Phase II Clinical Trial Recruiting Mesothelioma Patients for Immunotherapy

A clinical trial testing two immunotherapy drugs in the treatment of mesothelioma is still recruiting patients who want to participate. The trial, led by Dr. Arkadiusz Dudek of HealthPartners Regions Cancer Care Center in Minneapolis, Minnesota, needs 35 adults with mesothelioma. The trial is ready for phase II and will be held at several locations around the U.S. It is being sponsored by Bristol-Myers Squibb and Eli Lilly and Company.

Nivolumab and Ramucirumab

The clinical trial is testing two immunotherapy drugs used together for malignant mesothelioma: nivolumab and ramucirumab. The outcomes being measured in the study include the patient response rate to the treatment, adverse events, progression-free survival times, and overall survival. The researchers also hope to determine why some patients respond to this kind of treatment and others do not.

Nivolumab is an immunotherapy cancer drug that has already been used in treating many types of cancers. It is a PD-1 inhibitor, which means it blocks the interaction between a protein, PD-L1 on mesothelioma cancer cells, and another protein, PD-1 on immune system T-cells.

The interaction between these two proteins is used by the cancer cells to block the action of the T-cells. The immune system cells would otherwise recognize the cancer cells as problematic and move to destroy them. Nivolumab blocks the interaction so that T-cells are able to recognize cancer cells.

The idea of the current trial is to add ramucirumab to the mix to weaken and slow the growth of cancer cells so that nivolumab can be more effective. Ramucirumab blocks the development of new blood vessels, which are necessary for tumor growth. With fewer blood vessels the cancer cells cannot access the necessary oxygen and nutrients. Ramucirumab only acts on cancer cells, not healthy cells.

Who is Eligible for the Trial?

The current trial, in phase II, is recruiting patients who have been diagnosed with malignant mesothelioma who are not eligible for surgery to cure the cancer and who have already had one round of chemotherapy.

Participants must be at least 18 years old, must be prepared to undergo a biopsy guided by a CT-scan, and must meet several health requirements. Certain health conditions make participants ineligible. These include strokes or heart attacks in the past six months, major surgery in the last month, brain metastases, poorly controlled hypertension, hepatitis, cirrhosis, and others.

Clinical Trial Locations

Patients who wish to participate in this trial have the benefit of being able to choose from among several study locations:

• Moffitt Cancer Center, Tampa, Florida.
• University of Maryland, Baltimore, Maryland
• Karmanos Cancer Center, Wayne state University, Detroit, Michigan
• HealthPartners Institute Regions Cancer Care Center, Minneapolis, Minnesota

If you have been diagnosed with mesothelioma and have already had at least one round of chemotherapy, you may be eligible for this exciting clinical trial. Phase II is already under way, but the researchers still need qualified participants. Talk to your medical team about the benefits and risks of participating in clinical trials and let them know you’re interested in being a part of this one.