Tobias Peikert, M.D.

Closed for Enrollment

• A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed With Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma (S1619) Rochester, Minn., Scottsdale/Phoenix, Ariz.

  To evaluate if the regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, then maintenance atezolizumab is feasible and safe (as defined in Section 11.1) for patients with resectable malignant pleural mesothelioma.

  a. To evaluate progression free survival (both by RECIST 1.1 and also using a Modified RECIST for Pleural Tumors) in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.

  b. To evaluate overall survival in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.

  c. To evaluate response rate (confirmed and unconfirmed, complete and partial, both by RECIST 1.1 and also using a Modified RECIST for Pleural Tumors) in the subset of this patient population with measurable disease.

  a. To evaluate the association between immunohistochemical (IHC) expression of PD-L1 in tumors and clinical outcomes in mesothelioma patients treated with trimodality/bimodality therapy including atezolizumab (anti-PD-L1).

  b. To evaluate the association between expression of immune-related genes identified by Immune Nanostring (depending on RNA availability) and clinical outcomes in mesothelioma patients treated with trimodality/bimodality therapy including atezolizumab.

  c. To evaluate the association between multiplex immunofluorescence (IF) of up to 10 immune markers in two panels and clinical outcomes in mesothelioma patients treated with trimodality/bimodality therapy including atezolizumab.

• A Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With Relapsed or Refractory Malignant Mesothelioma With BAP1 Loss of Function Rochester, Minn.

  This is a Phase 2, multicenter, open-label, 2-part, single-arm, 2-stage study of tazemetostat 800 mg two times a day (BID) administered orally. Screening of subjects to determine eligibility for the study will be performed within 21 days of the first planned dose of tazemetostat. In Part 1, 12 subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status will be treated and undergo pharmacokinetics (PK) blood sample collection after a single tazemetostat 800 mg. Part 2 will include subjects with BAP1-deficient relapsed or refractory malignant mesothelioma. Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study. Response assessment will be evaluated after 6 weeks of treatment and then every 12 weeks thereafter while on study.

• A Phase 1 Trial of Oncolytic Measles Virotherapy in Mesothelioma Rochester, Minn.

  This phase I clinical trial investigates the side effects and the best dose of local (intrapleural measles virus therapy in treating patients with malignant pleural mesothelioma (MPM). The investigators anticipate that the intrapleural of the vaccine strain measles virus will enable the virus to specifically infect and kill cancer cells and spare, without damaging normal cells. Furthermore, the investigators expect the measles virus to trigger an anti-tumor immune response which will result in additional destruction of the tumor by immune cells.

• A Phase 2 Single-arm Study to Evaluate Safety and Efficacy of CRS-207 With Pembrolizumab in Adults With Previously-Treated Malignant Pleural Mesothelioma Rochester, Minn.

  The purpose of this study is to evaluate whether CRS-207 with pembrolizumab is safe and effective in adults with MPM who have failed prior anti-cancer therapy.

• DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers (DECAMP) Rochester, Minn.

  The purpose of this study is to improve the efficiency of the diagnostic evaluation of patients with indeterminate pulmonary nodules.

• Measles Virus Mediated Immune Modulation and Anti-tumor Immunity within the Tumor Micro-environment in Patients with Thoracic Malignancies-Non-Small Cell Lung Cancer and Mesothelioma Rochester, Minn.

  The purpose of this study is to explore the effects of the measles virus on tumor immunity in a laboratory-based study.

• Measuring Measles Virus Antibodies in Plasma Exchange Samples Rochester, Minn.

  The purpose of this study is to determine how many rounds of plasma exchange are required for maximal decrease in measles antibodies and how long it may last, for the successful use of measles virus cancer therapy.

• Pilot Study of Folate Receptor Beta Imaging in Patients with IPF Rochester, Minn.

  The purpose of this study is to assess the feasibility of Folate scan in patients with Idiopathic Pulmonary Fibrosis (IPF).

• Pilot Study to Evaluate the Effects of Intrapleural Cryotherapy on Tumor Infiltrating Lymphocytes in Malignant Pleural Mesothelioma using Spray cryotherapy Therapy and Possibly Followed by Pleurectomy or Extrapleural Pneumonectomy Rochester, Minn.

  Can neoadjuvant intrapleural cryotherapy be safely performed in patients with malignant pleural mesothelioma and will it trigger substantial systemic and local pro-inflammatory changes, resulting in the induction of anti-tumor immunity?

• Quantitative Analysis of Short-Term Follow-Up CT Scan in Patients Undergoing Bronchoscopic Lung Volume Reduction (BLVR) with Endobronchial Valves Rochester, Minn.

  The purpose of this story is to identify key radiographic variables that are predictive of symptomatic improvement in those patients undergoing endobronchial valve placement.  

  Symptomatic management of emphysema continues to be a difficult task by medical therapy alone. Bronchoscopic lung volume reduction (BLVR), utilizing minimal invasive placement of endobronchial valves, has emerged as a new therapeutic option. Early trial data demonstrated statistically and clinically significant improvement in FEV1, 6 minutes walk (6MW) distance, and quality of life.  However, following the procedure, there are currently no good early predictors of symptomatic benefit. Often, patients wait several months to know if valve placement was successful. This is not only inconvenient to the patient, but it can also increase adverse effects when a non-functional medical device remains in place.

   

• rAd-IFN-MM-301 - A Phase 3, Open-Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination With Celecoxib and Gemcitabine in Patients With Malignant Pleural Mesothelioma (INFINITE) Rochester, Minn.

  The purpose of this study is to evaluate intrapleural administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in combination with Celecoxib and Gemcitabine in patients with histologically confirmed Malignant Pleural Mesothelioma (MPM) who have failed a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, 1 of which must have been an anti-folate and platinum combination regimen.

• Tumor Heterogeneity of the Tumor Microenvironment in Malignant Pleural Mesothelioma (MPM) Rochester, Minn.

  The purpose of this study is to:

  1. Evaluate MPM tumor heterogeneity by determining the agreement of histology, molecular abnormalities, neo-antigen expression and immunological biomarkers between three tumor samples from MPM patients.

  2. Compare the information from tumor samples to pleural fluid, peripheral blood and density based radiomics analysis.