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

Description

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.

Conditions

Relapsed Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma

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Study Overview

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Study Details

Study overview

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.

A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)

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

Condition
Relapsed Diffuse Large B-cell Lymphoma
Intervention / Treatment

-

Contacts and Locations

Fountain Valley

Compassionate Cancer Care Medical Group, Fountain Valley, California, United States, 92708

Boca Raton

Boca Raton Regional Hospital, Boca Raton, Florida, United States, 33486

Hollywood

BRCR Medical Center Inc., Hollywood, Florida, United States, 33021

Plantation

BRCR Medical Center Inc., Plantation, Florida, United States, 33322

Saint Petersburg

Comprehensive Hematology and Oncology, Saint Petersburg, Florida, United States, 33709

Atlanta

Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States, 30342

Indianapolis

Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States, 46202

New Orleans

Tulane Cancer Center Office of Clinical Research, New Orleans, Louisiana, United States, 70112

Omaha

Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha, Nebraska, United States, 68130

Santa Fe

Christus St. Vincent Regional Cancer Center, Santa Fe, New Mexico, United States, 87505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ImmunoVaccine Technologies, Inc. (IMV Inc.),

Study Record Dates

2025-04