Home › Trials › NCT04920617

Combination of DPX-Survivac and Pembrolizumab for Relapsed 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/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)

PHASE2 · ImmunoVaccine Technologies, Inc. (IMV Inc.) · NCT04920617

This study is testing a new combination treatment of DPX-Survivac and pembrolizumab, with or without a low-dose chemotherapy drug, to see if it helps people with relapsed lymphoma feel better.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment102 (estimated)
Ages18 Years and up
SexAll
SponsorImmunoVaccine Technologies, Inc. (IMV Inc.) (industry)
Drugs / interventionsrituximab, CAR-T, Chimeric antigen receptor, Chemotherapy, immunotherapy, pembrolizumab, cyclophosphamide
Locations50 sites (Fountain Valley, California and 49 other locations)
Trial IDNCT04920617 on ClinicalTrials.gov

What this trial studies

This Phase 2b clinical trial evaluates the safety and efficacy of a combination treatment involving DPX-Survivac and pembrolizumab, with and without the addition of low-dose cyclophosphamide, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study will enroll up to 102 participants who will be randomized into two groups: one receiving all three treatments and the other receiving only DPX-Survivac and pembrolizumab. Participants will receive multiple doses of DPX-Survivac and pembrolizumab over a specified treatment schedule, with the option of intermittent cyclophosphamide for one group. The goal is to assess how well this combination therapy works in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of relapsed or refractory DLBCL who have failed or are ineligible for prior therapies such as ASCT or CAR-T.

Not a fit: Patients who have not been previously treated for DLBCL or those with other types of lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed or refractory DLBCL who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* Primary CNS lymphoma or active secondary CNS involvement and/or lymphomatous meningitis
* 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

Where this trial is running

Fountain Valley, California and 49 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Relapsed Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma, Immunotherapy, T cell activation, DLBCL, Anti-PD-1, CAR-T ineligible, ASCT ineligible

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.