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MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma

ConditionMesotheliomaEstimated Enrollment: 20Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Open LabelStudy ID Numbers: H-36952Study First Received: October 19, 2015Last Updated: December 6, 2016Estimated Primary Completion Date: May 2018Primary Outcome Measures:Intratumoral ratio of CD8 T cells to regulatory T cells (CD8/Treg). [Ratio]|The percentage of inducible T-cell co-stimulator (ICOS) + CD4 T cells.|The tumor expression programmed death-ligand 1 (PD-L1). [Semi-quantitative assessment: 0, 1+, 2+, 3+, 4+]Sponsors and Collaborators:Baylor College of MedicineResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT02592551...

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PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma

ConditionMesotheliomaEstimated Enrollment: 374Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: PreventionStudy ID Numbers: 08_DOG07_93|ISRCTN04240319|PB-PG-1010-23232Study First Received: May 21, 2012Last Updated: September 10, 2015Estimated Primary Completion Date: May 2017Primary Outcome Measures:Incidence of chest wall tract metastasis 6 months from randomisation|Time from randomisation to chest wall tract metastasis|Position of chest wall tract metastasis recurrence in relation to radiotherapy field in patients randomised to experimental arm (in field/out-of-field)|Acute and late skin radiotherapy toxicity|Pain from chest wall tract metastasisSponsors and Collaborators:Brynn Chappell|The Christie NHS Foundation TrustResult Received: No Study Results...

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11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)

ConditionMesothelioma, MalignantEstimated Enrollment: 20Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: ObservationalStudy Design Allocation: Time Perspective: ProspectiveStudy ID Numbers: 1287Study First Received: June 26, 2015Last Updated: November 18, 2016Estimated Primary Completion Date: September 2017Primary Outcome Measures:Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing talc pleurodesisSponsors and Collaborators:Istituto Clinico HumanitasResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT02519049...

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Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma

ConditionMesotheliomaEstimated Enrollment: 81Age Group: 18 Years to 80 Years   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: TreatmentStudy ID Numbers: 08-053Study First Received: July 11, 2008Last Updated: February 22, 2017Estimated Primary Completion Date: July 2017Primary Outcome Measures:number of patients ≥ grade 3 pneumonitisSponsors and Collaborators:Memorial Sloan Kettering Cancer Center|Eli Lilly and Company|M.D. Anderson Cancer Center|Princess Margaret Hospital, Canada|Mayo Clinic|Brigham and Women's HospitalResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT00715611...

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A Study of Tremelimumab Combined With the Anti-PD-L1 MEDI4736 Antibody in Malignant Mesothelioma (NIBIT-MESO-1)

ConditionPleural Mesothelioma|Peritoneal MesotheliomaEstimated Enrollment: 40Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: TreatmentStudy ID Numbers: NIBIT-MESO-1Study First Received: October 26, 2015Last Updated: October 26, 2015Estimated Primary Completion Date: June 2016Primary Outcome Measures:immune-related (ir)- objective response rate (ORR)|Immune-related-Disease control rate (ir-DCR)|Disease control rate (DCR)|Immune-related-progression-free-survival (PFS)|progression-free-survival (PFS)|Overall survival (OS)|Safety (adverse events)|Immune-related-ORR based on PD-L1 tumor expression|Immune-related-Disease control rate based on PD-L1 tumor expression|Immune-related-progression- free-survival based on PD-L1 tumor expression|Overall survival based on PD-L1 tumor expressionSponsors and Collaborators:Italian Network for Tumor Biotherapy Foundation|AstraZenecaResult Received: No Study Results PostedWebsite Link:...

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A Pilot Window-Of-Opportunity Study of the Anti-PD-1 Antibody Pembrolizumab in Patients With Resectable Malignant Pleural Mesothelioma

ConditionPleural MesotheliomaEstimated Enrollment: 15Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: TreatmentStudy ID Numbers: IRB15-1149Study First Received: February 29, 2016Last Updated: December 28, 2016Estimated Primary Completion Date: March 2018Primary Outcome Measures:Gamma-Interferon Gene Expression profile (GEP) response rate defined as an increase beyond the median value of the sum of individual genes|Number of participants with adverse events as measured by CTCAEv4.0Sponsors and Collaborators:University of ChicagoResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT02707666...

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ATREUS – Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM)

ConditionMalignant Pleural MesotheliomaEstimated Enrollment: 141Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: TreatmentStudy ID Numbers: IRFMN-MPM-6077|2011-006330-16Study First Received: July 16, 2014Last Updated: August 30, 2016Estimated Primary Completion Date: October 2016Primary Outcome Measures:Progression Free Survival - PFS12w|Progression Free Survival (PFS)|Overall survival (OS)|Objective response rate|Trabectedin tolerability and safety|Pain Intensity (PI)|Pain type and characteristics|Antalgic treatments|microRNA (miRs) profile|High Mobility Group B1 (HMGB1) protein assessment|Blood Macrophages analysisSponsors and Collaborators:Mario Negri Institute for Pharmacological Research|PharmaMarResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT02194231...

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Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma

ConditionLung Cancer|MesotheliomaEstimated Enrollment: 200Age Group: 50 Years to 80 Years   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: ScreeningStudy ID Numbers: 10007822Study First Received: November 27, 2014Last Updated: September 6, 2016Estimated Primary Completion Date: December 2019Primary Outcome Measures:Change in SF-12 quality of life score|Change in EQ-5D and STAI|Lung cancer detection rate|Mesothelioma detection rateSponsors and Collaborators:University of CalgaryResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT02385812...

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A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma

ConditionMesotheliomaEstimated Enrollment: 40Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: TreatmentStudy ID Numbers: 16-549Study First Received: March 2, 2017Last Updated: April 20, 2017Estimated Primary Completion Date: September 30, 2020Primary Outcome Measures:Overall Response Rate|Overall Survival|Progression Free Survival|Duration of Response|Number of participants with treatment-related adverse events as assessed by CTCAE v4.0Sponsors and Collaborators:Dana-Farber Cancer Institute|AstraZenecaResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT03075527...

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Vinorelbine in Mesothelioma

ConditionMesotheliomaEstimated Enrollment: 200Age Group: 18 Years and older   (Adult, Senior)Gender: AllStudy Type: InterventionalStudy Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: TreatmentStudy ID Numbers: UNOLE 0329Study First Received: May 9, 2014Last Updated: April 7, 2017Estimated Primary Completion Date: March 1, 2018Primary Outcome Measures:Overall Survival|Progression Free Survival|Number of serious adverse events reported|BRCA1 status in blood and tumour samplesSponsors and Collaborators:Wales Cancer Trials Unit|Pierre Fabre LaboratoriesResult Received: No Study Results PostedWebsite Link: https://ClinicalTrials.gov/show/NCT02139904...

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