New Mesothelioma Clinical Trial Combines Keytruda, CRS-207

mesothelioma clinical trial Any new mesothelioma clinical trial is worth getting excited about.  The thorough formalized research process involved in a clinical trial offers the best hope we have of vanquishing mesothelioma; the deadly cancer caused by asbestos exposure. A mesothelioma clinical trial offers the opportunity for the medical community to discover new treatments, analyze new data, and monitor the performance of new drugs in combination or by themselves.

Two Pharmaceutical Companies Team Up for New Mesothelioma Clinical Trial

What makes this new mesothelioma clinical trial exceptionally promising is that two major pharmaceutical companies who normally compete are joining forces.  In the spirit of cooperation for the greater good, these two companies are each putting up their MVP cancer-fighting drug to see whether as a team the two drugs can be more effective than each alone.

The two companies are Merck and Aduro Biotech. Aduro Biotech, headquartered in Berkeley, CA is a relatively new company founded in 2000 and exclusively focused on immunotherapy.  The company is contributing its new drug CRS-207 to the collaborative mesothelioma clinical trial.  The other company is the well-known pharmaceutical company Merck.  Founded in the late 1800s, Merck, one of the largest pharmaceutical companies in the world, is headquartered in Kenilworth, New Jersey.  Merck is putting its current star immunotherapy cancer-fighting drug Keytruda in the clinical trial with CRS-207.

Here at Mesothelioma Circle, we have highlighted Keytruda in previous posts because of its great potential as a possible mesothelioma treatment. We are encouraged that Merck is taking this step to place Keytruda in a new mesothelioma clinical trial together with a drug being produced by a smaller newer company.

Keytruda is Merck’s proprietary name for pembrolizumab. Working alone, it has been found to help reduce tumor size in 14 out of 25 patients in a recent mesothelioma clinical trial.  CRS-207, in a new mesothelioma clinical trial, was reported to have halted the disease progression in over 90 percent of the volunteer mesothelioma patients who participated.

Both these companies and many others right now are highly focused on immunotherapy.  Immunotherapy, a relatively new type of cancer treatment, activates the body’s own immune system to fight cancer. By zeroing in on blocking cancer cells that can prevent the immune system from working at full power to defend your body, immunotherapy works efficiently at the cellular level.

Malignant Pleural Mesothelioma: Is this Mesothelioma Clinical Trial’s Focus

This new mesothelioma clinical trial is focusing exclusively on malignant pleural mesothelioma.  Mesothelioma can affect the smooth layer of mesothelial cells that surround the chest, lungs, heart and abdomen. Malignant pleural mesothelioma specifically affects the mesothelial cell lining of the lungs. It is the most common type of mesothelioma with approximately 13,000 cases diagnosed a year in the United States, Europe and Japan. Malignant plural mesothelioma moves rapidly once symptoms are pronounced enough for a firm diagnosis. Currently, there is no U.S. Food and Drug Administration-approved therapy for second- or third-line treatment if standard chemotherapy and radiation treatments do not help halt the disease progression. This new mesothelioma clinical trial seeks to fill that void.

How the New Mesothelioma Clinical Trial Will Work

The new combination mesothelioma clinical trial will involve 35 malignant pleural mesothelioma patients who have volunteered to participate and have their doctor’s approval to do so.  One prerequisite for the study is that the mesothelioma patients will have had to have tried one or two other types of treatments and still suffered a progression of the disease.

During the clinical trial, both CRS-207 and Keytruda will be administered in 3-week cycles. For the first cycle of treatment, Keytruda will be given by intravenous infusion over 30 minutes on the first day and then CRS-207 will be administered the same way for an hour on the second day. If volunteer patients have no immediate adverse side effects, then the clinical trial physicians may try giving them both Keytruda and CRS-207 on the same day for the rest of the treatment cycles. After four cycles, Keytruda will continue to be given on the first day of each three-week treatment cycle. But at that point, CRS-207 will be administered only once every six weeks. Treatment cycles will continue for up to two years if no safety issues emerge and there is evidence of potential for clinical benefit to the participants.

How Does CRS-207 Fight Tumors?

Aduro’s immunotherapy product called CRS-207, belongs to a group of products based on the company’s Live, Attenuated Double-Deleted (LADD) platform. LADD uses toxic Listeria bacteria specifically engineered to act as agents that generate powerful immune responses to specific tumor antigens. Most important is the fact that CRS-207 evokes immune responses against the mesothelin protein. The mesothelin protein is “over-expressed” in mesothelioma tumors and many other tumors. According to the National Cancer Institute’s Dictionary of Cancer Terms, overexpression is defined as:

“In biology (overexpression) is to make too many copies of a protein or other substance. Overexpression of certain proteins or other substances may play a role in cancer development.”

Consequently CRS-207 – LADD, is engineered to provide a safe pathway for the administration of Listeria. It does this by deleting two genes that are vital for bacteria’s ability to cause damage to its host. The deletion of the two genes creates a weakened strain that expresses specific proteins from the tumor cells.

The desired results occur when the dendritic cells of cancer patients engulf the bacteria. At that point, the tumor proteins are recognized as foreign prompting tumor-killing T-cells to attack cancer cells with those particular proteins on their surface.

How to Participate in this Combination Mesothelioma Clinical Trial

An additional piece of good news about this exciting combination drug mesothelioma clinical trial is that there is a chance for you to participate. The study is currently recruiting volunteers.  Also, good news is that unlike some studies that take place in Europe, this study is being conducted right here in the U.S.A. So no passport or extensive travel needed. What’s more, it is being conducted at six locations around the country. Hopefully one of them might be convenient for you and your family.

Two of the study sites, the University of California in San Francisco and the University of Chicago in Illinois happen to have mesothelioma research programs supported by the foundation of the law firm that also provides support for Mesothelioma Circle. Other sites include the University of Pennsylvania in Philadelphia, New York University in New York City, the Lee Moffitt Cancer Center in Tampa Florida and the National Cancer Institute itself in Bethesda, Maryland near Washington D.C.

The researchers plan to have the clinical trial completed in March 2019. The stated goals of the clinical trial are to not only improve patients’ odds for survival without progression of their mesothelioma but also to improve their pulmonary functioning.

How to Qualify

To qualify, you need to be over 18, have confirmed malignant pleural mesothelioma, not have received more than two rounds of treatment such as chemotherapy, and not have any implanted medical devices such a pacemaker or prosthetics. Additional medical criteria need to be reviewed by your oncologist or primary care physician who can help you apply to be a participant if they think it is appropriate for your specific case.  They can find the clinical trial application information on the federal government’s website clinicaltrial.gov –  a site that should be familiar to them.  The identifying code number for this study is: NCT03175172

A mesothelioma clinical trial can provide a mesothelioma patient like you with an important and unique opportunity to try a promising new mesothelioma treatment not yet available to all patients. You also get the chance to be seen by top clinicians in one of the nation’s leading cancer centers. Plus you will be playing a vital role in contributing to the scientific knowledge needed to find a treatment that works to cure mesothelioma.

Collaborative Mesothelioma Clinical Trial May Mark a Turning Point

The collaboration of separate pharmaceutical companies to combine their best new anti-cancer drugs into one mesothelioma clinical trial may mark a turning point in mesothelioma research. The cooperative spirit may mean that the drug companies are putting patient needs first. Here’s hoping the results are beneficial for all.

 

 

 

 

 

 

 

 

 

 

 

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