DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
This study tests a new cancer vaccine called DPX-Survivac combined with the immunotherapy drug pembrolizumab, with or without a low-dose chemotherapy drug called cyclophosphamide, in patients whose diffuse large B-cell lymphoma (a type of blood cancer) has come back or stopped responding to previous treatment. Researchers want to see if this combination helps control the cancer and how safe it is.
Key Objective: This trial is testing whether combining a personalized cancer vaccine with immunotherapy can help treat lymphomas that have stopped responding to standard treatments.
Who to Consider: Patients with relapsed or refractory diffuse large B-cell lymphoma who have limited treatment options should consider enrolling.
Trial Parameters
Brief Summary
This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.
Eligibility 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