Tests two immune treatments for relapsed or refractory large B-cell lymphoma
Tests DPX-Survivac and pembrolizumab, with or without low-dose cyclophosphamide, in adults with lymphoma.
Plain-language title generated from the registry record
Registry title: DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Key facts
- Where
- Saskatoon, CanadaSee the site
- Phase
- Phase 2
Where in Canada
- Saskatoon Cancer CenterSaskatoon, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ImmunoVaccine Technologies, Inc. (IMV Inc.)
- Trial code
- NCT04920617
- Record updated
- 7 April 2023
- Original description
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.Read full original descriptionShow less
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/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)
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.
Inclusion: Adults ≥ 18 years of age who are willing and able to provide written informed consent; Have an ECOG performance status of ≤ 1. Subjects with an ECOG performance status of 2 may be enrolled with Medical Monitor approval; 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/or 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; 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); Subjects must have failed or be ineligible for ASCT or CAR-T; Have at least one bi-dimensionally measurable lesion per Lugano (2014); Willing to provide pre-treatment and on-treatment tumor biopsy tissue; Meet protocol-specified laboratory requirements; Life expectancy > 3 months.
Exclusion: Chemotherapy, immunotherapy, major surgery, or investigational agent treatment within 28 days of D0 or 5 half-lives, whichever is shorter; Radiotherapy within 14 days of day 0; Autologous stem cell transplant (ASCT) within ˂100 days prior to D0; Chimeric antigen receptor T cell (CAR-T) therapy within ˂28 days prior to D0; Diagnosis of immunodeficiency disorder or history of active autoimmune disease that has required systemic treatment in the past 2 years; Uncontrolled significant active infections (controlled Hepatitis B, Hepatitis C, or HIV may be eligible); 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; Primary CNS lymphoma or active secondary CNS involvement and/or lymphomatous meningitis.