Over 500 patients have enrolled in a Phase II clinical trial for pleural and peritoneal mesothelioma. The trial is investigating tremelimumab, an emerging immunotherapy that may prove effective for mesothelioma patients.
One of the most exciting things about this trial is the speed with which it enrolled hundreds of patients; the trial managed to nearly fill its enrollment goal in less than two years. For a rare disease like mesothelioma, this is incredible.
It also means that researchers will be able to determine quickly if tremelimumab is a viable treatment for mesothelioma.
Phase II trials for tremelimumab will further evaluate the safety and efficacy of the drug. At this phase, researchers up the ante by finding out the highest doses that patients can tolerate. The logic is that higher doses may be more effective at inhibiting tumor growth. Finding the perfect dose is key to moving forward.
If the Phase II trial is a success, the study progresses into Phase III trials. This step is the true test for new drugs. In this phase, the results determine whether the drug will go to market, something that only one mesothelioma treatment has accomplished.
What is Tremelimumab and What Does It Do?
Cancer occurs when abnormal cells begin replicating uncontrollably. Everyone, healthy or not, has abnormal cells in their bodies. It’s the immune system’s job to find and eliminate these abnormal cells before they grow into a tumor.
Mesothelioma is good at evading the immune system. Immunotherapy drugs like tremelimumab are designed to activate the immune system to the presence of mesothelioma cells.
CTLA4 is found on the surface of T cells, which are a type of lymphocyte. T cells normally attack antigens, such as viruses, bacteria or abnormal cells. In a perfect scenario, T cells would find and destroy mesothelioma cells throughout the body, but for some reason they don’t.
Researchers believe the problem is CTLA4. This protein disengages T cells from going after mesothelioma cells. This is because the immune system needs to be regulated correctly; an overactive immune system causes issues like inflammation and allergies.
Tremelimumab is designed to bind to CTLA4 and disrupt signals telling T cells to stay put. Hopefully the result will be patient’s immune systems preventing mesothelioma from spreading.
Clinical Trial Still Recruiting
Although the trial has nearly reached full enrollment, it is still recruiting.
One-third of participants in the study will receive a placebo. Every patient who participates will get standard mesothelioma treatment, even those who receive the placebo.
The trial itself is fairly simple, only requiring three visits for treatment and observation. Each patient is screened to make sure they meet all the requirements of the trial. If they are, they’ll receive tremelimumab via IV and a follow-up screening three months later.
Patients and loved ones should keep in mind that this is only one of many clinical trials investigating immunotherapy treatments for mesothelioma. There are many emerging treatments on the horizon that are showing potential to significantly increase survival rates.