Trial results for a Phase 2 study (NCT03349450) investigating pembrolizumab in combination with DPX-Survivac and low-dose cyclophosphamide for recurrent diffuse large B-cell lymphoma (DLBCL) were posted on ClinicalTrials.gov on 2026-05-06. The study reported a median duration of response of 8.05 months in participants.
Background
The study investigated the combination of DPX-Survivac, low-dose cyclophosphamide, and the checkpoint inhibitor pembrolizumab in adult participants with recurrent or refractory diffuse large B-cell lymphoma (DLBCL).
Trial design
The Phase 2 study (NCT03349450) was a non-randomized, open-label, uncontrolled efficacy and safety study that enrolled 25 participants. The trial focused on individuals with recurrent or refractory adult diffuse large B-cell lymphoma. Participants received DPX-Survivac, low-dose metronomic oral cyclophosphamide (50 mg BID), and pembrolizumab (200 mg every 3 weeks).
Key results
The trial reported several key outcome measurements:
- For the "Objective Response Rate Using Modified Cheson Criteria to Treatment With DPX-Survivac and Low Dose Cyclophosphamide Administered Together With Pembrolizumab in Participants With Recurrent, Survivin-expressing B Cell Lymphomas" under the "Best Overall Response" group, various observed participant counts were 3, 4, 6, and 12 participants.
- The "Duration of Response Using Modified Cheson Criteria" had a median of 8.05 months (95% Confidence Interval).
- "Time to Next Treatment" for the "Intent-to-treat" group showed a median of 135.5 days (Inter-Quartile Range).
- For "Evidence of Regression Using Waterfall Analyses":
- In the "Best Overall Response in ITT" group, observed participant counts were 12, 7, and 13 participants.
- In the "Best Overall Response in PD-L1+" group, observed participant counts were 3, 6, and 10 participants.
What this means
The results from this Phase 2 uncontrolled study suggest that the combination of pembrolizumab, DPX-Survivac, and low-dose cyclophosphamide may elicit responses in participants with recurrent or refractory DLBCL. The observed median duration of response of 8.05 months indicates a sustained clinical benefit in some patients. These findings provide preliminary data on the activity of this triple combination in a challenging patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03349450, titled "DPX-Survivac and Checkpoint Inhibitor in DLBCL," were posted on 2026-05-06 on clinicaltrials.gov.