A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients

Related Clinical Trial
Neoadjuvant Toripalimab Combined With Chemotherapy in the Treatment of Malignant Pleural Mesothelioma 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

A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients

Official Title

A Phase I/II Trial of CDX-1401 (a Vaccine Consisting of a Human Monoclonal Antibody Specific for DEC-205, Fused to Full-length Tumor Antigen NY-ESO-1) in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients

Brief Summary

      This study will look at the safety of the combination of three drugs (CDX-1401, Poly-ICL, and
      Pembrolizumab) and its effect on decreasing tumors. Pembrolizumab is an experimental cancer
      drug. CDX-1401 is a tumor specific antigen and Poly-ICL is a Toll-like receptor agonist tumor
      specific antigens which when combined with Pembrolizumab may increase the tumor response to
      this drug.
    

Detailed Description

      Antigen presentation and cellular immunity are complex processes, and subject to modulation
      because of the tumor microenvironment. Antigen presenting cells in the tumor microenvironment
      acquire the antigens from tumor cells. Tumors express several tumor specific antigens that
      can be leveraged by the immune system to mount an effective anti-tumor response. NY-ESO-1,
      one of the cancer testis antigens, is expressed in several tumors including non-small cell
      lung cancer (NSCLC), triple negative breast cancer (TNBC), and melanoma. NY-ESO-1 is highly
      immunogenic and spontaneous tumor regressions in association with humoral and cellular
      responses to NY-ESO-1 have been reported. NY-ESO-1 is tumor specific and is not detected in
      non-malignant tissues with the exception of germ cells and trophoblasts, thus making it an
      attractive target for cancer vaccine development. Cancer vaccines can augment the process of
      cancer specific antigen presentation, however the efficacy of protein-based vaccines is
      limited due to weak immunogenicity and inefficient uptake by antigen presenting cells for
      presentation to T and B cells, and lack of targeting to appropriate antigen presenting cells.
      Dendritic cells (DCs) are highly specialized antigen-presenting cells that play a central
      role in initiating and regulating immunity. Deca-lectin, DEC-205 (CD205) is a surface
      receptor of DCs, which is highly expressed by human DCs and can mediate antigen uptake,
      processing, and presentation. CDX-1401 is a fully human anti-DEC-205 mAb (3G9) genetically
      fused to the full length NY-ESO-1. In preclinical studies, Dec-205 fused to NY-ESO-was more
      efficiently cross-presented to T-cells than NY-ESO-1 protein alone. In a recently concluded
      phase 1 study of CDX-1401 in combination with adjuvant Toll-like receptor agonists with
      Resiquimod (TLR7/8 agonist) and Hiltonol (poly-ICLC; TLR3 agonist), CDX-1401 was well
      tolerated with no dose-limiting toxicities and no treatment related grade 3/4 toxicities.
      Clinical activity was noted in solid tumors including NSCLC. Interestingly, few of the
      patients who progressed on CDX-1401 subsequently received immune checkpoint inhibitors and
      several of these patients with NY-ESO-1-specific cellular response had partial responses by
      RECISTimmune-related response criteria (IRRC). Previous studies reported enhanced T-cell
      responses in autologous dendritic cell/myeloma fusion vaccines with PD-1 blockade using
      CT-011 (Anti-PD1 antibody). In addition, increased tumor-infiltrating dendritic cells which
      are PD1 positive mediate immune suppression and PD-1 blockade in mice ovarian cancer models
      enhance effector T-cell responses and reduce tumor burden. Thus, we hypothesize that the
      ability of CDX-1401 to generate an effective anti-tumor immune response could be enhanced
      when co-administered with an anti-PD1 antibody.

      In this study, investigators will examine the safety of the three drug combination of
      CDX-1401, Poly-ICL (TLR-3 agonist), and Pembrolizumab, and its impact in generating robust
      and effective anti-tumor immune responses. The preliminary clinical data from Pembrolizumab
      are promising, and strategies such as this to enhance tumor specific antigen presentation may
      augment the responses and clinical benefit from Pembrolizumab.

      Primary Objective:

      To assess the safety, and tolerability of CDX-1401 in combination with Pembrolizumab

      Secondary Objectives:

        1. To determine whether the anti-tumor response is substantially increased by vaccination
           with CDX-1401 (anti-DEC205-NY-ESO-1 fusion protein vaccine) in combination with an
           immune-checkpoint inhibitor, Pembrolizumab (anti-PD1 mAb) in previously treated patients
           with advanced solid tumors.

        2. To determine immune response to NY-ESO-1 and other tumor specific antigens in patients
           treated with CDX-1401 and Pembrolizumab.

        3. To evaluate changes in Tumor infiltrating lymphocytes and other immune evasive pathway
           biomarkers post treatment with CDX-1401 and Pembrolizumab.

        4. To perform exploratory analysis to identify biomarkers to predict both antigen specific
           T-cell responses and clinical benefit to CDX-1401 and Pembrolizumab.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Dose Limiting Toxicity

Secondary Outcome

 Objective Response Rate for combination therapy

Condition

Non Small Cell Lung Cancer

Intervention

Pembrolizumab

Study Arms / Comparison Groups

 CDX-1401 + Poly-ICLC + Pembrolizumab followed by Pembrolizumab
Description:  Patients receive CDX-1401, Poly-ICLC and Pembrolizumab for 4 cycles (Q 3 weeks) followed by Pembrolizumab alone (Q 3 weeks) until disease progression.

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

Drug

Estimated Enrollment

0

Start Date

January 2017

Completion Date

July 2018

Primary Completion Date

July 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Be willing and able to provide written informed consent/assent for the trial.

          -  Patients with previously treated advanced lung cancer (NSCLC, SCLC and mesothelioma),
             advanced triple negative breast cancer, urothelial cancers and malignant melanoma.
             Tumors should be positive for expression of NY-ESO-1, as assessed by external central
             laboratory testing.

          -  Malignancy that has progressed after any therapies with curative potential or at least
             one approved palliative therapy for which the patient is a candidate. Patients with
             metastatic melanoma may be enrolled without prior treatment provided they meet rest of
             the eligibility criteria.

          -  Where applicable, chemotherapy or radiation therapy must have been completed at least
             4 weeks prior to the first dose of study treatment; the interval for prior anticancer
             therapeutic radiopharmaceuticals is at least 8 weeks. For patients on small molecule
             tyrosine kinase inhibitors therapy must have been completed 14 days prior to start of
             study treatment. The patient must have adequately recovered from any clinically
             significant toxicity experienced during prior treatment(s) in the investigator's
             opinion.

          -  Chemoembolization, surgery or any other local therapy completed at least 4 weeks prior
             to the first dose of study treatment.

          -  Have measurable disease based on immune-related Response Criteria (irRC).

          -  Availability of tumor tissue (preferably from a recent biopsy or resection, or if not
             available, on the archived tumor tissue from the primary resection) for NY-ESO-1
             expression analysis. Positive NY-ESO-1 expression will be required for entry. NY-ESO-1
             expression will be analyzed at a central laboratory.

          -  Have a performance status of 0 or 1 on the ECOG Performance Scale.

          -  10. Demonstrate adequate organ function as defined below , all screening labs should
             be performed within 10 days of treatment initiation.

               -  Absolute neutrophil count (ANC) >=1,500/mcL

               -  Platelets >= 100,00/mcL

               -  Hemoglobin >= 9g/dL or >= 5.6mmol/L without transfusion or EPO dependency (within
                  7 days of assessment)

               -  Serum creatinine =< 1.5X upper limit of normal

               -  Measured creatinine clearance >=mL/min for subject with creatinine levels >1.5 X
                  institutional upper limit of normal

               -  Serum total bilirubin =< 1.5X upper limit of normal

               -  AST (SGOT) =< 2.5 X upper limit of normal or =< 5X upper limit of normal for
                  subjects with liver metastases

               -  ALT (SGPT) =< 2.5 X upper limit of normal or =< 5X upper limit of normal for
                  subjects with liver metastases

               -  Albumin >= 2.5mg/dL

               -  International Normalized Ratio =< 1.5 X upper limit of normal unless subject is
                  receiving anticoagulant therapy as long as Prothrombin Time or Partial
                  Thromboplastin Time is within therapeutic range of intended use of anticoagulants
                  Activated Partial Thromboplastin Time (aPTT) =< 1.5 X upper limit of normal
                  unless subject is receiving anticoagulant therapy as long as Prothrombin Time or
                  Partial Thromboplastin Time is within therapeutic range of intended use of
                  anticoagulants

          -  Female subject of childbearing potential should have a negative urine or serum
             pregnancy within 72 hours prior to receiving the first dose of study medication. If
             the urine test is positive or cannot be confirmed as negative, a serum pregnancy test
             will be required

          -  Female subjects of childbearing potential must be willing to use an adequate method of
             contraception - Contraception, for the course of the study through 120 days after the
             last dose of study medication.

          -  Male subjects of childbearing potential must agree to use an adequate method of
             contraception - Contraception, starting with the first dose of study therapy through
             120 days after the last dose of study therapy.

        Exclusion Criteria:

          -  Is currently participating and receiving study therapy or has participated in a study
             of an investigational agent and received study therapy or used an investigational
             device within 4 weeks of the first dose of treatment.

          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
             other form of immunosuppressive therapy within 7 days prior to the first dose of trial
             treatment

          -  Has a known history of active bacillus tuberculosis

          -  Hypersensitivity to Pembrolizumab or any of its excipients

          -  Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study day 1 or
             who has not recovered (ie =< Grade 1 or at baseline) from adverse events due to agents
             administered more than 4 weeks earlier.

          -  Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy
             within 2 weeks prior to study Day 1 or who has not recovered (ie =< Grade 1 or at
             baseline) from adverse events due to a previously administered agent.

          -  Has a known additional malignancy that is progressing or required active treatment.
             Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the
             skin that has undergone potentially curative therapy or in situ cervical cancer.

          -  Has known active central nervous system metastases and/or carcinomatous meningitis.
             Subjects with previously treated brain metastases may participate provided therapy are
             stable (without evidence of progression by imagining for at least four weeks prior to
             the first dose of trial treatment and any neurologic symptoms have returned to
             baseline), have no evidence of new or enlarging brain metastases, and are not using
             steroids for at least 7 days prior to trial treatment. This exception does not include
             carcinomatous meningitis which is excluded regardless of clinical stability.

          -  Has active autoimmune disease that has required systemic treatment in the past 2 years
             (ie with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
             Replacement therapy (eg thyroxine, insulin, or physiologic corticosteroid replacement
             therapy for adrenal or pituitary insufficiency, etc) is not considered a form of
             systemic treatment.

          -  Has known history of, or any evidence of active, non-infectious pneumonitis.

          -  Has an active infection requiring systemic therapy.

          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality
             that might confound the results of the trial, interfere with the subject's
             participation for the full duration of the trial, or is not the best interest of the
             subject to participate, in the opinion of the treating investigator.

          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the
             projected duration of the trial, starting with the pre-screening or screening visit
             through 120 days after the last dose of trial treatment.

          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent and
             previous administration of vaccine therapy targeting NY-ESO-1.

          -  Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).

          -  Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
             [qualitative] is detected).

          -  Has received a live vaccine within 30 days of planned start of study therapy. -- Note:
             seasonal influenza vaccines for injection are generally inactivated flu vaccines and
             are allowed; however intranasal influenza vaccines are live attenuated vaccines, and
             are not allowed.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Vamsidhar Velcheti, MD, , 



Administrative Informations


NCT ID

NCT02661100

Organization ID

CASE2Y16


Responsible Party

Sponsor

Study Sponsor

Case Comprehensive Cancer Center


Study Sponsor

Vamsidhar Velcheti, MD, Principal Investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center


Verification Date

December 2016