A phase 3 randomized clinical trial looking into the efficacy of combination chemotherapy with immunotherapy is now open in the United States and Australia.
How does the trial work?
Patients who enroll in the trial will be split into two randomized groups, one receiving both standard chemotherapy of Alimta/cistplatin and durvalumab, an immunotherapeutic agent commercially known as Imfinzi. The other group will receive Alimta/cisplatin chemotherapy only. At the end of the study, researchers will compare the two arms to determine if the addition of immunotherapy has made a statistically significant impact on overall survival. They will also compare side-effects between two groups. Currently, the trial is looking to enroll 480 participants whose mesothelioma is deemed unresectable (who don’t qualify for surgery) and who haven’t received any previous treatment.
What did we learn from Phase 2 of this trial?
Phase 2 trials are generally not randomized and are much smaller in scope than Phase 3. In the Phase 2 iteration of this particular trial, researchers in Australia and the United States observed significant improvements in overall survival among patients when treated with this combination of chemotherapy with immunotherapy. In the US, the trial included 55 patients of which 74% consisted of predominantly epitheliod histological subtype. At the time of the report last May of 2020, overall survival was 21.1 months.
United States trial locations
Patients can enroll in this study at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Maryland, University of Michigan, Metro Minnesota Community Oncology Research Consortium, and the Cleveland Clinic in Ohio. We will continue to post updates as additional sites open.
About the investigators
Leading the study in the United States is Dr. Patrick Forde of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. In Australia, the study is led by Dr. Anna Nowak of the University of Western Australia. Both Dr. Forde and Dr. Nowak have been involved in the work of the Mesothelioma Applied Research Foundation as members of its board of directors and its science advisory board, respectively.
Thinking about enrolling or have other questions?
Contact the experts at the Mesothelioma Applied Research Foundation at (877) 363-6376 or visit the organization’s website at https://www.curemeso.org/.
The Mesothelioma Applied Research Foundation is the only 501(c)(3) nonprofit organization working to eradicate mesothelioma and end this national tragedy. Its programs include the funding of promising and peer-reviewed research, education, support, and advocacy. The organization strives to bring together thought leaders in the field to identify the most direct path to a cure.
