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

ConditionsRelapsed Diffuse Large B-cell LymphomaRefractory Diffuse Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunoVaccine Technologies, Inc. (IMV Inc.)

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • DPX-Survivac

    Drug

    SC injection on D7 and D28, then every 8 weeks

  • Pembrolizumab

    Drug

    IV infusion every 3 weeks

  • CPA

    Drug

    50 mg twice daily, week on then week off

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Arm 1: DPX-Survivac, pembrolizumab, CPAExperimental treatment 3 interventions
Group B: Arm 2: DPX-Survivac, pembrolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR) in each of the study arms

Centrally evaluated using Lugano (2014)

Time frame
Approximately 24 months

Secondary outcomes

1

Rate of Adverse Events using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in each of the study arms

Time frame
Approximately 24 months
2

Duration of response (DOR) in each of the study arms

Centrally evaluated using Lugano (2014)

Time frame
Approximately 24 months
3

Time to response in each of the study arms

Centrally evaluated using Lugano (2014)

Time frame
Approximately 24 months
4

Progression-Free Survival in each of the study arms

Centrally evaluated using Lugano (2014)

Time frame
Approximately 48 months

Other outcomes

1

Objective Response Rate (ORR) based on PD-L1 expression

Centrally evaluated using Lugano (2014) and central assessment of PD-L1 using validated 22C3 assay

Time frame
Approximately 24 months
2

Time to next treatment (TTNT) in each of the study arms

Time frame
Approximately 48 months
3

Overall survival (OS) in each of the study arms

Time frame
Approximately 48 months
4

Time to second objective disease progression (PFS2) in each of the study arms

Time frame
Approximately 48 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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