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

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac alone or in combination with pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Cyclophosphamide; Pembrolizumab

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.

• 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; 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.

Key Exclusion Criteria:

• Primary CNS lymphoma or active secondary CNS involvement and/or lymphomatous meningitis

• Primary refractory disease, defined as: documented persistent disease at the completion of first-line therapy, or progressive disease within 3 months of completion of treatment

• 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) or chimeric antigen receptor T cell (CAR-T) therapy within 100 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