[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sarcoma Oncology Research Center, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":129},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,63,87,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644495","phase-2-metronomic-gemcitabine-mitomycin-c-and-thalidomide-for-advanced-solid-tumors-100644495",false,"NCT07671534","Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors","GEMINI: Phase II Study Using Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors","GEMINI","Inclusion Criteria:\n\n1. Male or Female ≥ 18 years of age\n2. Pathologically confirmed diagnosis of locally advanced or metastatic solid tumor\n3. Previously treated participants\n4. Measurable disease by RECIST v1.1\n5. ECOG performance status ≤ 1\n6. Life expectancy of at least 3 months\n7. Acceptable liver function: Bilirubin ≤ 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \\\u003C 3.0 ULN); AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 3 x ULN (\\\u003C 5 x ULN if liver metastases); Acceptable renal function: Creatinine \\\u003C 1.5 times ULN\n8. Acceptable hematologic status (without hematologic support e.g. growth factors or transfusion within 21 days of first dose of study agents): ANC ≥ 1500 cells\u002FμL; Platelet count ≥ 100,000\u002FμL; Hemoglobin ≥ 9.0 g\u002FdL; Normal PT, PTT, INR\n9. All women of childbearing potential must have a negative pregnancy test and all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.\n10. Females of reproductive potential must have 2 negative pregnancy tests before initiating THALOMID. The first test should be performed within 10-14 days, and the second test within 24 hours prior to prescribing THALOMID. Once treatment has started and during dose interruptions, pregnancy testing for females of reproductive potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding. THALOMIDE treatment must be discontinued during this evaluation.\n11. Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the principal investigator's IRB\u002FEthics Committee\n12. Willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n1. Subjects with untreated CNS metastases. Subjects are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to treatment initiation. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of \\\u003C10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment initiation.\n2. Subjects with carcinomatous meningitis\n3. Subjects who participated in an investigational drug or device study within 14 days prior to study entry\n4. Subjects who had chemotherapy within 14 days prior to study entry\n5. Females who are pregnant or breast-feeding\n6. Unwillingness or inability to comply with the study protocol for any reason\n7. Evidence of severe or uncontrolled systemic disease or any other concurrent condition, including psychiatric, which in the principal investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the trial\n8. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection\n9. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open label phase II study using metronomic low-dose gemcitabine and mitomycin c given intravenously, and thalidomide administered orally, for patients with advanced solid tumors.",[27],"Solid Tumor Cancer","RECRUITING","2026-06-22",{"date":31,"type":32},"2026-06-26","ACTUAL",{"date":34,"type":21},"2026-06",{"date":36,"type":21},"2029-06",{"name":38,"class":39},"Sarcoma Oncology Research Center, LLC","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100403588","phase-2-metronomic-trabectedin-gemcitabine-and-dacarbazine-for-soft-tissue-sarcoma-100403588","NCT04535271","Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma","TAGGED: A Phase 2 Study Using Low Dose\u002FMetronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd\u002F3rd\u002F4th Line Therapy for Advanced Soft Tissue Sarcoma","TAGGED","Inclusion Criteria:\n\n* Male or Female ≥ 18 years of age\n* Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic leiomyosarcoma\n* Previously treated patient with measurable disease by RECIST v1.1\n* ECOG performance status ≤ 2\n* Life expectancy of at least 3 months\n* Acceptable liver function: Bilirubin \\\u003C 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \\\u003C 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos \\\u003C 2.5 x ULN (\\\u003C 5 x ULN if liver metastases present)\n* Acceptable renal function: Creatinine \\\u003C 1.5 times ULN and creatinine clearance \\> 60 ml\u002Fmin using the Crockroft-Gault formula\n* Acceptable hematologic status: ANC \\>1000 cells\u002FμL; Platelet count \\>100,000\u002FμL; Hemoglobin \\> 9.0 g\u002FdL\n* INR and PT \\\u003C 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants\n* Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB\u002FEthics Committee\n* Willingness to comply with all study procedures and availability for the duration of the study\n* All women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.\n\nExclusion Criteria:\n\n* Currently receiving treatment with another investigational device or drug study, or \\\u003C14 days since ending treatment with another investigational device or drug study(s).\n* Subject has known sensitivity to trabectedin, gemcitabine or dacarbazine.\n* Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.\n* Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.\n* Sexually active subjects and their partners unwilling to use male or female latex condom",{"count":50,"type":21},80,[24],"This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.",[54],"Leiomyosarcoma","2025-02-21",{"date":57,"type":32},"2025-02-24",{"date":59,"type":32},"2021-09-09",{"date":61,"type":21},"2029-03-30",{"name":38,"class":39},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":40},"100353778","phase-2-talimogene-laherparepvec-nivolumab-and-trabectedin-for-sarcoma-100353778","NCT03886311","Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma","The TNT Protocol: A Phase 2 Study Using Talimogene Laherparepvec,Nivolumab and Trabectedin as First, Second\u002FThird Line Therapy for Advanced Sarcoma, Including Desmoid Tumor and Chordoma","TNT","Inclusion Criteria:\n\n* Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:\n\n  * Male or Female ≥ 18 years of age\n  * Pathologically confirmed diagnosis of locally advanced unresectable or metastatic sarcoma including desmoid tumor and chordoma\n  * Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB\u002FEthics Committee\n  * Willingness to comply with all study procedures and availability for the duration of the study.\n  * Previously untreated or treated patient with measurable disease by RECIST v1.1, and at least, one accessible tumor for intratumoral injection of TALIMOGENE LAHERPAREPVEC\n  * ECOG performance status ≤ 1\n  * Life expectancy of at least 3 months\n  * Acceptable liver function: Bilirubin \\\u003C1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \\\u003C 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos \\\u003C 2.5 x ULN (\\\u003C 5 x ULN if liver metastases present)\n  * Acceptable renal function: Creatinine \\\u003C 1.5 times ULN\n  * Acceptable hematologic status: ANC \\>1500 cells\u002FμL or greater; Platelet count \\>100,000\u002FμL or greater; Hemoglobin \\> 9.0 g\u002FdL or greater\n  * INR and PT \\\u003C 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants\n  * All women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.\n\nExclusion Criteria:\n\n* All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation, as follows:\n\n  * Known active central nervous system (CNS) metastases. 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 \\>10 mg\u002Fday of prednisone or equivalent. The exception does not include carcinomatosus meningitis which is excluded regardless of clinical stability.\n  * History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n  * Evidence of clinically significant immunosuppression such as the following: - Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease. - concurrent opportunistic infection. - receiving systemic immunosuppressive therapy (\\> 2 weeks) including oral steroid doses \\> 10 mg\u002Fday of prednisone or equivalent within 7 days prior to study treatment.\n  * Active herpetic skin lesions or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).\n  * Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use.\n  * Previous treatment with TALIMOGENE LAHERPAREPVEC or any other oncolytic virus.\n  * Received live vaccine within 28 days prior to study treatment.\n  * Prior immunosuppressive, chemotherapy, radiotherapy (in which the field encompassed a planned injection site), biological cancer therapy, or major surgery within 28 days prior to study treatment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to study treatment. Adjuvant hormonal therapy is allowed if appropriate for planned study.\n  * Prior radiotherapy in which the field does not overlap the injection sites or nonimmunosuppressive targeted therapy within 14 days prior to study treatment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 14 days prior to study treatment\n  * Currently receiving treatment with another investigational device or drug study, or \\\u003C 28 days since ending treatment with another investigational device or drug study(s).\n  * Other investigational procedures while participating in this study are excluded.\n  * Known to have acute or chronic active hepatitis B infection.\n  * Known to have acute or chronic active hepatitis C infection.\n  * Known to have human immunodeficiency virus (HIV) infection.\n  * History of other malignancy within the past 5 years with the following exceptions:\n\n    * Adequately treated non melanoma skin cancer without evidence of disease at the time of enrollment;\n    * Adequately treated cervical carcinoma in situ without evidence of disease at the time of enrollment;\n    * Adequately treated breast ductal carcinoma in situ without evidence of disease at the time of enrollment;\n    * Prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of enrollment.\n  * Subject has known sensitivity to TALIMOGENE LAHERPAREPVEC, NIVOLUMAB or TRABECTEDIN or any of its components to be administered during dosing.\n  * Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of TALIMOGENE LAHERPAREPVEC, NIVOLUMAB or TRABECTEDIN.\n  * Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of TALIMOGENE LAHERPAREPVEC, NIVOLUMAB or TRABECTEDIN.\n  * Sexually active subjects and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with TALIMOGENE LAHERPAREPVEC.\n  * Subjects who are unwilling to minimize exposure with his\u002Fher blood or other body fluids to individuals who are at higher risks for HSV-1 induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or infants under the age of 3 months, during TALIMOGENE LAHERPAREPVEC treatment and through 30 days after the last dose of TALIMOGENE LAHERPAREPVEC.",{"count":72,"type":21},200,[24],"This is a Phase 2 study using talimogene laherparepvec, nivolumab, and trabectedin as first, second or third line therapy for advanced sarcoma, including desmoid tumor and chordoma.",[76],"Sarcoma",[78,79,80],"marine derived alkaloid","PD1 inhibitor","CTLA4 inhibitor",{"date":57,"type":32},{"date":83,"type":32},"2019-05-15",{"date":85,"type":21},"2031-07-31",{"name":38,"class":39},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":108,"locationsCount":40},"100296375","phase-1-sainttrabectedin-ipilimumab-and-nivolumab-for-previously-treated-advanced-soft-tissue-sarcoma-100296375","NCT03138161","SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma","SAINT: A Phase 1\u002F2 Study of Safe Amounts of IPLIMUMAB, NIVOLUMAB and TRABECTEDIN for Previously Treated Advanced Soft Tissue Sarcoma (STS)","Inclusion Criteria:\n\n* Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:\n\n  * Male or Female ≥ 18 years of age\n  * Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma\n  * For the Phase 1 Part of Study, previously treated patients will be enrolled. For the Phase 2 Part of Study, previously treated patients will be enrolled.\n  * Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the investigator's IRB\u002FEthics Committee\n  * Willingness to comply with all study procedures and availability for the duration of the study.\n  * Measurable disease by RECIST v1.1\n  * ECOG performance status ≤1\n  * Life expectancy of at least 3 months\n  * Acceptable liver function: Bilirubin ≤ 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level ≤ 3.0 ULN);AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 3 x ULN (≤ 5 x ULN if liver metastases)\n  * Acceptable renal function: Creatinine ≤1.5 times ULN or ≥ 60 mL\u002Fmin (using the Cockcroft Gault formula)\n  * Acceptable hematologic status (without hematologic support): WBC ≥2000\u002FµL; ANC ≥ 1500 cells\u002FμL; Platelet count ≥ 100,000\u002FμL; Hemoglobin ≥ 9.0 g\u002FdL; Normal PT, PTT, INR\n  * All women of childbearing potential must have a negative pregnancy test and all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.\n\nExclusion Criteria:\n\n* All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation, as follows:\n\n  * Subjects with untreated CNS metastases. Subjects are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to treatment initiation. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment initiation.\n  * Subjects with carcinomatous meningitis\n  * Anticancer treatment with radiation therapy, chemotherapy, targeted therapy or other antitumor treatment within 2 weeks prior to study entry\n  * Subjects who participated in an investigational drug or device study within 14 days prior to study entry\n  * Females who are pregnant or breast-feeding\n  * Unwillingness or inability to comply with the study protocol for any reason\n  * Non-oncology vaccine therapy used for prevention of infectious disease within 4 weeks of trial enrollment\n  * • History of or known or suspected autoimmune disease (exception(s): patients with vitiligo, Type I diabetes, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at Screening are allowed). Other exceptions may be allowed following discussion with the Sponsor Medical Monitor for patients who have not received treatment for their autoimmune disorder in the past 3 years.\n  * Systemic immunosuppression, including HIV positive status with or without AIDS\n  * Skin rash (psoriasis, eczema) affecting ≥ 25% body surface area\n  * Inflammatory bowel disease (Crohn's or ulcerative colitis)\n  * Ongoing or uncontrolled diarrhea within 4 weeks of trial enrollment\n  * Recent history of acute diverticulitis, intraabdominal abscess or gastrointestinal obstruction within 6 months of trial enrollment, which are known risk factors for bowel perforation\n  * Patients with congestive heart failure or recent cardiac event\n  * Evidence of severe or uncontrolled systemic disease or any other concurrent condition, including psychiatric, which in the principal investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial\n  * Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection\n  * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n  * Inadequate hematologic, renal or hepatic function defined by any of the following screening laboratory values: WBC ≤2000\u002FµL; Neutrophils ≤1500\u002FµL; Platelets ≤ 100,000\u002FµL; hemoglobin ≤9.0 g\u002FdL; Serum creatinine ≥1.5 x ULN or creatinine clearance ≤ 60 mL\u002Fmin (using the Cockcroft Gault formula); AST\u002FALT ≥3 x ULN (≥ 5 x ULN if liver metastases); Total Bilirubin ≥1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level ≥ 3.0 ULN)\n  * Current, active or previous history of heavy alcohol abuse\n  * Pituitary endocrinopathy\n  * Adrenal insufficiency or excess",{"count":95,"type":21},250,[97,24],"PHASE1","This is an open label, dose-seeking phase 1\u002F2 study using escalating doses of TRABECTEDIN given intravenously with defined doses of IPILIMUMAB and NIVOLUMAB based on preliminary results of the Checkmate 012 trial for NSCLC (Hellman et al., 2016). For the Phase 1 Part of Study, only previously treated patients will be enrolled. For the Phase 2 Part of Study, previously treated patients will be enrolled.",[100,101],"Advanced Soft Tissue Sarcoma","Metastatic Soft Tissue Sarcoma",[103],"cancer immunotherapy, combination chemo-\u002Fimmunotherapy",{"date":57,"type":32},{"date":106,"type":32},"2017-04-13",{"date":85,"type":21},{"name":38,"class":39},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":40},"100403622","phase-2-gallant-metronomic-gemcitabine-doxorubicin-docetaxel-and-nivolumab-for-advanced-sarcoma-100403622","NCT04535713","GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma","GALLANT: A Phase 2 Study Using Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab as Second\u002FThird Line Therapy for Advanced Sarcoma","Inclusion Criteria:\n\n* Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic sarcoma\n* Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB\u002FEthics Committee\n* Willingness to comply with all study procedures and availability for the duration of the study.\n* Previously treated patient with measurable disease by RECIST v1.1\n* ECOG performance status ≤ 2\n* Life expectancy of at least 3 months\n* Acceptable cardiac function with LV ejection fraction of \\> 50%\n* Acceptable liver function: Bilirubin \\\u003C 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \\\u003C 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos \\\u003C 2.5 x ULN (\\\u003C 5 x ULN if liver metastases present)\n* Acceptable renal function: Creatinine \\\u003C 1.5 times ULN and creatinine clearance \\> 60 ml\u002Fmin using the Crockroft-Gault formula\n* Acceptable hematologic status: ANC \\>1000 cells\u002FμL; Platelet count \\>100,000\u002FμL; Hemoglobin \\> 9.0 g\u002FdL\n* INR and PT \\\u003C 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants\n* All women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.\n\nExclusion Criteria:\n\n* History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Currently receiving treatment with another investigational device or drug study, or \\\u003C14 days since ending treatment with another investigational device or drug study(s).\n* Subject has known sensitivity to gemcitabine, doxorubicin, docetaxel or nivolumab.\n* Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of gemcitabine, doxorubicin, docetaxel or nivolumab.\n* Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of gemcitabine, doxorubicin, docetaxel or nivolumab.\n* Sexually active subjects and their partners unwilling to use male or female latex condom",{"count":117,"type":21},260,[24],"This is an open label phase 2 study for advanced sarcoma using metronomic doses of gemcitabine, doxorubicin and docetaxel, and nivolumab immunotherapy given intravenously.",[76],"2024-07-02",{"date":123,"type":32},"2024-07-05",{"date":125,"type":32},"2020-09-30",{"date":127,"type":21},"2025-12-31",{"name":38,"class":39},""]