RECRUITING

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

Conditions

Relapsed Diffuse Large B-cell Lymphoma Refractory Diffuse Large B-cell Lymphoma Immunotherapy T cell activation DLBCL Anti-PD-1 CAR-T ineligible ASCT ineligible

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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)

Quick Facts

Study Start:2021-06-18

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04920617

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Locations (Sites)

Compassionate Cancer Care Medical Group

Fountain Valley, California, 92708

United States

Boca Raton Regional Hospital

Boca Raton, Florida, 33486

United States

BRCR Medical Center Inc.

Hollywood, Florida, 33021

United States

BRCR Medical Center Inc.

Plantation, Florida, 33322

United States

Comprehensive Hematology and Oncology

Saint Petersburg, Florida, 33709

United States

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, 30342

United States

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

United States

Tulane Cancer Center Office of Clinical Research

New Orleans, Louisiana, 70112

United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130

United States

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, 87505

United States

Brody School of Medicine at East Carolina University

Greenville, North Carolina, 27834

United States

Gabrail Cancer Center Research

Canton, Ohio, 44718

United States

University of Toledo Medical Center

Toledo, Ohio, 43614

United States

Toledo Clinic Cancer Center

Toledo, Ohio, 43623

United States

Allegheny Health Network (AHN) West Penn Hospital

Pittsburgh, Pennsylvania, 15224

United States

Reading Hospital - McGlinn Cancer Institute

West Reading, Pennsylvania, 19611

United States

Prairie Lakes Health Care System

Watertown, South Dakota, 57201

United States

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-18

Study Completion Date2025-04

Study Record Updates

Study Start Date2021-06-18

Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

Immunotherapy
T cell activation
DLBCL
Anti-PD-1
CAR-T ineligible
ASCT ineligible

Additional Relevant MeSH Terms

Relapsed Diffuse Large B-cell Lymphoma
Refractory Diffuse Large B-cell Lymphoma