned despite standard therapy, has stopped responding to standard therapy, or (by patient’s choice) is not being treated with standard therapy.
  • Patients should have recovered from the serious side effects of prior therapies.
  • 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 open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Naiyer Rizvi at 646-888-4204.

Disease(s)
Lung Cancer, Non-Small Cell
Locations

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