Johns Hopkins Sidney Kimmel CCC Launches Cutting-Edge Mesothelioma Clinical Trial
The lung cancer program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University features a team of experienced specialists and subspecialists, who are leaders in groundbreaking lung cancer research and clinical trials. The center provides the latest treatments for even the rarest and most complex cancers, including pleural mesothelioma.
Johns Hopkins, a Center of Excellence (COE) for mesothelioma clinical trials, conducts dozens of cutting-edge studies at any given time. One of the latest will evaluate the safety and feasibility of neoadjuvant nivolumab +/- ipilimumab in resectable malignant pleural mesothelioma (MPM).
Ipilimumab (brand name Yervoy) is a type of targeted cancer drug called a monoclonal antibody. This type of treatment helps the body's immune system fight cancer cells.
Nivolumab (brand name Opdivo) is a type of systemic, immunotherapy drug. A checkpoint inhibitor, this type of immunotherapy helps make cancer cells more vulnerable to attack by the body’s own immune system. Systemic means that the drugs travel through the bloodstream to all parts of the body, making it more effective at fighting cancer that has spread and shrinking tumors.
With an estimated June 2019 start date, the interventional, non-randomized study will have an estimated 30 participants with resectable MPM. 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, known as Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural Mesothelioma, is June 2025, with an estimated completion date of June 2026.
In addition to Johns Hopkins University, the study, in collaboration with Bristol-Myers Squibb, will take place at Greenebaum Comprehensive Cancer Center University of Maryland School of Medicine.
This study is not yet recruiting patients, but to learn more, patients and their doctors may contact the study research staff: Patrick Forde, MD, email@example.com or Heather Schneider, BS, firstname.lastname@example.org. Please refer to the study by its ClinicalTrials.gov identifier (NCT number): NCT03918252.
If you have been diagnosed with mesothelioma, a clinical trial could be helpful in treating your specific type of mesothelioma. Talk to your doctor about participating in a clinical trial today.
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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.