Study on DPX-Survivac and Pembrolizumab, With or Without Low-Dose Cyclophosphamide, for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04920617

Provider View

This clinical trial is testing the safety and effectiveness of a combination of treatments, including DPX-Survivac and pembrolizumab, with or without low-dose cyclophosphamide, in patients with Diffuse Large B-Cell Lymphoma (DLBCL) that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to evaluate if the combination of DPX-Survivac and pembrolizumab, with or without low-dose cyclophosphamide, can help treat patients with Diffuse Large B-Cell Lymphoma (DLBCL) that has come back or not responded to other treatments. Up to 102 participants will be randomly assigned to one of two groups: one receiving DPX-Survivac, pembrolizumab, and low-dose cyclophosphamide, and the other receiving only DPX-Survivac and pembrolizumab.

Description

This study involves two groups of participants. One group will receive a combination of DPX-Survivac, pembrolizumab, and low-dose cyclophosphamide, while the other group will receive only DPX-Survivac and pembrolizumab.

Participants will receive two initial doses of DPX-Survivac three weeks apart, followed by smaller doses every eight weeks. Pembrolizumab will be given through an IV every three weeks, starting one week after the first DPX-Survivac dose.

For those in the first group, cyclophosphamide will be taken orally twice a day for seven days, followed by a seven-day break, and this cycle will continue throughout the study. The study will help determine if these treatments are safe and effective for patients with relapsed or refractory DLBCL.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older who can provide written consent.
  • Have a performance status score of 1 or less, or 2 with approval.
  • Diagnosed with specific types of DLBCL, including those with certain genetic changes or virus associations.
  • Have tried at least two previous treatments, including anthracycline and rituximab.
  • Not eligible for or have not succeeded with stem cell transplant or CAR-T therapy.
  • Have at least one measurable tumor.
  • Willing to provide tumor samples before and during treatment.
  • Meet specific lab test requirements.
  • Have a life expectancy of more than 3 months.

Exclusion Criteria

  • Have primary or active secondary CNS lymphoma or lymphomatous meningitis.
  • Have had recent chemotherapy, immunotherapy, major surgery, or experimental treatments.
  • Have had recent radiotherapy.
  • Have had a stem cell transplant within the last 100 days.
  • Have had CAR-T therapy within the last 28 days.
  • Have an immune deficiency or active autoimmune disease needing treatment in the last 2 years.
  • Have uncontrolled active infections (controlled Hepatitis B, C, or HIV may be allowed).
  • Have had another cancer unless free of it for at least 2 years.

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