DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT04920617 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2023-04-07
Summary
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
Interventions
- DRUG
-
DPX-Survivac
SC injection on D7 and D28, then every 8 weeks
- DRUG
-
IV infusion every 3 weeks
- DRUG
-
CPA
50 mg twice daily, week on then week off
Sponsors & Collaborators
- collaborator INDUSTRY
-
ImmunoVaccine Technologies, Inc. (IMV Inc.)
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-18
- Primary Completion
- 2024-10-31
- Completion
- 2025-04-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- France
- Hungary
- New Zealand
- Poland
- Romania
- Serbia
- Spain
Study Locations
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