drugset / Trial / NCT03349450
DPX-Survivac and Checkpoint Inhibitor in DLBCL
Phase 2
Completed
25 enrolled
Sunnybrook Health Sciences Centre
ImmunoVaccine Technologies, Inc. (IMV Inc.) · collabMerck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 2 non-randomized, open label, uncontrolled, efficacy and safety study. Study participants will receive two priming doses of 0.5mL of DPX-Survivac 21 days apart and up to six 0.1ml maintenance injections every two months with low dose metronomic oral cyclophosphamide (50 mg BID) for one year or until disease progression, whichever occurs first. Pembrolizumab 200 mg will be administered every 3 weeks for up to one year or until disease progression, whichever occurs first.
Timeline
- Start
- 2018-03-13
- Primary completion
- 2021-10-31
- Completion
- 2023-07-18
Publications
- Results Amitai I, Roos K, Rashedi I, Jiang Y, Mangoff K, Klein G, Forward N, Stewart D, Laneuville P, Bence-Bruckler I, Mangel J, Tomlinson G, Berinstein NL. PD-L1 expression predicts efficacy in the phase II SPiReL trial with MVP-S, pembrolizumab, and low-dose CPA in R/R DLBCL. Eur J Haematol. 2023 Aug;111(2):191-200. doi: 10.1111/ejh.13982. Epub 2023 May 8.
- Pandey A, Roos K, Jiang Y, Mangoff K, Klein G, Forward N, Stewart D, Laneuville P, Bence-Bruckler I, Mangel J, Tomlinson G, Berinstein NL. Characteristics of relapsed/refractory diffuse large B-cell lymphoma patients with durable responses to maveropepimut-S, pembrolizumab, and cyclophosphamide: Long-term follow-up from the SPiReL trial. EJHaem. 2024 Dec 12;6(1):e1062. doi: 10.1002/jha2.1062. eCollection 2025 Feb.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 50 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | maveropepimut-S | Vaccine | 0.1 ml | Subcutaneous |