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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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.

Exclusion Criteria

  • 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1: DPX-Survivac, pembrolizumab, CPA 		Subjects will receive two 0.5 mL doses of DPX-Survivac three weeks apart followed by up to twelve 0.1 mL doses eight weeks apart. Pembrolizumab will be administered on the first day of every three week cycle at a flat dose of 200 mg. CPA will be self-administered 50 mg BID for 7 days on and 7 days off starting on D0.
  • Drug: DPX-Survivac
    SC injection on D7 and D28, then every 8 weeks
    Other names:
    • maveropepimut-S
  • Drug: Pembrolizumab
    IV infusion every 3 weeks
    Other names:
    • MK-3475
    • Keytruda
  • Drug: CPA
    50 mg twice daily, week on then week off
    Other names:
    • Intermittent, low-dose cyclophosphamide
    • Procytox
    • Cytoxan
Experimental
Arm 2: DPX-Survivac, pembrolizumab 		Subjects will receive two 0.5 mL doses of DPX-Survivac three weeks apart followed by up to twelve 0.1 mL doses eight weeks apart. Pembrolizumab will be administered on the first day of every three week cycle at a flat dose of 200 mg. Subjects randomized to Arm 2 will not receive CPA.
  • Drug: DPX-Survivac
    SC injection on D7 and D28, then every 8 weeks
    Other names:
    • maveropepimut-S
  • Drug: Pembrolizumab
    IV infusion every 3 weeks
    Other names:
    • MK-3475
    • Keytruda

Recruiting Locations

Tulane Cancer Center Office of Clinical Research
New Orleans, Louisiana 70112
Contact:
Leta Ko
504-988-6120
lko@tulane.edu

More Details

Status
Recruiting
Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)

Study Contact

Detailed 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. The study will enroll up to 102 subjects. Eligible subjects will be randomized (1:1) to receive: - Arm 1: DPX-Survivac, pembrolizumab and intermittent, low-dose CPA; or, - Arm 2: DPX-Survivac and pembrolizumab All subjects will receive two 0.5 mL doses of DPX-Survivac 3 weeks apart on day 7 (D7) and D28 followed by up to twelve 0.1 mL doses of DPX-Survivac, 8 weeks apart (Q8W). All subjects will receive pembrolizumab intravenously (IV) at a flat dose of 200 mg starting at D7 and on day 1 of each 3-week cycle thereafter (i.e., D28, D49, D70 etc.) (Q3W). For subjects randomized to Arm 1, intermittent oral CPA at a dose of 50 mg twice a day (BID) is administered from D0 to D6 (7 days) followed by 7 days off. This 14-day cycle of "7 days on and 7 days off" will be repeated until the end of study treatment.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.