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Name of the Trial

Phase II Study of Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody (MDX-010) in Patients With Unresectable Stage IV (Locally or Distantly Metastatic) Pancreatic Adenocarcinoma (NCI-05-C-0141). See the protocol summary ³.

Principal Investigator

Dr. Richard Royal Principal Investigator

Dr. Richard Royal, NCI Center for Cancer Research.

Why This Trial Is Important

When foreign cells invade our body, our immune system mounts an immune response to the invading cells and kills them. The immune system is also capable of mounting a response to tumor cells. Often, however, the body's immune response isn't strong enough to completely destroy tumors.

During an immune response, cells signal each other in complex ways that serve to start, stop, or control the intensity of the response. Molecules found on many types of cancer cells stimulate certain immune system cells (called cytotoxic T lymphocytes, or activated T cells) to attack the cancer cells. Once the attack has started, however, the activated T cells produce a molecule called cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). This molecule then produces a signal that tells the T cells to stop their attack. This T-cell inhibition helps prevent normal cells from being harmed by an immune response, but it may also prevent the immune system from destroying malignant tumors. Researchers hope that blocking CTLA-4's inhibitory signal will lead to a more robust immune response against tumors.

In this trial, researchers are using a monoclonal antibody called MDX-010 to treat patients with advanced pancreatic cancer. MDX-010 binds to and blocks the activity of CTLA-4.

"We know that T lymphocytes infiltrate pancreatic tumors in great numbers, but the tumors present an immunosuppressive environment," said Dr. Royal. "We hope that MDX-010 will help lymphocytes overcome this immunosuppression and allow the patient's own immune system to destroy their cancer."

Contact Information

This trial is no longer accepting new patients. To locate other clinical trials for pancreatic cancer, search the NCI database of clinical trials ¹ or call the NCI Clinical Trials Referral Office toll-free at 1-888-NCI-1937. This call is confidential.

Glossary Terms

A type of immune cell that can kill certain cells, including foreign cells, cancer cells, and cells infected with a virus. Cytotoxic T cells can be separated from other blood cells, grown in the laboratory, and then given to a patient to kill cancer cells. A cytotoxic T cell is a type of white blood cell and a type of lymphocyte. Also called cytotoxic T lymphocyte and killer T cell.

The activity of the immune system against foreign substances (antigens).

The complex group of organs and cells that defends the body against infections and other diseases.

Describes the ability to decrease the body's immune system responses.

A monoclonal antibody being studied in the treatment of certain types of cancer. MDX-010 is made in the laboratory and binds to the molecule CTLA-4 on T cells (a type of white blood cell). MDX-010 may block CTLA-4 and help the immune system kill cancer cells. Also called ipilimumab.

A type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. There are many kinds of monoclonal antibodies. Each monoclonal antibody is made to find one substance. Monoclonal antibodies are being used to treat some types of cancer and are being studied in the treatment of other types. They can be used alone or to carry drugs, toxins, or radioactive materials directly to a tumor.