[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-mesothelioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-mesothelioma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,77,107,128,153],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100286313","phase-2-brentuximab-vedotin-in-treating-patients-with-cd30-malignant-mesothelioma-that-cannot-be-removed-by-surgery-100286313",false,"NCT03007030","Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery","Phase II Trial of Adcetris (Brentuximab Vedotin) in CD30+ Malignant Mesothelioma","Inclusion Criteria:\n\n* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care\n* Female subject is either: a. post-menopausal for at least one year before the screening visit; or b. surgically sterilized; or c. willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and at least 6 months after the last dose of brentuximab vedotin\n* Male subject, even if surgically sterilized (i.e., status postvasectomy), agrees to use an acceptable barrier method for contraception (condom with a spermicidal agent), or completely abstain from heterosexual intercourse during the entire study treatment period through 6 months after the last dose of brentuximab vedotin\n* Absolute neutrophil count (ANC) \\> 1500\u002Fmm\\^3\n* Platelets \\> 100,000\u002Fmm\\^3\n* Hemoglobin (Hgb) \\> 8.5 g\u002FdL\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) \\\u003C 3 x ULN; AST and\u002For ALT may be up to 5 X ULN if with known liver metastases (mets)\n* Calculated creatinine clearance must be \\>= 30 mL\u002Fminute\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Pathologic diagnosis of malignant mesothelioma (any primary site is acceptable, any histology is acceptable)\n* Have unresectable malignant mesothelioma (any histology)\n* Positive CD30+ immunohistochemical expression\n* Any line of prior therapy - patients may be chemo-naive or chemo-refractory (any line)\n* Patients must have measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) or RECIST; examinations for assessment of measurable disease must have been completed within 28 days prior to registration\n\nExclusion Criteria:\n\n* Radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25%\n* Prior allogeneic bone marrow or organ transplantation\n* Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women\n* Patient has received other investigational drugs with 14 days before enrollment\n* Serious medical or psychiatric illness likely to interfere with participation in this clinical study\n* No prior history of malignancy within 2 years, unless cured of a skin cancer or a stage I-III solid tumor; no prior hematologic malignancy within 3 years\n* Known hypersensitivity to brentuximab vedotin components\n* Persons who are incarcerated at time of enrollment (e.g., prisoners) or likely to become incarcerated during the study","ALL","18 Years",{"count":19,"type":20},55,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies how well brentuximab vedotin works in treating patients with CD30 positive (+) malignant mesothelioma that cannot be removed by surgery. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability of tumor cells to grow and spread.",[26,27],"CD30-Positive Neoplastic Cells Present","Malignant Mesothelioma","RECRUITING","2026-05-13",{"date":31,"type":32},"2026-05-15","ACTUAL",{"date":34,"type":32},"2017-04-05",{"date":36,"type":20},"2027-05-01",{"name":38,"class":39},"M.D. Anderson Cancer Center","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":40},"100627006","phase-1-fast-tils-to-treat-metastatic-pleural-effusions-from-epithelial-or-mesothelial-primary-tumors-100627006","NCT07443020","Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors","Fast TILs to Treat Metastatic Pleural Effusions From Epithelial or Mesothelial Primary Tumors: A Phase I Trial (FAST TILS 2)","RIOT 4B","Inclusion Criteria:\n\n1. Patients with symptomatic, biopsy-proven malignant to the pleura, or mesothelioma with pleural effusions. Patients must have received and be refractory to available standard of care (SOC) therapy specific to their cancer type and must have exhausted or failed available standard of care with clinical benefit.\n2. Patients will be ≥ 18 and \\\u003C 80 years of age.\n3. Female patients of childbearing potential must have a negative urine or serum pregnancy test and if sexually active must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), an injectable contraceptive (such as Depo-Provera), or an oral contraceptive. Active contraception should continue for at least 12 months after ACT administration.\n\n   Male participants must be willing to practice birth control from the time of enrollment on this study and for 4 months after receiving the preparative regimen.\n4. Cardiac ejection fraction ≥ 0.45 by MUGA or echocardiography.\n5. No requirement for supplemental oxygen and no dyspnea immediately after effusion drainage.\n6. ECOG Performance Status 0 or 1.\n7. Patients must have an expected survival \\> 12 weeks.\n8. Patients must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate.\n9. Patients must consent to collection of demographic and clinical data.\n\nExclusion Criteria:\n\n1. Infection with HIV and active viral replication. Patients with an undetectable viral load on Anti-retroviral Therapy (ART) can be considered for participation on this protocol.\n2. Infection with hepatitis B and active viral replication.\n3. Infection with hepatitis C and active viral replication.\n4. Patients currently being treated for bacterial, fungal or viral infection.\n5. Documented myocardial infarction within 6 months of study participation and\u002For symptomatic coronary artery or valvular disease or uncontrolled arrhythmia.\n6. Investigational drug use within 30 days before effusion collection.\n7. Cytotoxic anti-cancer or radiation therapy administration within 2 weeks of effusion collection. The exclusion does not apply to patients receiving monoclonal antibody therapy targeting immune checkpoint molecules.\n8. Corticosteroid therapy \\> 10 mg of prednisone (biological equivalent) daily within 2 weeks before effusion collection.\n9. Immunosuppressive therapy that cannot be stopped for 4 weeks prior to effusion collection as deemed by the prescribing physician.\n10. Laboratory abnormalities that indicate clinically significant hematological, hepatobiliary, or renal disease:\n\n    AST\u002FSGOT \\> 2.0 times the upper limit of normal ALT\u002FSGPT \\> 2.0 times the upper limit of normal Total bilirubin \\> 2.0 times the upper limit of normal, unless patient has Gilbert Syndrome (\\>3.0 times the upper limit of normal) Hemoglobin \\\u003C 8 gm\u002FdL or dependent upon transfusion to maintain ≥ 8 gm\u002FdL White blood cell count \\\u003C 2,000\u002Fmm3 Platelet count \\\u003C 100,000\u002Fmm3 or dependent upon transfusion to maintain ≥ 100,000 mm3 Creatinine \\> 2.0 times the upper limit of normal or calculated creatinine clearance ≤ 40 mL\u002Fmin.\n11. Pregnant or lactating females.\n12. Prior solid organ transplantation\n13. Patients who, in the opinion of the Investigator, will be non-compliant with study schedules or procedures.\n14. Patients who belong to a vulnerable population such as the homeless, the developmentally disabled and prisoners or have any condition that impairs their ability to provide informed consent or comply with study schedules or procedures.\n15. Patients with documented anaphylaxis as a result of penicillin allergy.","79 Years",{"count":51,"type":20},10,[53],"PHASE1","This research study aims to evaluate the safety and effectiveness of a novel immunotherapy, Fast TIL, an Adoptive Cellular Therapeutic (ACT), to fight cancer that has spread to the pleura or pleural mesothelioma. The ACT product is created at AHN West Penn using the participant's pleural infiltrating T-cells (PIT). It is administered through a pleural catheter along with the drug Interleukin-2 (IL-2). Based on previous research it is believed that it may help fight the tumor and relieve symptoms.\n\nAs a participant, their pleural fluid will be collected and the PIT cells will be isolated and expanded in the lab to create the ACT product. Before receiving the ACT product through their pleural catheter, they will undergo outpatient lymphodepleting chemotherapy. LDC is a standard procedure for many approved immunotherapy treatments Following the infusion, they'll receive IL-2 through the catheter for two days to stimulate the expanded PIT cells.\n\nThe active treatment phase lasts about three weeks, with follow-up visits over five years at AHN West Penn Hospital, potentially requiring a hospital stay of up to six days. Blood samples will be taken to monitor their response. As this is a first-in-human study, treatment carries an unknown risk up to and including death from toxicity. However, the risks of similar immunotherapy treatments are well documented.",[56,27,57,58],"Malignant Pleural Effusion","Pleural Effusion, Malignant","Metastasis to Pleura",[60,61,62,63,64,65,66,67],"metastasis to pleura","pleural infiltrating T cells","CliniMACS Prodigy","malignant mesothelioma","pleural effusion, malignant","Adoptive Cellular Therapeutic","immunotherapy","autologous tumor infiltrating lymphocytes (TIL)","2026-04-01",{"date":70,"type":32},"2026-04-07",{"date":72,"type":20},"2026-05",{"date":74,"type":20},"2038-03",{"name":76,"class":39},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":51},"100559588","phase-1-study-of-ism6331-in-participants-with-advancedmetastatic-malignant-mesothelioma-or-other-solid-tumors-100559588","NCT06566079","Study of ISM6331 in Participants With Advanced\u002FMetastatic Malignant Mesothelioma or Other Solid Tumors","A Phase 1, Open-Label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics, and Preliminary Efficacy of ISM6331 in Participants With Advanced\u002FMetastatic Malignant Mesothelioma or Other Solid Tumors","Inclusion Criteria:\n\n1. Male or female participants with age ≥18 years at the time of signing the informed consent.\n2. Histologically confirmed unresectable advanced or metastatic malignant mesothelioma or other solid tumors, who have failed standard therapy or for whom no effective standard therapy exists, participants for part 1 is regardless of the presence or absence of the genetic alterations of the Hippo pathway, but for part 2 participants with solid tumors other than mesothelioma, genetic testing documentation must demonstrate Hippo signaling pathway dysregulation.\n3. Participants with malignant mesothelioma must have prior exposure to at least immune checkpoint therapy and platinum-based chemotherapy.\n4. Presence of at least one evaluable lesion in Part 1 or one measurable target lesion in Part 2 according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for participants with non-pleural mesothelioma or other solid tumors and modified RECIST (mRECIST) v1.1 for participants with malignant pleural mesothelioma.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.\n6. Life expectancy of ≥12 weeks as judged by the investigator.\n7. Adequate organ function as determined by medical assessment (within 7 days prior to the first dose of study treatment).\n8. Capable of providing signed informed consent form (ICF) and complying with the requirements and restrictions listed in the ICF and in this study protocol.\n\nExclusion Criteria:\n\n1. Participants who have previously received a TEAD inhibitor.\n2. Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.\n3. Anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.\n4. Known active central nervous system (CNS) primary tumor or untreated CNS metastases.\n5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases.\n6. Unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition\n7. Have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, laboratory abnormality or any other conditions that, in the investigator's opinion, would not be in the best interest of the participant; or that could alter the absorption, distribution, metabolism, or excretion of the study treatment; or impair the assessment of study result.\n8. Currently receiving any of Strong inhibitors or inducers of P-gp, or Sensitive substrates of P-gp, CYP1A2, CYP2B6, and CYP3A4 that cannot be discontinued 14 days or 5 half-lives for inhibitors or substrates (whichever is shorter) prior to the first dose of study treatment.\n\nOther protocol inclusion and exclusion criteria may apply.",{"count":85,"type":20},100,[53],"This is a Phase 1, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK\u002FPD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic malignant mesothelioma or other solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2).",[27,89,90],"Metastatic Malignant Solid Tumor","Advanced Solid Tumor",[92,93,94,95,96],"Transcriptional enhanced associate domain (TEAD)","TEAD inhibitor","ISM6331","Hippo pathway","YAP\u002FTAZ-TEAD","2026-02-12",{"date":99,"type":32},"2026-02-17",{"date":101,"type":32},"2024-12-27",{"date":103,"type":20},"2028-02-28",{"name":105,"class":106},"InSilico Medicine Hong Kong Limited","INDUSTRY",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":54,"conditions":117,"keywords":118,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":40},"100607772","phase-1-fast-tils-to-treat-metastatic-cancer-patients-with-pleural-disease-100607772","NCT07192900","Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease","Fast TILs to Treat Metastatic Cancer Patients With Pleural Disease: A Phase I Trial","(RIOT 4A)","Inclusion Criteria:\n\n1. Patients with symptomatic, biopsy-proven malignant to the pleura, or mesothelioma with pleural effusions. Patients must have received and be refractory to available standard of care (SOC) therapy specific to their cancer type and must have exhausted or failed available standard of care with clinical benefit.\n2. Patients will be ≥ 18 and \\\u003C 80 years of age.\n3. Female patients of childbearing potential must have a negative urine or serum pregnancy test and if sexually active must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), an injectable contraceptive (such as Depo-Provera), or an oral contraceptive. Active contraception should continue for at least 6 months after ACT administration. Male participants must be willing to practice birth control from the time of enrollment on this study and for 6 months after receiving the preparative regimen.\n4. Cardiac ejection fraction ≥ 0.45 by Multiple-Gated Acquisition (MUGA) or echocardiography.\n5. No requirement for supplemental oxygen and no dyspnea immediately after effusion drainage.\n6. Karnofsky performance score ≥ 70.\n7. Patients must have an expected survival \\> 12 weeks.\n8. Patients must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate.\n9. Patients must consent to collection of demographic and clinical data.\n\nExclusion Criteria:\n\n1. Patients with breast, kidney, lung, pancreatic, prostate, ovarian, rare cancers, and melanoma.\n2. Infection with Human Immunodeficiency Virus (HIV) and active viral replication. Patients with an undetectable viral load on Anti-retroviral Therapy (ART) can be considered for participation on this protocol.\n3. Infection with hepatitis B and active viral replication.\n4. Infection with hepatitis C and active viral replication.\n5. Patients currently being treated for bacterial, fungal or viral infection.\n6. Documented myocardial infarction within 6 months of study participation and\u002For symptomatic coronary artery or valvular disease or uncontrolled arrhythmia.\n7. Investigational drug use within 30 days before effusion collection.\n8. Cytotoxic anti-cancer or radiation therapy administration within 2 weeks of effusion collection. The exclusion does not apply to patients receiving monoclonal antibody therapy targeting immune checkpoint molecules.\n9. Corticosteroid therapy \\> 10 milligrams (mg) of prednisone (biological equivalent) daily within 2 weeks before effusion collection.\n10. Immunosuppressive therapy that cannot be stopped for 4 weeks prior to effusion collection as deemed by the prescribing physician.\n11. Laboratory abnormalities that indicate clinically significant hematological, hepatobiliary, or renal disease:\n\n    AST\u002FSGOT \\> 2.0 times the upper limit of normal ALT\u002FSGPT \\> 2.0 times the upper limit of normal Total bilirubin \\> 2.0 times the upper limit of normal, unless patient has Gilbert Syndrome (\\>3.0 times the upper limit of normal) Hemoglobin \\\u003C 8 gm\u002FdL or dependent upon transfusion to maintain ≥ 8 gm\u002FdL White blood cell count \\\u003C 2,000\u002Fmm3 Platelet count \\\u003C 100,000\u002Fmm3 or dependent upon transfusion to maintain ≥ 100,000 mm3 Creatinine \\> 2.0 times the upper limit of normal or calculated creatinine clearance ≤ 40 mL\u002Fmin.\n12. Pregnant or lactating females.\n13. Prior solid organ transplantation\n14. Patients who, in the opinion of the Investigator, will be non-compliant with study schedules or procedures.\n15. Patients who belong to a vulnerable population such as the homeless, the developmentally disabled and prisoners or have any condition that impairs their ability to provide informed consent or comply with study schedules or procedures.\n16. Patients with documented anaphylaxis as a result of penicillin allergy.",{"count":51,"type":20},[53],[56,27,57,58],[60,61,62,63,64,65,66,67],"2026-01-13",{"date":121,"type":32},"2026-01-15",{"date":123,"type":20},"2026-03",{"date":125,"type":20},"2037-12",{"name":127,"class":39},"David Bartlett, MD",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":4},"100603040","phase-1-study-of-iparomlimab-and-tuvonralimab-plus-chemotherapy-in-malignant-mesothelioma-100603040","NCT07131345","Study of Iparomlimab and Tuvonralimab Plus Chemotherapy in Malignant Mesothelioma","A Single-Arm, Multicenter, Open-Label Phase Ib\u002FII Clinical Study Exploring the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy for the Treatment of Malignant Mesothelioma","Inclusion Criteria:\n\n* Subjects must provide informed consent prior to initiating any study-specific procedures.\n* Male or female subjects aged ≥18 and ≤75 years.\n* Histologically\u002Fcytologically confirmed malignant mesothelioma (MM), including malignant pleural mesothelioma (PM) and malignant peritoneal mesothelioma (PeM).\n* Subjects with MM unsuitable for radical resection and\u002For radiotherapy per AJCC 8th Edition.\n* Subjects who received neoadjuvant\u002Fadjuvant chemotherapy for radical surgery completed \\>6 months prior to current recurrent disease diagnosis, not counted in subsequent treatment lines.\n* Prior systemic anti-tumor therapy requirements:\n\n  * Safety run-in phase: ≥1 prior anti-tumor therapy line (maximum 3 lines)\n  * Phase II first-line cohort: No prior systemic anti-tumor therapy\n  * Phase II second-line cohort: Only 1 prior systemic anti-tumor therapy line\n* ECOG performance status 0-2.\n* Investigator-assessed life expectancy \\>3 months.\n* Adequate hematological parameters.\n\nExclusion Criteria:\n\n* Prior CTLA-4 inhibitors prohibited; prior PD-1\u002FPD-L1 allowed unless discontinued for immune toxicity\n* Immunomodulators within 14 days (e.g., thymosin, interleukin-2, interferon)\n* Significant cardiovascular history within 6 months","75 Years",{"count":19,"type":20},[53,23],"This clinical trial aims to investigate the effectiveness and safety of a new treatment combination-Iparomlimab and Tuvonralimab (QL1706, a dual-function antibody targeting PD-1 and CTLA-4) combined with chemotherapy-for patients with malignant mesothelioma (MM). MM is a rare and aggressive cancer often linked to asbestos exposure. Current treatments have limited success, and this study seeks to explore a potentially more effective and safer option.\n\nStudy Design:\n\nPhase Ib (Safety Phase): 6 patients will receive the combination therapy to assess safety. If no major safety issues arise, the study will proceed to Phase II.\n\nPhase II (Efficacy Phase): 49 patients will be enrolled to evaluate treatment effectiveness. The study includes two groups for first-line treatment and second-line treatment.",[27,140],"Mesothelioma",[27,142,66],"iparomlimab and tuvonralimab","NOT_YET_RECRUITING","2025-08-19",{"date":146,"type":32},"2025-08-20",{"date":148,"type":20},"2025-09-01",{"date":150,"type":20},"2027-07-01",{"name":152,"class":39},"National Cancer Center, China",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":168,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},"100520543","phase-2-a-study-of-additional-chemotherapy-after-surgery-for-people-with-malignant-peritoneal-mesothelioma-100520543","NCT06057935","A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma","ICARuS II (Intraperitoneal Chemotherapy After cytoReductive Surgery): A Multicenter, Randomized Phase II Trial of Normothermic Intraperitoneal Chemotherapy and Intravenous Chemotherapy After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Malignant Peritoneal Mesothelioma","Inclusion Criteria:\n\n* Patient age 18 years or older, both sexes.\n* Clinical diagnosis of MPM at enrolling institution.\n* Prior to randomization, intraoperative pathologic confirmation of epithelioid MPM at enrolling institution.\n* Complete or near-complete CRS achieved.\n* Patient must be planning to undergo complete cytoreduction of all peritoneal disease.\n* ECOG performance status ≤ 1.\n* Hematology: ANC ≥ 1,500\u002Fµl.\n* Platelets \\> 75,000\u002Fµl.\n* Adequate renal function: creatinine \\\u003C 1.5× the upper limit of normal (ULN) or calculated creatinine clearance of ≥50 ml\u002Fmin.\n* Adequate hepatic function: bilirubin \\\u003C 1.5 mg\u002Fdl (except in patients with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL).\n* Women of childbearing potential with a negative pregnancy test result (urine or blood) who agree to use an effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.\n* A man participating in this study must agree to utilize a reliable barrier form of contraception for the duration of the study\n* Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.\n\nExclusion Criteria:\n\n* Subjects who have previously undergone intraperitoneal chemotherapy or systemic chemotherapy for peritoneal mesothelioma.\n* Subjects who have previously received platinum-containing chemotherapy regimens.\n* Subjects with preoperative or intraoperative biopsy consistent with sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma.\n* Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than three years, or indolent tumors for which observation over two years is a reasonable option.\n* High suspicion for extra-abdominal metastases.\n* Women who are pregnant or lactating.\n* Active coronary artery disease (defined as unstable angina or a positive cardiac stress test). Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 60 days of enrollment or are determined by a cardiologist to be of acceptable perioperative risk.\n* Uncontrolled hypertension defined as \\>140\u002F90 and not cleared for surgery at the time of consent.\n* New York Heart Association (NYHA) Class II or higher congestive heart failure; restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.\n* History of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.\n* Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or place them at an unacceptable risk for participation in the study.\n* Patients with known cisplatin, carboplatin, pemetrexed or mitomycin allergy.\n* Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.\n* Any condition that would preclude the ability to deliver appropriate IP therapy.\n* Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator.\n* Life expectancy \\\u003C 12 weeks.",{"count":161,"type":20},64,[23],"The purpose of this study is to find out whether intraperitoneal or intravenous chemotherapy given after cytoreductive surgery and HIPEC are effective treatments for people with malignant peritoneal mesothelioma. Outcomes will be compared by observing intraperitoneal versus intravenous treatments to analyze if one is better than the other.",[165,166,140,167,27],"Malignant Peritoneal Mesothelioma","Peritoneal Mesothelioma","Mesothelioma, Malignant",[165,166,140,167,27,169,170,171],"ICARuS II","Memorial Sloan Kettering Cancer Center","23-145","2025-07-17",{"date":174,"type":32},"2025-07-22",{"date":176,"type":32},"2023-09-21",{"date":178,"type":20},"2028-09-21",{"name":170,"class":39},13]