[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mesotheliomas-pleural\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mesotheliomas-pleural":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,74,95,121,151,177,204],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":45},"100552771","phase-2-a-study-of-sacituzumab-govitecan-in-people-with-mesothelioma-100552771",false,"NCT06477419","A Study of Sacituzumab Govitecan in People With Mesothelioma","Phase 2 Study of Sacituzumab Govitecan-hziy in Patients With Previously Treated Mesothelioma","Inclusion Criteria:\n\n* Patient, or legally authorized representative (LAR), willing and able to provide written informed consent for the trial\n* Patient age ≥ 18 at time of consent\n* Pathologically confirmed diffuse pleural mesothelioma\n* Must have received at least one prior systemic therapy (platinum\u002Fpemetrexed, immunotherapy or a combination thereof)\n* Measurable disease as defined primarily by the modified RECIST criteria for mesothelioma (at PI discretion RECIST v1.1 may be used)\n* Consent to undergo a biopsy prior to Cycle 1 Day 1 and Cycle 3 Day 1 if deemed medically safe and feasible\n* Eastern Cooperative Oncology Group (ECOG) score 0 or Karnofsky Performance Status ≥ 70%\n* Adequate organ function, defined as\n\n  * Absolute neutrophil count ≥ 1.5K\u002FmcL\n  * Platelet count ≥ 100K\u002FmcL\n  * Adequate renal function defined as creatinine clearance ≥ 30ml\u002Fmin (as calculated by Cockcroft-Gault Formula)\n  * Hemoglobin \\> 9g\u002FdL (prior transfusion permitted if not within 7 days of enrollment)\n  * Total bilirubin ≤1.5 x upper limit of normal (ULN) if no liver metastases or \\\u003C3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits\n  * AST, ALT ≤ 2.5 x ULN (if liver metastases are present, ≤5 × ULN)\n* If of childbearing potential, must be willing to use highly effective mode of contraception for at least one month prior, during, and for 2 months after the end of active therapy\n\nExclusion Criteria:\n\n* Currently participating in another study and receiving another study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment\n* Prior hypersensitivity to irinotecan or any components of sacituzumab govitecan-hziy\n* Prior cytotoxic\u002Fimmunologic systemic therapy within 3 weeks prior to study Day 1 or has not recovered (i.e., CTCAE v5 ≥ Grade 1 at baseline; from clinically significant adverse events due to a previously administered agent (excluding Grade 2 neuropathy)\n* Known psychiatric or substance abuse disorders that would interfere with the requirements of the trial within the opinion of the investigator\n* Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early stage prostate cancer, or in situ cervical cancer after definitive treatment\n* Positive hepatitis B (hepatitis B virus \\[HBV\\]) surface antigen (HBsAg)\n\n  o NOTE: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Patients who fit these criteria must use Hep B prophylaxis during treatment. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing\n* Positive hepatitis C antibody (anti-HCV)\n\n  o NOTE: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible\n* Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:\n\n  * Receiving ART that may interfere with study treatment (consult sponsor for review of medication prior to enrollment)\n  * CD4 count \\\u003C 350 cells\u002Fmm3 at screening\n  * AIDS-defining opportunistic infection within 6 months of start of screening\n  * Not agreeing to start ART and be on ART \\> 4 weeks plus having HIV viral load \\\u003C400 copies\u002FmL at end of 4-week period (to ensure ART is tolerated and HIV controlled)\n* Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), or coronary\u002Fperipheral artery bypass graft, or any acute coronary syndrome within 6 months of start of study drug\n* Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of study Day 1\n* Pregnant women or women who are breastfeeding or of childbearing potential and not using a highly effective method of birth control for at least one month prior to enrollment. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 60 days after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and\u002For a progesterone agent)","ALL","18 Years",{"count":19,"type":20},33,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Participants will receive sacituzumab govitecan until their disease gets worse (progresses), they have severe side effects and cannot continue study treatment, or the participants or the study doctor thinks it's in your best interest to stop treatment.",[26,27,28],"Mesothelioma","Mesotheliomas Pleural","Mesothelioma; Pleura",[26,27,28,30,31,32,33],"Diffuse Pleural Mesothelioma","Sacituzumab","24-081","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-05-26",{"date":37,"type":38},"2026-05-28","ACTUAL",{"date":40,"type":38},"2024-06-21",{"date":42,"type":20},"2029-06-21",{"name":33,"class":44},"OTHER",7,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100602668","partial-pleurectomy-surgery-for-unresectable-pleural-mesothelioma-100602668","NCT07126509","Partial Pleurectomy (Surgery) for Unresectable Pleural Mesothelioma","A Pilot Study of Partial Pleurectomy in Borderline and Unresectable Pleural Mesothelioma","Inclusion Criteria\n\n* Patients must have histologically confirmed epithelioid subtype pleural mesothelioma, as determined by surgical (i.e. VATS) biopsy.\n* Disease confined to the unilateral hemithorax.\n* Disease that is classified as unresectable or borderline resectable:\n* Unresectable disease is defined by cross sectional imaging (CT or MRI) demonstrating invasion of unresectable mediastinal structures (heart, great vessels, esophagus) or spine, unresectable invasion of the chest wall (multifocal chest wall invasion or apical chest wall invasion), or disease outside intended resection field.\n* Borderline resectable disease is defined by cross sectional imaging (CT or MRI) demonstrating extensive pulmonary parenchymal invasion (anticipated need for anatomic resection or complex wedge resection to clear disease) or extensive\u002Fbulky disease of (1) the diaphragm or sulci (anticipated need for diaphragm resection and reconstruction to clear disease), or (2) the chest wall (anticipated need for chest wall resection and reconstruction to clear disease). Disease with pathologically proven hilar or mediastinal lymph node involvement.\n* Successful completion of at least 6 weeks of systemic induction therapy (regimen according to treating physician choice, including the below) with no unresolved adverse event that would preclude surgery:\n* Platinum agent, pemetrexed, +\u002F- bevacizumab\n* Platinum agent, pemetrexed, pembrolizumab\n* Ipilimumab\u002Fnivolumab\n* Age ≥18 years.\n* ECOG performance status ≤1.\n* Patients must have adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * PT\u002FINR \\>1.5\n  * PTT \\>Upper limit of normal\n  * total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional upper limit of normal\n  * creatinine within normal institutional limits OR\n  * creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification21. To be eligible for this trial, patients should be class 2B or better.\n* Review by multidisciplinary treatment conference consisting of mesothelioma surgeons, radiologists, pathologists, medical oncologists, and palliative care physicians. Date of review will be documented in on the patient's elgibility checklist\n* Prior or concurrent enrollment to UChicago's Mesothelioma Biobank (IRB15-0443).\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Patients with biphasic or sarcomatoid pleural mesothelioma.\n* Patients with metastatic disease or disease which extends to the abdominal cavity or subdiaphragm as identified on post-induction therapy cross sectional imaging (CT, MRI, or PET).\n* Patients who demonstrate disease progression during or following induction therapy.\n* FEV1 \\\u003C 50% and\u002For postoperative predicted DLCO \\\u003C 50%.\n* Patients who are receiving any other investigational agents.\n* Patients with uncontrolled intercurrent illness.\n* Prior malignancy active 2 years prior to registration except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast, or papillary thyroid.",{"count":54,"type":20},30,[56],"NA","Purpose of the study: The main purpose of this research study is to see if a surgery procedure (limited partial pleurectomy and decortication) helps symptoms in people who have cancer that is unresectable that might not be able to be removed completely. This is called unresectable cancer. This study will also help the research team learn more about the types of symptoms and quality of life for people who have undergone this surgery, the number of complications following , and the time from surgery to starting other therapy. Th e study team also wants to see see the overall survival of people who have had this procedure as part of their care.\n\nWhat will be done as part of research on this study:\n\n* Surgery (Partial Pleurectomy - surgery to remove lining of lungs)\n* The research team will also ask study participants questions about their symptoms through questionnaires at certain times after surgery.\n\nHow long this study will last:\n\nParticipation in this research (pre-surgery, surgery and follow-up) will last for about 2 years.\n\nConfidentiality: All personal information will be kept confidential, and data will be used only for research purposes.\n\nContact Information: For more information about this study, please contact PhaseIICRA@medicine.bsd.uchicago.edu",[26,59,27,60,61],"Mesothelioma; Lung","Mesothelioma Malignant Advanced","Mesothelioma, Malignant",[63],"PLEURECTOMY","2026-02-13",{"date":66,"type":38},"2026-02-17",{"date":68,"type":38},"2025-12-02",{"date":70,"type":20},"2028-12-01",{"name":72,"class":44},"University of Chicago",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":73},"100344123","phase-1-pembrolizumab-in-combination-with-chemotherapy-and-image-guided-surgery-for-malignant-pleural-mesothelioma-mpm-100344123","NCT03760575","Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Malignant Pleural Mesothelioma (MPM)","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent for the trial.\n* Be 18 years of age on day of signing informed consent.\n* Have measurable disease based on RECIST 1.1.\n* Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.\n* Have a performance status of 0 or 1 on the ECOG Performance Scale.\n* Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation.\n* 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.\n* Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n* Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\nExclusion Criteria:\n\n* 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.\n* Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment OR Is taking chronic systemic steroids (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of trial treatment. (Note: Subjects with asthma or chronic obstructive pulmonary disease that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.)\n* Has a known history of active TB (Bacillus Tuberculosis)\n* Hypersensitivity to ICG or pembrolizumab or any of their excipients.\n* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n* Has a known additional malignancy that is progressing or requires 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.\n* Has known metastatic disease and\u002For disease that is otherwise determined to be unresectable.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. 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.\n* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Evidence of interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* 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 in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* 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.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\n* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies).\n* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* 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 (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed",{"count":81,"type":20},20,[83],"PHASE1","The study is a single-arm phase I trial to evaluate the safety, feasibility, and preliminary efficacy of the addition of pembrolizumab and image-guided resection to surgical therapy and chemotherapy for malignant pleural mesothelioma (MPM).",[27],"2025-12-03",{"date":88,"type":38},"2025-12-04",{"date":90,"type":38},"2023-01-10",{"date":92,"type":20},"2027-02-01",{"name":94,"class":44},"Abramson Cancer Center at Penn Medicine",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":73},"100393247","phase-2-the-immunotherapy-pleural-5-ala-pdt-100393247","NCT04400539","The IMmunotherapy Pleural 5-ALA PDT","Intrapleural Photodynamic Therapy by Video-Assisted Thoracoscopy Followed by Anti-PD-1 NIVOLUMAB in Patients With Malignant Pleural Mesothelioma - a Pilot Study","IMPALA","Inclusion Criteria:\n\n* ECOG Performance status (PS) 0-1 (WHO)\n* Unresectable Malignant Pleural Mesothelioma\n* suffering from unresectable MPM (n=20), relapsing after one or 2 lines of treatment with platinum-based doublet of chemotherapy (including pemetrexed) \\[Note: MPM patients having contra-indications for, or refusing chemotherapy may also be recruited\\], and candidate for palliative pleural procedure (i.e. thoracoscopy for pleurodesis by talc or by insertion of indwelled pleural catheter, IPC)\n* Documented progression after previous 1 or 2 lines of chemotherapy including Platinum\u002FPemetrexed chemotherapy\\*\n* Measurable disease according to modified RECIST 1.1. for MPM\n* Malignant pleural lesion assessed to be accessible by local PDT treatment during thoracoscopy, as validated by expert MTB (\"MESOCLIN\", Lille, France)\n* Histological diagnosis confirmed by national expert pathology panel (\"MESOPATH\" - Institut Léon Bérard, Lyon, France)\n* Weight loss \\\u003C10%\n* available tumor tissue (archival or fresh)\n* obtention of an informed written consent before any specific procedure of the study\n* Decision to treat the patient within this clinical trial taken during MPM dedicated multidisciplinary board (RCP MESOCLIN in France )\n* Patient affiliated to and covered by social security for standard care\n* Women of child-bearing potential must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 5 months after the final dose of investigational product\n* Women of child-bearing potential must have a negative pregnancy test within 24h before administration of investigational product\n* First line patients may also be recruited if they declined or if they have contra-indications for chemotherapy.\n\nExclusion Criteria:\n\n* lack of informed written consent; or refusal to sign or to participate\n* Pregnant, breastfeeding patients, and female patients of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for the duration of the study and for at least 5 months after the last dose of nivolumab\n* Male patients who are unwilling or unable to use contraception methods for the duration of the study and for at least 7 months after the last dose of nivolumab\n* a previous treatment by anti-PD-1 or anti-PD-L1 antibodies for their cancer or any other cancer in the last 5 years\n* hypersensitivity to Nivolumab (anti-PD-1 antibodies)\n* contra-indications for 5-ALA or PDT\n* contra-indications for thoracoscopy (VATS)\n* any other comorbidity precluding the feasibility of the therapeutic protocol: uncontrolled cardiac failure, pulmonary hypertension, liver or kidney severe dysfunction (creatinin clearance \\\u003C60 ml\u002Fmin), uncontrolled infection, or other disease according to the investigator\n* other cancer treated within 5 years before inclusion except baso-cellular skin carcinoma or cervical \u002F bladder in situ carcinoma\n* inability to receive study information and to give informed consent\n* patient unable to have a clinical follow-up due to psychological, familial, social or geographical reasons\n* legal incapacity (people in jail), or under supervision (i.e. guardianship or curatorship)\n* treatment with experimental drug within 30 days before the start of the study",{"count":81,"type":20},[23],"Pilot study of the feasibility of an innovative multimodal treatment combining intrapleural photodynamic therapy with videothoracoscopy followed by adjuvant immunotherapy with anti-PD-1 Nivolumab antibodies in patients with malignant pleural mesothelioma",[27,107],"Malignant Pleural Mesothelioma",[109,110,111],"Immunotherapy","anti-PD-1","Photodynamic Therapy","2025-09-24",{"date":114,"type":38},"2025-09-25",{"date":116,"type":38},"2022-05-09",{"date":118,"type":20},"2026-05-09",{"name":120,"class":44},"University Hospital, Lille",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100560776","immune-microenvironment-and-gene-expression-profiling-in-mesothelioma-100560776","NCT06581549","Immune Microenvironment and Gene Expression Profiling in Mesothelioma","From Immune Microenvironment Characterization and Gene Expression Profiling to New Drugs Testing in Pleural and Peritoneal Mesothelioma: Imaging-Meso Study","Imaging-Meso","Inclusion Criteria:\n\n* Patients with Mesothelioma of the Pleura and Peritoneum\n* Age greater than 18 years of age\n* Patients undergoing surgery will require both biopsy and surgical sampling material\n* Pathologist's confirmation of the presence of tumor sections in the excised specimens\n* Patients in follow-up from active cancer treatment for at least 6 months\n\nExclusion Criteria:\n\n* Inadequacy of biological material for analysis under study\n* Patients not amenable to active oncologic treatment\n* Patients lost to follow-up before 6 months after the end of active oncologic treatment",{"count":130,"type":20},220,"OBSERVATIONAL","Pleural and peritoneal mesotheliomas (PPM) are rare cancers mostly related to asbestos-exposure, which are characterized by a complex histopathological diagnosis and staging, few therapeutic options and a dismal prognosis. The main unmet medical need in PPM is the lack of a treatment sequence for affected patients. The advent of immune checkpoint inhibitors has changed the first line treatment of PPM, thanks to the improvement in survival achieved by the combination of ipilimumab and nivolumab that are currently approved for non-epithelioid histology in our Country.\n\nPPM is characterized by a large heterogeneity of the genomic landscape, which is mainly characterized by the loss of tumour suppressor genes and mutations in DNA repair genes and by an \"altered- suppressed\" or \"excluded\" tumor immune microenvironment (TIME).\n\nThe goal of this project is to improve the immune-biological and molecular stratification of PPM subgroups that can lead to the identification of different personalized treatment approaches. PPM patients (N=220) will be retrospectively (N=150) and prospectively (N=70) recruited from the coordinator center and 6 participating Italian centers. Treatment-naïve tumor samples will be collected and analyzed by bulk gene expression and spatial whole transcriptome analysis, and by 9-color multiplex immunofluorescence.\n\nNew targets or actionable pathways potentially emerging from such studies will be finally assessed and validated in patient-derived organoids\u002Fxenografts that accurately reflect PPM tumorigenesis.",[26,27,59],[135,136,137,138,139,140],"pleura","mesothelioma","PPM patients","lung","Gene expression profiling","Immune microenvironment","2025-09-04",{"date":143,"type":38},"2025-09-05",{"date":145,"type":38},"2023-11-02",{"date":147,"type":20},"2026-12-31",{"name":149,"class":44},"Istituto Oncologico Veneto IRCCS",10,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":175,"locationsCount":73},"100462633","phase-1-dendritic-cell-therapy-combined-with-surgery-in-mesothelioma-100462633","NCT05304208","dENdritic Cell Therapy Combined With SURgEry in Mesothelioma","Phase I, Open-Label Study With Dendritic Cell Therapy (MesoPher) In Combination With Ex-tended-Pleurectomy\u002FDecortication After Chemotherapy in Subjects With Resectable Mesothelioma","ENSURE","Inclusion Criteria:\n\n* Patients with a histologically confirmed diagnosis of epithelioid MPM who are eligible for 2 to 4 cycles of platinum-based chemotherapy. Patients who progressed after chemotherapy will not be discontinued from the trial if they are still eligible for eP\u002FD and none of the exclusion criteria is present (e.g. local progression with only focal chest invasion).\n* Patients must be at least 18 years old and must be able to give written informed con-sent.\n* Resectable disease defined by stage cT1-3, N0-1, M0 (I to IIIA) according to UICC TNM classification (8th edition). A fluorodeoxyglucose (FDG)-positron emission tomography (PET)-computerized tomography (CT) scan with fusion images showing absence of M1, N2 involvement is required. Focal chest wall lesions are acceptable.\n* Tumor tissue available after completing chemotherapy and before starting treatment with DCT. Tumor tissue can be obtained by either a CT-guided needle biopsy or a Video-assisted thoracoscopic surgery (VATS) biopsy.\n* Fit to receive platinum-based chemotherapy (as per standard of care of the treating physician\u002FInstitution) and undergo a P\u002FD with optional removal of hemidiaphragm and pericardium. The responsible surgeon and chest physician should judge the required fitness prior to registration, taking into account the results of all the relevant (i.e. pulmonary, cardiac) examinations.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix 2).\n* Ability to return to the study center for adequate follow-up and vaccinations.\n* Positive delayed-type hypersensitivity (DTH) skin test (induration \\> 2mm after 48 hrs) against at least one positive control antigen tetanus toxoid.\n* Written informed consent according to ICH-GCP.\n* Subjects must have adequate organ function and adequate bone marrow reserve at screening:\n\n  * creatinine ≤ 1.5 × upper limit of normal \\[ULN\\] or glomerular filtration rate ≥ 50 mL\u002Fmin\n  * alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin ≤ 1.5 × ULN\n  * Absolute neutrophil count ≥1.5 x 109\u002FL, platelet count ≥100 x 109\u002FL, and Hb ≥9.0 g\u002FdL. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n* Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test just prior to the first study drug administration on Day 1, and must be willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) or true abstinence (when this is in line with the preferred and usual lifestyle)\\* during the study and for at least 12 months after the last study drug administration.\n\n  \\*True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n* Men must be willing to use an effective contraceptive method (e.g. condom, vasectomy) during the study and for at least 12 months after the last study drug administration.\n* Written informed consent according to the International Conference on Harmonisation (ICH)\u002FGood Clinical Practice (GCP) guidelines.\n\nExclusion Criteria:\n\n* Clinical or radiological invasion of mediastinal structures (heart, aorta, spine, esophagus, etc.) and widespread chest wall invasion (stage T4). Involvement of N2 nodes. Stage IV (metastatic disease).\n* Any different histology from the epithelioid MPM (as per assessed at time of diagnosis).\n* Unavailability of tumor tissue after completing chemotherapy and before starting treatment with DCT.\n* Subject with any concurrent medical, psychological or psychiatric disease or condition that is likely to compromise the ability to give informed consent or to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study.\n* Use of \\>10 mg of prednisolone or equivalent\u002Fday (or other immunosuppressive agents) during the past 6 weeks before the first study drug administration and throughout the study. Prophylactic usage of dexamethasone (steroids) during chemotherapy is excluded from this 6-week interval. Inhaled or topical steroids, and adrenal replacement steroid ≤10 mg daily prednisone equivalent, are permit-ted in the absence of active autoimmune disease.\n* Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery (other than eP\u002FD) during the course of study treatment.\n* Subject with any previous malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the subject has been disease-free for at least 3 years.\n* Prior treatment of any kind for mesothelioma, especially prophylactic track irradiation after diagnostic procedures.\n* Clinically significant pleural effusion that cannot be managed with thoracentesis or pleurodesis (according to institutional practice). If pleurodesis is considered, it should be done before randomization.\n* Subject with any known active serious infection, including human immunodeficiency virus (HIV), hepatitis B or C virus, or syphilis infection.\n* Subject with a history of autoimmune disease, except for diabetes mellitus type I or other conditions, where patient can be eligible following discussion with medical monitor.\n* Subject who has received an organ allograft.\n* Serious intercurrent chronic or acute illness such as pulmonary (COPD or asthma) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinator to constitute an unwarranted high risk for eP\u002FD or investigational DCT.\n* Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use effective contraceptive methods (intrauterine de-vices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) during the study and for at least 12 months after the last study drug administration.\n* Men unwilling to use effective contraception for the duration of the study and for at least 12 months after the last study drug administration.\n* Inadequate peripheral vein access to perform leukapheresis\n* History of receiving any investigational treatment within 28 days of randomization.\n* Absence of assurance of compliance with the protocol. Lack of availability for fol-low-up assessment.\n* Patients with a known allergy to shellfish (may contain KLH).",{"count":160,"type":20},16,[83],"The ENSURE trial is an open label, single center, phase 1, feasibility study. Sixteen adult patients diagnosed with resectable epithelioid malignant pleural mesothelioma (MPM) will be enrolled following first-line chemotherapy. Before standard-of-care chemotherapy, a leukapheresis will be performed and monocytes will be used for differentiation to dendritic cells (DCs) using specific cytokines. Allogeneic tumor lysate (Pheralys) loaded autologous DCs (MesoPher) will be re-injected 3 weeks after completing chemotherapy, 2 times every other week. Four weeks after the first injection with dendritic cell therapy (DCT), patients will undergo extrapleural pleurectomy\u002Fdecortication (eP\u002FD) surgery and receive three bi-weekly injections with DCT (starting 4 weeks after surgery). In total, five DC vaccinations will be administered. A tumor biopsy will be collected before starting neo-adjuvant DCT.",[27],[165,166,167,168],"dendritic cell therapy","malignant pleural mesothelioma","mesopher","pleurectomy\u002Fdecortication","2025-04-24",{"date":171,"type":38},"2025-04-25",{"date":173,"type":38},"2021-11-02",{"date":147,"type":20},{"name":176,"class":44},"Erasmus Medical Center",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":187,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"100438955","phase-3-atezolizumab-versus-placebo-for-the-adjuvant-treatment-of-malignant-pleural-mesothelioma-atezomeso-100438955","NCT04996017","Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso)","PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY\u002FDECORTICATION","AtezoMeso","Inclusion Criteria\n\n* Signed informed Consent Form\n* Age ≥ 18 years on day of signing informed consent\n* Histologically confirmed malignant pleural mesothelioma\n* Surgical resection (P\u002FD), without macroscopic residual. For stage I patient without visceral involvement a total pleurectomy is allowed\n* Absence of measurable or non-measurable disease assessed with CT scan after surgery\n* Patients must have received at least no 4 cycles of platinum\u002Fpemetrexed\n* perioperative chemotherapy as per local practice (neoadjuvant or adjuvant or both). Less than 4 cycles of chemotherapy are allowed for clinical decisions\n\n  \\- In patients previously treated with neoadjuvant chemotherapy, randomization\n* should occur within 50 days from surgical resection.\n\n  \\- In patients treated with adjuvant chemotherapy, randomization should occur\n* within 30 ±7 days from last dose of adjuvant treatment.\n* Performance status of 0-1 on the ECOG Performance Scale\n* Availability of a representative tumor specimen for exploratory biomarker research (see Section 4.5.6 for information on tumor specimens) A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 10 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report prior to study enrollment.\n* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: ANC ³ 1.5 ´ 109\u002FL (1500\u002FmL) without granulocyte colony-stimulating factor support Lymphocyte count ³ 0.5 ´ 109\u002FL (500\u002FmL) Platelet count ³ 100 ´ 109\u002FL (100,000\u002FmL) without transfusion Hemoglobin 9 g\u002FdL Patients may be transfused to meet this criterion. AST, ALT, and alkaline phosphatase (ALP) £ 2.5 ´ upper limit of normal (ULN)\n\nBilirubin £ 1.5 ´ ULN with the following exception:\n\nPatients with known Gilbert disease: bilirubin level £ 3 ´ ULN. Creatinine £ 1.5 ´ ULN Albumin ³ 25 g\u002FL (2.5 g\u002FdL) For patients not receiving therapeutic anticoagulation: INR or aPTT £ 1.5 ´ ULN\n\n• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below: Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for 5 months after the final dose of atezolizumab. Women must refrain from donating eggs during this same period.\n\nA woman is considered to be of childbearing potential if she is postmenarcheal, hasnot reached a postmenopausal state (³12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Examples of contraceptive methods with a failure rate of \\\u003C1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) andn withdrawal are not acceptable methods of contraception. If required per local guidelines or regulations, locally recognized acceptable methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n\nWomen with a positive pregnancy test at enrollment or prior to administration of study medication will be excluded.\n\nExclusion Criteria\n\n* Patient with macroscopic residual disease after surgery, evaluated with CT scan\n* after surgery or adjuvant therapy\n* Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition 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\n* Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy\n* Active infection requiring systemic therapy\n* Patient with positive result to Human Immunodeficiency Virus (HIV) (HIV 1\u002F2\n* antibodies) test\n* Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected) 7. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis\n* obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of\n* active pneumonitis on screening chest computed tomography (CT) scan. NOTE:\n* History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Known active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or\n* greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable\n* angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of\n* study treatment, or anticipation of need for a major surgical procedure during the\n* study\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but\n* not limited to, hospitalization for complications of infection, bacteremia, or severe\n* pneumonia\n* Prior allogeneic stem cell or solid organ transplantation\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab15. Current treatment with anti-viral therapy for HBV\n* Treatment with investigational therapy within 28 days prior to initiation of study\n* treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Scientific Responsible approval has been obtained\n  * Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment\n* Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.",{"count":186,"type":20},162,[188],"PHASE3","This is a multicentric double-blind, placebo controlled, phase III trial. In this study, patients who underwent to a surgical resection of pleural mesothelioma and are without signs of macroscopic residual disease will be randomized 2:1 to receive atezolizumab or placebo. Patients will be treated for 12 months or until recurrence, unacceptable toxicity or patient\u002Fphysician decision, whichever occurs first.\n\nRandomization will be done via a centralized system and patients will be stratified histology (epithelioid vs non epithelioid) and stage (I vs\n\n\\>I). Patients will be radiologically evaluated after surgical procedure before starting therapy and then every 12 weeks for 24 months or until disease progression. At screening patients should be without macroscopic residual disease. Quality of life questionnaire will be administered to patient at baseline and every 12 weeks. During the study baseline tumor blocks will be centrally analyzed to determinate biological characteristics and gene expression.",[27],[136,192,193],"Adjuvant therapy","immunotherapy","2025-03-11",{"date":196,"type":38},"2025-03-13",{"date":198,"type":38},"2021-12-14",{"date":200,"type":20},"2029-06-30",{"name":202,"class":44},"Gruppo Oncologico Italiano di Ricerca Clinica",19,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":73},"100550781","ga-68-fapi-pet-before-immunotherapy-100550781","NCT06451536","Ga-68 FAPI PET Before Immunotherapy","Prognostic Significance of Ga-68 FAPI PET Before Immunotherapy in Pleural Mesothelioma","FAPBI","Inclusion Criteria:\n\n* Having a histopathologically confirmed diagnosis of\n* Pleural Mesolthelioma\n* Patients scheduled for immunotherapy with anti-PDL-1 and\u002For anti-CTLA-4 antibodies as first or second line therapy\n* Patients who gave informed consent form to participate in the study\n\nExclusion Criteria:\n\n* ECOG\\>2\n* Patients who did not provide informed consent form to participate in the study",{"count":54,"type":20},[56],"It is aimed to evaluate FAP expression and its success in predicting treatment response before immunotherapy used in the treatment of malignant mesothelioma with Ga68 FAPI PET\u002FCT imaging, which allows in vivo evaluation of FAP expression, which is thought to be associated with immunosuppression and resistance to immunotherapy.",[27],"2024-06-04",{"date":218,"type":38},"2024-06-11",{"date":220,"type":38},"2024-04-30",{"date":222,"type":20},"2025-04-30",{"name":224,"class":44},"Ankara University"]