The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University has launched a cutting-edge clinical trial for malignant pleural mesothelioma (MPM). The study will evaluate the safety and feasibility of neoadjuvant nivolumab +/- ipilimumab in the disease. Known as Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural Mesothelioma, the study has an estimated June 2019 start date, with an expected 30 participants with resectable MPM.
Study details are as follows:
For Arm A, 15 patients with resectable MPM will be enrolled and receive preoperative nivolumab, 240mg IV, on Day -42, -28 and Day -14 (+/- two days for each time point) prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).
Subsequent to full accrual to Arm A, 15 patients with resectable MPM will be enrolled and receive preoperative nivolumab, 3mg/kg IV, on Day -42, -28 and Day -14 (+/- two days for each time point) + ipilimumab 1mg/kg IV on Day -42 prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).
Maintenance nivolumab will be administered for one year following completion of standard bi-/tri-modality therapy. The primary completion date for the study is June 2025, with an estimated completion date of June 2026.
In addition to Johns Hopkins University, the study will take place at Greenebaum Comprehensive Cancer Center University of Maryland School of Medicine, in collaboration with Bristol-Myers Squibb.
Although this study is not yet recruiting patients, potential candidates and their specialists may contact the study research staff: Patrick Forde, MD, pforde1@jhmi.edu or Heather Schneider, BS, hschne12@jhmi.edu. Please refer to the study by its ClinicalTrials.gov identifier (NCT number): NCT03918252.
If you have been diagnosed with mesothelioma, talk to your doctor about participating in a clinical trial. A new or experimental drug could be helpful in treating your specific type of mesothelioma. Talk to your doctor about participating in a clinical trial today.
Sources
“Conditions We Treat: Rare Lung Cancers.” The Sidney Kimmel Comprehensive Cancer Center. Johns Hopkins Medicine, 2019. Web. 12 Jun. 2019.
Dewitt, Karen. “Mesothelioma: Johns Hopkins conducts clinical trials for the rarest of diseases.” Baltimore Post-Examiner. Baltimore Post-Examiner, 16 Apr. 2019. Web. 12 Jun. 2019.
“Ipilimumab (Yervoy).” Cancerresearchuk.org. Cancer Research UK, 2019. Web. 12 Jun. 2019.
“Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural Mesothelioma.” ClinicalTrials.gov. U.S. National Library of Medicine (NLM), U.S. National Institutes of Health (NIH), U.S. Department of Health and Human Services (HHS), 23 May 2019. Web. 12 Jun. 2019.
“Nivolumab (Opdivo).” Curemelanoma.org. Melanoma Research Alliance, 2019. Web. 12 Jun. 2019.
