Phase 2b Study of DPX-Survivac and Pembrolizumab with or without Low-Dose Cyclophosphamide in Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of DPX-Survivac combined with pembrolizumab, with and without low-dose cyclophosphamide CPA, in adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL. This Phase 2b, randomized, open-label study aims to better understand how these treatments work in this group of patients who have had previous therapies. The study is sponsored by ImmunoVaccine Technologies, Inc. IMV Inc.. Participants will be randomly assigned to one of two groups one group receives DPX-Survivac, pembrolizumab, and intermittent low-dose CPA, while the other group receives DPX-Survivac and pembrolizumab without CPA. DPX-Survivac is given as two 0.5 mL doses three weeks apart on days 7 and 28, followed by up to twelve 0.1 mL doses every eight weeks. Pembrolizumab is administered intravenously at 200 mg on day 7 and then every three weeks. In the CPA group, subjects take 50 mg of oral CPA twice daily for 7 days followed by 7 days off, repeating this cycle throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response and safety for about 24 months, with some measures extending up to 48 months. Researchers will evaluate objective response rates, adverse events, duration and time to response, progression-free survival, and disease control rates. Patient-reported outcomes will be collected using specific questionnaires. The study involves regular visits for treatment administration, tumor biopsies, and laboratory tests to track the participants health and treatment effects over time.

DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma