[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-gliosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-gliosarcoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,65,93,115,138],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100625417","phase-1-testing-the-combination-of-anti-cancer-drugs-actimab-a-and-cemiplimab-regn2810-to-improve-outcomes-for-patients-with-recurrent-glioblastoma-100625417",false,"NCT07422363","Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma","A Phase I Trial of 225Ac-anti-CD33 and PD1-Inhibitor in Recurrent Glioblastoma","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed glioblastoma isocitrate dehydrogenase wild type (IDH-WT) World Health Organization (WHO) grade 4 inclusive of gliosarcoma (Louis et al., 2021)\n\n  * Note: Isocitrate dehydrogenase (IDH) status confirmed by immunohistochemistry (IHC) for IDH1 R132H + next-generation sequencing (NGS) for IDH1 and IDH2 hotspots\n* Evidence of recurrent disease (RD) that is measurable (1 x 1cm) at first or second relapse demonstrated by disease progression using Response Assessment in Neuro-Oncology 2.0 (RANO 2.0) criteria, unless the recurrence is outside the radiation field or has been histologically documented\n* Tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) methylation status must be available from any prior GBM tumor specimen; results of routinely used methods for MGMT methylation testing (e.g., mutagenically separated polymerase chain reaction \\[MSPCR\\] or quantitative polymerase chain reaction \\[PCR\\] are acceptable)\n* Previous first-line treatment with at least radiotherapy (prior dose ≥ 40 gray \\[Gy\\])\n\n  * Note: Prior temozolomide, prior tumor-treatment fields and\u002For Gliadel wafer (if placed at initial tumor resection) are allowed, but none of these are required\n* Last radiation ≥ 6 months (182 days) prior to enrollment if received ≥ 60 Gy or ≥ 3 months (84 days) if received \\\u003C 60 Gy to limit the risk of radiation necrosis\n* No previous treatment with anti PD1, PDL1, CTLA-4, or other immune checkpoint inhibitors\n* No tumor-directed therapy for most recent progression\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of Actimab-A in combination with cemiplimab (REGN2810) 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 ≥ 1,500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Hemoglobin ≥ 9 g\u002FdL\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within six (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 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 Functional Classification. To be eligible for this trial, patients should be class II or better\n* The effects of Actimab-A and cemiplimab (REGN2810) on the developing human fetus are unknown. For this reason and because anti-PD-1 agents as well as other therapeutic agents used in this trial 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, for the duration of study participation and for at least six (6) months after completion of Actimab-A. 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 six (6) months after completion of Actimab-A and cemiplimab (REGN2810) administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives (LAR) may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered to grade 0 or 1 or pre-treatment baseline 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\n* Presence of extracranial metastatic or leptomeningeal disease\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Actimab-A and cemiplimab (REGN2810)\n* Patients being treated with systemic immunostimulatory agents (including, but not limited to, interferon \\[IFN\\]-α or interleukin \\[IL\\]-2) within four (4) weeks prior to cycle 1 day 1. The study principal investigator (PI) must be consulted if a patient was being treated with any antibody within four (4) half-lives of said antibody\n\nTreatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha \\[TNF-α\\] agents) within two (2) weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n* Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study\n* Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study\n\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 cemiplimab (REGN2810) is an anti-PD-1 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 cemiplimab (REGN2810), breastfeeding should be discontinued if the mother is treated with cemiplimab (REGN2810). These potential risks also apply to Actimab-A\n  * Early disease progression prior to three (3) months from the completion of radiotherapy\n  * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy defined as dexamethasone \\> 2 mg\u002Fday or bioequivalent for at least three (3) consecutive days within two (2) weeks of start of study drug\n  * Has active autoimmune disease that has required systemic treatment in the past two (2) years\n  * Prior administration of a radiopharmaceutical unless 10 or more effective half-lives have elapsed before injection of Actimab-A (Ac225-lintuzumab)\n  * Previous treatment with bevacizumab for the treatment of glioblastoma with therapeutic intent, or with bevacizumab as supportive therapy (e.g., edema reduction) within six (6) weeks (42 days) of initiation of study treatment. This is approximately two (2) half-lives which is justified based on median time to rebound tumor progression following bevacizumab discontinuation (6.1 weeks), median time to clinical deterioration following bevacizumab discontinuation after disease progression from multiple studies indicating that washout periods longer than eight (8) weeks are unlikely to be tolerated, and perioperative outcome data after neoadjuvant bevacizumab demonstrating relative safety of surgical intervention at least four (4) weeks after bevacizumab discontinuation (Sener et al., 2024)\n  * Patients who are unable to take spironolactone or eplerenone due to intolerance, allergy, drug-drug interactions, or for any other reason","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial studies the side effects and best dose of Actimab-A when given together with cemiplimab (REGN2810) in treating patients with glioblastomas that have come back after a period of improvement (recurrent). Actimab-A consists of the monoclonal antibody lintuzumab combined with the radioactive drug actinium Ac 225. Lintuzumab specifically binds to the cell surface antigen CD33 which is found on the glioblastoma cells and delivers the actinium Ac 225. This may allow the glioblastoma to be found and treated by Actimab-A. Immunotherapy with monoclonal antibodies, such as cemiplimab (REGN2810), may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving Actimab-A with cemiplimab (REGN2810) may be safe, tolerable and\u002For effective in treating recurrent glioblastoma.",[26,27,28],"Recurrent Glioblastoma, IDH-Wildtype","Recurrent Gliosarcoma","Recurrent WHO Grade 4 Glioma","NOT_YET_RECRUITING","2026-06-11",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":20},"2026-12-04",{"date":37,"type":20},"2027-02-28",{"name":39,"class":40},"National Cancer Institute (NCI)","NIH",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100442276","phase-1-atezolizumab-and-cabozantinib-for-the-treatment-of-recurrent-glioblastoma-100442276","NCT05039281","Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma","Phase I\u002FII Study to Evaluate the Safety and Clinical Efficacy of Atezolizumab (Anti-PD-L1) in Combination With Cabozantinib in Patients With Recurrent Glioblastoma (rGBM)","Inclusion Criteria:\n\n* Signed informed consent form (ICF)\n* Ability and willingness to comply with the requirements of the study protocol\n* Age \\>= 18 years\n* Have histologically confirmed World Health Organization grade IV glioma (glioblastoma or gliosarcoma). Archival tissue will be required for diagnosis confirmation. Receipt of archival tissue is not required for the start of treatment\n* Patients must have been previously treated with radiation and temozolomide\n* Patients must be at least 12 weeks out from completion of concurrent chemoradiation\n* Have a performance status of \\>= 60 on the Karnofsky performance status (KPS)\n* Patients at either first or second recurrence will be considered eligible\n* A baseline brain magnetic resonance imaging (MRI) obtained no more than 14 days prior to study enrollment\n* Absolute neutrophil count (ANC) \\>= 1,500 \u002FmcL\n* Platelets \\>= 100,000 \u002FmcL\n* Hemoglobin \\>= 9 g\u002FdL or \\>= 5.6 mmol\u002FL\n* Serum creatinine =\\\u003C 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) \\>= 60 mL\u002Fmin for subject with creatinine levels \\> 1.5 X institutional ULN\n\n  * Creatinine clearance should be calculated per institutional standard\n* Urine protein\u002Fcreatinine ratio (UPCR) =\\\u003C 1 mg\u002Fmg (=\\\u003C 113.2 mg\u002Fmmol) OR 24 hour (h) urine protein =\\\u003C 1g\n* Serum total bilirubin =\\\u003C 1.5 X ULN OR direct bilirubin =\\\u003C ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 X ULN\n* Serum albumin \\>= 2.8 g\u002Fdl\n* International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =\\\u003C 1.3 X ULN\n* All screening labs should be performed within 14 days (+3 working days) of treatment initiation\n* Female subject of childbearing potential should have a negative serum pregnancy test within 14 days (+\u002F- 3 working days) of study enrollment\n* Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the duration of the study and 5 months after the last dose of study treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year\n* Male subjects should agree to use an adequate method of contraception during the course of the study and 5 months after the last dose of study treatment\n\nExclusion Criteria:\n\n* Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery. Prior treatment with Gliadel wafers will be excluded. Active treatment with the Optune device will be excluded\n* Has received radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment, or systemic treatment with radionuclides within 6 weeks before first dose of study treatment\n* Has clinically relevant ongoing complications from prior radiation therapy\n* Is currently participating in any other recurrent therapeutic trial after completion of chemoradiation\n* Has history of cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation\n* Any serious medical condition that interferes with adherence to study procedures\n* Malignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0)\n* Has known leptomeningeal disease, gliomatosis cerebri, extracranial disease, or multifocal disease. Subject has multifocal glioblastoma (GBM), defined as discrete sites of contrast enhancing disease without contiguous T2\u002Ffluid attenuated inversion recovery (FLAIR) abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2\u002FFLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted\n* Has history of interstitial lung disease or active, non-infectious pneumonitis\n* Has an active infection requiring systemic therapy\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit\n* Contraindication for undergoing MRIs\n* Inability to comply with study and follow-up procedures\n* History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\n\n  * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\n  * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\n  * Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\n\n    * Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\n    * Rash must cover less than 10% of body surface area (BSA)\n    * Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\n    * No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \\[PUVA\\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)\n* Has a medical history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or active pneumonitis\n\n  * History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications\n* History of human immunodeficiency virus (HIV) infection or active hepatitis B (HBV) (chronic or acute) or hepatitis C infection\n\n  * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive anti-HBc \\[antibody to hepatitis B core antigen\\] antibody test) are eligible. Patients will be sampled for HBV DNA and will be referred to a virologist to monitor for HBV re-activation\n  * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA\n* Active tuberculosis\n* Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1\n* Received oral or IV antibiotics within 2 weeks prior to cycle 1, day 1\n\n  * Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible\n* Anticipation of need for a major surgical procedure (e.g., laparoscopic nephrectomy, gastrointestinal \\[GI\\] surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment, or of need for a minor surgery within 10 days before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible\n* Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study\n* Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to cycle 1, day 1 or at any time during the study and for 5 months after last dose of atezolizumab\n* Patients may not receive concomitant chemotherapy, hormonal therapy, immunotherapy, or radiotherapy while patients are on study\n* MEDICATION-RELATED EXCLUSION CRITERIA:\n* Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents\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* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment\n* Prior treatment with anti-angiogenic (e.g. anti-vascular endothelial growth factor \\[VEGF\\]) therapeutic antibody or pathway targeting agents\n* Treatment with systemic immunostimulatory agents (including but not limited to interferon \\[IFN\\]- or interleukin \\[IL\\]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1\n* Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[anti-TNF\\] agents) within 2 weeks prior to cycle 1, day 1\n\n  * Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\n  * The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed\n* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, fusion proteins or components of cabozantinib\n* Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation\n* Evidence of recent hemorrhage on post-operative MRI of the brain, however patients with clinically asymptomatic presence of hemosiderin, resolving post-operative changes and punctate intratumoral hemorrhage are permitted\n* Known lesions invading or encasing any major blood vessels. Subjects with lesions invading the intrahepatic vasculature, including portal vein, hepatic vein, and hepatic artery, are eligible\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment\n\n  * Note: if a single ECG shows a QTcF with an absolute value \\> 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 minutes after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility\n* Inability to swallow tablets\n* Inadequately controlled hypertension (defined as systolic blood pressure \\> 140mmHg and\u002For diastolic blood pressure \\> 90mmHg)\n* A history of or active nephrotic syndrome\n* Prior history of hypertensive crisis or hypertensive encephalopathy\n* New York Heart Assocation (NYHA) grade II or greater congestive heart failure\n* History of myocardial infarction or unstable angina within 6 months prior to study enrollment\n* History of stroke or transient ischemic attack (TIA) within 6 months prior to study enrollment\n* Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study enrollment\n* History of clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or any other history of significant bleeding (e.g. pulmonary hemorrhage) within 12 weeks before first dose of study treatment\n* Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)\n* Major surgical procedure, open biopsy, intracranial biopsy, ventriculoperitoneal shunt or significant traumatic injury within 28 days prior to study enrollment\n* Core biopsy (excluding intracranial biopsy) or other minor surgical procedure within 107 days prior to study enrollment. Placement of a central vascular access device if performed within 2 days prior to cabozantinib administration\n* History of abdominal fistula, bowel obstruction, gastrointestinal perforation or intra-abdominal abscess within 6 months before first dose of study treatment\n\n  * Note: complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment\n* History of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction\n* History of intracranial abscess within 6 months prior to study enrollment\n* Clinically-significant disorders that would preclude safe study participation\n\n  * Serious non-healing wound, active ulcer or untreated bone fracture\n  * Uncompensated\u002Fsymptomatic hypothyroidism\n  * Moderate to severe hepatic impairment (Child-Pugh B or C)\n* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g. , dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel)\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH) are allowed\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 or the tumor are also allowed",{"count":5,"type":20},[23,50],"PHASE2","This phase I\u002FII trial tests the safety and side effects of atezolizumab in combination with cabozantinib and whether they work to shrink tumors in patients with glioblastoma that has come back (recurrent). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab and cabozantinib may help control the disease in patients with recurrent glioblastoma.",[53,27],"Recurrent Glioblastoma","RECRUITING","2026-06-09",{"date":30,"type":33},{"date":58,"type":33},"2022-09-23",{"date":60,"type":20},"2027-12-31",{"name":62,"class":63},"M.D. Anderson Cancer Center","OTHER",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":64},"100616104","phase-2-gi-102-alone-or-with-pembrolizumab-before-surgery-for-treatment-of-recurrent-or-progressive-idh-wildtype-glioblastoma-and-idh-mutated-grade-4-astrocytoma-100616104","NCT07301268","GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma","MC230719 Window Of Opportunity Study Of GI-102 In Patients With Recurrent High-Grade Glioblastoma","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease characteristics\n\n  * Tissue-confirmed progressive or recurrent World Health Organization (WHO) grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma); and IDH mutated WHO grade 4 astrocytoma\n  * Candidates for surgical resection\n* Measurable or non-measurable disease as defined by Response Assessment in Neuro-Oncology (RANO) 2.0\n* Willing to undergo clinically indicated biopsy followed by resection of high-grade glioma at Mayo Clinic in Rochester, Minnesota (MN)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0,1, or 2 and Karnofsky performance status (KPS) ≥ 60\n\n  * NOTE: PS must be assessed (again) ≤ 7 days prior to first dose of study drug\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml\u002Fmin (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 x ULN (obtained ≤ 15 days prior to registration)\n* Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN (obtained ≤ 15 days prior to registration)\n* Amylase and lipase ≤ ULN (obtained ≤ 15 days prior to registration)\n* Left ventricular ejection fraction (LVEF) ≥ 50% (obtained ≤ 29 days prior to registration)\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Persons of childbearing potential (POCBP) or able to father a child must be willing to use adequate contraception starting with first dose through 180 days after last dose\n* Provide written informed consent\n* Willingness to provide blood specimens for correlative research\n* Willingness to provide tissue specimens for correlative research\n* Willingness to provide written informed consent for the neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and\u002For blood samples collected on this protocol\n* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait)\n* Prior treatment\n\n  * Received bevacizumab (AVASTIN) \\\u003C 30 days prior to registration\n\n    * NOTE: Bevacizumab is allowed for symptom control during the adjuvant phase of the study\n  * Increasing dexamethasone dose prior to registration\n\n    * NOTE: Patients currently on dexamethasone must be on dose ≤ 4 mg\u002Fday at time of registration\n  * Received chemotherapy \\\u003C 30 days prior to registration\n  * Received a live vaccine \\\u003C 30 days prior to registration\n* Failure to recover from any adverse events related to any of the following therapies received prior to registration:\n\n  * Major surgery \\\u003C 28 days prior to registration\n  * Radiation therapy \\\u003C 14 days prior to registration\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring IV antibiotics\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness\u002Fsocial situations (e.g., drug addiction) that would limit compliance with study requirements\n* Receiving any other investigational agent at the time of registration\n* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) ≤ 2 years prior to registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Concurrent known active hepatitis B (i.e., known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] reactive) AND known active hepatitis C (i.e., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] detected by polymerase chain reaction \\[PCR\\]). Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority\n\n  * NOTE: Patients with known hepatitis B OR hepatitis C may be enrolled if they meet the following criteria:\n\n    * Hepatitis B: Patients who are HBsAG positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on anti-viral therapy throughout the treatment phase of the trial and should follow local guidelines for HBV anti-viral therapy after completing study treatment\n    * Hepatitis C: Patients with history of hepatitis C infection are eligible if HCV viral load is undetectable at screening. Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration\n* Known history of active TB (Bacillus tuberculosis)\n* History of (non-infectious) pneumonitis or interstitial lung disease that required steroids, or current pneumonitis or interstitial lung disease\n* Hypersensitivity to pembrolizumab, IL-2, GI-102 or any of its excipients\n* History of allogeneic tissue\u002Fsolid organ transplant",{"count":73,"type":20},36,[50],"This phase II trial compares the effect of GI-102 alone and in combination with pembrolizumab given before surgery in treating patients with IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). Glioblastoma is the most common and the most aggressive primary brain tumor in adults. Current standard of care includes surgical resection, radiation and chemotherapy. Treatment is often given before surgery (neoadjuvant therapy) to shrink the tumor and make it easier to remove. Treatment with GI-102, a bispecific fusion protein, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving GI-102 alone and in combination with pembrolizumab between neoadjuvant therapy and surgery may be safe, tolerable, and effective in treating patients with recurrent or progressive IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma.",[77,78,79,80,81,26,27,82,83],"Glioblastoma, IDH-Wildtype","Progressive Astrocytoma, IDH-Mutant, Grade 4","Progressive Glioblastoma","Progressive Gliosarcoma","Recurrent Astrocytoma, IDH-Mutant, Grade 4","Resectable Astrocytoma","Resectable Glioblastoma","2026-04-02",{"date":86,"type":33},"2026-04-08",{"date":88,"type":33},"2026-04-01",{"date":90,"type":20},"2034-04-30",{"name":92,"class":63},"Mayo Clinic",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":64},"100354565","phase-1-msc-dnx-2401-in-treating-patients-with-recurrent-high-grade-glioma-100354565","NCT03896568","MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma","Phase I Clinical Trial of Allogeneic Bone Marrow Human Mesenchymal Stem Cells Loaded With A Tumor Selective Oncolytic Adenovirus, DNX-2401, Administered Via Intra-Arterial Injection in Patients With Recurrent High-Grade Glioma","Inclusion Criteria:\n\nSubjects must meet the following inclusion criteria to be eligible and enroll:\n\n1. Subjects must be willing and able to provide informed consent, undergo and comply with all study assessments, and adhere to the protocol schedule.\n2. Patients with recurrent malignant GBM or gliosarcoma will be eligible. Patients with recurrent anaplastic astrocytoma with wild-type IDH-1 gene will also be eligible if there is a significant enhancing mass on MRI (≥1.0 cm in diameter with upper limit of 5 cm maximal diameter) because their prognosis\u002Fbehavior is similar to GBM. Subjects with an initial diagnosis of an IDH-mutant grade 2 or 3 astrocytoma are also eligible at recurrence if a biopsy at recurrence is determined to be IDH-mutant grade 4 astrocytoma, and there is a significant enhancing mass on MRI (≥1.0 cm in diameter with upper limit of 5 cm maximal diameter). A pathology report constitutes adequate documentation of histology for study inclusion.\n3. Patients must show unequivocal evidence for tumor recurrence or progression by MRI scan after failing prior surgical resection, biopsy, chemotherapy or radiation. A baseline MRI must be performed within 24 days prior to registration. Biopsy is encouraged at the time of recurrence if it is unclear that there is recurrent tumor. However, biopsy is not required if the practicing physician thinks that there is adequate radiographic and clinical evidence for recurrence.\n4. Male or female patients ≥ 18 years of age.\n5. Patients must be able to undergo endovascular treatment based on Doppler studies showing ICA that is less than 50% occluded.\n6. For patients undergoing resection for biological endpoints, tumors must be surgically resectable at the time of baseline evaluation and craniotomy for tumor resection is indicated as part of their standard medical care.\n7. Tumors must be ≥1.0 cm in diameter with upper limit of 5 cm maximal diameter.\n8. Patients must have a Karnofsky performance score ≥ 70.\n9. Patients must have a life expectancy of at least 16 weeks.\n10. Patients must have adequate bone marrow function (absolute granulocyte count \\> 1,500 and platelet count of \\> 75,000), adequate liver function (SGPT and SGOT and bilirubin \\\u003C 2 times institutional normal ranges), and adequate renal function (creatinine \\\u003C 2.0 times institutional normal) prior to starting therapy.\n11. Prothrombin time\u002Finternational normalized ratio (PT\u002FINR) or partial thromboplastin time (PTT) ≤ 1.5x ULN.\n12. Subjects who have received the following chemotherapies must have completed them within the following time periods prior to Baseline\u002FDay 0 of hMSC-DNX2401 delivery with recovery from any drug-related toxic effects to Grade 1, or less, severity:\n\n    * Four weeks from cytotoxic agents (3 weeks from procarbazine or Temozolomide, 2 weeks from vincristine)\n    * 6 weeks from nitrosoureas (CCNU, BCNU)\n    * Four weeks from any targeted investigational agent\n    * One week from non-cytotoxic agents\n13. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender.\n14. No exclusion to this study will be based on race. Minorities will actively be recruited to participate. The malignant glioma patient population treated at MDACC over the past year is as follows:\n\n    * American Indian or Alaskan Native - 0\n    * Asian or Pacific Islander - \\\u003C2%\n    * Black, not of Hispanic Origin - 3%\n    * Hispanic - 6%\n    * White, not of Hispanic Origin - 88%\n    * Other or Unknown - 2%\n    * Total - 100%\n15. Patients must be 8 weeks from radiotherapy to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, or 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is outside the primary radiation field (beyond 80% isodose line). However, if a biopsy is undertaken prior to these times and this biopsy documents histological evidence for recurrent disease, then patients will be eligible regardless of the time after radiation.\n16. Patients must be willing to forego other cytotoxic and non-cytotoxic drug or radiation therapy against the tumor while enrolled in the study.\n17. Women of childbearing potential must have a negative urine or serum pregnancy test at screening.\n18. Subjects and their partners must be willing to use effective birth control during the study and for up to 6 months following administration of hMSC-DNX2401. Birth control that is acceptable to use in this study:\n\n    * Using twice the normal protection of birth control (i.e., double-barrier) by using a condom AND spermicidal jelly or foam, or a diaphragm AND spermicidal jelly or foam. A spermicidal jelly or foam must be used in addition to a barrier method (e.g., condom or diaphragm)\n    * Birth control pills (\"The Pill\")\n    * Depot or injectable birth control\n    * IUD (Intrauterine Device)\n    * Birth Control Patch (e.g., Othro Evra®)\n    * NuvaRing®\n    * Surgical sterilization (i.e., tubal ligation or hysterectomy for women or vasectomy for men)\n\nExclusion Criteria:\n\n1. Histology other than GBM, gliosarcoma, IDH wild-type astrocytoma grade III or IDH-mutant astrocytoma grade 4.\n2. Tumor foci detected below the tentorium or beyond the cranial vault.\n3. Tumor within the posterior fossa.\n4. Tumor with leptomeningeal spread.\n5. Difficulty in obtaining vascular access for percutaneous procedure.\n6. Ipsilateral carotid stenosis (\\>50%, by Doppler studies).\n7. Thrombophilias or primary hematological diseases.\n8. Transfusions or medications (G-CSF) to treat pancytopenia or other hematological conditions \\\u003C 28 days prior to Baseline\u002FDay 0\u002FhMSC-DNX2401 administration.\n9. Biologic\u002Fimmunotherapy within 2 weeks of baseline.\n10. Clinical or laboratory evidence of inflammatory and\u002For autoimmune disorders.\n11. Any contraindication for undergoing MRI such as: individuals with pacemakers, epicardial pacer wires, infusion pumps, surgical and\u002For aneurysm clips, shrapnel, metal prosthesis, implants with potential magnetic properties, metallic bodies in the eyes, etc. In addition, subjects must present with tumor that is evaluable by MRI.\n12. Pregnant or nursing females.\n13. Evidence of active uncontrolled infection or unstable or severe intercurrent medical conditions. All subjects must be afebrile (i.e., \\\u003C38.0° Celsius \\[C\\]).\n14. Any medical condition that precludes surgery or endovascular treatment\n15. Alcoholism (dependency), alcohol or substance abuse within twelve (12) months prior to screening that has caused health consequences.\n16. Immunocompromised subjects or those with autoimmune conditions, active hepatitis (Liver function tests \\> 2x normal) or human immunodeficiency virus (HIV) seropositivity.\n17. Evidence of bleeding diathesis or use of anticoagulant medication or any medication that may increase the risk of bleeding that cannot be stopped prior to surgery. If the medication can be discontinued prior to DNX-2401 injection then the subject may be eligible following consultation with the Study Chair. Low weight heparin and Lovenox (enoxaparin) administered on a temporary limited basis for post procedure DVT prophylaxis is permitted.\n18. History or current diagnosis of any medical or psychological condition that in the Investigator's opinion might interfere with the subject's ability to participate or inability to obtain informed consent because of psychiatric or complicating medical problems.\n19. Encephalitis, multiple sclerosis or other central nervous system (CNS) infection or primary CNS disease that would interfere with subject evaluation.\n20. Subjects with known Li-Fraumini Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.\n21. Subjects with significant systemic or major illnesses including but not limited to: congestive heart failure, ischemic heart disease, cerebrovascular disease (history of strokes or TIAs in large vessel or small vessel distribution), kidney disease or renal failure, active liver disease, organ transplantation, or significant psychiatric disorder.\n22. Enrollment in a concomitant therapeutic clinical study.\n23. Any condition that prevents compliance with the protocol or adherence to therapy.\n24. For patients enrolled in the biological endpoint phase of the study, patients will be excluded if in the assessment of the surgeon, after resecting the tumor, there is high likelihood of injecting BM-hMSC-DNX2401 into the ventricles.",{"count":73,"type":20},[23],"This phase I trial studies best dose and side effects of oncolytic adenovirus DNX-2401 in treating patients with high-grade glioma that has come back (recurrent). Oncolytic adenovirus DNX-2401 is made from the common cold virus that has been changed in the laboratory to make it less likely to cause an infection (such as a cold). The virus is also changed to target brain cancer cells and attack them.",[104,105,53,27,106],"IDH1 wt Allele","Recurrent Anaplastic Astrocytoma","Recurrent Malignant Glioma","2026-03-03",{"date":109,"type":33},"2026-03-05",{"date":111,"type":33},"2019-02-12",{"date":113,"type":20},"2027-09-30",{"name":62,"class":63},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":64},"100438637","phase-1-phase-i-cb-nk-tgf-r2-nr3c1--in-rgbm-100438637","NCT04991870","Phase I CB-NK-TGF-ßR2-\u002FNR3C1- in rGBM","A Phase I Clinical Trial With a Window-of-Opportunity Component of Engineered NK Cells Containing Deleted TGF-ßR2 and NR3C1 in Recurrent Grade 4 Astrocytoma (Glioblastoma)","Inclusion Criteria\n\n1. Signed and dated informed consent.\n2. Male or female participants aged ≥ 12 years on the day of signing informed consent.\n3. Has histologically confirmed supratentorial World Health Organization grade 4 recurrent astrocytoma to include recurrent IDH WT glioblastoma or gliosarcoma and recurrent IDHmutant grade 4 astrocytoma, and recurrent gliosarcoma with any prior number of recurrences, and who have received prior radiation and temozolomide therapy. Participants will be eligible if the original histology was lower-grade glioma grade 2 or 3 and a subsequent histological diagnosis of recurrent glioblastoma or IDH-mutant grade 4 astrocytoma is made.\n4. Karnofsky Performance Score (KPS) of \\>70 at trial entry. Lansky \\>70 at trial entry for patients less than 16.\n5. Must be at least 12 weeks from receiving conformal radiation, unless RANO criteria for early progression are met.\n6. A baseline brain MRI with Advance Brain Tumor Imaging (ABTI) must be obtained no more than 30 days prior to study registration\n7. Patients having undergone recent surgery are eligible so long as they are at least 3 weeks from resection or at least 1 week from stereotactic biopsy and recovered from any operative or perioperative complications.\n8. Adequate hematological function defined by white blood cell (WBC) count ≥ 3 x 10°9\u002FL with absolute neutrophil count (ANC) ≥ 1.5 x 10°9\u002FL, lymphocyte count ≥ 0.5 x 10°9\u002FL, platelet count ≥ 100 x 10°\u002FL, and Hgb ≥ 9 g\u002F dL (in absence of blood transfusion).\n9. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 x ULN, an AST level ≤ 2.5 x ULN, and an ALT level ≤ 2.5 x ULN, and INR ≤ 1.5 10. Adequate renal function defined creatinine ≥ 1.5 X upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL\u002Fmin for participant with creatinine levels \\> 1.5 X institutional ULN\n\n11\\. Female participant of childbearing potential should have a negative serum pregnancy test within 14 days (+\u002F-2 working days) of study registration.\n\n12\\. Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study and for 3 months after the last dose of study therapy. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n\n13\\. Male participants should agree to use 2 methods of highly effective contraception starting with the first dose of study therapy and for 3 months after the last dose of study therapy.\n\n14\\. For the surgical expansion group (Group 2): there must be at least 1 cm2 of contrast-enhancing disease that is considered resectable by the neurosurgeon.\n\nExclusion Criteria\n\n1. Has received prior therapy with Gliadel or bevacizumab.\n2. Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery.\n3. Is currently participating in or has participated in a study of cancer directed investigational agent or using an investigational device within 4 weeks since last dose of agent administration or device use, or is planning to continue or start treatment with Optune® during participation in this trial.\n4. Has known severe hypersensitivity to monoclonal antibodies, any history of anaphylaxis, or recent, within 5 months, history of uncontrolled asthma.\n5. Has a known history of Human Immunodeficiency Virus (HIV) (positive HIV 1\u002F2 antibodies); HTLV1 and\u002For HTLV2; active Hepatitis B (e.g., HbsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected). Patients with prior HBV vaccination (anti-HBs positive, HbsAg negative, anti-HBc negative) will NOT be excluded.\n6. Has a diagnosis of immunodeficiency or is receiving any immunosuppressive therapy within 7 days prior to study registration.\n7. Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 0.\n\n   1. Note: Participants with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n   2. Note: If participant received major surgery (other than craniotomy), they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n8. Has had prior radiation therapy less than 12 weeks prior to study registration, unless RANO criteria for early progression are met.\n9. Has had prior therapy with any antibody\u002Fdrug targeting T cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody within the last three months prior to study registration -.\n10. Has a known additional malignancy that is progressing or requires active treatment.\n\n    Exceptions include but are not limited to basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. Any exceptions must be discussed with the protocol PI.\n11. Has known gliomatous cerebri, extracranial disease, or tumor localized primarily to the brainstem or spinal cord.\n12. Brain midline shift greater than 0.5 cm or pending herniation seen on baseline MRI ABTI.\n13. Tumors larger than 5 cm at greatest diameter\n14. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Participants with vitiligo or resolved childhood asthma\u002Fatopy would be an exception to this rule. Participants that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.\n15. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.\n16. Has an active infection requiring systemic therapy or that in the opinion of the PI may interfere with the participant's participation, assessment of experimental treatment toxicity or increase the participant's risk of side effects.\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate in the opinion of the treating investigator.\n18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n19. Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit and through 3 months after last dose of the study treatment.\n20. Has received a live vaccine within 30 days prior to the first dose of trial treatment.\n21. Has a contraindication for undergoing MRIs.\n22. Has evidence of bleeding diathesis or coagulopathy.\n23. Is on full dose anticoagulants or antiplatelet therapy that cannot be held.\n24. Has significant hemorrhage on baseline MRI ABTI defined as \\>1 cm diameter of acute blood.\n25. Has received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).\n26. Has multicentric disease. Subject has multicentric GBM, defined as discrete sites of contrast enhancing disease without contiguous T2\u002FFLAIR abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2\u002FFLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted.\n\nTreatment will be up to 32 weeks in duration.\n\nThe number of cells administered will be based on gene editing efficiency. CB-NK-TGF-£\\]R2-\u002FNR3C1-cells will be administered via intraventricular injection via an Ommaya reservoir on day 0 and every 4 weeks y for up to 8 doses total in Group 1.\n\nSurgical patients in Group 2 will undergo intraventricular insertion of an Ommaya (day -14 to -\n\n1). They will then undergo IT injection via the Ommaya reservoir of CB-NK-TGF-£\\]R2-\u002FNR3C1-cells on day 0. Prior to planned tumor resection to occur between days 7-14. Every 4 week intraventricular injections of CB-NK-TGF-£\\]R2-\u002FNR3C1- cells will be administered for a total of 8 intraventricular treatments.\n\nIn the setting of any surgical complications following Ommaya placement, CB-NK-TGF-£\\]R2-\u002FNR3C1- cells may be delayed and administered once the patient is deemed stable by the neurosurgeon following Ommaya placement.\n\nTreatment will continue until tumor progression or intolerable toxicity, or a maximum of 8 intraventricular treatments with CB-NK-TGF-£\\]R2-\u002FNR3C1- cells whichever occurs first.","12 Years",{"count":124,"type":20},25,[23],"This phase I trial is to find out the best dose, possible benefits and\u002For side effects of engineered natural killer (NK) cells containing deleted TGF-betaR2 and NR3C1 (cord blood \\[CB\\]-NK-TGF-betaR2-\u002FNR3C1-) in treating patients with glioblastoma that has come back (recurrent). CB-NK-TGF-betaR2-\u002FNR3C1- cells are genetically changed immune cells that may help to control the disease.",[27,128,129],"Recurrent Supratentorial Glioblastoma","Supratentorial Gliosarcoma","2026-01-22",{"date":132,"type":33},"2026-01-23",{"date":134,"type":33},"2023-04-28",{"date":136,"type":20},"2027-01-31",{"name":62,"class":63},{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":64},"100475057","phase-2-efineptakin-alfa-and-pembrolizumab-for-the-treatment-of-recurrent-glioblastoma-100475057","NCT05465954","Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma","Efficacy and Safety Study of Neoadjuvant Efineptakin Alfa (NT-I7) and Pembrolizumab in Recurrent Glioblastoma","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Disease characteristics:\n\n  * Tissue-confirmed progressive or recurrent World Health Organization (WHO) Grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma)\n  * Previously treated with maximum feasible resection or biopsy, radiation, and temozolomide\n* Have an enhancing mass on magnetic resonance imaging (MRI) amenable to resection or biopsy of the tumor (as determined by the neurosurgeon pre-operatively) and histological diagnosis of glioblastoma from a prior biopsy or surgery\n* Willing to undergo clinically indicated biopsy and\u002For resection of their glioblastoma at Mayo Clinic in Rochester, Minnesota (MN).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 and Karnofsky Performance Scale (KPS) \\>= 70 NOTE: PS must be assessed (again) within 7 days prior to first dose of study drug\n* Hemoglobin \\>= 9.0 g\u002FdL (obtained =\\\u003C 15 days prior to registration) (without transfusion or erythropoietin \\[EPO\\] dependency =\\\u003C 7 days prior to assessment)\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* Platelet count \\>= 100,000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* Creatinine =\\\u003C 1.5 x upper limits of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be \\>= 45 ml\u002Fmin (obtained =\\\u003C 15 days prior to registration)\n* Total bilirubin =\\\u003C1.5 x ULN OR direct bilirubin =\\\u003C ULN for patients with total bilirubin levels \\>1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* Aspartate transaminase (AST) AND alanine transaminase (ALT) =\\\u003C 2.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN OR if patient is receiving anticoagulant therapy then INR or aPTT is within target range of therapy (obtained =\\\u003C 15 days prior to registration)\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only (POCBP) Note: If testing done for eligibility is \\> 72 hours prior to first dose, then pregnancy testing must be repeated, and result must be negative for patient to receive treatment.\n* POCBP or able to father a child must be willing to use adequate contraception starting with first dose through 180 days after last dose\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).\n* Willing to provide tissue and blood samples for correlative research purposes\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent for which genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait).\n* Prior treatment\n\n  * Received bevacizumab (AVASTIN) =\\\u003C 4 months prior to registration\n\n    * Note: Bevacizumab is allowed for symptom control during the adjuvant phase of the study\n  * Received a live vaccine =\\\u003C 30 days prior to registration.\n  * Requirement for dexamethasone dose of \\> 2mg\u002Fday =\\\u003C 2 days prior to registration\n* Failure to recover from any adverse events related to any of the following therapies received prior to registration:\n\n  * Major surgery =\\\u003C 28 days prior to registration\n  * Radiation therapy =\\\u003C 14 days prior to registration\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Known history of human immunodeficiency virus (HIV) infection\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations (e.g., drug addiction) that would limit compliance with study requirements\n* Receiving any other investigational agent\n* Other active malignancy requiring systemic treatment =\\\u003C 1 year prior to registration\n* History of myocardial infarction =\\\u003C 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) =\\\u003C 2 years prior to registration NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Concurrent known active Hepatitis B (i.e., known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] reactive) AND known active Hepatitis C (i.e., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] detected by polymerase chain reaction \\[PCR\\])\n\n  * Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority\n  * NOTE: Patients with known Hepatitis B OR Hepatitis C may be enrolled if they meet the following criteria:\n\n    * Hepatitis B: Patients who are HBsAG positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on anti-viral therapy throughout the treatment phase of the trial and should follow local guidelines for HBV anti-viral therapy after completing study treatment\n    * Hepatitis C: Patients with history of Hepatitis C infection are eligible if HCV viral load is undetectable at screening. Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration\n* Known history of active TB (Bacillus Tuberculosis)\n* History of (non-infectious) pneumonitis or interstitial lung disease that required steroids, or current pneumonitis or interstitial lung disease\n* Hypersensitivity to pembrolizumab or any of its excipients\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent within \\\u003C 12 months prior to registration\n\n  * NOTE: If such therapy was given ≥ 12 months prior to registration, patient is eligible\n* History of allogenic tissue\u002Fsolid organ transplant",{"count":146,"type":20},54,[50],"This phase II trial tests the safety and side effects of efineptakin alfa and pembrolizumab in treating patients with glioblastoma that has come back (recurrent). Efineptakin alfa is an immunotherapy drug that works by helping the immune system fight tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving efineptakin alfa and pembrolizumab may kill more tumor cells in patients with recurrent glioblastoma.",[150,26,27],"High Grade Astrocytic Tumor","2026-01-09",{"date":153,"type":33},"2026-01-12",{"date":155,"type":33},"2023-01-24",{"date":157,"type":20},"2028-10-15",{"name":92,"class":63}]