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RecruitingLast updated: 15 August 2023

VITALIZE: This phase II trial is evaluating how safe and effective a combination of immunotherapy treatments (DPX-Survivac and Pembrolizumab) is both with and without chemotherapy (cyclophosphamide) is in people with relapsed or refractory Diffuse Large B-Cell LymphomaA 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)

Clinical summary

Summary

This is a randomised, open-label trial with two experimental arms. In Experimental Arm 1, participants will receive DPX-Survivac, pembrolizumab and intermittent, low-dose cyclophosphamide (CPA). In Experimental Arm 2, participants will receive DPX-Survivac and pembrolizumab. All participants will receive two 0.5mL 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 participants will also 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 those participants in 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.

Conditions

This trial is treating patients with Diffuse Large B-Cell Lymphoma.

Cancer

Blood Cancers Blood

Age

People18+

Phase

II

Trial Acronym

VITALIZE

More information

Trial Identifiers

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Commercial Sponsor

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Scientific Title

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)

Eligibility

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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