[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"undifferentiated-pleomorphic-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:undifferentiated-pleomorphic-sarcoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,50,98,126,158,198,225],{"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":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100388061","phase-2-a-study-of-pembrolizumab-plus-local-chemotherapy-using-isolated-limb-infusion-ili-for-patients-with-sarcoma-in-the-arm-or-leg-100388061",false,"NCT04332874","A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg","A Phase II Study of Concurrent Systemic Pembrolizumab and Isolated Limb Infusion (ILI) With Melphalan and Dactinomycin for Patients With Locally Advanced or Metastatic Extremity Sarcoma","Inclusion Criteria:\n\nPatients must fulfill all of the following criteria to be eligible for admission to the study. Any exceptions from the protocol-specific selection criteria must be approved by the Principal Investigator and\u002For the Institutional Review Board (IRB) before enrollment.\n\n* Age \\>\u002F= 12 years at the time of informed consent\n* Willing and able to provide written informed consent\u002Fassent for the trial\n* Willing to comply with treatment protocol\n* Have a histologically confirmed metastatic and\u002For locally advanced sarcoma\n* Eligible for standard treatment with pembrolizumab\n* Eligible for an isolated limb infusion (ILI) as determined by the treating physician\n* Have undergone at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) or have declined the standard of care systemic option.\n* Have measurable disease (at least one index lesion) as defined by RECIST 1.1 or by clinical measurement for superficial lesions not amenable to radiographic surveillance. Index lesions must not be chosen from a previously irradiated field unless there has been radiographically and\u002For pathologically documented tumor progression in that lesion prior to enrollment.\n* Adequate performance status: ECOG \\\u003C\u002F= 2 or KPS \\>\u002F= 60%\n* Adequate organ function determined within 3 weeks of treatment initiation, defined as follows:\n\n  * Hemoglobin \\>\u002F= 8.0 g\u002FdL\n  * Absolute neutrophil count \\>\u002F= 1,000\u002Fmm\\^3 (1.0 x 10\\^9\u002FL)\n  * Platelet count \\>\u002F= 50,000\u002Fmm\\^3 (50 x 10\\^9\u002FL)\n  * Serum bilirubin \\\u003C\u002F= 1.5 x upper limit of normal (ULN) OR direct bilirubin \\\u003C\u002F= ° ° ULN for a patient with total bilirubin level \\> 1.5 x ULN Aspartate aminotransferase (AST) \\\u003C\u002F= 2.5 x ULN OR \\\u003C\u002F= 5 x ULN for patients with liver metastases\n  * Alanine aminotransferase (ALT) \\\u003C\u002F= 2.5 x ULN OR \\\u003C\u002F= 5 x ULN for patients with liver metastases\n  * Alkaline phosphatase \\\u003C 5 x ULN\n  * Serum creatinine \\\u003C\u002F= 1.5 x ULN or a measured or calculated creatinine clearance \\>\u002F= 60 mL\u002Fmin for a patient with creatinine levels \\> 1.5 x institutional ULN (Note: Creatinine clearance need not be determined if the baseline serum creatinine is within normal limits. GFR can also be used in place of creatinine or CrCl)\n  * International normalized ratio (INR) or prothrombin time (PT) \\\u003C\u002F= 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n  * Activated partial thromboplastin time (aPTT) \\\u003C\u002F= 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT is within therapeutic range of intended use of anticoagulants\n\nCreatinine clearance should be calculated per institutional standard.\n\nFor female patients of childbearing potential, negative serum pregnancy test at screening visit and within 72 h prior to the first dose of study medication.\n\nExclusion Criteria:\n\nPatients who fulfil any of the following criteria are not eligible for admission to the study:\n\n* Have any other malignancy that requires active treatment\n* Ineligible for ILI because of underlying physical conditions (e.g. coronary artery disease with inability to tolerate anesthesia) as determined by treating physician\n* Has previously experienced hypersensitivity to pembrolizumab or any of its excipients\n* Has uncontrolled intercurrent illness including active infection requiring systemic therapy or symptomatic congestive heart failure within the past 6 months\n* Has known active central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to study Day 1 and return to baseline of neurologic symptoms), 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 sarcomatous meningitis, which is excluded regardless of clinical stability.\n* Shows evidence of clinically significant immunosuppression such as the following:\n\n  * Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease\n  * Concurrent opportunistic infection\n  * Receiving systemic immunosuppressive therapy (\\> 2 weeks) including oral steroid doses \\> 10 mg\u002Fday of prednisone or equivalent within 7 days prior to enrollment. However, in the setting of non-immune mediated indications for use, chronic\u002Factive low dose steroid use may be permitted at the discretion of the principal investigator.\n* Has a known active or chronic infection with HIV if CD4 count is less than 500.\n* Has a known active infection with hepatitis B or hepatitis C\n* Has a known history of active tuberculosis infection\n* Has history or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in the past 2 years. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease.\n* For female subjects, is pregnant or breast-feeding, or planning to become pregnant\n* For male subjects, is planning to father a child within the projected duration of the trial, starting with the pre-screening or screening visit, during study treatment and through 4 months after the last dose of pembrolizumab\n* For patients of childbearing potential, is unwilling to use acceptable method(s) of effective contraception during study treatment and through 4 months after the last dose of pembrolizumab.\n\n(Women not of childbearing potential are defined as: post-menopausal \\[age \\> 55 years with cessation of menses for 12 or more months or less than 55 years but not spontaneous menses for at least 2 years or less than 55 years and spontaneous menses within the past 1 year, but currently amenorrhoeic (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels \\> 40 IU\u002FL) or postmenopausal estradiol levels (\\\u003C 5 ng\u002FdL) or according to the definition of \"postmenopausal range\" for the laboratory involved\\] or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.)\n\n* Underwent prior chemotherapy, radiotherapy, biological cancer therapy, targeted small molecule therapy, or major surgery within 14 days prior to study Day 1 or has not recovered (i.e., to CTCAE \\\u003C\u002F= grade 1 or at baseline) from adverse events due to previously administered therapy. Patients with \\\u003C\u002F= grade 2 neuropathy and alopecia are an exception and may qualify for the study. If patients received major surgery, they must have recovered adequately prior to starting therapy.\n* Is currently participating and receiving study therapy with another investigational device or study drug or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial","ALL","12 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to find out whether giving the study drug pembrolizumab in combination with the chemotherapy drugs melphalan and dactinomycin, delivered directly to the affected arm or leg using a technique called isolated limb infusion (ILI), is a safe treatment that can delay the time before your disease gets worse (progresses).",[26,27,28,29],"Sarcoma","Myxofibrosarcoma","Undifferentiated Pleomorphic Sarcoma","Alveolar Soft Part Sarcoma",[26,27,28,29,31,32,33,34,35,36,37,38],"Pembrolizumab","Isolate Limb Infusion","Melphalan","Dactinomycin","Metastatic Extremity Sarcoma","Locally Advanced Sarcoma","20-104","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-04-22",{"date":42,"type":43},"2026-04-23","ACTUAL",{"date":45,"type":43},"2020-04-01",{"date":47,"type":20},"2027-04-01",{"name":38,"class":49},"OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":70,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100366742","efficacy-and-safety-of-regorafenib-as-maintenance-therapy-after-first-line-treatment-in-patients-with-bone-sarcomas-100366742","NCT04055220","Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas","A Multicentre Exploratory Phase II Study Describing the Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas","REGOSTA","INCLUSION CRITERIA :\n\nI1. Age ≥ 12 years at the day of consenting to the study;\n\nI2. Patients must have histologically confirmed diagnosis of primary bone sarcoma including but not limited to: Osteosarcomas, Ewing sarcomas, Chondrosarcomas, Undifferentiated Pleomorphic Sarcomas (UPS), Leiomyosarcomas (LMS) and Angiosarcomas;\n\nI3. Prior treatment for localized or metastatic disease for bone sarcoma must have been completed, consisting of a standard multimodal treatment based on the histological subtype:\n\nFor OS, (excepted head and neck localisations), neoadjuvant and\u002For adjuvant chemotherapy should include methotrexate-based regimen for patients \\\u003C 18 years old; patients ≥ 18 years old may have received either methotrexate-based regimen or anthracycline and cisplatin-based regimen For head and neck OS, neoadjuvant and\u002For adjuvant chemotherapy should include adriamycin, cisplatin or ifosfamide-based regimen.\n\nFor non-OS, neoadjuvant and\u002For adjuvant chemotherapy should include adriamycin and\u002For cisplatin-based regimen.\n\nI4. Recovery to NCI-CTCAE v5 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug\u002Fprocedure related toxicity (except alopecia, anaemia, and hypothyroidism);\n\nI5. Interval between the last chemotherapy administration and the date of randomisation: at least 4 weeks but no longer than 2 months;\n\nI6. Confirmed complete remission or no evidence of disease (for metastatic disease);\n\nPatients with pulmonary micro nodules can be included provided they do not meet the following criteria:\n\n* At least one lung nodule of 10mm or more\n* And\u002For at least two nodules well limited between 6-9mm\n* And\u002For at least 5 nodules well limited of 5mm or less All the other situations will be considered as doubtful lesions except in case of metastatic disease confirmed during the lung surgery of the residual lung lesions after pre-operative chemotherapy. If no other metastatic localisation is detected at the initial staging, the patient will be considered as localised disease and eligible for randomisation.\n\nI7. Life expectancy of greater than 12 months;\n\nI8. Karnofsky Performance status ≥70 (patients younger than 18-year old) or ECOG performance status \\\u003C 2 (adult patients) ;\n\nI9. Patients must have adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:\n\n* Absolute neutrophil count ≥ 1.5 Giga\u002Fl\n* Platelets ≥ 100 Giga\u002Fl\n* Haemoglobin≥ 9 g\u002Fdl\n* Serum creatinine ≤ 1.5 x ULN\n* Glomerular filtration rate (GFR) ≥30 ml\u002Fmin\u002F1.73m2 according to the Modified Diet in Renal Disease (MDRD) abbreviated formula\n* AST and ALT ≤2.5 x ULN ( ≤5.0 × ULN for patients with liver involvement of their cancer)\n* Bilirubin ≤1.5 X ULN\n* Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN in patient with liver involvement of their cancer). If Alkaline phosphatase \\> 2.5 ULN, hepatic isoenzymes 5-nucleotidase or GGT tests must be performed; hepatic isoenzymes 5-nucleotidase must be within the normal range and\u002For GGT \\\u003C 1.5 x ULN.\n* Lipase ≤1.5 x ULN\n* Spot urine must not show ≥ 1 \"+\"protein in urine or the patient will require a repeat urine analysis. If repeat urinalysis shows 1 \"+\" protein or more, a 24-hour urine collection will be required and must show total protein excretion \\\u003C1000 mg\u002F24 hours\n\nI10. INR\u002FPTT ≤1.5 x ULN; Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR\u002FPTT is stable based on a measurement that is pre-dose as defined by the local standard of care;\n\nI11. Women of childbearing potential and male patients must agree to use adequate contraception (Appendix 4) for the duration of treatment and for 7 months (210 days) in WOCBP or 4 months (120 days) in men sexually active with WOCBP after the last dose of regorafenib;\n\nI12. Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior randomization and\u002For urine pregnancy test within 48 hours before the first administration of the study treatment;\n\nI13. Patients, and their parents when applicable, must sign and date an informed consent document indicating that they have been informed of all the pertinent aspects of the trial prior to enrolment;\n\nI14. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures;\n\nI15. Patients covered by a medical insurance.\n\nI16. Body Surface Area (BSA) ≥ 1.30m² at the time of consenting to the study.\n\nNON-INCLUSION CRITERIA :\n\nE1. Prior treatment with any VEGFR inhibitor (thus, any prior exposure to sunitinib, sorafenib, pazopanib, bevacizumab, or other VEGFR inhibitor);\n\nE2. All soft tissue sarcomas (including but not limited to soft tissue osteosarcomas and Ewing soft tissue sarcomas) and chordomas;\n\nE3. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within 3 years prior to randomization;\n\nE4. Cardiovascular dysfunction:\n\n* Left ventricular ejection fraction (LVEF) \\\u003C 50%,\n* Congestive heart failure ≥ New York Heart Association (NYHA) class 2,\n* Myocardial infarction \\\u003C 6 months prior to first study drug administration,\n* Cardiac arrhythmias requiring therapy (beta blockers or digoxin are permitted),\n* Unstable (angina symptoms at rest) or new-onset angina within the last 3 months prior to first study drug administration;\n\nE5. Uncontrolled hypertension (systolic blood pressure \\> 150mmHg or diastolic pressure \\> 90 mmHg despite optimal treatment);\n\nE6. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the last 6 months before the first study drug administration;\n\nE7. Major surgical procedure, open biopsy or significant traumatic injury within 28 days before the first study drug administration;\n\nE8. Ongoing infection \\> Grade 2 according to NCI-CTCAE v5;\n\nE9. Known history of human immunodeficiency virus (HIV) infection;\n\nNota Bene: Subjects with diagnosed human immunodeficiency virus (HIV) are eligible to participate in the study if they meet the following criteria:\n\n1. No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months prior to enrolment;\n2. No history of AIDS-defining cancers (e.g. Kaposi's sarcoma, aggressive B-cell lymphoma and invasive cervical cancer);\n3. Subjects should be on established anti-retroviral therapy for at least 4 weeks and have an HIV viral load of \\\u003C 400 copies\u002FmL prior to enrolment;\n\nE10. Active hepatitis B or C or chronic hepatitis B or C requiring treatment with antiviral therapy; Nota Bene: Subjects with a history of hepatitis B or C who have normal alanine aminotransferase (ALT) and are hepatitis B surface antigen negative and\u002For have undetectable HCV RNA are eligible;\n\nE11. Dehydration according to NCI-CTC v5 Grade \\>1;\n\nE12. Difficulties to swallow oral medication and\u002For any mal-absorption condition and\u002For any Gastrointestinal (GI) disease that may significantly alter the absorption of regorafenib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection);\n\nE13. Patients with seizure disorder requiring medication;\n\nE14. Concurrent enrolment in another clinical trial in which investigational therapies are administered;\n\nE15. Known hypersensitivity to the active substance or to any of the excipients;\n\nE16. Pregnant women, women who are likely to become pregnant or are breast-feeding\n\nE17. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;\n\nE18. Patients with history of non-compliance to medical regimens or unwilling or unable to comply with the protocol;\n\nE19. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent;\n\nE20. Non-healing wound, non-healing ulcer, or non-healing bone fracture;\n\nE21. Patients with evidence or history of any bleeding diathesis, irrespective of severity;\n\nE22. Any haemorrhage or bleeding event ≥ CTCAE v5 Grade 3 within 4 weeks prior to the first study drug administration;\n\nE23. Clinically significant unrelated systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results;\n\nE24. Patients using prohibited concomitant and\u002For concurrent medications (see section \"Prohibited concomitant\u002Fconcurrent treatments);\n\nE25.Patients under tutorship or curatorship.",{"count":59,"type":20},168,[61],"NA","Randomized, non-comparative, multicentre exploratory phase II study.\n\nTwo arms concerning patients with bone sarcoma after the first line therapy: in the first arm, patients will be treated with Regorafenib for a maximum of 12 months as maintenance therapy after first line therapy, whereas in the second arm, patients will be kept under surveillance (standard of care). Regardless of their study arm, all the patients will be followed up until end of the study.\n\nThe comparison between these two arms will allow to determine whether or not regorafenib is efficient for disease control, in terms of Relapse-Free Survival improvement.",[64,65,66,67,28,68,69],"Bone Sarcoma","Osteosarcoma","Ewing Sarcoma","Chondrosarcoma","Leiomyosarcoma","Angiosarcoma",[71,72,73,74,75,76,77,78,79,80,81,82,65,83,84,85,86,87],"Maintenance therapy","First line therapy","Regorafenib","Randomization","Double-blinded","Placebo controlled","Relapse-free survival","Time to treatment failure","Overall survival","Quality of life","Compliance","Bone sarcoma","Efficacy","Complete response","Tyrosine kinase inhibitor","Multi-target inhibitor","Safety","2026-02-13",{"date":90,"type":43},"2026-02-17",{"date":92,"type":43},"2020-03-03",{"date":94,"type":20},"2026-10-01",{"name":96,"class":49},"Centre Leon Berard",16,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100453255","phase-2-combination-of-pembrolizumab-and-cabozantinib-in-patients-with-advanced-sarcomas-100453255","NCT05182164","Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas","PEMBROCABOSARC","Inclusion Criteria:\n\n1. Histology: undifferentiated pleomorphic sarcoma (stratum 1), bone osteosarcoma (stratum 2), bone or extraskeletal or Ewing sarcoma (stratum 3),\n2. Advanced non resectable \u002F metastatic disease,\n3. Recurrent disease or progression after standard therapy,\n4. Documented progression according to RECIST criteria.\n5. Have provided tissue of a tumor lesion from \\\u003C 3 months old archival tissue sample obtained on locally advanced disease, or metastatis with no subsequent treatment since or from a newly obtained core or excisional biopsy,\n6. No more of three previous lines of systemic therapy for advanced disease,\n7. Age ≥ 18 years,\n8. Eastern Cooperative Oncology Group ≤ 1,\n9. Measurable disease according to RECIST v1.1 outside any previously irradiated field. At least one site of disease must be uni-dimensionally ≥ 10 mm,\n10. Life expectancy \\> 3 months,\n11. Participant must have advanced disease and must not be a candidate for other approved therapeutic regimen known to provide significant clinical benefit based on investigator judgement,\n12. No symptomatic central nervous system disease,\n13. No chronic use of glucocorticoids.\n14. Adequate hematological, renal, metabolic and hepatic function,\n15. No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,\n16. At least three weeks since last chemotherapy, immunotherapy and two weeks for any other pharmacological treatment and\u002For radiotherapy,\n17. Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment (excluding alopecia of any grade, non-painful peripheral neuropathy grade ≤ 2 and endocrine-related grade ≤ 2 requiring treatment or hormone replacement) (according to NCI-CTCAE, version 5.0). For patients previously treated by radiotherapy, they must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis,\n18. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication. Both women and men must agree to use 2 medically acceptable methods of contraception throughout the treatment period and for 6 months after discontinuation of treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥ 1 year,\n19. Voluntary signed and dated written informed consents prior to any specific study procedure,\n20. Patients with a social security in compliance with the French Law.\n\nExclusion Criteria:\n\n1. Previous treatment with Pembrolizumab or Cabozantinib,\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumabor any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways),\n3. Evidence of progressive or symptomatic central nervous system or leptomeningeal metastases,\n4. Men or women of childbearing potential who are not using an effective method of contraception; women who are pregnant or breast feeding, men or women who are planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment,\n5. Participation to a study involving a medical or therapeutic intervention in the last 21 days,\n6. Previous enrolment in the present study,\n7. Patient unable to follow and comply with the study procedures because of any geographical, familial, social or psychological reasons,\n8. Patient unable to swallow,\n9. Known hypersensitivity to any involved study drug or of its formulation components,\n10. Has an 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 is not considered a form of systemic treatment and is allowed.\n11. 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,\n12. History of idiopathic pulmonary fibrosis, history of non-infectious pneumonitis that required steroids, current pneumonitis\u002Finterstitial lung disease, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted,\n13. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n14. Has a known history of HIV infection and\u002For of active TB (Bacillus Tuberculosis),\n15. Treatment with anticoagulants such as anti-Vitamin K, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel),\n16. Previous allogenic bone marrow transplant or solid organ transplantation,\n17. Has an active infection requiring systemic treatment at study entry,\n18. The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms within 28 days before treatment. Note: if initial QTcF is found to be \\> 500 ms, two additional ECGs separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is ≤ 500 ms, the subject meets eligibility in this regard,\n19. The subject requires chronic concomitant treatment of strong CYP3A4 inducers\n20. The subject has experienced any of the following: Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment, Hemoptysis of ≥ 2.5 mL of red blood within 3 months before the first dose of study treatment, Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment, The subject has radiographic evidence of cavitating pulmonary lesion(s), The subject has tumor in contact with, invading or encasing any major blood vessels, or The subject has evidence of tumor invading the GI tract, or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib.\n21. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions which are fully described in the study protocol: Cardiovascular disorders, Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation, Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy,\n22. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n23. Has an history or current evidence of any condition, therapy, or laboratory abnormality that might counfound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n24. The subject is planning to have oral surgery\u002Finvasive dental procedure within the projected duration of the study, starting with the screening visit through 3 months after the last dose of study treatment or had such a procedure within 3 months of first dose of study treatment.","18 Years",{"count":107,"type":20},119,[23],"Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.",[111,112,66,65,28],"Soft Tissue Sarcoma Adult","Advanced Soft-tissue Sarcoma",[114,115],"soft-tissue sarcoma","immune checkpoint inhibitor","2025-10-01",{"date":118,"type":43},"2025-10-07",{"date":120,"type":43},"2022-04-25",{"date":122,"type":20},"2027-12",{"name":124,"class":49},"Institut Bergonié",10,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":157},"100537386","phase-2-masct-i-combined-with-doxorubicin-and-ifosfamide-for-first-line-treatment-of-advanced-soft-tissue-sarcoma-100537386","NCT06277154","MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma","A Phase II Study Evaluating the Safety and Efficacy of MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment in Patients With Advanced Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Age≥18 years and≤70 years;\n2. According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor.\n3. No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy.\n4. At least one measurable and assessable lesion defined by RECIST 1.1;\n5. ECOG performance status of 0-1;\n6. Estimated life expectancy≥6 months;\n7. Pulmonary function is basically normal;\n8. Subjects with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis): a) Hemoglobin ≥90g\u002FL; b) Leukocyte≥3.5x10\\^9\u002FL; c) The absolute neutrophil count (ANC)\\>1.5x10\\^9\u002FL; d) Platelet≥100x10\\^9\u002FL; e) ALT, AST≤2.5 ULN (Upper Limit of Normal), ALT, AST≤5 ULN for liver metastases; f) ALP≤2.5 ULN; g) Serum total bilirubin≤1.5 ULN; Patients with Gilbert's syndromes (persistent or repeated hyperbilirubinemia \\[mainly unconjugated bilirubin\\], in the absence of evidence of hemolysis or liver disease), are allowed to enroll with investigator's agreement; h) Serum urea nitrogen or urea and creatinine≤2.5 ULN; i) Serum albumin≥35g\u002FL; j) PT, APTT, INR≤1.5 ULN (without anticoagulation treatment);\n9. Obtain the written informed consent of the patient\u002Flegal representative;\n10. Subjects with potential fertility must agree to use effective contraceptive measure during and within 6 months after the treatment period. HCG test for female with potential fertility must be negative before the study was included.\n\nExclusion Criteria:\n\n1. Previous treatment with targeted therapy, radiotherapy (radiotherapy to non-target lesions or disease progressed after radiotherapy could be included.) or other antineoplastic drugs such as anlotinib, gemcitabine, within 4 weeks before randomization, or have received Chinese medicine or proprietary Chinese medicine for anti-tumor treatment within 2 weeks before randomization.\n2. Highly differentiated liposarcoma, malignant perivascular epithelioid tumor, protuberant cutaneous fibrosarcoma, extraosseous osteosarcoma, solitary fibroma\u002Fhemangiopericytoma, acinous soft tissue sarcoma, extraosseous myxoid chondrosarcoma, gastrointestinal stromal tumor, invasive fibroma, renal angiomyolipoma, malignant mesothelioma, clear cell sarcoma, Ewing's sarcoma, etc., which are not suitable for Doxorubicin+ Ifosfamide (AI) treatment.\n3. Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg\u002Fm2 doxorubicin.\n4. Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.\n5. Use of immunosuppressive agents or systemic or inhaled local hormones (exceeding 10mg\u002Fday prednisone or its equivalent) and were still using them within 2 weeks before randomization.\n6. Use of immunomodulators and were still using them within 2 weeks before randomization.\n7. Allergic to sodium citrate or human albumin.\n8. Subjects with uncontrolled pleural effusion and abdominal effusion requiring repeated drainage and with moderate or higher volume of pericardial effusion.\n9. Have known active central nervous system (CNS) or meningeal metastases. Subjects with previously treated brain metastases may participate provided they are stable based on the following: 1) any neurologic symptoms have returned to baseline at least 2 weeks before randomization, 2) no requirement for steroids at least 2 weeks before randomization or receiving low-dose of steroids (Not exceeding 10mg\u002Fday prednisone or its equivalent).\n10. Have any active autoimmune disease or history of autoimmune disease.\n11. Subjects with active tuberculosis.\n12. Subjects were infected with hepatitis B virus, hepatitis C virus or HIV, or syphilis.\n13. Severe cardiovascular disease, such as: (1) complete left bundle branch block or III atrioventricular block; (2) history of myocardial infarction, angioplasty, coronary artery bypass graft; (3) prolonged QT\u002FQTc interval at baseline (male\\>450ms, female \\>480ms); (4) LVEF≤50%; (5) heart failure of NYHA class 2 or higher; (6) poorly controlled hypertension (BP≥150\u002F95 mmHg, despite optimal medical treatment); (7) cardiomyopathy or severe arrhythmia and may have impact on the study based on investigator's judgement.\n14. Subjects with history of thrombus or experienced a cerebrovascular accident within 6 months before randomization;\n15. Other malignant tumors (except cured skin basal cell carcinoma, prostate carcinoma in situ and cervical carcinoma in situ) in the past 5 years;\n16. Known history of organ transplantation or ready to receive an organ transplantation;\n17. Subjects who have undergone major surgery or traumatic injury within 4 weeks before randomization;\n18. Those who have a history of alcohol dependence, psychotropic substance abuse and cannot abstain or have mental disorders.\n19. Surgery for soft tissue sarcoma is planned during the study.\n20. Subjects have participated in another investigational trial within 4 weeks before randomization.\n21. Any condition that the investigator considers to be prejudicial to the subject or to the subject's inability to meet or perform the study requirements exists.","70 Years",{"count":135,"type":20},148,[23],"This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.",[68,139,140,69,28,141,142,143,144,145,146],"Liposarcoma","Synovial Sarcoma","Epithelioid Sarcoma","Malignant Peripheral Nerve Sheath Tumors","Fibrosarcoma","Pleomorphic Rhabdomyosarcoma","Endometrial Stromal Sarcoma","Desmoplastic Small Round Cell Tumor","2025-07-20",{"date":149,"type":43},"2025-07-24",{"date":151,"type":43},"2024-02-21",{"date":153,"type":20},"2027-02",{"name":155,"class":156},"HRYZ Biotech Co.","INDUSTRY",1,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":4},"100556576","evaluation-of-chest-ct-versus-chest-x-ray-for-lung-surveillance-after-curative-intent-resection-of-high-risk-truncal-extremity-soft-tissue-sarcoma-100556576","NCT06526897","Evaluation of Chest CT Versus Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","A Phase III Randomized Controlled Trial of Chest CT vs Chest X-Ray for Lung Surveillance After Curative-Intent Resection of High-Risk Truncal-Extremity Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Patient must be ≥ 1 and ≤ 85 years old on the day of randomization\n* Patient must have and undergone curative-intent (R0 or R1) resection of an American Joint Committee on Cancer (AJCC) 8th edition stage III truncal or extremity soft tissue sarcoma\n* Patient must have a high-risk (grade 2 or 3) soft tissue carcinoma according to the French Federation of Cancer Centers Sarcoma Group (FNCLCC)\n\n  * Patients with the following histiotypes are eligible: dedifferentiated liposarcoma, pleomorphic liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma\u002Fmalignant fibrous histiocytoma, myxofibrosarcoma, fibrosarcomatous dermatofibrosarcoma protuberant variant, spindle cell sarcomas, pleomorphic sarcoma, fibrosarcoma,extra-skeletal myxoid chrondrosarcoma, extraskeletal Ewing and Ewing-like sarcoma, sarcoma not otherwise specified (NOS), or other grade 2 or grade 3 sarcomas not further classified\n  * Patients with a high-risk histiotype that is typically not graded, including adult pleomorphic rhabdomyosarcoma, synovial sarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma, epithelioid sarcoma, or clear cell sarcoma are eligible\n* Patient must have a tumor size ≥ 5 cm\n* Patient must have had a R0 or R1 oncologic resection on final pathologic report\n* Patient must have a baseline chest CT obtained within 30 days prior to randomization that is negative or detecting only non-suspicious nodules ≤ 4 mm\n* Patients receiving preoperative or post-operative chemotherapy and\u002For radiotherapy for the primary tumor are eligible. However, all chemotherapy and\u002For radiotherapy must be completed prior to randomization\n* Patient must not be pregnant due to the potential harmful risks associated with CXR and CT imaging to the unborn fetus\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not have a chest wall\u002Fupper truncal primary tumor requiring locoregional surveillance with CT or magnetic resonance imaging (MRI)\n* Patient must not have retroperitoneal, mesenteric\u002Fabdominal sarcoma\n* Patient must not have a primary bone sarcoma (including osteosarcomas, Ewings sarcoma, or chondrosarcomas), desmoid tumor, gastrointestinal stromal tumor (GIST), Kaposi sarcoma, pediatric rhabdomyosarcoma, nor uterine sarcoma\n* Patient must not have had a palliative or R2 resection\n* Patient must not require routine cross-sectional imaging of the chest\u002Flungs with CT\u002FMRI\u002Fpositron emission tomography (PET)\n* Patient must not have participation in another clinical trial that is incompatible with this study surveillance schema and follow-up regimen\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Pediatric patients (\\\u003C 18 years of age) and patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible. Child assent must be obtained as appropriate in accordance with institutional guidelines\n* Patient must be English speaking to be eligible for the quality of life (QOL) component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms","1 Year","85 Years",{"count":168,"type":20},1582,[61],"This phase III trial compares chest computed tomography (CT) to chest x-ray (CXR) for lung surveillance after curative-intent resection of high-risk truncal-extremity soft tissue sarcoma. Currently, complete oncologic resection (with or without radiation therapy) is the standard of care for most high-risk soft tissue sarcoma that has not spread to other parts of the body (localized). However, despite curative-intent resection, 20-40% of patients will develop cancer that has spread from where it first started (primary site) to other places in the body (distant metastases), with the lungs being the most common site. Thus, lung surveillance is important for detection of lung metastases in order to facilitate timely treatment. Although there is general agreement about the usefulness of postoperative surveillance, consensus is lacking regarding the optimal modality for lung surveillance after curative-intent resection for high-risk soft tissue sarcoma. Current National Comprehensive Cancer Network guidelines recommend chest imaging with CT or CXR every 3-6 months for 2-3 years, then every 6 months for the next two years, and then annually after that for high-risk tumors. Data from across the United States and internationally indicate that there is considerable variation in clinical practice with regards to the use of CXR versus CT chest for lung surveillance. The information gained from this trial may allow researchers to determine the effectiveness of varying imaging modalities needed for optimal surveillance for patients with extremity or truncal soft tissue sarcoma.",[172,173,174,29,69,175,176,177,178,143,179,68,180,27,181,182,26,183,184,185,186,140,28],"Adult Pleomorphic Rhabdomyosarcoma","AJCC Grade 2 Sarcoma","AJCC Grade 3 Sarcoma","Clear Cell Sarcoma of Soft Tissue","Dedifferentiated Liposarcoma","Extraskeletal Ewing Sarcoma","Extraskeletal Myxoid Chondrosarcoma","Fibrosarcomatous Dermatofibrosarcoma Protuberans","Malignant Peripheral Nerve Sheath Tumor","Pleomorphic Liposarcoma","Round Cell Sarcoma With EWSR1-non-ETS Fusion","Soft Tissue Sarcoma","Soft Tissue Sarcoma of the Trunk and Extremities","Spindle Cell Sarcoma","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","NOT_YET_RECRUITING","2024-07-24",{"date":190,"type":43},"2024-07-30",{"date":192,"type":20},"2025-01-28",{"date":194,"type":20},"2032-11-01",{"name":196,"class":197},"ECOG-ACRIN Cancer Research Group","NETWORK",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":208,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100513153","phase-2-propranolol-and-pembrolizumab-in-advanced-soft-tissue-sarcoma-patients-100513153","NCT05961761","Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients","An Open Label Phase 2 Study on Propranolol and Pembrolizumab in Advanced Angiosarcoma and Undifferentiated Pleomorphic Sarcoma - a Scandinavian Sarcoma Group Collaboration","PROPANE","Inclusion Criteria:\n\n* Subjects must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care\n* Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study\n* Histologically confirmed diagnosis of unresectable locally advanced or metastatic Angiosarcoma or Undifferentiated Pleomorphic Sarcoma, who has progressed\u002Ffailed to provide clinical benefit on first line standard chemotherapy.\n* Age ≥18 years\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of ≤2 at the time of enrollment.\n* Evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n* Available material from archived formalin-fixed paraffin-embedded tumor tissue obtained within 3 months of study enrollment for biomarker related studies. If not sufficient or available, a newly obtained core or excisional biopsy of a tumor lesion may be performed.\n* Patients must have normal organ and marrow function as defined below:\n* Absolute neutrophil count (ANC) ≥ 1 x 10⁹\u002FL\n* Platelet count ≥ 75 x 10⁹\u002FL\n* Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin ≤ 50 mmol\u002FL)\n* Aspartate transaminase (AST)\u002FAlanine transaminase (ALT) ≤ 5 x ULN\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin (using the Cockcroft-Gault formula)\n* Women of childbearing potential (WOCBP): Agreement to use contraceptive methods with a failure rate of \\\u003C 1 % per year during the treatment period and for at least 120 days after the treatment. Safe contraceptive methods for women are birth control pills, intrauterine device, contraceptive injection, contraceptive implant,contraceptive patch or contraceptive vaginal ring.\n* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year during the treatment period and for at least 120 days after the treatment.\n* Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception\n\nExclusion Criteria:\n\n* Have an anticipated life expectancy of \\\u003C3 months.\n* Moderate to severe degree of bronchial asthma or chronic obstructive pulmonary disease.\n* Acute or non-stable congestive heart failure\n* Any other condition listed as contraindication for treatment with propranolol according to SPC\n* Have received any previous systemic therapy targeting the PD-1\u002FPDL-1 signaling pathway or other immune checkpoint inhibitors.\n* Have received propranolol within 4 weeks prior to treatment.\n* Prior to study day one received radiation therapy, chemotherapy or targeted small molecule therapy within 2 weeks and\u002For monoclonal antibody treatment within 4 weeks.\n* Not recovered from the effects of previously administered agents\n* Clinically active or unstable CNS metastases as assessed by the treating physician\n* Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results\n* Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism Inclusion criteria\n* Subjects must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care\n* Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study\n* Histologically confirmed diagnosis of unresectable locally advanced or metastatic Angiosarcoma or Undifferentiated Pleomorphic Sarcoma, who has progressed\u002Ffailed to provide clinical benefit on first line standard chemotherapy.\n* Age ≥18 years\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of ≤2 at the time of enrollment.\n* Evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).\n* Available material from archived formalin-fixed paraffin-embedded tumor tissue obtained within 3 months of study enrollment for biomarker related studies. If not sufficient or available, a newly obtained core or excisional biopsy of a tumor lesion may be performed.\n* Patients must have normal organ and marrow function as defined below:\n* Absolute neutrophil count (ANC) ≥ 1 x 10⁹\u002FL\n* Platelet count ≥ 75 x 10⁹\u002FL\n* Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin ≤ 50 mmol\u002FL)\n* Aspartate transaminase (AST)\u002FAlanine transaminase (ALT) ≤ 5 x ULN\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin (using the Cockcroft-Gault formula)\n* Women of childbearing potential (WOCBP): Agreement to use contraceptive methods with a failure rate of \\\u003C 1 % per year during the treatment period and for at least 120 days after the treatment. Safe contraceptive methods for women are birth control pills, intrauterine device, contraceptive injection, contraceptive implant,contraceptive patch or contraceptive vaginal ring.\n* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year during the treatment period and for at least 120 days after the treatment.\n* Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception\n\nExclusion criteria\n\n* Have an anticipated life expectancy of \\\u003C3 months.\n* Moderate to severe degree of bronchial asthma or chronic obstructive pulmonary disease.\n* Acute or non-stable congestive heart failure\n* Any other condition listed as contraindication for treatment with propranolol according to SPC\n* Have received any previous systemic therapy targeting the PD-1\u002FPDL-1 signaling pathway or other immune checkpoint inhibitors.\n* Have received propranolol within 4 weeks prior to treatment.\n* Prior to study day one received radiation therapy, chemotherapy or targeted small molecule therapy within 2 weeks and\u002For monoclonal antibody treatment within 4 weeks.\n* Not recovered from the effects of previously administered agents\n* Clinically active or unstable CNS metastases as assessed by the treating physician\n* Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results\n* Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* Participants with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\n* Allergies and Adverse Drug Reaction\n* History of allergy to study drug components\n* History of severe hypersensitivity reaction to any monoclonal antibody\n* WOCBP who are pregnant or breastfeeding",{"count":207,"type":20},80,[23],"The goal of this phase 2 clinical trial is to test efficacy and tolerability of combining propranolol and pembrolizumab in patients with advanced angiosarcoma or undifferentiated pleomorphic sarcoma. The main questions aims to answer:\n\n* Primary: determine the progression-free survival rate (PFSR) at 3 months\n\nSecondary: determine the objective response rate (ORR), duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS). Ensure the safety and tolerability, Determine Quality of Life (QoL)\n\n• Exploratory: Characterize the TME\n\nParticipants will be asked to ensure\n\n* Baseline biopsy and further optional biopsies\n* Treatment propranolol 40 mg BID and pembrolizumab 2 mg\u002Fkg Q3 weeks\n* Evaluation, blood counts, QoL and blood samples for biomarkers according to schedule",[111,69,28],[212,213,31,214,26],"Immunotherapy","Propranolol","PD-1 inhibitor","2023-07-23",{"date":217,"type":43},"2023-07-27",{"date":219,"type":43},"2021-08-17",{"date":221,"type":20},"2028-12",{"name":223,"class":49},"Niels Junker",4,{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":233,"targetDuration":235,"studyType":236,"phases":4,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":4},"100478829","registry-for-children-adolescents-and-adults-with-osteosarcoma-and-biologically-related-bone-sarcomas-100478829","NCT05515068","Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas","Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas (COSS-Registry)","COSS-Registry","Inclusion Criteria:\n\n* high-grade osteosarcoma (conventional and non-conventional)\n* parosteal, periosteal or extraosseous osteosarcoma\n* low grade central osteosarcoma\n* (osseous) Undifferentiated pleomorphic sarcoma (UPS)\n* (osseous) leiomyosarcoma\n* (osseous) dedifferentiated chondrosarcoma\n* (osseous) mesenchymal chondrosarcoma\n* (osseous) fibrosarcoma\n* (osseous) angiosarcoma\n* informed consent\n\nExclusion Criteria:\n\n* no informed consent",{"count":234,"type":20},1000,"20 Years","OBSERVATIONAL","The Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas (COSS-Registry) is a non-interventional, multicentric, international, clinical and epidemiologic patient registry. The COSS-Registry collects key data on osteosarcomas or biologically related bone sarcomas. With that data collection we want to gain new scientific insights and results about this tumor disease, prognosis, surveillance and long-term effects.\n\nBesides the data collection we would also like to foster the collection of biomaterial (tumor specimen and blood samples) for scientific research.\n\nThe stored material will be used to perform cell and molecular biological analyses to identify the causes of osteosarcoma, the prognosis and possible new treatment options.\n\nAs a starting point the donated biomaterial of registered patients will be analyzed firstly for the presence of a tumor predisposition by germline mutations.\n\nIn case of detected genetic variations that are related to the tumor disease and which may affect the patient's health and follow-up care (because of the potentially increased risk of developing other malignant tumors), affected patients will be informed and referred to genetic counseling.\n\nRegistry patients will be asked at the time of diagnosis if they wish to be informed about germline variants detected as part of the study procedures.",[65,239,64,240,241,242,243,244,245,246,247,248,249,250,28,251,252,253,254,255,256,257,258,259,260,261],"Bone Tumor","High Grade Sarcoma","Osteoblastic Osteosarcoma","Chondroblastic Osteosarcoma","Fibroblastic Osteosarcoma","Conventional Osteosarcoma","Conventional Central Osteosarcoma of Bone","Low Grade Central Osteosarcoma","Osseous Sarcoma","Osseous Tumor","Small Cell Osteosarcoma","Telangiectatic Osteosarcoma","Parosteal Osteosarcoma","Periosteal Osteosarcoma","Extraskeletal Osteosarcoma","Recurrent Osteosarcoma","High Grade Surface Osteosarcoma","Osseous Angiosarcoma","Osseous Fibrosarcoma","Osseous Leiomyosarcoma","Osseous Dedifferentiated Chondrosarcoma","Osseous Mesenchymal Chondrosarcoma","Clear Cell Osteosarcoma","2022-08-24",{"date":264,"type":43},"2022-08-25",{"date":266,"type":20},"2022-09",{"date":268,"type":20},"2032-03",{"name":270,"class":49},"Klinikum Stuttgart"]