[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-related-adverse-event\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-related-adverse-event":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,43,68,92,117,141,173,200,222,247,276,307,332,355],{"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":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100644358","phase-2-mycophenolate-mofetil-w-prednisone-for-immune-related-hepatitis-from-checkpoint-inhibitor-therapy-100644358",false,"NCT07663422","Mycophenolate Mofetil w\u002F Prednisone for Immune Related Hepatitis From Checkpoint Inhibitor Therapy","GU-228: Mycophenolate Mofetil in Combination With Prednisone as First-line Treatment of Immune Related Hepatitis Resulting From Checkpoint Inhibitor Therapy","Inclusion Criteria:\n\n* Patients must be ≥ 18 years at the time of irAE diagnosis and must have been diagnosed with a solid tumor or hematologic malignancy being treated with non-curative intent.\n* Patients must be diagnosed or presumed to have by a treating Medical Oncology or Hematology-Oncology clinician with immune-related hepatitis, G2-G3 (as defined in section 11.0), with plan for at least temporary interruption of IO therapy and initiation of corticosteroid treatment.\n* Patients must have been previously treated for any malignancy with at least one dose of an IO agent targeting the Programmed cell death protein 1 (PD-1)\u002Fprogrammed death-ligand 1 (PDL-1) or CTLA-4 axis. IO use may have occurred at any time prior to diagnosis of irAE.\n* Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin must have been measured within screening window outlined in Section 8.0 (Study Calendar).\n* Patient must be able to take study medications by mouth.\n* Baseline hemoglobin (HgB) at time of enrollment ≥8.0 g\u002FdL, absolute neutrophil count (ANC) ≥ 1500\u002Fmm3, and platelet count ≥ 100,000\u002Fmm3 without red blood cell or platelet transfusion in the two weeks preceding measurement of lab values. Lab values are to be assessed within screening window outlined in Section 8.0 (Study Calendar).\n* Baseline estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m2\n* Patients must be able to understand and willing to sign a written informed consent and HIPAA consent document.\n\nExclusion Criteria:\n\n* Patients previously treated for irAE hepatitis.\n* Patients diagnosed or presumed to have G4 immune-related hepatitis.\n* Patients receiving renal replacement therapy with hemodialysis or peritoneal dialysis at time of enrollment.\n* Patients with a documented history of Child-Turcotte-Pugh class B and C liver dysfunction.\n* Patients with significant liver dysfunction at time of presentation, as defined by an otherwise unexplained change in mental status or International Normalized Ratio (INR) ≥ 1.5 attributed to synthetic liver dysfunction.\n* Patients with active hepatitis B (HBV), hepatitis C (HCV), or tuberculosis. Confirmatory testing for these infections may be performed if no recent result is available in the patient's records and, in the opinion of the treating physician, such testing is clinically warranted. Past HBV is exclusionary. Patients with treated HCV infection and documented eradication are eligible to enroll.\n* Patients with uncontrolled human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), cytomegalovirus (CMV), herpes simplex virus (HSV), or Varicella-zoster virus (VZV). Confirmatory testing for these infections is not required.\n* Patients with a history of gastrointestinal bleeding, ulceration, or perforations within one year of trial enrollment. Use of proton-pump inhibitor therapy is allowed.\n* Patients with any history of solid organ or allogeneic stem cell transplantation.\n* Patients with type I diabetes mellitus (DM).\n* Patients with type II DM with most recent glycated hemoglobin measurement greater than or equal to 9.0%.\n* Patients with a documented history of phosphoribosyl-transferase deficiency.\n* History of allergic reactions to MMF, prednisone, methylprednisolone, or dexamethasone.\n* Patients with decompensated congestive heart failure at time of enrollment, at the discretion of treating clinician, regardless of ejection fraction.\n* Patients with history of suicidal ideation or past suicide attempt.\n* Uncontrolled or intercurrent severe medical illness at the time of enrollment, as defined below:\n\n  1. Patients being treated with vasopressors\n  2. Patient requiring mechanical ventilation or extracorporeal membrane oxygenation\n  3. Patients being treated with parenteral antibiotic, antifungal, or antiviral medications\n* Patients with chronic autoimmune diseases requiring long-term immunosuppressive treatment at the time of enrollment, or for whom the mechanism of index inflammatory changes is too uncertain to initiate irAE-directed treatment at the discretion of treating provider.\n* Patients with congenital (e.g. combine variable immunodeficiency) or acquired (e.g. chronic leukemia) immunodeficiency requiring long-term prophylactic antimicrobial treatment at time of enrollment (e.g. intravenous immunoglobulin (IVIg), prophylactic antiviral treatment, etc.)\n* Women of child-bearing potential (WOCBP) who are pregnant or breast-feeding.\n* Patients unable to commit to use of reliable contraception throughout the study period.","ALL","18 Years",{"count":19,"type":20},31,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II study evaluates whether early treatment with mycophenolate mofetil (MMF) plus prednisone improves liver inflammation caused by immune checkpoint inhibitors. The study includes patients who develop moderate to severe immune-related hepatitis after receiving PD-(L)1 or CTLA-4-based cancer therapy. The main goal is to determine how many patients experience improvement in liver function within 30 days while successfully tapering steroids. Safety and treatment-related side effects will also be monitored.",[26,27],"Immune-mediated Hepatitis","Immune-related Adverse Event",[29,30,27],"irAE","Immune-mediated hepatitis","NOT_YET_RECRUITING","2026-06-17",{"date":34,"type":35},"2026-06-23","ACTUAL",{"date":37,"type":20},"2026-06-30",{"date":39,"type":20},"2028-09-30",{"name":41,"class":42},"Fox Chase Cancer Center","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100642768","phase-2-thymosin-alpha-1-combined-with-anti-pd-1-monoclonal-antibody-in-elderly-patients-with-advanced-melanoma-100642768","NCT07644897","Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma","Inclusion Criteria:\n\n1. Aged 60 years or older;\n2. Diagnosis of malignant melanoma confirmed by pathological histology or cytology examination.\n3. According to the 8th edition of AJCC staging, patients with unresectable stage III or IV melanoma;\n4. One or more lesions evaluable by RECIST1.1 standards.\n5. The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States has a score range of 0-2.\n6. Total bilirubin ≤1.5× upper limit of normal (ULN); AST and AST \\\u003C2.5× upper limit of normal (ULN).(No liver metastasis), or \\\u003C5 times the upper limit of normal (ULN) (with liver metastasis);\n7. Patients with recurrent metastasis who have not previously received immunotherapy such as PD-1, PD-L1, CTLA-4 antibodies，also allowed for the enrollment of patients who had used adjuvant\u002Fneoadjuvant therapies\n\n   * If the adjuvant or neoadjuvant treatment plan includes PD(L)-1 or CTLA-4 monoclonal antibodies, it is required that only those who progress more than 6 months after the end of the treatment plan can be included in the study group.\n   * If the adjuvant or neo-adjuvant treatment plan does not include PD(L)-1 or CTLA-4 monoclonal antibodies, patients who progress during the adjuvant treatment are allowed to participate in the study.\n8. Has signed the informed consent form, able to comply with the study protocol and follow-up plan.\n\nExclusion Criteria:\n\n1. Received treatment involving PD-1, PD-L1, or CTLA-4 antibody regimen within the past 6 months;\n2. Patients who have received treatment with thymosin, thymopentin, or thymosin a-1d within 3 months prior to enrollment.\n3. Presence of symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis. For subjects with previously treated CNS metastases, if the subject's condition is stable (no evidence of radiographic progression for at least weeks prior to the first administration of the study intervention, and all neurological symptoms have returned to baseline), repeat radiographic examination confirms no evidence of new brain metastases or enlargement of existing brain metastases, and no need for steroid treatment for at least 14 days prior to the first administration of the study intervention, they may participate in the study.\n4. Patients with active systemic autoimmune diseases requiring systemic treatment (i.e., using immunomodulators, corticosteroids, or immunosuppressants). Replacement therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment.\n5. Has a history of immunodeficiency, including testing positive for HIV, or suffering from other acquired or congenital immunodeficiency diseases, or has a history of organ transplantation and bone marrow transplantation.\n\n6）Allergic to the investigational drug or its components; 7）Presence of active infection requiring systemic treatment; 8) Uncontrolled internal medical complications, such as unstable congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accidents, and hemodynamically unstable arrhythmias, etc.\n\n9\\) The investigator deems them unsuitable for inclusion.","60 Years",{"count":51,"type":20},55,[23],"Primary Objective:\n\nTo evaluate the effectiveness of Thymosin Alpha-1 combined with PD-1 monoclonal antibody in elderly patients with advanced melanoma .\n\nSecondary Objective:\n\nTo evaluate the safety and tolerability of adenpeptide-α1 combined with PD-1 antibody in elderly patients with advanced melanoma .\n\nStudy Design：Open-label, single-arm, non-controlled clinical trial.\n\nPrimary Inclusion Criteria:\n\n1. Age ≥60 years old;\n2. Pathologically confirmed as inoperable or metastatic melanoma;\n3. one or more lesions evaluable by RECIST1.1 standards.\n4. The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States scores from 0-2;\n\nMain exclusion criteria:\n\n1. Received treatment with a regimen containing PD-1, PD-L1, or CTLA-4 antibodies within the past 6 months;\n2. Received thymosin class drug treatment within 3 months before signing the informed consent.\n3. Symptomatic, untreated central nervous system metastases. Treatment： Thymosin Alpha 1 1.6mg, sc，QD，d1-7;1.6mg, sc， three times per week, d8-21. Each 21 days is considered one cycle, for a total of 12 weeks.\n\nAnti-PD-1 monoclonal antibody (Toripalimab) 240mg per dose,ivdrip，Q3W，4 cycles.\n\nPrimary study endpoints:\n\nObjective Response Rate (ORR: CR+PR)\n\nSecondary study endpoints:\n\nProgression-Free Survival (PFS), Duration of Response (DOR), Overall Survival (OS) Adverse Events (AEs)",[55,27,56],"Melanoma","Immune Checkpoint Inhibitor","RECRUITING","2026-06-08",{"date":60,"type":35},"2026-06-12",{"date":62,"type":35},"2023-05-30",{"date":64,"type":20},"2027-09-30",{"name":66,"class":42},"Sun Yat-sen University",2,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100582225","phase-2-inhaled-budesonide-for-recurrence-prevention-and-adjuvant-therapy-in-checkpoint-inhibitor-pneumonitis-100582225","NCT06860542","Inhaled Budesonide for REcurrence Prevention and Adjuvant THerapy in Checkpoint Inhibitor Pneumonitis","Inclusion Criteria:\n\n1. Patients must be 18 years of age, or older on the day of signing informed consent and be willing and able to provide written informed consent\u002Fassent and, in the opinion of the Investigator, comply with protocol tests and procedures\n2. Patients require histologically confirmed solid tumour undergoing immune checkpoint inhibitor (ICI) therapy\n3. Diagnosis of first documented diagnosis of Checkpoint Inhibitor Pneumonitis (CIP) made per European Society for Medical Oncology (ESMO)\u002FAmerican Society for Medical Oncology (ASCO) guidelines with severity \\>\u002Fgrade 2 by Common Terminology Criteria for Adverse Events (CTCAE)v5.0\n\n   a. Per ASCO\u002FESMO consensus guidelines, workup must include a compatible clinical picture, plus\u002Fminus supporting radiographic evidence (chest x-ray or preferably computed tomography (CT)), combined with clinical and\u002For microbiologic ruling out of alternative etiologies including infections or pulmonary disease progression. This includes a negative COVID test. Bronchoscopic sampling is not required, but can be considered.\n4. Be able to effectively operate and use budesonide delivery method (Turbuhaler®), either independently or with aid of caregiver who anticipates being able to do so throughout trial period\n5. Have adequate organ function, as judged by enrolling clinician\n6. Females of childbearing potential have a negative urine or serum pregnancy test prior to study day 1. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses for at least 1 year\n7. Females of childbearing potential are willing to use contraception or abstain from heterosexual sexual contact for the course of the study\n\nExclusion Criteria:\n\n1. Diagnosis of interstitial lung disease (ILD) active (clinically and radiologically evident) within last year prior to diagnosis of CIP\n2. Clinically suspected significant lung disease for which inhaled steroid would be standard of care (moderate asthma or severe chronic obstructive pulmonary disease (COPD)) and for which randomization to no inhaled steroids (control arm) would not represent optimal medical care. Based on enrolling physicians judgement; spirometry\u002Fpulmonary function tests are NOT required to assess this exclusion criteria.\n3. Current (within last two weeks), active (not medically able or unwilling to discontinue prior to treatment start) and regular (2 or more times per week) use of inhaled steroids (for any indication) or systemic (\\>10mg prednisone equivalent) corticosteroids (for indication other than CIP) at time of randomization\n4. Receiving systemic, non-chemotherapy immunosuppressive agent at time of randomization (hydroxychloroquine is acceptable)\n5. Use of a medication with significant interaction with inhaled budesonide (HIV protease inhibitors, ketoconazole or other potent CYP3A4 inhibitors), unless deemed required and safe by co-investigator.\n6. Known poorly controlled diabetes, defined as A1c \\>10, prior to initiation of steroids for CIP\n7. History of active and unstable systemic disease, including heart failure New York Heart Association (NYHA) III or IV, cirrhosis with Child Pugh B or C, Renal Failure with creatinine clearance (CrCl) \\\u003C30 per Cockcroft-Gault formula, or other unstable life limiting condition as determined by trial investigators\n8. Current or prior participation in a study of an investigational agent or device within 4 weeks of randomization\n9. History or current evidence of any condition, therapy, or laboratory abnormalities which might confound trial results, interfere with the patient's participation for the full duration of the trial, or otherwise causing it to be not in the best interest of the patient to participate in the trial, in the opinion of the treating investigator.\n10. Is or has an immediate family member (e.g., spouse, parent\u002Flegal guardian, sibling or child) who is directly involved with this trial, unless prospective ethics board approval (by chair or designee) is given allowing exception to this criterion for a specific patient\n11. Breastfeeding is not permitted during the duration of trial participation.",{"count":75,"type":20},94,[23],"The introduction of immune checkpoint inhibitors (immunotherapy) that stimulate our immune system to recognize and attack cancer cells has been one of the most exciting advances in oncology over the last decade. These medications are now employed across almost half of cancer types and settings, however they come with a cost. In some patients, instead of attacking cancer cells alone, the stimulated immune system damages healthy tissues (immune related adverse events), with one of the most severe and potentially deadly such complications being immune attack on the lungs, or checkpoint inhibitor pneumonitis (CIP). When treated promptly with oral or intravenous steroids, acute CIP improves in many cases, however for approximately one-fifth of patients the lung inflammation is difficult to control, resulting in recurrent shortness of breath, the need for extended courses of oral or intravenous steroids, impacting quality of life and cancer therapy decisions. The goal of the trial is to assess whether use of inhaled steroids, a type of medication commonly used in asthma patients, for one year after a first diagnosis of CIP may help the lung inflammation resolve and not return, without the repeated use of oral or intravenous medications that carry more side effects.",[79,27],"Pneumonitis",[27,81],"Checkpoint Inhibitor Pneumonitis","2026-03-19",{"date":84,"type":35},"2026-03-23",{"date":86,"type":35},"2026-02-10",{"date":88,"type":20},"2030-12-01",{"name":90,"class":42},"AHS Cancer Control Alberta",1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":91},"100518997","phase-2-early-adalimumab-induction-for-immune-checkpoint-inhibitor-associated-inflammatory-arthritis-100518997","NCT06037811","Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis","Early Adalimumab Induction for Treatment of Steroid Dependent Immune Checkpoint Inhibitor Associated Inflammatory Arthritis: A Pragmatic Randomized Clinical Trial","Inclusion Criteria:\n\n* • Patients are deemed eligible for study participation if they meet all the following:\n\n  * Adult patients (age 18 or older)\n  * New (within the last 6 months prior to enrollment) inflammatory arthritis defined by any of the following at the time of screening (either on physical exam or by ultrasound) by a certified rheumatologist:\n* 1 or more swollen joints OR\n* 1 or more tenosynovitis OR\n* 1 or more enthesitis\n\n  * Arthritis onset with taking ICI therapy OR within 4 weeks of stopping ICI therapy including CTLA-4, PD-1, and PDL-1 inhibitors\n  * Initiation of ICI therapy must predate the onset of inflammatory arthritis\n  * Glucocorticoid dependence at any time before enrolment, defined by either:\n* Patients requiring prednisone at a dose of at least 10 mg daily (or equivalent) OR\n* Patients for whom at least 1 glucocorticoid taper failed to control the disease activity\n\n  * Negative tuberculosis (TB) status within the past 12 months (TB skin test or quantiferon) for the patients in the adalimumab group. If not available, the status should be confirmed within 6 months of enrollment in the study (adalimumab group only)\n  * Written informed consent provided by patient or power of attorney\n\nExclusion Criteria:\n\n* Patients are excluded if they meet any of the following:\n* Previous diagnosis of inflammatory arthritis or other rheumatic disease (prior to current acute episode)\n\n  * Including but not limited to: rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, systemic vasculitis, undifferentiated inflammatory arthritis, undifferentiated connective tissue disease\n* Tenosynovitis, synovitis or enthesitis attributed to another cause, fracture or acute gout\u002FCPPD flare.\n* Presence of a contraindication to adalimumab therapy\n\n  * Any of the following in the 7 days prior to initiation of adalimumab: positive tuberculin skin test (\\>5mm induration within 48 to 72 hours) or positive quantiferon, evidence of untreated active infection including fungal infection, opportunistic infection, hepatitis B\u002FC, or HIV\n  * Personal history of congestive heart failure\n  * Personal or family history of demyelinating neurologic disease\n* History of previous TNF inhibitor use\n* Current use of other disease modifying agents including: Chloroquine, Sulfasalazine, Azathioprine, 6-MP, and Leflunomide\n* Presence of a concomitant non-rheumatic irAE which required systemic immunosuppression within the past 3 months e.g. pneumonitis, hepatitis, colitis, scleritis, nephritis\n* Require chronic steroid treatment for adrenal insufficiency or another medical reason other than ir-IA\n* Pregnancy, breastfeeding or childbearing potential without practicing highly effective contraception.\n* Inability to participate in follow-up visits",{"count":100,"type":20},30,[23],"This study will examine the effectiveness of administering adalimumab as a treatment for patients in the early stages of steroid-dependent immune checkpoint Inhibitor associated inflammatory arthritis (ir-IA). Adalimumab (ADA) is a TNF inhibitor (TNFi) that is well established as a standard of care treatment for numerous types of inflammatory arthritis. It is hoped that adalimumab at the early stages of the ir-IA will reduce the symptoms and therefore reduce the need for steroids. This study is a pragmatic randomized clinical trial. Patients will be randomized 1:1 to each treatment group. To evaluate the steroid sparing effect of early induction six doses of Adalimumab will be administered to patients in the study treatment arm as compared to the usual standard of care of a predefined corticosteroid regimen and taper at 12 weeks administered in the control group.",[104,27],"Inflammatory Arthritis",[56,106,107],"Adalimumab","TNF-alpha inhibitor","2026-02-27",{"date":110,"type":35},"2026-03-03",{"date":112,"type":35},"2024-04-15",{"date":114,"type":20},"2028-12",{"name":116,"class":42},"Tom Appleton",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":91},"100490257","phase-2-prophylactic-mesalamine-to-prevent-colitis-following-treatment-with-ipilimumabnivolumab-ipinivo-100490257","NCT05663775","Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab\u002FNivolumab (Ipi\u002FNivo)","Prophylactic Oral Mesalamine for the Prevention of Immune-Related Colitis in Patients Treated With Ipilimumab\u002FNivolumab","IMPACT 1","Inclusion Criteria:\n\n1. Patients must be 18 years of age or older.\n2. Patients with histologically confirmed, unresectable stage III or IV malignant melanoma.\n3. Patients must be capable of providing consent to enrolment and treatment.\n4. Patients with a performance status of ECOG 0-224 will be eligible for enrolment (see appendix16.1).\n5. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n6. Patients of childbearing \u002F reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 30 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n\n   -Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n7. Female patients who are breast-feeding should discontinue nursing prior to the first dose of study treatment and until 30 days after the last dose of study drug.\n8. Male patients should agree to not donate sperm during the study and for a period of at least 30 days after last dose of study drug\n9. Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.\n\n   * The following adequate organ function laboratory values must be met:\n\nHematological:\n\n* Absolute neutrophil count (ANC) \\>1.5 x109\u002FL\n* Platelet count \\>100 x109\u002FL\n* Hemoglobin \\>9 g\u002FdL (may have been transfused)\n\nRenal:\n\no Estimated creatinine clearance ≥ 30 mL\u002Fmin according to the Cockcroft-Gault formula (or local institutional standard method)\n\nHepatic:\n\n* Total serum bilirubin \\\u003C2x ULN\n* AST and ALT \\\u003C2.5x ULN (or ≤ 5 x ULN for subjects with documented metastatic disease to the liver)\n\nExclusion Criteria:\n\n1. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n2. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n3. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE v5 Grade ≥ 3).\n4. Other severe acute or chronic medical conditions or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.",{"count":126,"type":20},20,[23],"The study team's principal interest is to address the question, \"Will prophylactic treatment with mesalamine reduce the incidence and severity of immune-related diarrhea occurring secondarily to treatment with ipi\u002Fnivo?\"",[27,130,131,132],"Diarrhea","Advanced Melanoma","Advanced Rectal Carcinoma","2025-06-24",{"date":135,"type":35},"2025-06-27",{"date":137,"type":35},"2024-08-20",{"date":139,"type":20},"2027-08",{"name":90,"class":42},{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":153,"conditions":154,"keywords":158,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":91},"100501758","identification-of-predictive-biomarkers-for-immune-related-adverse-events-iraes-in-patients-undergoing-immune-checkpoint-inhibitors-icpi-treatment-100501758","NCT05813418","Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment","Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients","Ibe2i-TIPCI","Inclusion Criteria:\n\n* patient with cancer, whatever initial tumoral histology and disease stage under ICPI treatment (anti-PD1 and\u002For anti-CTLA-4)\n* age \\> 18\n* followed in oncology, pneumology, dermatology, gastroenterology departments of Amiens-Picardie University Hospital or Saint Quentin hospital\n* who received verbal and written information, and signed the consent form for the study\n\nExclusion Criteria:\n\n* non ICPI treated patients\n* patient who received a first line of ICPI treatment\n* patient who received or is receiving MEK inhibitors as a treatment (because of possible lower response to ICPI treatment when associated)",{"count":150,"type":20},150,[152],"NA","In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy.\n\nRecently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). The last ones can induce durable anti-tumoral responses in patients, even if metastases are present. Their mechanisms of action are focused on the activation of immune system in order to eliminate the tumor. ICPI, because of their mechanisms of action, target immune tolerance key components and can induce important immune toxicities (colitis, hepatitis, dermatitis, thyroiditis ...), leading to early discontinuation of treatment, severe or chronic morbidity, and can sometimes be lethal. It is of importance to detect patient at risk of irAEs, because of the increasing use of ICPI and the long- term response capacity in treated patients.",[155,156,27,157],"Immunotherapy","Immune Checkpoint Inhibitors","Predictive Biomarkers",[159,160,27,161,162,163],"immunotherapy","immune checkpoint inhibitors","predictive biomarkers","plasmatic cytokines","circulating immune subpopulations","2025-06-03",{"date":166,"type":35},"2025-06-04",{"date":168,"type":35},"2021-07-02",{"date":170,"type":20},"2025-12",{"name":172,"class":42},"Centre Hospitalier Universitaire, Amiens",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":180,"sex":16,"minAge":17,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":4},"100585872","early-phase-1-safety-virological-and-immunological-assessment-of-the-controlled-dengue-human-infection-model-in-dengue-immune-participants-in-thailand-dhit-immune-100585872","NCT06908018","Safety, Virological and Immunological Assessment of the Controlled Dengue Human Infection Model in Dengue-Immune Participants in Thailand (DHIT-Immune)","DHIT-Immune","Inclusion Criteria:\n\n1. Thai healthy volunteers, aged between 18 to 40 years old, weight is greater than or equal to 50 kg and have Thai language literacy.\n2. Have not given blood donation in the past 3 months.\n3. Education: high school diploma or above\n4. Positive dengue-immune status against DENV-1 and\u002For DENV-3 and\u002For DENV-4 with naive DENV-2 status by the standard FRNT 50% (FRNT50) as follows: FRNT50 titer against\n\n   * DENV1 ≥ 1:5 and\u002For\n   * DENV3 ≥ 1:5 and\u002For\n   * DENV4 ≥ 1:5 with\n   * DENV2 ≤ 1:16\n5. Willingness to participate in the study as evidenced by signing the informed consent document.\n6. Female participants of childbearing potential should be agreed to either abstinence or use at least one primary form of contraception from the time of screening for rDEN2Δ30-7169 administration until 1 month after complete course of Dengue vaccination (Study Day 298).\n\nExclusion Criteria:\n\n1. For female participants: Currently pregnant, as determined by positive urine human choriogonadotropin (HCG) test or breast-feeding, and given birth or abortion within 6 months.\n2. History of previous acute undifferentiated febrile illness leading to hospitalization in the past 3 months.\n3. Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the subject's ability to understand and cooperate with the requirements of the study protocol.\n4. Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by subject history.\n5. History of a severe allergic reaction or anaphylaxis.\n6. Severe asthma (emergency room visit or hospitalization within the last 6 months).\n7. Any known immunodeficiency syndrome.\n8. Having any pre-existing medical conditions consist of thrombocytopenia, autoimmune disease and cancer based on history, physical examination, and\u002For laboratory studies.\n9. Current use of anticoagulant medications (this includes anti-platelet medication such as aspirin or non-steroidal anti-inflammatory medications).\n10. Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as ≥ 10 mg of a prednisone equivalent per day for ≥ 14 days.\n11. Asplenia\n12. Receipt of any vaccine within 28 days or a killed vaccine within 14 days prior to receiving virus administration, or anticipated receipt of any vaccine during the 28 days following rDEN2Δ30-7169 administration.\n13. Has an obvious history of receiving any type of dengue vaccine or has previously participated in dengue vaccine research.\n14. Receipt of blood products within the past 6 months, including transfusions or immunoglobulin, or anticipated receipt of any blood products or immunoglobulin during the 28 days following rDEN2Δ30-7169 administration.\n15. History of allergy to Qdenga vaccine or any components of the vaccine.\n16. Previous episode of severe dengue infection defined by WHO 2009\n17. Screening laboratory values of Grade 1 or above (as defined in this protocol) for ANC (\\\u003C750 \u002Fmm3), Platelet (\\\u003C100,000 \u002Fmm3), PT (\\> 1.25 x ULN), APTT (\\> 1.66 x ULN), ALT (\\>2.5 x ULN) and plasma creatinine (\\> 1.3 x ULN OR Increase to \\>1.3 x participant's baseline).\n18. A participant with hemoglobin level less than 10 g\u002FdL at initial screening.\n19. Body temperature is greater than or equal to 38.0 °C (Oral)\n20. HIV infection, as indicated by anti-HIV screening assays.\n21. Hepatitis C virus (HCV) infection, as indicated by anti-HCV screening assays.\n22. Hepatitis B virus (HBV) infection, as indicated by hepatitis B surface antigen (HBsAg) and\u002For anti-HBc screening.\n23. Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, or would render the subject unable to comply with the protocol.",true,"40 Years",{"count":183,"type":20},12,[185],"EARLY_PHASE1","rDEN2Δ30-7169 is a dengue challenge strain that previously reports its viremia induction effect in participants with minimal symptoms in US flavivirus naïve participants. Moreover, preliminary result of five Thai dengue naïve participants from previous project (registered number NCT05476757) demonstrated 100% viremia status without severe adverse event after 60 days post-virus challenge. However, result from previous project may not fully represent the clinical manifestation and immunological responses of major population of endemic areas, where most people in endemic area have dengue immune status. Therefore, this controlled human infection model protocol proposes to challenge the attenuated virus in 12 dengue-immune participants recruited from Bangkok metropolitan area, Thailand. We aim to assess the safety, viremia, NS1 antigenemia profile, and immunogenicity of the challenge virus in the dengue immune participants. After finish safety assessment, all participants will be vaccinated with a full course of dengue vaccines to prevent recurrent dengue infection. Immunological responses after vaccination will be also evaluated the vaccine efficacy.\n\nOur expected outcomes are all participants present viremia profiles after virus challenge without serious adverse events (SAE). The exploratory profiles include assesment of immune profiles and parameters comparison with the other dengue challenge study.",[188,189,190,27],"Safety Issues","Dengue","Viremia","2025-04-01",{"date":193,"type":35},"2025-04-03",{"date":195,"type":20},"2025-09",{"date":197,"type":20},"2028-09",{"name":199,"class":42},"Mahidol University",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":91},"100503234","food-intervention-to-reduce-immunotherapy-toxicity-100503234","NCT05832606","Food Intervention to Reduce Immunotherapy ToXicity","FORX01","Inclusion Criteria:\n\n* solid tumor starting anti-programmed cell death protein 1 (anti-PD1) and\u002For anti-cytotoxic T-lymphocyte-associated antigen 4 (anti-CTLA4) antibodies as part of standard of care.\n* able to sign informed consent.\n\nExclusion Criteria:\n\n* no oral intake possible.\n* probiotic use and unwillingness to stop during the trial.\n* combination therapy with chemotherapy or targeted agents.",{"count":208,"type":20},60,[152],"The FORX (Food intervention to Reduce immunotherapy toXicity) trial will assess whether supplementing dietary fiber intake by providing weekly boxes containing 30 different plants to patients with solid tumors starting immune checkpoint inhibitor therapy affects the incidence of immune related adverse events.",[27,212],"Dietary Habits","2025-03-21",{"date":215,"type":35},"2025-03-26",{"date":217,"type":35},"2024-01-01",{"date":219,"type":20},"2026-12-31",{"name":221,"class":42},"Universitair Ziekenhuis Brussel",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":91},"100576490","phase-4-statins-to-prevent-immune-checkpoint-inhibitor-induced-progression-of-atheroslerosis-100576490","NCT06785974","Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis","SPIRAL","Inclusion Criteria:\n\n* In order to be eligible to participate in this study, a subject must meet all of the following criteria:\n* Age ≥ 18 years\n* Able to understand the written information and able to give informed consent\n* Melanoma diagnosis with planned ICI treatment according to standard of care (nivolumab, pembrolizumab, monotherapy or combination therapy with ipilimumab)\n* Presence of atherosclerosis in the descending thoracic aorta at baseline.\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Baseline statin use or previously reported statin intolerance\n* Current or recent (≤1 year) history of alcohol or drug abuse\n* Contra-indication for statin therapy, including:\n\n  * Active liver disease, including ALT\u002FAST levels ≥ 3x ULN\n  * (History of) myopathy Congenital muscular disorder History of (drug-induced) rhabdomyolysis History of drug-induced myopathy with elevated creatine kinase (CK)\n  * Severe kidney failure (creatinine clearance \\\u003C 30 ml\u002Fmin)\n* Use of essential medication with (potential) interactions with atorvastatin, including:\n\n  * strong CYP3A4 inhibitors such as clarithromycin, ciclosporin, itraconazol, ketoconazole, voriconazol, posconazol, HCV agents, HIV protease inhibitors\n  * BCRP inhibitors such as elbasvir and grazoprevir\n  * Fibrates (including gemfibrozil)\n* Life expectancy \\\u003C 12 months\n* High MESA-score at baseline",{"count":230,"type":20},140,[232],"PHASE4","The goal of this interventional study is to test whether atorvastatin prevents accelerated progression of atherosclerosis in melanoma patients who receive immune checkpoint inhibitor (ICI) therapy. The main questions it aims to answer are:\n\n* difference in percentage growth of total atherosclerotic plaque volume (+ calcified and non-calcified plaque volume) in the descending thoracic segment of the aorta\n* difference in percentage growth of total atherosclerotic plaque volume (+ calcified and non-calcified plaque volume) in coronary arteries.\n\nResearchers will compare patients that receive ICI-therapy and atorvastatin with patients that receive ICI-therapy + placebo to see if atorvastatin will prevent accelerated ICI induced plaque growth.",[235,55,27],"Atherosclerosis",[237,56],"Statin","2025-01-14",{"date":240,"type":35},"2025-01-22",{"date":242,"type":20},"2025-02",{"date":244,"type":20},"2030-02",{"name":246,"class":42},"Erasmus Medical Center",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":258,"conditions":259,"keywords":262,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":91},"100563207","exploring-the-treatment-duration-of-pd-1-neoadjuvant-therapy-in-stage-ii-iii-dmmr-rectal-cancer-100563207","NCT06613165","Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer","Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer: a Prospective，Multicentre, Single-arm Study","Inclusion Criteria:\n\n* 1.Age: 18 to 80 years old, male or female;\n* 2.Patients with histologically or cytologically confirmed dMMR\u002FMSI-H rectal adenocarcinoma, clinical stage II-III;\n* 3.No prior systemic therapy, including chemotherapy, radiotherapy, immunotherapy, or targeted therapy;\n* 4.ECOG Performance Status (PS) score of 0-1;\n* 5.Estimated life expectancy of ≥ 3 months;\n* 6.Normal function of major organs, with no severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, or immunodeficiency. Laboratory tests must meet the following criteria: Hemoglobin (Hb) ≥ 90 g\u002FL; White blood cell count (WBC) ≥ 3.0 × 10\\^9\u002FL; Neutrophil count (NEUT) ≥ 1.5 × 10\\^9\u002FL; Platelet count (PLT) ≥ 90 × 10\\^9\u002FL; Liver function (Aspartate Aminotransferase AST or Alanine Aminotransferase ALT) ≤ 2.5 times the upper limit of normal (ULN); Renal function (serum creatinine sCr) ≤ 1.5 times ULN; Total bilirubin (TBIL) ≤ 1.5 times ULN; Urine protein and occult blood \\\u003C 2+; Fecal occult blood \\\u003C 2+;\n* 7.Subjects must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits;\n* 8.The investigator believes that the patient can benefit from the treatment. Physical status score PS ≤ 2;\n* 9.Patients and their families must understand and be willing to participate in this study, providing written informed consent.\n\nExclusion Criteria:\n\n* 1.Patients with a confirmed allergy to the investigational drug and\u002For its excipients;\n* 2.Subjects who have received or are currently receiving additional chemotherapy, radiotherapy, targeted therapy, or immunotherapy;\n* 3.Patients with any active autoimmune disease or a history of autoimmune disease;\n* 4.Patients with Lynch syndrome;\n* 5.Patients with poorly controlled cardiac symptoms or diseases, such as New York Heart Association (NYHA) Class II or higher heart failure, unstable angina pectoris, or myocardial infarction within the past year;\n* 6.Pregnant or lactating women;\n* 7.Patients with acute infections requiring antibiotic treatment;\n* 8.Patients with positive hepatitis B or hepatitis C antibodies;\n* 9.Patients with positive HIV antibodies;\n* 10.Patients with other diseases that the investigating physician considers may affect prognosis and survival;\n* 11.Any other conditions deemed inappropriate for participation in this study by the investigating physician.","80 Years",{"count":256,"type":20},100,"OBSERVATIONAL","This study aims to explore the optimal number of cycles of PD-1 monotherapy required at minimum, under the premise of ensuring pathological complete response (pCR) among patients with dMMR\u002FMSI-H rectal cancer.\n\nParticipants will receive preoperative monotherapy with PD-1 antibodies, with regular reassessments every 2 cycles. Surgical intervention will be performed if clinical complete response (cCR) is achieved.\n\nResearchers will compare the pathological complete response rates, adverse reactions, and three-year event-free survival rates across different treatment cycles.",[27,260,261],"Neoadjuvant Therapy","dMMR Colorectal Cancer",[263,264,265,266],"Colorectal Cancer","deficient Mismatch Repair","locally advanced","immune checkpoint","2024-12-22",{"date":269,"type":35},"2024-12-27",{"date":271,"type":20},"2025-01-01",{"date":273,"type":20},"2028-09-20",{"name":275,"class":42},"Xijing Hospital",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":284,"minAge":17,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":21,"phases":287,"briefSummary":288,"conditions":289,"keywords":293,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":306},"100537517","phase-2-satellite-study-feasibility-safety-efficacy-dostarlimab-early-stage-deficient-endometrial-cancer-100537517","NCT06278857","SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)","A Phase 2b, Open-label, Single Arm, Multicentre, Pilot Study of the Efficacy, Safety and Tolerability of Dostarlimab in Women With Early-stage MMR Deficient Endometrioid Endometrial Adenocarcinoma.","SATELLITE","Inclusion Criteria:\n\n1. Female participant is at least 18 years of age (at the time of informed consent).\n2. Participant has:\n\n   i. histologically or cytologically proven Stage 1, FIGO grade 1 or 2, MMR deficient (Absence of at least one MMR protein (MLH1, PMS2, MSH2, MSH6) by immunohistochemistry.) endometrioid endometrial adenocarcinoma, and\n\n   ii. wish to preserve the uterus or are not a suitable candidate for hysterectomy.\n3. Participant has an ECOG performance status of ≤ 2\n4. Participant demonstrates no evidence of extrauterine disease assessed from all available clinical evidence (physical examination findings) and medical imaging including standard of care diagnostic CT, MRI, ultrasound, or X-ray and screening gadolinium contrast pelvic MRI\n5. Participants must have adequate organ and bone marrow function defined as:\n\n   i. absolute neutrophil count 1.5 x 109\u002FL ii. platelets 100 x 109\u002FL iii. haemoglobin ≥9 g\u002FdL\n\n   Adequate liver function:\n\n   iv. total bilirubin \\\u003C 1.5x institutional upper limit normal (ULN) v. AST\u002FALT \\\u003C 2. 5 - 3x ULN\n\n   Adequate renal function as defined by:\n\n   vi. Creatinine \\\u003C 1.5x institutional upper limits OR creatinine clearance \\> 30 ml\u002Fmin\n\n   Adequate coagulation profile:\n\n   vii. INR or PT ≤ 1.5 x ULN unless the participant is receiving anticoagulant therapy as long as INR or PTT is within the therapeutic range of intended use of anticoagulants viii. aPTT ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy as long as INR or PTT is within the therapeutic range of intended use of anticoagulant\n6. A potential participant with a clinical abnormality or laboratory parameters outside the normal reference range for the population being studied may be rescreened once, at the Investigator's discretion, and may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors to the participant and will not interfere with the study procedures.\n7. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at enrolment prior to each treatment cycle and use a highly effective contraceptive method including; oral contraceptive pills \\[OCPs\\], or an intrauterine hormone device \\[IUD\\]) from screening until at least 4 months following the last dose of dostarlimab. Females who are abstinent from heterosexual intercourse as part of their usual lifestyle do not need to use contraception.\n8. Post-menopausal females. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels (≥ 40 IU\u002FmL) at screening for amenorrhoeic (≥ 12 months) female participants.\n9. Participants with confirmed Type I or Type II diabetes mellitus must be well controlled by medication and\u002For diet and have glycated haemoglobin (HBAc1) \\\u003C 8.5% at screening and be willing to monitor blood glucose levels at home during study participation.\n10. Participants must have normal blood pressure (BP) or adequately treated and controlled hypertension.\n11. Participant is able to provide written informed consent and are willing to participate for the duration of the study and to follow study procedures.\n\nExclusion Criteria:\n\n1. Participant has a histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high-risk endometrial e.g., papillary serous, clear cell).\n2. Participant is pregnant, breastfeeding, or planning to become pregnant during the trial period.\n3. Participant has had an allogeneic tissue\u002Fsolid organ transplant.\n4. Participants with uncontrolled hypertension, history of hypertension crisis, history of hypertensive encephalopathy, QTc\\>450 at baseline, other severe cardiovascular diseases including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, New York Heart Association (NYHA) class III and IV heart failure and uncontrolled arrhythmia within the past 6 months. Rate-controlled arrhythmia may be eligible at the discretion of the Investigator.\n5. Participant is considered a poor medical risk due to an uncontrolled medical disorder, non-malignant systemic disease, or active infection (including, r acute pelvic inflammatory disease), requiring intravenous antibiotics within the past 2 weeks. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).\n6. Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the study start.\n7. Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Use of inhaled steroids, local injection of steroids, and steroid eye drops are allowed.\n8. Participant with severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2; COVID-19) influenza A\u002FB within 3 months of screening.\n9. Participant received a transfusion of blood products (including platelets or red blood cells) within 21 days prior to the first dose of the study drug.\n10. Participant has undergone major surgery in the 4 weeks prior to consent.\n11. Participant has -experienced any of the following with prior immunotherapy: any immune-related AE (irAE) of Grade 3 or higher, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome\u002Fmyasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms \\[DRESS\\] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.)\n12. Participant has taken part in a clinical trial of an investigational medical product or device within 30 days or 5 half-lives before study start, whichever comes later. \\[except hormonal IUD\\]\n13. Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for ≤5 years since end of treatment for the malignancy Non-melanoma skin cancer and definitively treated in-situ carcinomas is allowed.\n14. Participant has a known history of Human Immunodeficiency Virus (HIV), or a positive test at screening.\n15. Known active Hepatitis B or C, complete curative treatment and have no detectable viral RNA.\n16. Participants are known to be hypersensitive to the active substance or any of the excipients.\n17. Participant has a history or current diagnosis of interstitial lung disease.\n18. Participant has received or is scheduled to receive, a live vaccine within 30 days before the first dose of study treatment, during study treatment, and for up to 180 days after receiving the last dose of study treatment.\n19. Unwilling or unable to follow protocol requirements, including attendance at follow-up visit\u002Fs.\n20. Participant has any condition contraindicated with tumor \u002Fblood sampling procedures required by the protocol.","FEMALE",{"count":286,"type":20},10,[23],"The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions.\n\nParticipants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks.\n\nThis research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer.",[290,291,292,27],"Endometrial Cancer Stage I","Mmr Deficiency","Endometrioid Endometrial Adenocarcinoma",[290,291,294,295],"Immunotherapy drug","Anti-programmed death receptor - 1(PD-1)","2024-12-02",{"date":298,"type":35},"2024-12-03",{"date":300,"type":35},"2024-08-01",{"date":302,"type":20},"2028-06-30",{"name":304,"class":305},"Queensland Centre for Gynaecological Cancer","OTHER_GOV",3,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":21,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":91},"100570078","the-effect-of-serum-ferritin-in-irae-100570078","NCT06702566","The Effect of Serum Ferritin in irAE","The Significance of Serum Ferritin in the Diagnosis, Differential Diagnosis, and Prognosis of Immune-related Adverse Event (irAE)","Inclusion Criteria:\n\nOnly patient who meet all the following conditions can be selected for this trial:\n\n1. Patients voluntarily sign informed consent;\n2. The age was 18-75 years old, and the gender was not limited;\n3. Patients with definitive diagnosis of malignant solid tumor or acute leukemia;\n4. Patients enrolled in will be treated with immunotherapy (including immuno- monotherapy，or immuno- plus targeted therapy, or immuno- plus chemotherapy), or targeted therapy (including targeted monotherapy, or targeted plus chemotherapy), or chemotherapy.\n5. The Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 or 2 for physical fitness;\n6. Sufficient bone marrow reserve at screening, defined as:\n\n   * Neutrophil absolute value (ANC) \\> 1.5 × 10\\^9\u002FL；\n   * Lymphocyte absolute value (ALC) ≥ 0.3 × 10\\^9\u002FL；\n   * Platelet (PLT) ≥ 100 × 10\\^9\u002FL；\n   * Hemoglobin (HGB) ≥ 100g \u002F L;\n7. The screening has appropriate organ function and meets the following criteria:\n\n   * Aspartate aminotransferase (AST) ≤ 2.5 times ULN (due to tumor infiltration ≤ 5 times ULN);\n   * Alanine aminotransferase (ALT) ≤ 2.5 times ULN (due to tumor infiltration ≤ 5 times ULN);\n   * Total serum bilirubin ≤ 1.5 times ULN (due to tumor infiltration ≤ 3 times ULN);\n   * Serum creatinine (SCR) ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60ml \u002F min;\n   * Have the lowest level of lung reserve, defined as ≤ grade 1 dyspnea and oxygen saturation \\> 91% in non oxygen breathing state;\n   * International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial prothrombin time (APTT) ≤ 1.5 times ULN;\n8. The urine pregnancy test of women of childbearing age is negative. Any male and female patient with fertility must agree to use effective contraceptive methods during the whole study and at least 1 year after the study treatment.\n\nExclusion Criteria:\n\nPatient who meet any of the following conditions well excluded in this trial:\n\n1. Active systemic autoimmune disease is known before screening and is under treatment;\n2. Those who stopped systemic hormone therapy for less than 2 weeks before enrollment；\n3. Those who have received organ \u002F tissue transplantation before screening;\n4. Those who meet any of the following conditions during screening:\n\n   * positive for hepatitis B surface antigen (HBsAg) and \u002F or hepatitis B e antigen (HBeAg);\n   * hepatitis B e antibody (HBE AB) and \u002F or hepatitis B core antibody (HBC AB) are positive, and the copy number of HBV-DNA is greater than the lower measurable limit;\n   * positive for hepatitis C antibody (HCV AB);\n   * positive anti Treponema pallidum antibody (TP AB);\n   * HIV antibody test positive;\n   * the copy number of EBV-DNA and cmv-dna is greater than the lower measurable limit;\n5. The heart meets any of the following conditions during screening:\n\n   * left ventricular ejection fraction (LVEF) ≤ 50% (echo);\n   * New York Heart Association (NYHA) class III or IV congestive heart failure;\n   * hypertension (systolic blood pressure ≥ 140mmHg and \u002F or diastolic blood pressure ≥ 90mmHg) or pulmonary hypertension that has not been controlled by standard treatment;\n   * have had myocardial infarction or cardiac surgery within 12 months before cell transfusion;\n   * clinically significant valvular disease.\n6. There are clinical emergencies (such as intestinal obstruction or vascular compression) requiring urgent treatment due to tumor body obstruction or compression during screening;\n7. Patients with active bleeding during screening;\n8. Patients with deep venous thrombosis or pulmonary embolism within 6 months before screening;\n9. Those who received live vaccine within 6 weeks before screening;\n10. Patients with active infection and need treatment during screening;\n11. Poor compliance.","75 Years",{"count":316,"type":20},1500,[152],"This is a prospective clinical study to clarify serum ferritin as a biomarker for the diagnosis, differential diagnosis and prognosis of immune-related adverse event(irAE).",[27,320,321,322],"Malignant Solid Tumors","Acute Leukemia","Serum Ferritin","2024-11-21",{"date":325,"type":35},"2024-11-25",{"date":327,"type":35},"2024-07-04",{"date":329,"type":20},"2027-07-01",{"name":331,"class":42},"Tianjin Medical University Cancer Institute and Hospital",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":91},"100493085","treatment-of-immune-related-adverse-events-refractory-to-standard-therapy-and-associated-changes-in-immunophenotype-100493085","NCT05700565","Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype","PRIA","Inclusion Criteria:\n\n1. Subjects must we willing and able to comply with scheduled visits and must have given written informed consent.\n2. irAE after immune checkpoint inhibitor therapy (PD-1\u002FPD-L1 or PD-1 + CTLA4 blockade)\n3. irAE refractory to therapy with corticosteroids or inability to taper corticosteroids to prednisone equivalent \\\u003C= 5mg. An irAE is defined as refractory if corticosteroids do not improve symptoms within 72 hours. The inability to taper corticosteroids is defined as relapse on standard tapering of 1 mg\u002Fkg corticosteroid over 28 days.\n\nExclusion Criteria:\n\n1. Contraindications for the treatment with ECP including a known sensitivity to psoralen compounds such as 8-MOP, comorbidities that may result in photosensitivity, aphakia, history of heparin-induced thrombocytopenia, unsatisfactory cardio-circulatory function, low hematocrit values\n2. Pregnancy\n3. Body weight less than 40 kg.",{"count":340,"type":20},50,"This study is an open, monocentric study. It includes patients with irAE refractory to standard therapy or patients where corticosteroids cannot be tapered. Patients will either be treated with ECP or second line immunosuppressive therapy according to investigator's choice. Patients will be followed for 24 weeks after first treatment.",[27],[344,345],"Steroid-refractory","Steroid-dependent","2024-03-13",{"date":348,"type":35},"2024-03-15",{"date":350,"type":35},"2022-01-01",{"date":352,"type":20},"2027-01-01",{"name":354,"class":42},"Lucie Heinzerling",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":91},"100500718","fast-track-cardiovascular-assessment-for-suspicion-of-cardiovascular-events-on-immunecheckpoint-inhibitors-100500718","NCT05799898","Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors","Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors: Prospective Cohort Study.","FAST-TRACK","Inclusion Criteria:\n\n* all patient referred to the cardio oncology unit for suspected immune related cardiovascular complication on immune checkpoint inhibitors\n\nExclusion Criteria:\n\n* none",{"count":364,"type":20},200,"Prospective study cohort on patients addressed for suspected cardiovascular event on immune checkpoint inchibitors.\n\nLongitudinal prospective single center cohort. Inclusion criteria: all patient willing to particiupate seen in the cardio-oncology unit at our institution for the suspicion of heart failure, atherosclerosis related event, Tako Tsubo, arrhymias, pericarditis, myocarditis on antiPD1, antiPDL1, or antiCTLA4 immune checkpoint inhibitors.\n\nDescription of patients characteristics, investigations, diagnosis after multidisciplinary meeting, outcomes.",[367,56,368,27],"Cancer","Cardiovascular Complication","2023-03-23",{"date":371,"type":35},"2023-04-05",{"date":373,"type":35},"2022-03-01",{"date":375,"type":20},"2030-01-01",{"name":377,"class":42},"Institut Mutualiste Montsouris"]