Mesothelioma clinical trials are the forefront of the development of new mesothelioma treatments. Mesothelioma patients first got the opportunity to try immunotherapy treatments during mesothelioma clinical trials. Based on promising results for some patients with mesothelioma and other hard-to-treat cancers, immunotherapy has now become available to a wider cohort of patients. A mesothelioma clinical trial is an option that patients and their families should research and consider.
Clinical trial NCT02637531 explores a new and promising treatment for cancer patients with advanced tumors. Infinity Pharmaceuticals is testing the effects of a drug called IPI-549, both alone and in combination with immunotherapy drug nivolumab (Opdivo). One patient with peritoneal mesothelioma showed positive results after taking IPI-549 alone, so Infinity has recently expanded the trial to enroll additional mesothelioma patients.
What is a Phase 1/1b Mesothelioma Clinical Trial?
After initial development in the laboratory, pharmaceutical companies run mesothelioma clinical trials to determine the safety, dosage, and effectiveness of potential new mesothelioma drugs. These studies involve giving the drug to humans while closely monitoring patients to see how they respond to the treatment and to make sure that the adverse effects, if any, are limited.
There are many reasons that a new drug might fail. It might be effective in killing cancer cells but make patients too sick to tolerate taking it. Conversely, some drugs have few side effects but don’t produce better results than currently available treatments. A Phase 1 mesothelioma clinical trial is designed to answer the most basic questions about a new treatment: What are the side effects? What is the maximum dose? What is the most effective dose?
In a Phase 1 trial, there are no control groups or placebos. Every participant in the trial receives the drug. During the escalation phase of the IPI-549 trial, researchers slowly increase the dose of the drug, to determine how much patients can take before the side effects are too harsh.
Clinical trial NCT02637531 is a phase 1/1b trial. The escalation phase to determine the optimal dose of IPI-549 as a standalone treatment, is complete. The expansion phase, to study the effectiveness of IPI-549 alone, is getting underway.
Researchers are also conducting an escalation phase to determine the optimal dosage of IPI-549 in combination with nivolumab. That will be followed by an expansion phase to follow patients on the combined treatments and report on their results.
While most Phase 1 trials include fewer than 100 participants, researchers have expanded this trial to about 200 patients with advanced cancer.
The IPI-549 study is called: “A Phase 1/1b First-In-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549 Monotherapy and in Combination With Nivolumab in Subjects With Advanced Solid Tumors.” It includes patients with non-small cell lung cancer (NSCLC), melanoma, squamous cell cancer of the head and neck, and triple negative breast cancer. The recently-added cohort includes adrenocortical carcinoma patients, as well as mesothelioma patients.
Promising Initial Results: IPI-549 Mesothelioma Clinical Trial
Researchers found that participants had few side effects when given IPI-549 as a single, monotherapy, and those side effects tended to be mild. They didn’t find a maximum dose or a dangerous level of toxicity for IPI-549. This is an encouraging sign because it indicates that this new treatment could be effective at turning on your immune system to attack mesothelioma tumors without doing harm to healthy cells.
IPI-549 is administered orally. Initial results, presented at an Infinity shareholder meeting in November 2017, show that 44 percent of participants in the clinical trial were able to stick with the treatment for at least four months.
One participant in this mesothelioma clinical trial who has peritoneal mesothelioma has shown a partial response to the treatment and has been taking IPI-549 for more than a year. A partial response means that the patient’s tumor has not advanced and might even have shrunk, but it has not disappeared altogether. For advanced peritoneal mesothelioma, this is an exciting result since there are few if any available second line treatments for peritoneal mesothelioma once first line treatments stop working.
What is Mesothelioma Immunotherapy?
Mesothelioma immunotherapy drugs target the interactions between cancer cells and our immune system. In normal circumstances, the immune system, and especially the powerful T cells, recognize cancer cells as abnormal and destroy them. Cancer cells have developed a number of ways to trick the immune system into ignoring them so they can grow into tumors.
Many of the currently available immunotherapy drugs, such as Opdivo (nivolumab), are called checkpoint inhibitors. They block the PD1 or PD-L1 pathway, which cancer cells use to avoid the programmed death that normal cells experience, letting them stay alive longer and reproduce more quickly.
The IPI-549 mesothelioma clinical trial represents a different approach to immunotherapy. The mesothelioma drug is the only PI3K-gamma inhibitor currently under development. PI3K-gamma is one of a family of enzymes that play a role in cellular reproduction. It interacts with both immune system cells and cancer cells.
Before this mesothelioma clinical trial, researchers found that IPI-549 can change macrophages (white blood cells that act as the cleanup crew, eating and disposing of unhealthy materials) from a type that supports tumors into one that attacks them.
When given alone, checkpoint inhibiting mesothelioma immunotherapy works well for some patients, moderately for some, and not at all for some. Preclinical research showed that IPI-549 also helped checkpoint inhibitors like nivolumab work better. This is why the current mesothelioma clinical trial is testing the combination treatment, to see if these two therapies together can deliver a one-two punch to mesothelioma.
How Do You Qualify for a Mesothelioma Clinical Trial?
Clinical trial NCT02637531 is currently recruiting certain types of mesothelioma patients. To qualify for this study, you must have advanced or metastatic mesothelioma that has progressed after first line mesothelioma treatments such as traditional chemotherapy or surgery or radiation (or a combination of these).
Other requirements include at least one measurable tumor, as defined by RECIST 1.1 guidelines. RECIST is an agreed standard for measuring cancerous tumors that helps doctors and researchers evaluate when treatments have helped tumors shrink and by how much. Patients with either peritoneal or pleural mesothelioma and all three mesothelioma tumor types are welcome. You will need to get two tumor biopsies, a before and after, as part of this study.
Whether the IPI-549 mesothelioma clinical trial is right for you or not, Mesothelioma Circle can help. Check out our clinical trial tool to find a research study that could connect you with life-extending treatment.