A clinical trial is currently analyzing a unique combination of immunotherapy and antiangiogenic. It is exploring whether or not this will be able to serve as an adequate second-line treatment for the dangerous cancer pleural mesothelioma.
The early indications of this new phase II clinical trial, which is being run in four different centers, are hopeful. This combination uses a well-known immunotherapy drug called nivolumab (or Opdivo), and a therapy drug called ramucirumab (or Cyramza). This therapy drug blocks the construction of blood vessels which are needed for new tumors to grow. Both of these drugs have been approved by the Food and Drug Administration for the treatment of other cancers. This clinical trial is novel in that it is the first to test these two drugs in combination with mesothelioma. This single-arm trial began in 2018 and is expected to be completed in 2021. Medical oncologist Dr. Alberto Chiappori, who is the principal investigator at the Moffitt Cancer Center in Tampa, Florida, said that any judgments made on the outcome this early on in the study would be preliminary. Nothing has come up, though, for them not to be encouraged. There is no reason not to assume there will be a positive outcome. This trial is for patients whose tumors are incapable of being surgically removed and have progressed even after chemotherapy. The Moffit Cancer Center is one of four institutions hosting this trial. The others are the Regions Hospital Cancer Center in St. Paul Minnesota, the University of Maryland Cancer Center in Baltimore, Maryland, and the Karmanos Cancer Center in Detroit, Michigan. Medical oncologist Dr. Arek Dudek is at Regions Hospital, principal investigator and sponsor. He says details cannot be provided yet, but the patients are doing well, and this encourages them to offer this study to more participants. The potential synergy between the two drugs which are being used in this study, which both have already shown individual effectiveness, led to particular enthusiasm before the trial began. Dudek said earlier, he believed this combination might eventually replace chemotherapy as the standard option to treating pleural mesothelioma. Chiappori said his nature is not to jump to conclusions early. This trial is not at all definitive, but a building block. Is it a breakthrough? It could be, but that depends on how the rest of the study goes and it’s results. It’s early on, after all. All four of the study sites are continuing to accept patients. The goal is to admit at least 35 participants. Those coming into the study will receive the combination being used in the study of Opdivo and Cyramza intravenously every two weeks for up to two years unless severe side effects occur or the disease worsens. This study will measure progression-free survival, the response rate, and two-year survival. At any point, if they desire, patients may withdraw from the study. Now, more than ever before, there is a need for a reliable second-line treatment for pleural mesothelioma. The lack of a process to help patients with pleural mesothelioma throughout the past two decades has been extremely obvious. To start with, less than a third of patients who are diagnosed with pleural mesothelioma are even qualified for potentially curative surgery. The first-line standard treatment continues to be chemotherapy, often combined with pemetrexed (or Alimta) and cisplatin. That has shown only short term effectiveness. Most patients who are receiving only first-line therapy often survive less than 18 months. Chiappori shares what he thinks, which is that the currently available treatments for mesothelioma fall way short of where one would hope. The only way that new therapies will be discovered is through the scientific process that Chiappori says is being followed in this study. Most oncologists believe that some form of an immunotherapy combination much like this one will eventually be the future of treatment. Finding it, though, has been quite difficult. There are ten clinical trials worldwide using Opdivo. This one, though, is the only one that combines it with an antiangiogenic drug-like Cyramza. Recently, the FDA approved Cyramza in combination with specific chemotherapies for a few stomach, lung, and colorectal cancers. Cyramza targets and cancels the protein, which causes blood vessel growth within a tumor. The other drug being used in this trial, Opdivo, blocks a different protein, which often prevents the immune system of a patient from recognizing that the tumor is foreign, which in turn prevents the body from fighting the tumor. Chiappori said the hope for the study is at least a 40% response rate. That is double the standard rate of effectiveness for pleural mesothelioma. Chiappori tells patients who are considering the trail there is no right or wrong answer. The question they need to consider is do I want to follow the known, which has proven to be insufficient, or follow the unknown, which I hope will be better? Mesothelioma, which this study is all about, is caused by asbestos. Unsure if you have asbestos in your home or building? Or sure that you do, and want it removed? Call us today at (313) 437-4530 for a free quote for asbestos removal and testing.