[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ImmunoVaccine Technologies, Inc. (IMV Inc.)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100433168","phase-2-dpx-survivac-and-pembrolizumab-with-and-without-intermittent-low-dose-cyclophosphamide-in-subjects-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100433168",false,"NCT04920617","DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma (VITALIZE)","VITALIZE","Key Inclusion Criteria:\n\n* Adults ≥ 18 years of age who are willing and able to provide written informed consent\n* Have an ECOG performance status of ≤ 1. Subjects with an ECOG performance status of 2 may be enrolled with Medical Monitor approval.\n* Pathologically confirmed diagnosis of DLBCL, as defined by the 2016 World Health Organization classification including DLBCL NOS high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, Epstein-barr virus (EBV) positive DLBCL, and T cell rich B cell lymphoma (TCRBCL). Subjects with DLBCL transformed from indolent lymphoma (except for Richter's transformation) are eligible.\n* Subjects must have progressive disease following at least two (2) lines of prior systemic therapy for DLBCL; prior treatment must have included an anthracycline and rituximab (or another CD20-targeted agent).\n* Subjects must have failed or be ineligible for ASCT or CAR-T\n* Have at least one bi-dimensionally measurable lesion per Lugano (2014)\n* Willing to provide pre-treatment and on-treatment tumor biopsy tissue.\n* Meet protocol-specified laboratory requirements\n* Life expectancy \\> 3 months.\n\nKey Exclusion Criteria:\n\n* Primary CNS lymphoma or active secondary CNS involvement and\u002For lymphomatous meningitis\n* Chemotherapy, immunotherapy, major surgery, or investigational agent treatment within 28 days of D0 or 5 half-lives, whichever is shorter\n* Radiotherapy within 14 days of day 0\n* Autologous stem cell transplant (ASCT) within ˂100 days prior to D0\n* Chimeric antigen receptor T cell (CAR-T) therapy within ˂28 days prior to D0\n* Diagnosis of immunodeficiency disorder or history of active autoimmune disease that has required systemic treatment in the past 2 years\n* Uncontrolled significant active infections (controlled Hepatitis B, Hepatitis C, or HIV may be eligible)\n* Prior history of malignancy other than eligible lymphoma sub-types, unless the subject has been free of the disease for ≥ 2 years prior to the start of study treatment","ALL","18 Years",{"count":20,"type":21},102,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.",[27,28],"Relapsed Diffuse Large B-cell Lymphoma","Refractory Diffuse Large B-cell Lymphoma",[30,31,32,33,34,35],"Immunotherapy","T cell activation","DLBCL","Anti-PD-1","CAR-T ineligible","ASCT ineligible","RECRUITING","2023-04-05",{"date":39,"type":40},"2023-04-07","ACTUAL",{"date":42,"type":40},"2021-06-18",{"date":44,"type":21},"2025-04",{"name":46,"class":47},"ImmunoVaccine Technologies, Inc. (IMV Inc.)","INDUSTRY",50,""]