Vitalize Trial: A Phase 2b, Open-Label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of the Novel Immunotherapeutic, Maveropepimut-S, and Pembrolizumab with and without Intermittent Low-Dose Cyclophosphamide, in Subjects with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Bibliographic record
Abstract
Background Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in adults, and up to 40% of patients are refractory to front-line therapy or experience a relapse. In the relapsed/refractory (r/r) setting, novel treatment options are available, but many patients relapse following or are ineligible for such treatment options, due in part to their safety profiles. Thus, more effective, better tolerated therapeutic options are needed. Maveropepimut-S (MVP-S) leverages the DPX platform, a non-aqueous, lipid-based delivery system, to educate a specific, and persistent T cell-based immune response to HLA-restricted peptides of survivin, a cancer-associated protein commonly upregulated in advanced DLBCL. In a prior study in patients with r/r DLBCL (SPiReL), MVP-S with pembrolizumab and low dose, intermittent cyclophosphamide (CPA) led to durable complete and partial responses, and persistent, survivin-specific T cells, particularly in patients with PD-L1+ disease. Importantly, treatment was well-tolerated. Further exploration of the regimen in r/r DLBCL is warranted to confirm and extend these encouraging results. Methods The VITALIZE trial (NCT04920617) is a phase 2b, open-label, randomized trial of MVP-S and pembrolizumab, with or without intermittent low-dose CPA. Eligible patients have r/r persistent or progressive DLBCL following ≥ 2 lines of prior systemic therapy and are ineligible for, or have relapsed after, ASCT and/or CAR-T. Using a Simon's two-stage design, patients are randomized (1:1) to: Arm 1: MVP-S, pembrolizumab and CPA or Arm 2: MVP-S and pembrolizumab and will be treated for up to 2 years. The primary objective of the study is centrally assessed ORR, and secondary endpoints include PFS, DoR, DCR, OS and safety. Exploratory objectives include characterization of outcomes based on PD-L1 expression, and survivin-specific immunogenicity in baseline and on-treatment blood and tissue samples. This study will enroll up to 102 eligible patients at 65 global study sites. As of now, 21 sites are actively recruiting in US, Canada, Australia, New-Zealand, and France. Enrollment has begun. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.008 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".