[{"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:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":19,"type":20},102,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Relapsed Diffuse Large B-cell Lymphoma","Refractory Diffuse Large B-cell Lymphoma",[29,30,31,32,33,34],"Immunotherapy","T cell activation","DLBCL","Anti-PD-1","CAR-T ineligible","ASCT ineligible","RECRUITING","2023-04-05",{"date":38,"type":39},"2023-04-07","ACTUAL",{"date":41,"type":39},"2021-06-18",{"date":43,"type":20},"2025-04",{"name":45,"class":46},"ImmunoVaccine Technologies, Inc. (IMV Inc.)","INDUSTRY",50,""]