[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-soft-tissue-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-soft-tissue-sarcoma":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,77,103,124,152,180,209],{"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":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100590559","phase-1-zanzalintinib-in-combination-with-ipilimumab-and-nivolumab-in-patients-with-metastatic-soft-tissue-sarcoma-100590559",false,"NCT06968988","Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma","Phase I Study With Expansion Cohort of Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed soft tissue sarcoma that is metastatic or unresectable.\n* Must have received at least one but no more than 3 lines of therapy in the metastatic setting, with progression on last line of therapy. Neoadjuvant or adjuvant therapy completed more than one year prior does not count towards as a line of therapy in the metastatic. Individuals with alveolar soft part sarcoma may enroll without being refractory to at least one line of therapy.\n* Measurable disease per RECIST 1.1.\n* At least 18 years of age.\n* ECOG performance status ≤ 1.\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5 K\u002Fcumm without granulocyte colony-stimulating factor support within 2 weeks prior to screening laboratory collection\n  * Platelets ≥ 100 K\u002Fcumm without transfusion within 2 weeks prior to screening laboratory collection\n  * Hemoglobin ≥ 9.0 g\u002FdL without transfusion within 2 weeks prior to screening laboratory collection\n  * INR ≤ 1.5 and aPTT ≤ 1.2 x IULN. For subjects on Factor Xa inhibitors, criteria does not apply.\n  * Total bilirubin ≤ 1.5 x IULN (for subjects with Gilbert's disease ≤ 3 x IULN)\n  * AST(SGOT), ALT(SGPT), and alkaline phosphatase (ALP) ≤ 3.0 x IULN. For subjects with documented bone metastasis, ALP ≤ 5.0 x IULN.\n  * Serum albumin ≥ 2.8 g\u002FdL.\n  * Calculated creatinine clearance ≥ 40 mL\u002Fmin by Cockcroft-Gault.\n  * UPCR ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol) creatinine.\n* Recovery to baseline or ≤ grade 1 from AEs, including immune-related AEs related to any prior treatments, unless AEs are clinically nonsignificant and\u002For stable on supportive therapy (e.g., physiological replacement of corticosteroid). Low-grade or controlled toxicities such as alopecia, ≤ grade 2 hypomagnesemia, ≤ grade 2 neuropathy are permitted.\n* Sexually active fertile subjects and their partners must agree to use highly effective method of contraception during the course of the study and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (eg, condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods:\n\n  * 186 days after last dose of zanzalintinib (for women) or 96 days after last dose of zanzalintinib (for men).\n  * 5 months after the last dose of nivolumab or 3 months after the last dose of ipilimumab.\n* Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating hormone \\[FSH\\] level \\> 40 mIU\u002FmL to confirm menopause). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Translocation-driven sarcoma except for ASPS.\n* Prior treatment with zanzalintinib, cabozantinib, PD-1 inhibitor (eg, cemiplimab, nivolumab, pembrolizumab), PD-L1 inhibitor (eg, atezolizumab, avelumab, durvalumab), or CTLA-4 inhibitor (eg, ipilimumab).\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.\n* Radiation therapy for bone metastasis within 2 weeks before first dose of study treatment; any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to zanzalintinib, ipilimumab, nivolumab, or other agents used in the study.\n* Concomitant anticoagulation with warfarin or other vitamin-K antagonists, direct thrombin inhibitors, or antiplatelet agents (e.g. clopidogrel). Allowed anticoagulants are the following:\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n  * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen. Note: subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.\n* Any complementary medications (e.g. herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Uncontrolled, significant intercurrent or recent illness including, but not limited to:\n\n  * Unstable or deteriorating cardiovascular disorders:\n\n    * Congestive heart failure NYHA Class 3 or 4, or Class 2 or higher unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (e.g. ventricular flutter, ventricular fibrillation, Torsades de pointes).\n    * Uncontrolled hypertension defined as sustained blood pressure \\> 140 mmHg systolic or \\> 90 mmHg diastolic despite optimal antihypertensive treatment.\n    * Stroke (including transient ischemic attack), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before first dose of study treatment.\n    * Pulmonary embolism or deep vein thrombosis or prior clinically significant venous events within 3 months before first dose of study treatment. Note: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen. Note: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the PI.\n    * Prior history of myocarditis.\n  * Gastrointestinal disorders, including those associated with a high risk of perforation or fistula formation:\n\n    * Tumors invading the GI tract from external viscera\n    * Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis\n    * Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic.\n    * Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n    * Known gastric or esophageal varices.\n    * Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks.\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g. pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n* Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n* Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Note: subjects with intravascular tumor extension (e.g. tumor thrombus in renal vein on inferior vena cava) may be eligible following PI approval.\n* Other clinically significant disorders that would preclude safe study participation, in the opinion of the investigator. Specific conditions are noted below:\n\n  * Active infection requiring systemic treatment. Note: prophylactic antimicrobial treatments (antibiotics, antimycotics, antivirals) are allowed.\n  * Known infection with acute or chronic hepatitis B or C, known HIV or AIDS-related illness except for subjects meeting all of the following criteria:\n\n    * On stable anti-retroviral therapy\n    * CD4+ T cell count ≥ 200\u002FμL\n    * Undetectable viral load. Note: HIV testing will be performed at screening if and as required by local regulation. Note: to be eligible, participants taking CYP inhibitors (e.g. zidovudine, ritonavir, cobicistat, didanosine) orCYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies must have been received for at least 4 weeks prior to the first dose. Note: CD4+ T cell counts and viral load are monitored per standard of care by the local health provider.\n  * Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n  * Malabsorption syndrome.\n  * Pharmacologically uncompensated, symptomatic hypothyroidism.\n  * Moderate to severe hepatic impairment (Child-Pugh B or C).\n  * Requirement for hemodialysis or peritoneal dialysis.\n  * History of solid organ or allogeneic stem cell transplant.\n* Major surgery (e.g. GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (e.g. nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (e.g. simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment. Note: fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per ECG before first dose of study treatment. Note: triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n* History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.\n* Inability to swallow tablets or ingest a suspension either orally or by a NG or PEG tube.\n* Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to study treatment, within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy\n* Any active, known, or suspected autoimmune disease. Note: subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger, or permitted to enroll.\n* Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Free thyroxine (FT4) outside the laboratory normal reference range. Asymptomatic subjects with FT4 abnormalities can be eligible after Principal Investigator approval.\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\> 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. Inhaled, intranasal, intraarticular, and topical corticosteroids and mineralocorticoids are allowed. Note: Adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Transient short-term use of higher doses of systemic corticosteroids for allergic conditions (eg, contrast allergy) is also allowed.\n* Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.","ALL","18 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The investigators hypothesize that zanzalintinib in combination with ipilimumab and nivolumab will be well tolerated and serve as a potential therapeutic strategy in metastatic soft tissue sarcoma (mSTS) including myxofibrosarcoma, undifferentiated pleomorphic sarcoma, dedifferentiated liposarcoma, cutaneous angiosarcoma, and undifferentiated sarcoma histologies.",[26],"Metastatic Soft-tissue Sarcoma",[28,29,30,31,32],"Soft Tissue Sarcoma","Zanzalintinib","Immunotherapy","Nivolumab","Ipilimumab","RECRUITING","2026-06-29",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":37},"2026-01-05",{"date":41,"type":20},"2034-01-31",{"name":43,"class":44},"Washington University School of Medicine","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100554404","phase-1-testing-the-addition-of-an-anti-cancer-drug-abemaciclib-to-the-usual-chemotherapy-treatment-gemcitabine-for-soft-tissue-sarcoma-100554404","NCT06498648","Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma","Phase I\u002FII Study to Evaluate the Feasibility and Efficacy of Sequential Abemaciclib and Gemcitabine Treatment in Patients With Retinoblastoma (Rb)+ Sarcomas","Inclusion Criteria:\n\n* Phase 1: Patients must have advanced\u002Fmetastatic histologically confirmed soft tissue sarcoma and have received at least one prior standard systemic therapy (prior gemcitabine is allowed)\n* Phase 2: Patients must have advanced\u002Fmetastatic pathologically confirmed leiomyosarcoma or dedifferentiated liposarcoma for which gemcitabine and docetaxel is considered standard-of-care, patients may be systemic-treatment naïve. Prior gemcitabine is not allowed\n* Patients must have presence of measurable\u002Fassessable tumor\n* Patients must have intact Rb gene expression in the baseline tumor biopsy or archived tumor sample, as assessed by immunohistochemistry (at MD Anderson: clone G3- 245, BD Pharmagen, RRID:AB\\_385259, Clinical Laboratory Improvement Act \\[CLIA\\] certified antibody)\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of abemaciclib in combination with gemcitabine in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count ˃ 1.2K\u002FµL\n* Hemoglobin ˃ 9.0 g\u002FdL\n* Platelets ˃ 100K\u002Fmm\\^3\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN), patient with Gilbert's syndrome ≤ 2.0 times ULN, or direct bilirubin within normal limits\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) ≤ 1.5 × institutional ULN\n* Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 1.5 × institutional ULN\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\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* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification. To be eligible for this trial, patients should be class congestive heart failure (CHF) II or better\n* Patients must have a life expectancy of greater than 6 months\n* Females of childbearing potential must have a negative serum pregnancy test within one week of trial enrollment and be willing to use an adequate method of contraception to avoid pregnancy throughout the trial and for up to 6 months after the last dose of drug therapy. The effects of abemaciclib on the developing human fetus are unknown. For this reason and because CDK 4\u002F6 inhibiting agents as well as gemcitabine are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of abemaciclib administration. Abstinence is considered an effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study ranging from three weeks prior to initiation of treatment and up to 6 months after the last dose of treatment\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Patient is capable of swallowing oral medications\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents. There must be no investigational drug use within 30 days or 5 half-lives of receiving the first dose of treatment on this treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to abemaciclib or gemcitabine\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because abemaciclib is a CDK4\u002F6 inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with abemaciclib or gemcitabine, breastfeeding should be discontinued if the mother is treated with abemaciclib or gemcitabine\n* Use of strong CYP34A inhibitors which cannot be discontinued by the patient prior to trial initiation. The washout period of these drugs should be 5 half-lives\n* Progression on prior CDK4 inhibitor therapy\n* Phase 2 only: Prior gemcitabine-based chemotherapy\n* Presence of significant cardiac disease. Significant cardiac disease includes personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* Patients with interstitial lung disease (ILD)\n* Patients with gastrointestinal conditions that may affect the absorption of oral medications\n* Patients must not have received or be scheduled to receive radiation therapy within 7 days or less from gemcitabine administration\n* Patients must not have had major surgery within 14 days prior to randomization",{"count":54,"type":20},74,[23,56],"PHASE2","This phase I\u002FII trial tests the side effects and best dose of abemaciclib when added to gemcitabine and compares the effectiveness of that treatment to the usual treatment of gemcitabine with docetaxel for the treatment of patients with soft tissue sarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) (phase 1) or patients with leiomyosarcoma or dedifferentiated liposarcoma (phase 2). Abemaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic soft tissue sarcoma or leiomyosarcoma or dedifferentiated liposarcoma.",[59,60,61,62,63,64,65,66],"Advanced Dedifferentiated Liposarcoma","Advanced Leiomyosarcoma","Advanced Soft Tissue Sarcoma","Metastatic Dedifferentiated Liposarcoma","Metastatic Leiomyosarcoma","Metastatic Soft Tissue Sarcoma","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","2026-06-16",{"date":69,"type":37},"2026-06-17",{"date":71,"type":37},"2026-03-18",{"date":73,"type":20},"2027-01-31",{"name":75,"class":76},"National Cancer Institute (NCI)","NIH",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":45},"100359833","phase-1-pulmonary-suffusion-in-controlling-minimal-residual-disease-in-patients-with-sarcoma-or-colorectal-metastases-100359833","NCT03965234","Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases","Phase I\u002F II Study of Pulmonary Suffusion to Control Minimal Residual Disease in Resectable or Ablatable Sarcoma or Colorectal Pulmonary Metastases","Inclusion Criteria:\n\n* Tumors metastatic to the lungs that are the focus of this protocol specifically:\n\n  * Soft tissue sarcoma\n  * Osteosarcoma\n  * Colorectal carcinoma\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n* Hemoglobin \\> 8.0 g\u002FL\n* Granulocytes \\> 1,500 uL\n* Platelets \\>= 100,000 uL\n* Creatinine clearance \\>= 30 mL\u002Fmin\n* Clinically diagnosed resectable sarcoma lung metastases(while preregistration histologic or cytologic confirmation is desirable, this may not be required in clinical scenarios where a biopsy may not change the need to resect suspicious lung nodules or the biopsy itself poses a risk for tumor seeding. In such cases, the diagnosis will be supported by rapid pathologic evaluations intraoperatively before proceeding with Suffusion) Given the emergence of other acceptable options to destroy lung metastases such as SBRT or microwave ablation, a hybrid approach to eliminate all sites of disease will be permitted; however, supplemental approaches should be delayed, if possible, until after the 30 day post-suffusion endpoint\n* Forced expiratory volume in 1 second (FEV1) \\>= 50% predicted\n* Diffusion capacity of the lung for carbon monoxide (DLCO) \\>= 50% predicted\n* Vital capacity (VC) \\>= 50% predicted\n* Ambulatory and resting oxygen (O2) saturation \\> 88%\n* Six minute walk \\>= 50 % of the expected distance\n* Surgeon affirmation that suffusion is technically feasible\n* Borg Dyspnea scale (modified) \\\u003C 5\n* Control of the primary tumor as determined by clinical assessment per standard of care; may include stable tumor status of primary tumor and other metastases, in the clinical judgement of the PI\u002FPhysician.\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier\n* Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n* Allergy, intolerance, or other serious reaction to chemotherapy drugs that may be used in the procedure\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Pulmonary metastases unable to be completely resected or ablated based on pre-registration review of imaging by a thoracic surgeon or proceduralist.\n* Any additional condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug or the suffusion technique, may include uncontrolled intercurrent illness and other conditions that, in the judgement of the PI\u002FPhysician, would limit compliance with the study requirements and have safety concerns\n* Received an investigational agent within 30 days prior to enrollment\n* Severe peripheral neuropathy",{"count":85,"type":20},99,[23,56],"This phase I\u002FII trial studies the side effects of pulmonary suffusion in controlling minimal residual disease in patients with sarcoma or colorectal carcinoma that has spread to the lungs. Pulmonary suffusion is a minimally invasive delivery of chemotherapeutic agents like cisplatin to lung tissues. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pulmonary suffusion may also be useful in avoiding later use of drugs by vein that demonstrate no effect on tumors when delivered locally.",[89,90,64,91,92,93],"Metastatic Bone Sarcoma","Metastatic Malignant Neoplasm in the Lung","Metastatic Unresectable Sarcoma","Resectable Sarcoma","Colorectal Cancer","2026-03-13",{"date":96,"type":37},"2026-03-17",{"date":98,"type":37},"2020-07-16",{"date":100,"type":20},"2030-05-25",{"name":102,"class":44},"Roswell Park Cancer Institute",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":45},"100552560","phase-1-t-cell-membrane-anchored-tumor-targeted-il12--modified-til-cell-therapy-attil12-til-for-advancedmetastatic-soft-tissue-and-bone-sarcoma-patients-100552560","NCT06474676","T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy (attIL12-TIL) for Advanced\u002FMetastatic Soft Tissue and Bone Sarcoma Patients.","Inclusion Criteria:\n\n1. Age ≥ 12 years old\n2. Histologically-confirmed locally advanced or metastatic soft tissue or bone sarcoma scheduled to undergo resection or biopsy as part of standard of care\n3. Liposarcoma expansion cohort: histologically confirmed unresectable recurrent\u002Fmetastatic liposarcoma scheduled to undergo resection or biopsy as part of standard of care\n4. Participants undergoing resection should have other measurable disease or be high risk for recurrence within 12 month per investigator assessment and has prior approval by PI.\n5. Measurable disease according to RECIST 1.1 present prior to infusion of attIL12-TIL. If the only measurable disease is the same as the lesion biopsied for the study, it needs to be at least 2 cm in largest diameter.\n6. Participants must have received at least 1 prior line of systemic therapy for the treatment of sarcoma, unless no standard therapy exists for a specific sarcoma subtype.\n7. At least 3 weeks must have elapsed since the last cytotoxic chemotherapy or immunotherapy prior to tumor tissue collection. For targeted therapies, at least 4 half-lives or 3 weeks must have elapsed prior to tumor tissue collection (whichever is shorter). Standard of care anti- cancer therapy will be permitted following tumor tissue collection but prior to initiation of cyclophosphamide such that at least 3 weeks must have elapsed since last cytotoxic chemotherapy or immunotherapy prior to starting treatment with cyclophosphamide. For targeted therapies, at least 4 half-lives or 3 weeks must have elapsed prior to initiation of treatment with cyclophosphamide (whichever is shorter). Investigational anti-cancer therapy will not be permitted.\n8. At least 2 weeks must have elapsed for palliative radiation to any tumor site other than the tumor site identified for tissue collection\n9. Participants must have organ and marrow function as defined below\n10. Absolute neutrophil count (ANC) \\> 1 K\u002FuL, Hemoglobin \\> 9 g\u002FdL, Platelets \\> 100 K\u002Fmm3\n11. Serum creatinine \\\u003C\u002F= 2 mg\u002FdL OR creatinine clearance \\> 50 mL\u002Fmin\n12. Aspartic transaminase (AST) . 1.5 x upper limit of normal (ULN), Alanine transaminase (ALT) \\\u003C\u002F= 1.5 x ULN, Bilirubin ≤ 1.5 x ULN\n13. Women of childbearing potential (WOCBP) must agree to use method(s) of contraception: at least one highly effective or two effective accepted methods of contraception to avoid conception throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion.\n\n    WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal\n14. Men must be willing and able to use an acceptable method of birth control such as latex condom during the dosing period and for at least 3 months after completion of the study agent administration (T cell infusion) if their sexual partners are WOCBP.\n15. Signed Informed Consent and if applicable, pediatric assent\n\nExclusion Criteria:\n\n1. Known sensitivity to cyclophosphamide and\u002For study agents\n2. Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. Participants with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded\n3. Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression. Participants previously treated central nervous system metastases that are radiographically and neurologically stable for at least 6 weeks and do not require corticosteroids (of any dose) for symptomatic management for at least 14 days prior to first dose of attIL12-TIL cells are permitted to enroll.\n4. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment at the time of tumor tissue collection or attIL12 TIL cell infusion. Any prior radiation to the tumor site that is being collected for attIL12 TIL production. Palliative radiation to any tumor site within the past 2 weeks. Standard of care anti-cancer therapy will be permitted following tumor tissue collection but prior to initiation of cyclophosphamide as bridging therapy (per section 5.5). Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.\n5. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5 Grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (eg, hearing loss) after consultation with the PI.\n6. History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis.\n7. Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products.\n8. Major surgery (as defined by the investigator) within 4 weeks prior to first dose of treatment. Biopsy as per study protocol is allowed\n9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unhealed wound, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from the study agents, or compromise the ability of the participant to give written informed consent. Participants with cognitive impairment, including adults with cognitive impairment such as trisomy 21 or similar conditions are not specifically excluded from participation, such that appropriate written informed consent is obtained from the parent or legal guardian and they are able to complete with the study protocol requirements and treatment.\n10. Active concurrent second malignancy\n11. Pregnant or lactating women\n12. Any positive test result for hepatitis B or C virus indicating acute or chronic infection\n13. Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome","12 Years",{"count":111,"type":20},40,[23],"To find a recommended dose of attIL2-TIL cell therapy that can be given to participant with either relapsed or metastatic sarcomas (has come back or spread to other parts of the body, respectively).\n\nTo further test the dose found in Part A to see if it can help to control liposarcoma growth.",[26],"2026-02-25",{"date":117,"type":37},"2026-02-27",{"date":119,"type":37},"2025-09-29",{"date":121,"type":20},"2032-12-31",{"name":123,"class":44},"M.D. Anderson Cancer Center",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":5},"100577415","phase-1-first-in-human-study-of-adce-d01-in-soft-tissue-sarcoma-100577415","NCT06797999","First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma","A First-in-human, Phase 1\u002F2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of ADCE-D01, a Humanized Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients With Metastatic and\u002For Unresectable Soft Tissue Sarcoma","ADCElerate1","Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. Histologically confirmed STS with metastatic and\u002For unresectable disease (not amenable to treatment with curative intent).\n3. Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic\u002Funresectable disease.\n4. Measurable disease as per RECIST v 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Life expectancy of at least 3 months.\n7. A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate.\n8. A female patient is eligible if not pregnant, not breast feeding, and not a woman of childbearing potential (WOCBP), or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment.\n\nExclusion Criteria:\n\n1. Patients who have had systemic anticancer therapy, including any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration.\n2. Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.\n3. Clinically significant cardiovascular disease\n4. Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2.\n5. Current active liver disease due to hepatitis B\n6. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest computed tomography (CT) scan at screening.",{"count":133,"type":20},270,[23,56],"The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.",[64,137],"Unresectable Soft Tissue Sarcoma",[139,140,141],"Phase 1\u002FPhase 2","Sequential","Treatment","2026-01-27",{"date":144,"type":37},"2026-01-28",{"date":146,"type":37},"2025-06-05",{"date":148,"type":20},"2029-02-27",{"name":150,"class":151},"Adcendo ApS","INDUSTRY",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":5},"100429610","phase-2-bintrafusp-alfa-and-doxorubicin-hydrochloride-in-treating-patients-with-advanced-sarcoma-100429610","NCT04874311","Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma","Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST Study","TRUST","Inclusion Criteria:\n\n1. Histologically confirmed soft-tissue sarcoma with unknown translocation (including the following histologies but not limited to undifferentiated pleomorphic sarcomas, dedifferentiated liposaromas or leiomyosarcomas). Diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de référence en pathologie des sarcomes et des viscères) as recommended by the French NCI (Institut National du Cancer, Inca).\n2. Metastatic or unresectable locally advanced disease,\n3. No previous systemic treatment for advanced\u002Fmetastatic disease,\n4. For TLS status: available archived FFPE (Formalin-Fixed Paraffin-Embedded) tumor tissue sample or tumor material newly obtained by biopsy. Except if TLS analysis have been already performed by Biopathological platform at Bergonié Institute, presence or absence of TLS should be confirmed by central review based on FFPE tumor tissue sample (archived or newly obtained by biopsy for research purpose),\n5. Age ≥ 18 years,\n6. ECOG ≤ 1,\n7. Life expectancy \\> 3 months,\n8. Patients must have measurable disease defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension as \\> 10 mm with spiral CT scan.,\n9. Patient must comply with the collection of tumor biopsies and biomarkers study. Tumors must be accessible for biopsy,\n10. Adequate hematological, renal, metabolic and hepatic function\n11. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization. Serum or urine pregnancy test must be repeated within 72 hours prior to receiving the first dose of study medication,\n12. Both women and men must agree to use a highly effective method of contraception throughout the treatment period and for at least two months after discontinuation of treatment for women and four months for men.\n13. No prior or concurrent malignant disease diagnosed or treated in the last 3 years except for superficial\u002Fnon-invasive bladder cancer, or basal or squamous cell carcinoma in situ treated with curative intent; b. endoscopically resected GI cancers limited to the mucosal layer without recurrence in \\> 1 year,\n14. Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia and vitiligo of any grade and non-painful peripheral neuropathy grade ≤ 2) according to to NCI-CTCAE, version 5.0,\n15. Voluntarily signed and dated written informed consent prior to any study specific procedure,\n16. Patients with a social security in compliance with the French law.\n\nExclusion Criteria:\n\n1. Previous treatment with doxorubicin, daunorubicin, epirubicin, idarubicin and\u002For any other anthracyclines or anthracediones at the maximum cumulative dose or any approved or investigational treatment targeting PD1, PD-L1 or TGFB1,\n2. Known central nervous system malignancy (CNS),\n3. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding,\n4. Participation to a study involving a medical or therapeutic intervention in the last 30 days,\n5. Previous enrolment in the present study,\n6. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,\n7. Known hypersensitivity to any involved study drug or any of its formulation components,\n8. Any history of anaphylaxis, or recent, within 5 months, history of uncontrollable asthma,\n9. Individuals deprived of liberty or placed under legal guardianship,\n10. Any of the following cardiac criteria:\n\n    1. Mean resting corrected QT interval (QTcF) ≥ 470 msec, obtained from three consecutive ECGs,\n    2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG,\n    3. LVEF ≤ 50% per CTCAE v5 by MUGA or echocardiogram\n    4. Any factors increasing the risk of QTc prolongation or arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years old or any concomitant medication known to prolong the QT interval,\n    5. Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris, uncontrolled hypertension, congestive heart failure NYHA Grade ≥2, ventricular arrhythmias requiring continuous therapy, supraventricular arrhythmias including atrial fibrillation, which are uncontrolled, haemorrhagic or thrombotic stroke, including transient ischaemic attacks, cerebral vascular accident\u002Fstroke or any other central nervous system bleeding\n11. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:\n12. History of bleeding diathesis or recent major bleeding event ,\n13. Prior organ transplantation including allogenic stem-cell transplantation, except transplants that do not require immunosuppression,\n14. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection requiring systemic therapy, drug-induced interstitial lung disease or subject has had a history of drug-induced pneumonitis that has required oral or IV steroids, and\u002For other diseases, which in the opinion of the investigator might impair the subject's tolerance for the study or ability to consistently participate in study procedures,\n15. Active infection including tuberculosis ,\n16. Has known active hepatitis B or hepatitis C,\n17. Has a known history of Human Immunodeficiency Virus infection,\n18. Receipt of live attenuated vaccine within 30 days prior to the first dose of treatment. Note: Patients, if enrolled, should not receive live vaccine within 30 days prior to the first dose of treatment, whilst receiving study treatments and up to 30 days after the last dose. Seasonal flu vaccines that do not contain a live virus are permitted,\n19. Patients with current or history of deep vein thrombosis within 6 months prior to randomization,\n20. Any contraindication to biopsy for the research,\n21. Any other contraindication to Doxorubicin administration,.\n22. Patients with oral anticoagulation therapy based on Vitamin K antagonist.\n23. Prior mediastinal radiation.",{"count":161,"type":20},80,[56],"This study encompasses two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin",[165,26],"Advanced Soft-tissue Sarcoma",[167,168,169,170],"tertiary lymphoid structure","soft-tissue sarcoma","advanced\u002Fmetastatic","immunotherapy","2025-08-11",{"date":173,"type":37},"2025-08-13",{"date":175,"type":37},"2022-03-01",{"date":177,"type":20},"2027-07",{"name":179,"class":44},"Institut Bergonié",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":188,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":45},"100420636","phase-3-comparison-of-oral-cyclophosphamide-vs-doxorubicin-in-65-years-old-advanced-or-metastatic-soft-tissue-sarcoma-patients-100420636","NCT04757337","Comparison of Oral Cyclophosphamide vs Doxorubicin in ≥65 Years Old Advanced or Metastatic Soft Tissue Sarcoma Patients","Randomized Phase III Study of Oral Cyclophosphamide vs Doxorubicin in 65 Years or Older Patients With Advanced or Metastatic Soft Tissue Sarcoma: a UNICANCER\u002FGERICO Multicenter Program","GERICO14","Inclusion criteria:\n\n1. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trust person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent\n2. Age ≥65 years (inclusions will be managed to ensure that at least 50% of the randomized patients are ≥75 years old)\n3. Diagnosis of soft-tissue sarcoma histologically confirmed by Réseau de Référence en Pathologie des Sarcomes et des Viscères (RRePS)\n4. Metastatic or locally advanced disease not amenable to surgery, radiation, or combined modality treatment with curative intent. Palliative radiation therapy is permitted only if direct on nontarget lesion\n5. Documentation of disease progression within the last 6 months before randomization\n6. Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT-scan as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)\n7. Life expectancy of at least 6 months\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n9. G8 score \\>14\n10. Left ventricular ejection fraction (LVEF) value by echocardiogram or Multiple gated acquisition scanning (MUGA) ≥55%\n11. Adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:\n\n    1. Absolute neutrophil count (ANC) ≥1,500\u002Fmm³\n    2. Platelets ≥100,000\u002Fmm³\n    3. Hemoglobin ≥9.0 g\u002FdL\n    4. Serum creatinine ≤2 x upper limit of normal (ULN)\n    5. Glomerular filtration rate (GFR) ≥50 ml\u002Fmin\u002F1.73m² (calculated with MDRD)\n    6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5.0 × ULN for patients with liver involvement of their cancer )\n    7. Total bilirubin ≤1.5 X ULN\n    8. Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN with liver involvement of their cancer)\n    9. serum albumin \\>25 g\u002FL\n    10. Prothrombin time (PT)\u002FInternational normalized ratio (INR) ≤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 PT\u002FINR is stable based on a measurement that is pre-dose as defined by the local standard of care\n12. Male patients must agree to use adequate contraception for the duration of trial participation and up to 6 months after completing treatment\u002Ftherapy. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care\n13. Patients must be affiliated to a Social Security System (or equivalent)\n14. Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures including follow-up\n\nExclusion Criteria:\n\n1. Previous systemic treatment for advance or metastatic sarcoma\n2. Previous neoadjuvant or adjuvant anthracycline treatment for localized sarcoma\n3. Soft-tissue sarcoma with the following histological subtypes: dermatofibrosarcoma protuberans, desmoid tumor, alveolar or embryonal rhabdomyosarcoma, Desmoplastic small round cell tumor, Kaposi Sarcoma, Gastro-Intestinal stromal tumor, Peripheral neuroectodermal tumors\n4. Primary bone sarcoma (including osteosarcoma, Ewing tumor, chondrosarcoma, and chordoma)\n5. Symptomatic or known central nervous system (CNS) metastases\n6. Known history of or concomitant malignancy likely to affect life expectancy in the judgment of the investigator and history of radiotherapy mediastinal in the last five years\n7. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before Day 1 of treatment\n8. Active cardio vascular disease including any of the following: Congestive heart failure (New York Heart Association (NYHA) ≥Class 2), unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), acute inflammatory cardiopathy, severe arrythmia, high risk of bleeding, cerebrovascular accident within the last 6 months\n9. Uncontrolled grade \\>2 hypertension. (Systolic blood pressure ≥160 mmHg or diastolic pressure ≥100 mmHg despite optimal medical management)\n10. Ongoing infection ≥Grade 2 according to NCI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)\n11. Known history of human immunodeficiency virus (HIV) infection\n12. Known history of chronic hepatitis B or C\n13. History of organ allograft\n14. Pre-existing acute hemorrhagic cystitis, urinary tract obstruction, acute urinary tract infection\n15. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study\n16. Substance abuse, medical condition, that may interfere with the patient's participation in the study or evaluation of the study results\n17. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation\n18. Inability to swallow oral medications, any malabsorption condition.\n19. Persons deprived of their liberty or under protective custody or guardianship\n20. Participation in another therapeutic trial within the 30 days prior to randomization and during the study\n21. Patients having received live attenuated vaccine therapy used for prevention of diseases as influenza, chickenpox, zoster, measles, mumps, rubella, tuberculosis, rotavirus or yellow fever within 4 weeks of the first dose of study drug. These vaccinations are not permitted during the study up to 6 months after the last treatment\n22. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons","65 Years",{"count":190,"type":20},214,[192],"PHASE3","Most advanced or metastatic soft tissue sarcoma (STS) are unfortunately incurable, making the preservation of the patient's quality of life a major goal, along with prolonging survival.\n\nAge is not a criterion for not providing effective treatment, but the goals of treatment change with age and must be integrated into the treatment decision. Elderly patients prioritise a life free of dependency, preservation of their cognitive functions and quality of life related to their state of health. They are therefore reluctant to receive a treatment that does little to improve life expectancy at the cost of significant functional losses.\n\nPatients aged 65 years and older account for one third of all patients with STS. In the absence of dedicated recommendations, these elderly patients are currently receiving doxorubicin-based chemotherapy as first-line treatment (as recommended for younger patients), with a substantial risk of toxicity (especially cardiac). In this specific population, previous studies have shown that oral cyclophosphamide seems to have a promising activity, but also a very acceptable toxicity.\n\nThus, the GERICO study aims to compare standard doxorubicin chemotherapy with oral cyclophosphamide for the treatment of elderly patients with STS.",[165,26],[196,197,198,199],"Elderly","older patients","oral cyclophosphamide","doxorubicin","2025-03-24",{"date":202,"type":37},"2025-03-25",{"date":204,"type":37},"2021-06-18",{"date":206,"type":20},"2026-04",{"name":208,"class":44},"UNICANCER",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":219,"conditions":220,"keywords":221,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":45},"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":217,"type":20},250,[23,56],"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.",[61,64],[222],"cancer immunotherapy, combination chemo-\u002Fimmunotherapy","2025-02-21",{"date":225,"type":37},"2025-02-24",{"date":227,"type":37},"2017-04-13",{"date":229,"type":20},"2031-07-31",{"name":231,"class":44},"Sarcoma Oncology Research Center, LLC"]