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.
Key facts
- Who runs it
- ImmunoVaccine Technologies, Inc. (IMV Inc.)
- Where
- Belgrade, Kamenitz, Kragujevac, and Zemun, SerbiaSee the 4 sitesAlso in 9 other countries, 46 sites
- Trial code
- Registry title
- DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 102 people, planned
- Started
- 18 Jun 2021
- Planned end
- Apr 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- DPX-Survivac
- Pembrolizumab
- CPA
- Record updated
- 7 April 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with diffuse large B-cell lymphoma (DLBCL) that came back or did not respond after at least two earlier treatments.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- DLBCL confirmed by tissue testing, with disease that got worse after at least 2 lines of earlier treatment. It must be measurable on scans.
- Earlier treatment
- Must have had at least 2 lines of earlier treatment, including an anthracycline and rituximab (or another CD20-targeted drug). Must have failed or be unable to have a stem cell transplant (ASCT) or CAR-T therapy.
Main reasons for not taking part
- Lymphoma in the brain or spinal fluid (central nervous system)
- Recent chemotherapy, immunotherapy, major surgery or other trial drug within 28 days
- Autoimmune disease needing treatment in the past 2 years, or an immune deficiency
- Uncontrolled serious infection
- Other cancer in the past 2 years (apart from the allowed lymphoma types)
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Serbia
Also in 9 other countries, 46 sites
- University Clinical Center of SerbiaBelgrade, SerbiaContact: Darko Antic, MDTaking people
- Oncology Institute of VojvodinaKamenitz, SerbiaContact: Dijana ZekicTaking people
- University Clinical Center KragujevacKragujevac, SerbiaContact: Ana DragovicTaking people
- Clinical Hospital Center ZemunZemun, SerbiaContact: Tamara BibicTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Arm 1: DPX-Survivac, pembrolizumab, CPATreatment being tested
Subjects will receive two 0.5 mL doses of DPX-Survivac three weeks apart followed by up to twelve 0.1 mL doses eight weeks apart. Pembrolizumab will be administered on the first day of every three week cycle at a flat dose of 200 mg. CPA will be self-administered 50 mg BID for 7 days on and 7 days off starting on D0.
Treatment: DPX-Survivac, Pembrolizumab, and CPA
- Arm 2: DPX-Survivac, pembrolizumabTreatment being tested
Subjects will receive two 0.5 mL doses of DPX-Survivac three weeks apart followed by up to twelve 0.1 mL doses eight weeks apart. Pembrolizumab will be administered on the first day of every three week cycle at a flat dose of 200 mg. Subjects randomized to Arm 2 will not receive CPA.
Treatment: DPX-Survivac and Pembrolizumab
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Plain-language title
- Tests two immune treatments for relapsed or refractory large B-cell lymphomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 7 April 2023