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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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 provide pre-treatment and on-treatment tumor biopsy tissue.
• Meet protocol-specified laboratory requirements
• Life expectancy > 3 months.

🚫 You may not be able to join if…

• Primary CNS lymphoma or active secondary CNS involvement and/or lymphomatous meningitis
• Chemotherapy, immunotherapy, major surgery, or investigational agent treatment within 28 days of D0 or 5 half-lives, whichever is shorter
• Radiotherapy within 14 days of day 0
• Autologous stem cell transplant (ASCT) within ˂100 days prior to D0
• Chimeric antigen receptor T cell (CAR-T) therapy within ˂28 days prior to D0
• Diagnosis of immunodeficiency disorder or history of active autoimmune disease that has required systemic treatment in the past 2 years
• Uncontrolled significant active infections (controlled Hepatitis B, Hepatitis C, or HIV may be eligible)
• Prior history of malignancy other than eligible lymphoma sub-types, unless the subject has been free of the disease for ≥ 2 years prior to the start of study treatment

Where this trial is running

• Compassionate Cancer Care Medical Group, Fountain Valley, California, United States
• Boca Raton Regional Hospital, Boca Raton, Florida, United States
• BRCR Medical Center Inc., Hollywood, Florida, United States
• BRCR Medical Center Inc., Plantation, Florida, United States
• Comprehensive Hematology and Oncology, St. Petersburg, Florida, United States
• Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
• Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
• Tulane Cancer Center Office of Clinical Research, New Orleans, Louisiana, United States
• Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha, Nebraska, United States
• Christus St. Vincent Regional Cancer Center, Santa Fe, New Mexico, United States
• Brody School of Medicine at East Carolina University, Greenville, North Carolina, United States
• Gabrail Cancer Center Research, Canton, Ohio, United States

+ 38 more sites.