[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-thymic-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-thymic-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100650678","phase-2-a-phase-ii-investigator-initiated-exploratory-study-of-sacituzumab-tirumotecan-for-previously-treated-unresectable-thymic-carcinomas-100650678",false,"NCT07750353","A Phase II, Investigator-Initiated Exploratory Study of Sacituzumab Tirumotecan for Previously Treated Unresectable Thymic Carcinomas","XANTHOS","Inclusion Criteria:\n\n1. Pathologically diagnosed (histological or cytological examination) as thymic carcinoma originating in the thymus or from a metastatic site Immunohistochemical staining including diagnostic marker testing is recommended. If performed prior to registration, the timing is not restricted. However, if histological examination was conducted at another institution, the pathological diagnosis must generally be obtained by a pathologist at the study site, e.g., by requesting the pathological specimen.)\n2. Meets any of the following criteria:\n\n   1. Thymic carcinoma was classified as Stage IV by the Masaoka-Koga staging at initial diagnosis\n   2. Thymic carcinoma was classified as Stage III by the Masaoka-Koga staging at initial diagnosis and was judged to be unresectable with curative resection\n   3. The disease is a postoperative recurrence of thymic carcinoma\n3. The patients do not have symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiation therapy or surgical intervention\n4. The patients do not have pericardial effusion, pleural effusion, or ascites requiring treatment\n5. Age ≥ 18 years at registration\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1\n7. At least one measurable lesion on contrast-enhanced CT (brain, neck, chest, abdomen, pelvis: slice thickness ≤ 5 mm) performed within 14 days prior to registration (same day of the week 2 weeks prior to registration date is acceptable; same applies below)\n8. History of combination chemotherapy including platinum agents for unresectable thymic carcinoma (treatment in this study will be second-line or later)\n9. No administration of anticancer drugs (chemotherapy, molecularly targeted therapy, immunotherapy, etc.) or other investigational drugs within 28 days prior to the registration date (same day of the week 4 weeks prior to registration date is acceptable; same applies below)\n10. No surgery under general anesthesia within 28 days prior to the registration date\n11. No radiation therapy (including gamma knife, cyberknife) within 14 days prior to the registration date\n12. Laboratory tests performed within 14 days prior to the registration date meet the following criteria #1 to #8. However, no administration of granulocyte colony-stimulating factor (G-CSF) or blood transfusion within 14 days prior to the blood draw date\n\n    1. Neutrophil count ≥ 1,500\u002Fmm³\n    2. Platelet count ≥ 10 × 10⁴\u002Fmm³\n    3. Hemoglobin ≥ 9.0 g\u002FdL\n    4. AST ≤ 75 U\u002FL (up to 150 U\u002FL allowed if liver metastases are present)\n    5. ALT ≤ 75 U\u002FL (up to 150 U\u002FL allowed if liver metastases are present)\n    6. Total bilirubin ≤ 1.5 mg\u002FdL\n    7. PT-INR ≤ 1.5\n    8. Creatinine ≤ 1.5 mg\u002FdL (If creatinine \\> 1.5 mg\u002FdL, eligibility is confirmed if creatinine clearance (CrCl)\\* ≥ 30 mL\u002Fmin) \\*CrCl is calculated using the Cockcroft-Gault formula: \\[\\[140-age (years)\\] × weight (kg)\\] \u002F \\[72 × serum creatinine (mg\u002FdL) × 0.85 (for females)\\]. Alternatively, CrCl may be measured from a 24-hour urine collection.\n13. Percutaneous oxygen saturation (SpO2) ≥ 92% under room air within 14 days prior to registration date\n14. Patients with adverse events from prior anticancer therapy must have recovered to Grade 1 or below or to baseline values (excluding alopecia and leukoplakia). If endocrine-related adverse events are present, they must be adequately managed with hormone replacement therapy.\n15. For males: Agree to the following for at least 120 days after the last dose of study drug:\n\n    Refrain from sperm donation Use condoms during sexual intercourse with non-study participants of childbearing potential, and have the partner use an additional contraceptive method as described in the Appendix 18.2\n16. For females: Not pregnant or breastfeeding, and meeting at least one of the following conditions:\n\n    1. The patients do not fall under the definition of a woman of childbearing potential (POCBP, Appendix 18.2)\n    2. Falls under the definition of a woman of childbearing potential and has agreed to the following:\n\n    For at least 210 days from consent to the final study drug administration, use a highly effective (failure rate \\\u003C1% per year) and low user-dependent contraceptive method as listed in the Appendix 18.2, or have permanently and continuously abstained from penile-vaginal intercourse as a preferred and habitual lifestyle. During this period, the patient agrees not to donate or freeze\u002Fstore eggs (ova, oocytes) to others. The period required to maintain contraception for the study treatment is from day 0 (final dose) to day 210. The investigator will assess compliance with the contraception requirements (Appendix 18.2) prior to the first study drug dose.\n\n    A negative pregnancy test must be confirmed using either a urine hCG pregnancy test within 14 days prior to the date of enrollment Refer to Appendix 18.2 for additional requirements regarding pregnancy testing during and after study treatment.\n\n    To reduce the risk of including women with very early, undetected pregnancies, the investigator is responsible for confirming the patient's medical history, menstrual history, and recent sexual activity.\n\n    For lactating patients, they must agree not to breastfeed for at least 10 days after the final study drug dose.\n17. Written informed consent for study participation has been obtained from the patient.\n18. Patients who have undergone cancer genomic profiling testing and have agreed to provide their C-CAT ID (limited to patients registered within Japan). For patients enrolled in South Korea, genomic profiling results, if available, may be provided for supplementary analyses.\n\nExclusion Criteria:\n\n1. Patients with thymoma and immune complications associated with thymoma (such as myasthenia gravis, aplastic anemia, hypogammaglobulinemia (Good syndrome), etc.)\n2. Patients with intestinal paralysis or intestinal obstruction\n3. Patients with a history of severe dry eye syndrome, severe meibomian gland disease, or severe corneal disease (impeding or delaying corneal healing)\n4. Uncontrolled major cardiovascular or cerebrovascular disease (NYHA Class III or IV heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, QTcF interval \\>480 ms, or other major cardiovascular or cerebrovascular disease within 6 months prior to enrollment\n5. Patients with unresolved stomatitis greater than Grade 1 at the time of registration are excluded. Prophylactic supportive care measures for stomatitis are permitted, provided there are no active stomatitis-related symptoms.\n6. Previous treatment history with a TROP2-targeted ADC (such as sacituzumab govitecan)\n7. Previous treatment history with topoisomerase I inhibitors (irinotecan, topotecan) or ADCs containing topoisomerase I inhibitors (e.g., trastuzumab deruxtecan)\n8. Received a live or live-attenuated vaccine within 30 days prior to the registration date. Inactivated vaccines may be administered.\n9. Currently receiving a strong CYP3A4 inducer\u002Finhibitor (Appendix 18.4) that cannot be discontinued during the treatment period of the protocol treatment. The required washout period prior to the registration date is 14 days.\n10. Known malignancy that has progressed or required active treatment within the past 3 years.\n\n    Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (except carcinoma in situ of the bladder) who have undergone curative resection are not excluded.\n\n    Note: Untreated patients with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤ 6, PSA \\\u003C 10 ng\u002FmL) who have undergone curative treatment or whose disease is stable under active surveillance are not excluded.\n11. Active infection requiring systemic therapy.\n12. Positive for HIV antibody, HBs antigen, or HCV-RNA (HCV-RNA measured only if HCV antibody is positive).\n13. HBs antigen negative, HBs antibody or HBc antibody positive, and HBV-DNA quantitative positive (not excluded if below detection limit).\n14. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the investigator or sub-investigator.\n15. Has a history of severe hypersensitivity (Grade 3 or higher) to the study drug, its excipients, or other biological therapies.\n16. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids, has current pneumonitis\u002Finterstitial lung disease, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.","ALL","18 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a non-randomized, open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of sacituzumab tirumotecan (hereafter referred to as sac-TMT) in patients with unresectable thymic carcinoma who have a history of platinum-based combination chemotherapy.",[26],"Unresectable Thymic Carcinoma",[28,29],"sacituzumab tirumotecan","thymic carcinoma","NOT_YET_RECRUITING","2026-08-02",{"date":33,"type":34},"2026-08-06","ACTUAL",{"date":36,"type":20},"2027-02-01",{"date":38,"type":20},"2030-06",{"name":40,"class":41},"National Cancer Center, Japan","OTHER_GOV",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100308432","phase-1-pembrolizumab-in-treating-participants-with-unresectable-thymoma-or-thymic-cancer-100308432","NCT03295227","Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer","Feasibility Trial of Pembrolizumab in Unresectable Thymoma and Thymic Carcinoma","Inclusion Criteria:\n\n* Unresectable thymoma or thymic carcinoma.\n* Any line of prior therapy allowed.\n* Be willing and able to provide written informed consent\u002Fassent for the trial.\n* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n* Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.\n* Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) PS.\n* No history of or current diagnosis of a 'significant autoimmune disease\" or paraneoplastic autoimmune disease, i.e. myasthenia gravis, Lambert-Eaton, systemic lupus, rheumatoid arthritis. For minor 'autoimmune' disorders such as psoriasis, arthritis (not including rheumatoid arthritis), Raynaud's disease; these are allowed onto trial.\n* No active hepatitis or diagnosis of human immunodeficiency virus (HIV) disease.\n* No prior malignancy unless it was cured over 2 years ago; i.e. prostate cancer, or early stage (I-III) solid tumors. Patients with a prior basal skin cancer or squamous cell carcinoma of the skin or in situ cervical malignancy that have undergone curative treatment are excluded from this requirement.\n* Absolute neutrophil count \\>= 1500\u002FmcL (within 10 days of treatment initiation).\n* Platelets \\>= 100000mcL (within 10 days of treatment initiation).\n* Hemoglobin \\>= 9 g\u002FdL or \\>= 5.6 mmol\u002FL without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment) (within 10 days of treatment initiation).\n* Serum creatinine OR measured or calculated creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) =\\\u003C 1.5 X upper limit of normal (ULN) OR \\>= 60 mL\u002Fmin for subject with creatinine levels \\> 1.5 X institutional ULN (within 10 days of treatment initiation). Note: Creatinine clearance should be calculated per institutional standard.\n* Serum total bilirubin =\\\u003C 1.5 X ULN OR direct bilirubin =\\\u003C ULN for subjects with total bilirubin levels \\> 1.5 ULN (within 10 days of treatment initiation).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 X ULN OR =\\\u003C 5 X ULN for subjects with liver metastases (within 10 days of treatment initiation).\n* Albumin \\>= 2.5 mg\u002FdL (within 10 days of treatment initiation).\n* International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =\\\u003C 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants =\\\u003C 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (within 10 days of treatment initiation).\n* Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n* Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\nExclusion Criteria:\n\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Has a known history of active TB (Bacillus tuberculosis).\n* Hypersensitivity to pembrolizumab or any of its excipients.\n* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =\\\u003C grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =\\\u003C grade 1 or at baseline) from adverse events due to a previously administered agent. - Note: Subjects with =\\\u003C grade 2 neuropathy are an exception to this criterion and may qualify for the study. - Note: If subject received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\n* Has a known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies).\n* Has known active hepatitis B (e.g., hepatitis B surface antigen \\[HBsAg\\] reactive) or hepatitis C (e.g., hepatitis C virus (HCV) ribonucleic acid (RNA) \\[qualitative\\] is detected).\n* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines are live attenuated vaccines, and are not allowed.",{"count":51,"type":20},37,[53],"PHASE1","This phase I trial studies the sides effects and best dose of pembrolizumab in treating participants with thymoma or thymic cancer that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.",[56,57,58,59,60,61,26],"Stage III Thymoma AJCC v8","Stage IIIA Thymoma AJCC v8","Stage IIIB Thymoma AJCC v8","Stage IV Thymoma AJCC v8","Stage IVA Thymoma AJCC v8","Stage IVB Thymoma AJCC v8","RECRUITING","2026-07-15",{"date":65,"type":34},"2026-07-16",{"date":67,"type":34},"2017-12-06",{"date":69,"type":20},"2027-12-31",{"name":71,"class":72},"M.D. Anderson Cancer Center","OTHER",1]