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Study of DPX-Survivac and Pembrolizumab for Relapsed/Refractory DLBCL

This study is testing two different combinations of treatments for people with diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or hasn't responded to previous treatments (refractory). You would receive DPX-Survivac (an injection) and pembrolizumab (an IV infusion). Some participants will also receive low-dose cyclophosphamide (CPA), a pill taken intermittently. The study aims to see how well these combinations work and if they are safe. We expect to enroll up to 102 adults aged 18 or older. The main goal is to measure how many participants respond to the treatment over approximately 24 months.

Study design
This is a Phase 2b, randomized, open-label study enrolling up to 102 participants. Participants will be randomly assigned to one of two treatment groups.
What's involved
You would receive DPX-Survivac injections on specific days, pembrolizumab infusions every three weeks, and potentially daily CPA pills for one week on, one week off.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study will be measured at approximately 24 months.

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NCT04920617

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
ImmunoVaccine Technologies, Inc. (IMV Inc.)
~102 participants
Updated 2023-04-07 on ClinicalTrials.gov
What's tested:DPX-SurvivacPembrolizumabCPA

At a glance

Recruiting sites
43 of 50 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR) in each of the study arms
Measured over Approximately 24 months

Conditions

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

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Diffuse Large B-Cell Lymphoma

NCT04920617

Where you'd take part

This study runs at 50 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Allegheny Health Network (AHN) West Penn Hospital

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

  • Blood and Marrow Transplant Group of Georgia

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Box Hill Hospital

    Melbourne, Victoria, Australiastudy coordinator listed

    Recruiting

  • Brody School of Medicine at East Carolina University

    Greenville, North Carolinastudy coordinator listed

    Recruiting

  • Bucharest Oncology Institute "Prof.Dr.Al. Trestioreanu"

    Bucharest, Romaniastudy coordinator listed

    Recruiting

  • Centre Antoine Lacassagne

    Nice, Francestudy coordinator listed

    Recruiting

  • Centre d'Oncologie de Gentilly

    Nancy, Francestudy coordinator listed

    Recruiting

  • Centre Hospitalier de Périgueux

    Périgueux, Francestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Eric Lee, MD
[email protected]
714-698-0300
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Objective response rate (ORR) in each of the study armsApproximately 24 months

    Centrally evaluated using Lugano (2014)