Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma

Related Clinical Trial
PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma Olaparib in Patients With HRD Malignant Mesothelioma αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors Intravenous Magnesium in Patients Receiving Cisplatin SAKK 17/18 (ORIGIN) MPM & NSCLC >1st Line Gemci & Atezo Ph II Transitions Project High Resolution Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients With BAP1 Tumor Predisposition Syndrome Cryoablation for the Promotion of Local Tumor Infiltration in Patients With Mesothelioma Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for the Treatment of Resectable, Refractory, or Recurrent Abdominal or Pelvic Tumors in Pediatric Patients, T.O.A.S.T. I.T. Study 18F-FSPG PET/CT for Cancer Patients on Therapy Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors Talazoparib in Treating Patients With Advanced or Metastatic Solid Tumors That Cannot Be Removed by Surgery and Liver or Kidney Dysfunction Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso Molecular Analysis of Thoracic Malignancies A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies Oral TrkA Inhibitor VMD-928 for Treatment of Advanced Adult Solid Tumors or Lymphoma Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion Pulmonary Interstitial Lymphography in Early Stage Lung Cancer Sorafenib, Pemetrexed, and Cisplatin in Treating Patients With Advanced Solid Tumors 177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer Phase 1/2 Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer Amatuximab for High Mesothelin Cancers αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies First-in-human Study of S-588210 (S-488210+S-488211) Study of the Glutaminase Inhibitor CB-839 in Solid Tumors Depsipeptide/Flavopiridol Infusion for Cancers of the Lungs, Esophagus, Pleura, Thymus or Mediastinum CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer Rapid Autopsy and Procurement of Cancer Tissue Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung, Esophagus and Lung Lining Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs Mithramycin for Lung, Esophagus, and Other Chest Cancers APG-2449 in Patients With Advanced Solid Tumors CryoSpray Ablation(tm)in Malignant Airway Disease to Determine Safety, and Tissue Effect in the Lung (ICE the MAD) Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy Study of Safety and Tolerability of Intravenous CRS-207 in Adults With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study. Rehabilitation by Effort for Patients With Advanced Bronchial Cancer A Study of LY3023414 in Participants With Advanced Cancer Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas Study of FAK (Defactinib) and PD-1 (Pembrolizumab) Inhibition in Advanced Solid Malignancies (FAK-PD1) A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers A Study of MORAb-009 in Subjects With Pancreatic Cancer, Mesothelioma, or Certain Types of Ovarian or Lung Cancer Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin Study of the Combination of Tivantinib Plus Pemetrexed and Carboplatin Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen Dose Individualization of Pemetrexed – IMPROVE-III Dose Individualization of Pemetrexed – IMPROVE-II Dose Individualization of Pemetrexed – IMPROVE-I Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura Radical Pleurectomy/Decortication (PD) and Intensity Modulated Radiotherapy (IMRT) uPAR-PET for Prognostication in Patients With Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma and Large Cell Neuroendocrine Carcinoma of the Lung Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery Sorafenib Tosylate in Treating Patients With Malignant Mesothelioma. Gefitinib in Treating Patients With Malignant Mesothelioma DENdritic Cell Immunotherapy for Mesothelioma Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma High-Dose Megestrol in Treating Patients With Metastatic Breast Cancer, Endometrial Cancer, or Mesothelioma Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage IIIA Non-small Cell Lung Cancer or With Stage I or Stage II Mesothelioma ALIMTA (Pemetrexed) Alone or in Combination With Cisplatin for Patients With Malignant Mesothelioma. Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901) Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma Early Diagnosis of Lung Cancer and Mesothelioma in Prior Asbestos Workers Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma A Phase 1 Dose Escalation Study of VS-5584 Administered in Combination With VS-6063, in Subjects With Relapsed Malignant Mesothelioma Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma Mesothelin-Targeted Immunotoxin LMB-100 in People With Malignant Mesothelioma Sorafenib in Previously Treated Malignant Mesothelioma A Phase II Study of the Association of Glivec® Plus Gemzar® in Patients With Unresectable, Refractory, Malignant Mesothelioma Mesothelin and Osteopontin as Diagnostic Markers in Patients With Mesothelioma or Atypical Mesothelial Hyperplasia Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma A Study of VEGF-Antisense Oligonucleotide in Combination With Pemetrexed and Cisplatin for the Treatment of Advanced Malignant Mesothelioma Biomarkers of Angiogenesis and Disease in Patients With Unresectable Malignant Mesothelioma Treated on Clinical Trial CALGB-30107 Capecitabine in Treating Patients With Malignant Mesothelioma A Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma Olaparib in People With Malignant Mesothelioma CheckpOiNt Blockade For Inhibition of Relapsed Mesothelioma IP3R Modulation by Cancer Genes in Mesothelioma Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery Combination Chemotherapy Before Surgery in Treating Patients With Mesothelioma of the Lung Cisplatin With Alimta or Gemcitabine in Long Infusion for Mesothelioma Magnetic Resonance Imaging for Detection of Peritoneal Mesothelioma PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma A Double Blind, Placebo Controlled, Randomized Phase II Study Evaluating Gemcitabine With or Without Ramucirumab , for II Line Treatment MPM Biomarkers to Detect Mesothelioma Early in Patients Exposed to Asbestos or Vermiculite Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed Dendritic Cell-based Immunotherapy Combined With Low-dose Cyclophosphamide in Patients With Malignant Mesothelioma Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung Mesothelin-Targeted Immunotoxin LMB-100 in Combination With SEL-110 in Subjects With Malignant Pleural or Peritoneal Mesothelioma ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment SU5416 in Treating Patients With Malignant Mesothelioma Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma Autologous Redirected RNA Meso-CIR T Cells Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma Pharmacokinetic, Safety, and Efficacy Effects of Oral LBH589 on Dextromethorphan in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma Mesothelioma Avastin Plus Pemetrexed-cisplatin Study Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma MesomiR 1: A Phase I Study of TargomiRs as 2nd or 3rd Line Treatment for Patients With Recurrent MPM and NSCLC Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery Metronomic Chemotherapy Based on Adaptative Bio-mathematical Model of Oral Vinorelbine in Patients With NSCLC or MPM Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma Long Term Follow-up of Mesothelioma Patients and Their Family Members With Germline Mutations in BAP1 and Other Genes Pleurectomy/ Decortication (P/D) Preceded or Followed by Chemotherapy in Patients With Early Stage MPM Cisplatin, Pemetrexed, and Imatinib Mesylate in Malignant Mesothelioma An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma Tomotherapy Treatment for Mesothelioma Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma Mesothelioma and Radical Surgery 2 Pemetrexed, Cisplatin, and Vitamin B12 in Treating Patients With Mesothelioma of the Chest That Cannot Be Removed by Surgery Isolated Thoracic Perfusion (ITP-F) for MPM Dendritic Cells Loaded With Allogeneous Cell Lysate in Mesothelioma Patients An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma S9810: Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery Tumor Cell Vaccines With ISCOMATRIX Adjuvant and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers and Malignant Pleural Mesotheliomas Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma Serum Biomarkers in Diagnosis of Mesothelioma Short Neoadjuvant Hemithoracic IMRT for MPM Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma Chemotherapy Followed by Surgery and Neoadjuvant Hemothoracic Intensity Modified Radiation Therapy (IMRT) for Patients With Malignant Pleural Mesothelioma A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma Nivolumab in Patients With Recurrent Malignant Mesothelioma Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma Four Versus Six Cycles of Pemetrexed/Platinum for MPM A Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma Nintedanib (BIBF 1120) in Mesothelioma Surgery for Mesothelioma After Radiation Therapy “SMART” for Resectable Malignant Pleural Mesothelioma Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced MPM Liposomal-Cisplatin Analogue (L-NDDP) in Treating Patients With Malignant Pleural Mesothelioma AMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, and Malignant Pleural Mesotheliomas A Phase II Trial to Assess TroVax® Plus Chemotherapy in Patients With Malignant Pleural Mesothelioma Vinorelbine in Mesothelioma Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma Cisplatin, Interferon Alfa, Surgery, and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma S0509 – AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma Staging Procedures to Diagnose Malignant Pleural Mesothelioma Observational Prospective Analysis of Biological Characteristics of Mesothelioma Patients Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma PIT: Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma S0722: Everolimus in Treating Patients With Pleural Malignant Mesothelioma That Cannot Be Removed By Surgery Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma Pemetrexed (ALIMTA) Plus Cisplatin Followed by Surgery and Radiation Therapy for Mesothelioma Pazopanib in Treating Patients With Malignant Pleural Mesothelioma Intrapleural Gene Transfer for Pleural Mesothelioma Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma Thromboelastography During Surgery for Malignant Pleural Mesothelioma Evaluation of CRS-207 With Pembrolizumab in Previously Treated Malignant Pleural Mesothelioma (MPM) Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With Malignant Pleural Mesothelioma (MPM) An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17) Pemetrexed Disodium and Cisplatin Followed by Surgery With or Without Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy Psychosocial Needs and Exploration of Online Support for Patients With Mesothelioma Combination Gene Transfer and Chemotherapy Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery Molecular Predictors of Pemetrexed and Carboplatin Response in Malignant Pleural Mesothelioma (MPM) Patients Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural Mesothelioma Bortezomib in Treating Patients With Malignant Pleural Mesothelioma Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM) A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma A Phase II Study of Single-agent DOVitinib in Advanced Malignant PlEural Mesothelioma Which Has Progressed Following Prior Platinum-Antifolate Chemotherapy Combination Chemotherapy With or Without Surgery and Chemoradiotherapy in Treating Patients With Malignant Pleural Mesothelioma The IMmunotherapy Pleural 5-ALA PDT Intrapleural Cryotherapy for Malignant Pleural Mesothelioma Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma MesoTRAP: A Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma. Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II) NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed Dendritic Cell-based Immunotherapy in Mesothelioma MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma Do Your Genes Put You at a Higher Risk of Developing Mesothelioma Trimodality Therapy for Malignant Pleural Mesothelioma Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma Ganetespib With Platinum, in Patients With Malignant Pleural Mesothelioma Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers Phase II Study of Six Hours Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma Intrapleural Photodynamic Therapy in a Multimodal Treatment for Patients With Malignant Pleural Mesothelioma Re-directed T Cells for the Treatment (FAP)-Positive Malignant Pleural Mesothelioma Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for Malignant Pleural Mesotheliomas Effect of FAS and FAS Ligand Polymorphisms on Patients With Platinum-Based -Treated Malignant Pleural Mesothelioma Dasatinib in Resectable Malignant Pleural Mesothelioma Palliative Treatment With Liposomal Doxorubicin Plus Cisplatin for Patients With Malignant Pleural Mesothelioma Effect of Expression of CD74 and VEGF on Outcome of Treatment in Patients With Malignant Pleural Mesothelioma Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma. Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR) A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma Direct Injection of Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma A Phase I/II Study of First Line Vorinostat With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma ATREUS – Phase II Study on the Activity of Trabectedin in Patients With Malignant Pleural Mesothelioma (MPM) Accelerated Hypofractionated Radiotherapy in the Treatment of Malignant Pleural Mesothelioma Pembrolizumab + Defactinib In Pleural Mesothelioma Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants A Study of Atezolizumab in Unresectable or Advaced Malignant Pleural Mesothelioma A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural Mesothelioma Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma Vascularity Impact on the Treatment Outcome in Malignant Pleural Mesothelioma(VITMPM) Safety Confirmation Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma. Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma Response Evaluation in Malignant Pleural Mesothelioma Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment

Brief Title

Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma

Official Title

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

Brief Summary

      This study will 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.

      Eligible patients will be randomized 1:1 to either:

        1. Treatment group: rAd-IFN + Celecoxib followed by Gemcitabine

        2. Control group: Celecoxib followed by Gemcitabine

      Patients randomized to the treatment group will receive rAd-IFN administered into the pleural
      space via an Intrapleural catheter (IPC) or similar intrapleural device on study Day 1.

      The primary objective of this study is to compare the overall survival (OS) associated with
      rAd IFN, when administered with celecoxib and gemcitabine, versus that associated with
      celecoxib and gemcitabine alone for the treatment of patients with MPM
    

Detailed Description

      TITLE: 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

      PROTOCOL NUMBER: rAd-IFN-MM-301

      STUDY DRUGS: Nadofaragene firadenovec (Recombinant adenovirus vector containing the human
      interferon alpha-2b gene: rAd-IFN), celecoxib, and gemcitabine

      PHASE: 3

      INDICATION: Malignant pleural mesothelioma (MPM)

      SPONSOR: Trizell, Ltd.

      SITES: Approximately 80 sites globally

      OBJECTIVES:

      The primary objective of this study is to compare the overall survival (OS) associated with
      rAd IFN, when administered with celecoxib and gemcitabine, versus that associated with
      celecoxib and gemcitabine alone for the treatment of patients with 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.

      The secondary objectives of this study are:

        -  To compare between rAd-IFN, when administered with celecoxib and gemcitabine, versus
           that associated with celecoxib and gemcitabine alone for the treatment of patients with
           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,
           with respect to:

             -  Survival rate at 12 months and every 6 months thereafter;

             -  Progression-free survival (PFS);

             -  Best response (complete response, partial response, or stable disease); and

             -  Safety of rAd-IFN; and

        -  To evaluate rAd-IFN, when administered with celecoxib and gemcitabine, in a sub-set of
           patients with 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, with respect to viral shedding and biodistribution.

      The exploratory objectives of this study are:

      • To compare between rAd-IFN, when administered with celecoxib and gemcitabine, versus that
      associated with celecoxib and gemcitabine alone for the treatment of patients with 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, with respect to:

        -  Health-related Quality-of-Life,

        -  The relationship between immunological status and response to treatment, and

        -  Biocorrelates of response to treatment.

      POPULATION:

      The population for this study is patients with histologically confirmed MPM of epithelioid or
      biphasic (predominantly [>50%] epithelioid) histology 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.

      STUDY DESIGN AND DURATION:

      The study is an open-label, randomized, parallel group study conducted in patients with
      histologically confirmed MPM of epithelioid or biphasic (predominantly [>50%] epithelioid)
      histology 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.

      Screening assessments must be completed within 28 days of Study Day 1, and eligible patients
      will be randomized to either:

        1. Treatment group: rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine
           (Study Days 14 and 21 [i.e., Days 1 and 8 of the first gemcitabine treatment cycle],
           gemcitabine will be repeated every 3 weeks until disease progression/early termination
           [ET]); or

        2. Control group: celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 [i.e.,
           Days 1 and 8 of the first gemcitabine treatment cycle], gemcitabine will be repeated
           every 3 weeks until disease progression/ET).

      Treatment Phase Patients randomized to receive rAd-IFN (treatment group) will have an
      intrapleural catheter (IPC) or other intrapleural access device previously in place or
      inserted for the study, permitting drug administration to an accessible pleural space. The
      rAd-IFN will be diluted to a volume of 25 mL using sterile normal saline and will be
      administered directly to the pleural space via the IPC or similar device.

      Patients will receive gemcitabine until disease progression/ET. All adverse events will be
      captured from the time of the main study's informed consent through 30 days after the last
      dose of study treatment (rAd-IFN, celecoxib, and/or gemcitabine). All treatment emergent
      adverse events (TEAEs) and serious adverse events (SAEs) will be followed until resolution or
      stabilization.

      Survival Follow-Up Phase Following disease progression, patients will be followed every 3
      months for survival. All previously recorded TEAEs and SAEs will be followed until resolution
      or stabilization.

      DOSAGE FORMS AND ROUTE OF ADMINISTRATION:

      Patients randomized to the treatment group will receive rAd-IFN (3 × E11 viral particles) on
      Day 1 of the study, diluted to a total volume of 25 mL using sterile normal saline and
      administered into the pleural space via an IPC or similar intrapleural device.

      All study patients (treatment and control) will receive:

        -  Celecoxib administered at a dose of 400 mg twice daily orally on Days 1 to 14 of the
           study; and

        -  Gemcitabine starting on Study Day 14, using the following treatment regimen: 1250 mg/m2
           administered intravenously on Days 1 and 8 of a 21-day gemcitabine cycle and continued
           every 3 weeks until disease progression/ET.

      STATISTICAL ANALYSES:

      The primary analysis of the primary endpoint is a comparison of the OS curves between the 2
      groups using a log-rank test. The log-rank test will be stratified using the same variables
      used for stratifying the randomization.

      Secondary analyses of the primary endpoint will include a comparison of the survival rates at
      various time points since randomization and a comparison of the median survival times. The
      effect of baseline covariates will be assessed by constructing a proportional hazard model.
      Exploratory analyses will include comparison of the survival curves by methods that do not
      rely on proportional hazards.

      Secondary time-to-event endpoints will be analyzed in the same manner as the primary efficacy
      endpoint.

      Categorical efficacy endpoints will be summarized and compared between groups using a
      Pearson's test, with the effect of baseline covariates assessed using logistic regression.

      The nature, incidence, severity, relatedness, expectedness, seriousness, and outcome of TEAEs
      will be summarized by treatment group for safety analyses.

      There are 2 interim analyses planned:

        -  Analysis for futility will be assessed upon reaching 123 deaths (estimated to occur 27
           months after first patient first visit [FPFV]). Approximately half of the available Beta
           will be spent at this interim; and

        -  Analysis for efficacy will be assessed upon reaching 234 deaths (estimated to occur 45
           months after FPFV). Approximately one-fifth of the available Alpha will be spent at this
           interim.

      The final analysis will be assessed upon reaching 267 deaths (estimated to occur 60 months
      after FPFV).

      SAMPLE SIZE DETERMINATION:

      The planned sample size is approximately 300 patients. Based on a 1:1 randomization between
      treatment groups, a 2.5% one-sided significance level, and a predicted survival at 18 months
      of 35% in the rAd-IFN treatment group versus 20% in the control group, the study will have at
      least 90% power (after adjusting for the interim analyses) to detect a statistically
      significant difference between the treatment groups in the primary endpoint using the
      log-rank test.

      The calculation was based on the assumptions that recruitment is uniform over 3 years and
      that all alive patients are followed-up for 2 years after the end of recruitment.

      DATA AND SAFETY MONITORING BOARD:

      An independent Data and Safety Monitoring Board (DSMB) will be convened for this study to
      monitor safety, efficacy, and study integrity. All aspects of the DSMB's scope of review and
      procedures will be detailed in a DSMB charter.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Overall Survival

Secondary Outcome

 Survival rate

Condition

Malignant Pleural Mesothelioma

Intervention

rAd-IFN

Study Arms / Comparison Groups

 Treatment Group
Description:  rAd-IFN (Study Day 1) + celecoxib oral product (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 [i.e., Days 1 and 8 of the first gemcitabine treatment cycle], gemcitabine will be repeated every 3 weeks until disease progression/early termination [ET]

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

300

Start Date

January 21, 2019

Completion Date

November 2024

Primary Completion Date

November 2023

Eligibility Criteria

        Inclusion Criteria

        Patients who meet all of the following criteria will be eligible to participate in the
        study:

          1. Aged 18 years or older at the time of consent;

          2. Able to give informed consent;

          3. Has a confirmed histological diagnosis of MPM with histological type epithelioid or
             biphasic (if biphasic, histology must be predominantly [50%] epithelioid).
             Histological diagnosis of MPM will be confirmed centrally using specimens or slides
             from tumor specimens obtained at the time of initial presentation or a subsequent
             procedure. Central confirmation of diagnosis with immunohistochemistry will be
             performed, and independent central confirmation will be required for study entry;

          4. Measurable disease, per modified Response Evaluation Criteria in Solid Tumors [RECIST]
             1.1 (see Section 7) for pleural mesothelioma;

          5. Has received a minimum of 1 treatment regimen and a maximum of 2 treatment regimens,
             which may have been chemotherapeutic and/or immunotherapeutic treatment regimens for
             MPM which included at least 1 anti-folate and platinum combination regimen;

               -  Adjuvant or neoadjuvant therapy represent 1 line of therapy each;

               -  Patients who have undergone primary surgical resection and/or radiation therapy
                  to the pulmonary site are eligible to participate. For clarity, surgical
                  resection and/or radiation therapy to the pulmonary site are not exclusionary and
                  are not considered a line of therapy;

               -  Treatment that is split between pre-surgical resection and post-surgical
                  resection and is the same regimen will be counted as 1 regimen. Patients meeting
                  this condition should be discussed with the Medical Monitor prior to including
                  the patient in the study;

          6. Has a pleural space accessible for IPC or similar device insertion. Patients with a
             previously inserted IPC or similar device may be enrolled, and the pre-existing IPC or
             similar device can be used for vector administration as long as it is functional and
             has no evidence of local infection;

          7. Life expectancy 12 weeks in the judgement of the Investigator;

          8. Eastern Cooperative Oncology Group (ECOG) status of 1 or 0;

          9. Female and male patients:

               -  Female patients of childbearing potential must have a negative pregnancy test
                  upon entry into this study and agree to use a highly effective method of
                  contraception from Screening until 1 month after the last dose of gemcitabine;

                    -  Highly effective methods of contraception that result in a low failure rate
                       (i.e., <1% per year) when used consistently and correctly include combined
                       (estrogen and progestogen containing) hormonal contraception associated with
                       inhibition of ovulation (oral, intravaginal, or transdermal),
                       progestogen-only hormonal contraception associated with inhibition of
                       ovulation (oral, injectable, or implantable), intrauterine device,
                       intrauterine hormone-releasing system, bilateral tubal occlusion,
                       vasectomized partner, or sexual abstinence;

                    -  True abstinence, when in line with the preferred and usual lifestyle of the
                       patient, is considered a highly effective method only if defined as
                       refraining from heterosexual intercourse during the entire period of study
                       participation and for 1 month after the last dose of gemcitabine. The
                       reliability of sexual abstinence needs to be evaluated in relation to the
                       duration of the clinical study and the preferred and usual lifestyle of the
                       patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, and
                       post-ovulation method) and withdrawal are not acceptable methods of
                       contraception; and

               -  Female patients of non-childbearing potential must be either postmenopausal (no
                  menstrual period for a minimum of 12 months) or surgically sterile upon entry
                  into the study;

               -  Male patients must be either surgically sterile or agree to use a double-barrier
                  contraception method from Screening until 6 months after the last dose of
                  gemcitabine; o Where available and in accordance with local practice, male
                  patients must be advised to seek further advice regarding cryoconservation of
                  sperm prior to gemcitabine treatment due to the possibility of infertility after
                  therapy with gemcitabine; and

         10. Adequate laboratory values at Screening:

               -  Hemoglobin 9 g/dL;

               -  White blood cell count 3500/µL;

               -  Absolute neutrophil count 1500/µL;

               -  • Platelet count 100,000/µL;

               -  International normalized ratio (INR) and activated partial thromboplastin time
                  (aPTT) below the upper limit of normal (ULN). It is expected that patients
                  receiving anticoagulation therapy will not have INR and aPTT results that fall
                  within normal limits. It is not intended to exclude these patients and,
                  therefore, medical discretion is permitted for patients who have clinically
                  acceptable results in regards to their current concomitant anticoagulant therapy;

               -  Aspartate aminotransferase (AST) 3 × ULN;

               -  Alanine aminotransferase (ALT) 3 × ULN;

               -  Total bilirubin 2 × ULN;

               -  Estimated glomerular filtration rate (calculated using the Modification of Diet
                  in Renal Disease study equation [see Appendix B]) 50 mL/min/1.73 m2; and

               -  Serum albumin 2.5 g/dL.

        Exclusion Criteria

        Patients who meet any of the following criteria will be excluded from participation in the
        study:

          1. Is "treatment-naïve" (i.e., has not received at least 1 anti-folate and platinum
             combination regimen);

          2. Has previously received 3 or more lines of systemic chemotherapeutic or
             immunotherapeutic treatment. Treatment that is split between pre-surgical resection
             and post-surgical resection and is the same regimen will be counted as 1 regimen.
             Patients meeting this condition should be discussed with the Medical Monitor prior to
             including the patient in the study;

          3. Has previously received treatment with gemcitabine;

          4. Has stage IV extrathoracic metastatic disease;

          5. Inadequate pulmonary function of clinical significance as per Investigator review;

          6. Clinically significant pericardial effusion (i.e., as judged by the Investigator
             and/or requiring drainage) detected by computed tomography (CT) scan at Screening.
             Standard of care CT scans completed within 2 weeks prior to Screening may be used in
             place of the Screening CT scan on a case by-case basis as agreed with the Medical
             Monitor;

          7. Prior therapy(ies), if applicable, must be completed according to the criteria below
             prior to vector administration:

               -  Cytotoxic chemotherapy, at least 21 days from last dose;

               -  Non-cytotoxic chemotherapy (e.g., small molecule inhibitor), at least 14 days
                  from last dose;

               -  Monoclonal antibody, at least 30 days from last dose;

               -  Non-antibody immunotherapy (e.g., tumor vaccine), at least 42 days from last
                  dose;

               -  Radiotherapy, at least 14 days from last local site radiotherapy;

               -  Hematopoietic growth factor, at least 14 days from last dose; or

               -  Study drug, 30 days or 5 half-lives, whichever is longer, from last dose;

          8. Patient previously treated with IFNs (e.g., for chronic active hepatitis);

          9. Suspected/known hypersensitivity to IFN-α2b or rAd-IFN (including any of its
             excipients);

         10. Known hypersensitivity to celecoxib (including any of its excipients) or sulfonamides;

         11. Known hypersensitivity to gemcitabine (including any of its excipients);

         12. Impaired cardiac function or clinically significant cardiac disease including the
             following:

               -  New York Heart Association class III or IV congestive heart failure;

               -  Myocardial infarction within the last 12 months; and

               -  Patients known to have impaired left ventricular ejection fraction per
                  institutional standards and of clinical significance as per Investigator review;

         13. Women who are pregnant or breastfeeding;

         14. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, depression, or psychiatric illness/social situations within the last 12
             months;

         15. Patients with active, known, or suspected auto-immune disease or a syndrome that
             requires systemic or immunosuppressive agents (oral prednisolone or equivalent at a
             dose of 10 mg per day is permitted); NOTE: patients with vitiligo, residual
             hypothyroidism due to auto immune disease only requiring hormone replacement,
             psoriasis not requiring systemic treatment, or conditions not expected to recur in the
             absence of an external trigger are permitted to enroll;

         16. History of asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria, or
             other allergic type reactions after taking acetylsalicylic acid or NSAIDs, including
             COX-2 inhibitors;

         17. History of ulcer disease or gastrointestinal bleeding;

         18. Uncontrolled or poorly controlled hypertension (i.e., blood pressure >160/100 mmHg)
             requiring 3 or more anti-hypertensive drugs;

         19. Heart rate corrected QT interval using Fridericia's formula >470 ms on resting 12-lead
             electrocardiogram (ECG);

         20. Patients receiving lithium;

         21. Any significant disease which, in the opinion of the Investigator, would place the
             patient at increased risk of harm if he/she participated in the study;

         22. History of a prior malignancy for which treatment was completed <2 years prior to
             Screening or for which the patient has continued evidence of disease, or concurrent
             malignancy that is clinically unstable and requires tumor-directed treatment;

         23. Has a congenital or acquired immunodeficiency, including patients with known history
             of infection with human immunodeficiency virus;

         24. Has both serum albumin 2.5 to 3.5 g/dL and total bilirubin >1.5 ULN;

         25. History of clinically significant inflammatory bowel disease requiring systemic
             (parenteral) immunosuppressive therapy within 5 years prior to Screening; or

         26. History of galactose intolerance, Lapp lactase deficiency, or glucose-galactose
             malabsorption.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Daniel Sterman, MD, +44 (0) 1844 355 625, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT03710876

Organization ID

rAd-IFN-MM-301

Secondary IDs

2017-003169-82

Responsible Party

Sponsor

Study Sponsor

Trizell Ltd

Collaborators

 University of Pennsylvania

Study Sponsor

Daniel Sterman, MD, Principal Investigator, NYU Langone Laura and Isaac Perlmutter Cancer Center


Verification Date

December 2020